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Treatment options for COVID-19: Dr. Annie Luetkemeyer
Annie Luetkemeyer, MD, professor of infectious diseases at UCSF, is an expert on the treatment of viral infections. Robert Wachter, MD, MHM, chair of the UCSF Department of Medicine, interviewed her about the evidence behind potential treatments for COVID-19 (including chloroquine/hydroxychloroquine, remdesivir, and others), as well as how to assess new and existing drugs in a pandemic.
Annie Luetkemeyer, MD, professor of infectious diseases at UCSF, is an expert on the treatment of viral infections. Robert Wachter, MD, MHM, chair of the UCSF Department of Medicine, interviewed her about the evidence behind potential treatments for COVID-19 (including chloroquine/hydroxychloroquine, remdesivir, and others), as well as how to assess new and existing drugs in a pandemic.
Annie Luetkemeyer, MD, professor of infectious diseases at UCSF, is an expert on the treatment of viral infections. Robert Wachter, MD, MHM, chair of the UCSF Department of Medicine, interviewed her about the evidence behind potential treatments for COVID-19 (including chloroquine/hydroxychloroquine, remdesivir, and others), as well as how to assess new and existing drugs in a pandemic.
FDA to allow alternative respiratory devices to treat COVID-19
“Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.
“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.
FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.
“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”
The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.
The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.
FDA is also allowing for products to be used past their indicated shelf life.
“Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.
“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.
FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.
“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”
The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.
The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.
FDA is also allowing for products to be used past their indicated shelf life.
“Whenever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure, or a device subject to an Emergency Use Authorization (EUA), if any,” FDA stated in a guidance document issued March 22.
“However, to help ensure the availability of the greatest possible number of devices for this purpose, ... FDA does not intend to object to limited modifications to indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification” for the duration of the declared national emergency related to the COVID-19 pandemic.
FDA Commissioner Stephen Hahn, MD, said in a statement that the agency is doing everything it can to support patients, health care professionals, and others during this pandemic.
“One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” he said. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability.”
The document identified examples of where modifications would not create undue risk, including the use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation; the use of ventilators outside of their cleared environment; the use of devices used to treat patients with sleep apnea, such as CPAPs and BiPAPs, to treat respiratory insufficiency when appropriate design mitigations are in place to minimize aerosolization; and the use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.
The agency also is allowing for changes to the hardware, software, and materials to FDA-cleared ventilators and anesthesia gas machines, such as modifications to motors, batteries, or other electrical components; material changes to components in the gas pathways or with other patient tissue contact; the introduction of filtration to minimize aerosolization; and other hardware and software modifications.
FDA is also allowing for products to be used past their indicated shelf life.
FDA issues warning on fecal transplant transmission of SARS-CoV-2
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
and that additional safety procedures may be required.
The risk of SARS-CoV-2 transmission through fecal microbiota transplant is unknown, but “several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals,” the FDA said in the press release. The testing of nasopharyngeal specimens from stool donors may not be available, and the availability and sensitivity of direct testing of stool for SARS-CoV-2 is currently unknown.
Because of the risk of serious adverse events, the FDA has issued several recommendations for any medically necessary usage of fecal microbiota transplantation involving stool samples donated after Dec. 1, 2019.
- Donor screening with questions directed at identifying those currently or recently infected with SARS-CoV-2.
- Testing donors and/or donor stool for SARS-CoV-2, as feasible.
- Development of criteria for exclusion of donors and donor stool based on screening and testing.
- Informed consent that includes information about the potential for transmission of SARS-CoV-2 via fecal microbiota transplantation, including transplantation prepared from stool from donors who are asymptomatic for COVID-19.
“As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted,” the agency said.
COVID-19 critical care guideline offers support for frontline clinicians
The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.
Useful guide nonspecialists
Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).
“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”
“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.
Perhaps the only potentially controversial aspect of the guidelines are a couple of weak recommendations that suggest using a high-flow nasal cannula (HFNC) rather than noninvasive positive pressure ventilation (NIPPV) in patients with acute hypoxemic respiratory failure who have not fully responded to conventional oxygen therapy. “This is controversial, and some of my colleagues are debating this,” said Dr. Narasimhan, but she noted that her clinic has decided to follow the recommended preference for HFNC, which seemed to have modest advantages over NIPPV in a recent meta-analysis (Intensive Care Med. 2019 May;45[5]:563-72).
Another issue with NIPPV is the higher risk for viral dispersion it seems to have, compared with a HFNC, said Dr. Ferraro. If a patient’s mask comes off during NIPPV, it creates a substantial risk for aerosolization of virus. That risk is likely lower with HFNC, especially a HFNC system that uses a small cannula without heating or humidification of the gas flow. “I’d recommend against NIPPV,” Dr. Ferraro said.
He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”
One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.
“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.
Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.
The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.
Useful guide nonspecialists
Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).
“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”
“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.
Perhaps the only potentially controversial aspect of the guidelines are a couple of weak recommendations that suggest using a high-flow nasal cannula (HFNC) rather than noninvasive positive pressure ventilation (NIPPV) in patients with acute hypoxemic respiratory failure who have not fully responded to conventional oxygen therapy. “This is controversial, and some of my colleagues are debating this,” said Dr. Narasimhan, but she noted that her clinic has decided to follow the recommended preference for HFNC, which seemed to have modest advantages over NIPPV in a recent meta-analysis (Intensive Care Med. 2019 May;45[5]:563-72).
Another issue with NIPPV is the higher risk for viral dispersion it seems to have, compared with a HFNC, said Dr. Ferraro. If a patient’s mask comes off during NIPPV, it creates a substantial risk for aerosolization of virus. That risk is likely lower with HFNC, especially a HFNC system that uses a small cannula without heating or humidification of the gas flow. “I’d recommend against NIPPV,” Dr. Ferraro said.
He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”
One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.
“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.
Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.
The 49 recommendations and statements it included are geared to “support hospital clinicians managing critically ill adults with COVID-19 in the ICU. The target users of this guideline are frontline clinicians, allied health professionals, and policy makers involved in the care of patients with COVID-19 in the ICU,” said the document, written by a panel of 36 experts organized by the Surviving Sepsis Campaign, a joint program of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine.
The document divides the recommendations into four categories: infection control, which includes 3 “best-practice” statements and 5 “weak” recommendations; hemodynamics with 2 “strong” recommendations and 13 weak ones; ventilation, with 1 best-practice statement, 6 strong recommendations, and 12 weak recommendations; and therapy with 7 weak recommendations. The guidelines also included five management questions considered by the writing panel without arriving at a recommendation because of insufficient evidence.
Useful guide nonspecialists
Some critical care medicine physicians saw the new guidelines as offering no surprises, but providing a very useful resource to guide management, especially for clinicians who may become involved in caring for COVID-19 patients despite having little experience caring for patients with acute respiratory distress syndrome (ARDS).
“For those of us who manage ARDS patients all the time, this is not a lot of new information, but many critically ill COVID-19 patients are now being cared for by physicians who have not cared for these patients before,” commented Mangala Narasimhan, DO, FCCP, a critical care medicine physician at Long Island Jewish Medical Center in New Hyde Park, N.Y. In fact, Dr, Narasimhan and associates took the new guidelines soon after their release and used them to create a one-page summary sheet to give to all their colleagues who are now seeing COVID-19 patients, she said in an interview. “The guidelines are very important for clinicians who are suddenly taking care of a roomful of patients with ARDS.”
“A lot of people want to know this information,” agreed David M. Ferraro, MD, FCCP, a pulmonologist and critical care medicine physician at National Jewish Health in Denver.
Perhaps the only potentially controversial aspect of the guidelines are a couple of weak recommendations that suggest using a high-flow nasal cannula (HFNC) rather than noninvasive positive pressure ventilation (NIPPV) in patients with acute hypoxemic respiratory failure who have not fully responded to conventional oxygen therapy. “This is controversial, and some of my colleagues are debating this,” said Dr. Narasimhan, but she noted that her clinic has decided to follow the recommended preference for HFNC, which seemed to have modest advantages over NIPPV in a recent meta-analysis (Intensive Care Med. 2019 May;45[5]:563-72).
Another issue with NIPPV is the higher risk for viral dispersion it seems to have, compared with a HFNC, said Dr. Ferraro. If a patient’s mask comes off during NIPPV, it creates a substantial risk for aerosolization of virus. That risk is likely lower with HFNC, especially a HFNC system that uses a small cannula without heating or humidification of the gas flow. “I’d recommend against NIPPV,” Dr. Ferraro said.
He also highlighted the value of quickly forgoing continued use of either of these ventilatory approaches in a declining patient and having a low threshold to switch to intubation. “Many clinicians now favor erring on the side of early intubation,” he noted, an approach that the new guidelines endorsed in a best-practice statement: “In adults with COVID-19 receiving NIPPV or HFNC we recommend close monitoring for worsening respiratory status and early intubation in a controlled setting if worsening occurs.”
One aspect of the COVID-19 pandemic that the new guidelines don’t address are some of the challenges being faced from skyrocketing numbers of patients and inadequate supplies and manpower to meet their acute clinical needs. “We need recommendations on how systems should manage when they are overwhelmed,” commented Dr. Ferraro, an omission that he also saw in the COVID-19 management guidance released on March 13, 2020, by the World Health Organization.
“Neither document gets into this in depth, but that wasn’t in their scope,” Dr. Ferraro acknowledged. He said that recommendations on how to deal with scarce resources, inadequate staffing, and the health of clinicians are probably best handled on a state or local level rather than trying to create recommendations that are applicable to the entire U.S. health system.
Dr. Narasimhan and Dr. Ferraro reported that they had no disclosures.
Three COVID-19 rapid diagnostic tests get FDA thumbs-up
The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.
The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.
The company plans to roll out the test by March 30, according to the FDA.
Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.
FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.
The test was developed with funding from the U.S. Department of Defense.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.
Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.
The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”
Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.
“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe
that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.
The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.
The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.
The company plans to roll out the test by March 30, according to the FDA.
Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.
FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.
The test was developed with funding from the U.S. Department of Defense.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.
Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.
The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”
Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.
“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe
that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.
The first authorization, announced by the agency on March 21, was for the Xpert Xpress SARS-CoV-2 test, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
The test, manufactured by Cepheid, has a detection time of 45 minutes and has been designed to operate on any of the company’s more than 23,000 automated GeneXpert Systems worldwide, according to a statement from the company.
The agency said in its EUA approval document the test is for a “qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and/or nasal wash/aspirate specimens collected from patients who are suspected of having COVID-19 infection.” Positive results are indicative of an infection but do not rule out other potential infections, it noted.
The company plans to roll out the test by March 30, according to the FDA.
Cepheid said in a statement that it has almost 5,000 GeneXpert systems in the United States that are capable of point-of-care testing and ready for use in hospitals. “Our automated systems do not require users to have specialty training to perform testing – they are capable of running 24/7, with many systems already doing so today,” Warren Kocmond, the company’s president, said in the statement.
FDA Commissioner Stephen Hahn, MD said in a statement that the authorization marked “an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to the patient in the patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”
On March 23, the agency issued an emergency use authorization to bioMerieux subsidiary BioFire Defense LLC for its BIOFIRE COVID-19 test, which detects SARS-CoV-2 from a nasopharyngeal swab in about 45 minutes.
The test was developed with funding from the U.S. Department of Defense.
“Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status,” the agency said in its approval document. It again noted that positive results did not rule out bacterial infection or coinfection with other viruses.
Also on March 23, the agency issued an EUA to Mesa Biotech for its Accula SARS-CoV-2 test, which gives COVID-19 diagnostic results in 30 minutes.
The test is indicated for “qualitative, visual detection of nucleic acid from the SARS-CoV-2 in throat swab and nasal swab specimens combined, collected from patients suspected of COVID-19 by their health care provider,” according to the FDA approval document. “The SARS-CoV-2 nucleic acid is generally detectable in throat and nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or coinfection with other viruses.”
Mesa Biotech said in a statement that the test is designed for point-of-care use, including at temporary screening facilities, physician office labs, urgent care, and long-term nursing facilities.
“Our test will provide a highly accessible means for health care professionals to access laboratory quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus,” Hong Cai, the CEO and cofounder of Mesa Biotech, said in a statement. “The potential to reduce the growing strain on our nation’s hospitals is tremendous.”
In separate letters to the three companies notifying them of the authorizations, the FDA said the emergency use of the products met the criteria for issuances of authorization because the SARS-CoV-2 can cause a serious or life-threatening disease or condition; it was “reasonable to believe
that [the] product may be effective in diagnosing COVID-19; and there is no “adequate, approved, and available alternative” to the emergency use of the three products.
Reports increasingly suggest anosmia/hyposmia can signal early COVID-19 infection
Unexplained anosmia, hyposmia, and dysgeusia should be added to the list of possible COVID-19 symptoms for screening purposes, and individuals with such symptoms should consider self-isolation, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) has proposed.
However, a World Health Organization expert said during a March 23 daily briefing on the novel coronavirus pandemic that the jury is still out on that.
The AAO-HNS proposal is based on “rapidly accumulating” anecdotal evidence that such symptoms – in the absence of other symptoms suggestive of COVID-19 – have sometimes preceded a COVID-19 diagnosis.
“ ... anosmia, hyposmia, and dysgeusia in the absence of other respiratory disease such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis should alert physicians to the possibility of COVID-19 infection and warrant serious consideration for self-isolation and testing of these individuals,” the AAO-HNS said in a statement on the proposal.
ENT UK, an organization representing Ear, Nose, and Throat surgery and its related specialties in the UK, also is emphasizing the potential importance of these symptoms. In a March 21 letter, ENT UK experts cited “good evidence from South Korea, China and Italy that significant numbers of patients with proven COVID-19 infection have developed anosmia/hyposmia.”
Claire Hopkins, BMBCh, president of the British Rhinological Society and a professor of Rhinology at King’s College London, along with ENT UK president Nirmal Kumar, also noted in the letter that two of every three cases in Germany, and 30% of patients testing positive in South Korea, had anosmia as their first symptom.
“While there is a chance the apparent increase in incidence could merely reflect the attention COVID-19 has attracted in the media, and that such cases may be caused by typical rhinovirus and coronavirus strains, it could potentially be used as a screening tool to help identify otherwise asymptomatic patients, who could then be better instructed on self-isolation,” they wrote.
Maria Van Kerkhove, MD, technical lead of the WHO Medical Emergencies Program, acknowledged the anecdotal evidence during the WHO briefing.
“Yes, we’ve seen quite a few reports ... but this is something that we need to look into to really capture if this is one of the early signs and symptoms of COVID-19,” she said, noting that WHO is working with more than a dozen countries that are systematically collecting data using molecular and serological testing to “capture more robustly” the early signs and symptoms, and is “reaching out to a number of countries and looking at the cases that have already been reported to see if [anosmia] is a common feature.”
“We don’t have the answer to that,” she said, adding that, in addition to the major symptoms – including dry cough, fever, and shortness of breath – that are well known at this point, “there are likely to be many signs and symptoms that people have.”
“A loss of smell or a loss of taste is something that we’re looking into, and we’re looking forward to the results of these early investigations ... so that we have a more evidence-based approach and we can add that to the list.”
Unexplained anosmia, hyposmia, and dysgeusia should be added to the list of possible COVID-19 symptoms for screening purposes, and individuals with such symptoms should consider self-isolation, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) has proposed.
However, a World Health Organization expert said during a March 23 daily briefing on the novel coronavirus pandemic that the jury is still out on that.
The AAO-HNS proposal is based on “rapidly accumulating” anecdotal evidence that such symptoms – in the absence of other symptoms suggestive of COVID-19 – have sometimes preceded a COVID-19 diagnosis.
“ ... anosmia, hyposmia, and dysgeusia in the absence of other respiratory disease such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis should alert physicians to the possibility of COVID-19 infection and warrant serious consideration for self-isolation and testing of these individuals,” the AAO-HNS said in a statement on the proposal.
ENT UK, an organization representing Ear, Nose, and Throat surgery and its related specialties in the UK, also is emphasizing the potential importance of these symptoms. In a March 21 letter, ENT UK experts cited “good evidence from South Korea, China and Italy that significant numbers of patients with proven COVID-19 infection have developed anosmia/hyposmia.”
Claire Hopkins, BMBCh, president of the British Rhinological Society and a professor of Rhinology at King’s College London, along with ENT UK president Nirmal Kumar, also noted in the letter that two of every three cases in Germany, and 30% of patients testing positive in South Korea, had anosmia as their first symptom.
“While there is a chance the apparent increase in incidence could merely reflect the attention COVID-19 has attracted in the media, and that such cases may be caused by typical rhinovirus and coronavirus strains, it could potentially be used as a screening tool to help identify otherwise asymptomatic patients, who could then be better instructed on self-isolation,” they wrote.
Maria Van Kerkhove, MD, technical lead of the WHO Medical Emergencies Program, acknowledged the anecdotal evidence during the WHO briefing.
“Yes, we’ve seen quite a few reports ... but this is something that we need to look into to really capture if this is one of the early signs and symptoms of COVID-19,” she said, noting that WHO is working with more than a dozen countries that are systematically collecting data using molecular and serological testing to “capture more robustly” the early signs and symptoms, and is “reaching out to a number of countries and looking at the cases that have already been reported to see if [anosmia] is a common feature.”
“We don’t have the answer to that,” she said, adding that, in addition to the major symptoms – including dry cough, fever, and shortness of breath – that are well known at this point, “there are likely to be many signs and symptoms that people have.”
“A loss of smell or a loss of taste is something that we’re looking into, and we’re looking forward to the results of these early investigations ... so that we have a more evidence-based approach and we can add that to the list.”
Unexplained anosmia, hyposmia, and dysgeusia should be added to the list of possible COVID-19 symptoms for screening purposes, and individuals with such symptoms should consider self-isolation, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) has proposed.
However, a World Health Organization expert said during a March 23 daily briefing on the novel coronavirus pandemic that the jury is still out on that.
The AAO-HNS proposal is based on “rapidly accumulating” anecdotal evidence that such symptoms – in the absence of other symptoms suggestive of COVID-19 – have sometimes preceded a COVID-19 diagnosis.
“ ... anosmia, hyposmia, and dysgeusia in the absence of other respiratory disease such as allergic rhinitis, acute rhinosinusitis, or chronic rhinosinusitis should alert physicians to the possibility of COVID-19 infection and warrant serious consideration for self-isolation and testing of these individuals,” the AAO-HNS said in a statement on the proposal.
ENT UK, an organization representing Ear, Nose, and Throat surgery and its related specialties in the UK, also is emphasizing the potential importance of these symptoms. In a March 21 letter, ENT UK experts cited “good evidence from South Korea, China and Italy that significant numbers of patients with proven COVID-19 infection have developed anosmia/hyposmia.”
Claire Hopkins, BMBCh, president of the British Rhinological Society and a professor of Rhinology at King’s College London, along with ENT UK president Nirmal Kumar, also noted in the letter that two of every three cases in Germany, and 30% of patients testing positive in South Korea, had anosmia as their first symptom.
“While there is a chance the apparent increase in incidence could merely reflect the attention COVID-19 has attracted in the media, and that such cases may be caused by typical rhinovirus and coronavirus strains, it could potentially be used as a screening tool to help identify otherwise asymptomatic patients, who could then be better instructed on self-isolation,” they wrote.
Maria Van Kerkhove, MD, technical lead of the WHO Medical Emergencies Program, acknowledged the anecdotal evidence during the WHO briefing.
“Yes, we’ve seen quite a few reports ... but this is something that we need to look into to really capture if this is one of the early signs and symptoms of COVID-19,” she said, noting that WHO is working with more than a dozen countries that are systematically collecting data using molecular and serological testing to “capture more robustly” the early signs and symptoms, and is “reaching out to a number of countries and looking at the cases that have already been reported to see if [anosmia] is a common feature.”
“We don’t have the answer to that,” she said, adding that, in addition to the major symptoms – including dry cough, fever, and shortness of breath – that are well known at this point, “there are likely to be many signs and symptoms that people have.”
“A loss of smell or a loss of taste is something that we’re looking into, and we’re looking forward to the results of these early investigations ... so that we have a more evidence-based approach and we can add that to the list.”
High rate of asymptomatic COVID-19 seen in cruise ship passengers
The high rate of asymptomatic COVID-19 infections aboard the cruise ship Diamond Princess “could partially explain the high attack rate among” the passengers and crew, according to the Centers for Disease Control and Prevention.
Testing of the 3,711 passengers and crew aboard the ship – the source of the largest outbreak outside of China during the initial stages of the pandemic – revealed that 19.2% were positive for COVID-19, Leah F. Moriarty, MPH, and associates reported in the Morbidity and Mortality Weekly Report.
At the time of testing, 46.5% (331) of the 712 infected individuals were asymptomatic, and “statistical models of the Diamond Princess outbreak suggest that 17.9% of infected persons never developed symptoms,” wrote Ms. Moriarty of the CDC COVID-19 response team, and associates.
RNA from the SARS-CoV-2 virus was found on surfaces in cabins up to 17 days after they had been vacated by passengers but before the cabins had been disinfected, the investigators noted.
The Diamond Princess departed from Yokohama, Japan, on Jan. 20, 2020, and returned on Feb. 3 after making six stops in three countries. The ship was quarantined upon its return because a symptomatic passenger who had departed Jan. 25 in Hong Kong tested positive for SARS-CoV-2, Ms. Moriarty and associates explained.
Of the 381 people from the ship who were symptomatic and tested positive, 37 (9.7%) needed intensive care and 9 (1.3%) died. There were 428 Americans on the ship, of whom 107 (25.0%) tested positive and 11 remained hospitalized in Japan as of March 13, they said.
“Many other cruise ships have since been implicated in SARS-CoV-2 transmission,” the investigators said, including the Grand Princess, which sailed out of San Francisco with 3,571 people on Feb. 21 and returned to Oakland on March 8.
That ship had been the site of virus transmission during its previous voyage from Feb. 11 to Feb. 21, from which more than 20 cases have been identified. During the latter trip, 21 of 45 passengers and crew tested positive before the ship docked. During the subsequent land-based quarantine, there have been 78 positive tests among the 469 people tested as of March 21, a rate of 16.6%, the research team reported.
“Public health responses to cruise ship outbreaks require extensive resources,” they wrote. “These responses required the coordination of stakeholders across multiple sectors, including U.S. government departments and agencies, foreign ministries of health, foreign embassies, state and local public health departments, hospitals, laboratories, and cruise ship companies.”
SOURCE: Moriarty LF et al. MMWR. 2020 Mar 23;69[early release]:1-6.
The high rate of asymptomatic COVID-19 infections aboard the cruise ship Diamond Princess “could partially explain the high attack rate among” the passengers and crew, according to the Centers for Disease Control and Prevention.
Testing of the 3,711 passengers and crew aboard the ship – the source of the largest outbreak outside of China during the initial stages of the pandemic – revealed that 19.2% were positive for COVID-19, Leah F. Moriarty, MPH, and associates reported in the Morbidity and Mortality Weekly Report.
At the time of testing, 46.5% (331) of the 712 infected individuals were asymptomatic, and “statistical models of the Diamond Princess outbreak suggest that 17.9% of infected persons never developed symptoms,” wrote Ms. Moriarty of the CDC COVID-19 response team, and associates.
RNA from the SARS-CoV-2 virus was found on surfaces in cabins up to 17 days after they had been vacated by passengers but before the cabins had been disinfected, the investigators noted.
The Diamond Princess departed from Yokohama, Japan, on Jan. 20, 2020, and returned on Feb. 3 after making six stops in three countries. The ship was quarantined upon its return because a symptomatic passenger who had departed Jan. 25 in Hong Kong tested positive for SARS-CoV-2, Ms. Moriarty and associates explained.
Of the 381 people from the ship who were symptomatic and tested positive, 37 (9.7%) needed intensive care and 9 (1.3%) died. There were 428 Americans on the ship, of whom 107 (25.0%) tested positive and 11 remained hospitalized in Japan as of March 13, they said.
“Many other cruise ships have since been implicated in SARS-CoV-2 transmission,” the investigators said, including the Grand Princess, which sailed out of San Francisco with 3,571 people on Feb. 21 and returned to Oakland on March 8.
That ship had been the site of virus transmission during its previous voyage from Feb. 11 to Feb. 21, from which more than 20 cases have been identified. During the latter trip, 21 of 45 passengers and crew tested positive before the ship docked. During the subsequent land-based quarantine, there have been 78 positive tests among the 469 people tested as of March 21, a rate of 16.6%, the research team reported.
“Public health responses to cruise ship outbreaks require extensive resources,” they wrote. “These responses required the coordination of stakeholders across multiple sectors, including U.S. government departments and agencies, foreign ministries of health, foreign embassies, state and local public health departments, hospitals, laboratories, and cruise ship companies.”
SOURCE: Moriarty LF et al. MMWR. 2020 Mar 23;69[early release]:1-6.
The high rate of asymptomatic COVID-19 infections aboard the cruise ship Diamond Princess “could partially explain the high attack rate among” the passengers and crew, according to the Centers for Disease Control and Prevention.
Testing of the 3,711 passengers and crew aboard the ship – the source of the largest outbreak outside of China during the initial stages of the pandemic – revealed that 19.2% were positive for COVID-19, Leah F. Moriarty, MPH, and associates reported in the Morbidity and Mortality Weekly Report.
At the time of testing, 46.5% (331) of the 712 infected individuals were asymptomatic, and “statistical models of the Diamond Princess outbreak suggest that 17.9% of infected persons never developed symptoms,” wrote Ms. Moriarty of the CDC COVID-19 response team, and associates.
RNA from the SARS-CoV-2 virus was found on surfaces in cabins up to 17 days after they had been vacated by passengers but before the cabins had been disinfected, the investigators noted.
The Diamond Princess departed from Yokohama, Japan, on Jan. 20, 2020, and returned on Feb. 3 after making six stops in three countries. The ship was quarantined upon its return because a symptomatic passenger who had departed Jan. 25 in Hong Kong tested positive for SARS-CoV-2, Ms. Moriarty and associates explained.
Of the 381 people from the ship who were symptomatic and tested positive, 37 (9.7%) needed intensive care and 9 (1.3%) died. There were 428 Americans on the ship, of whom 107 (25.0%) tested positive and 11 remained hospitalized in Japan as of March 13, they said.
“Many other cruise ships have since been implicated in SARS-CoV-2 transmission,” the investigators said, including the Grand Princess, which sailed out of San Francisco with 3,571 people on Feb. 21 and returned to Oakland on March 8.
That ship had been the site of virus transmission during its previous voyage from Feb. 11 to Feb. 21, from which more than 20 cases have been identified. During the latter trip, 21 of 45 passengers and crew tested positive before the ship docked. During the subsequent land-based quarantine, there have been 78 positive tests among the 469 people tested as of March 21, a rate of 16.6%, the research team reported.
“Public health responses to cruise ship outbreaks require extensive resources,” they wrote. “These responses required the coordination of stakeholders across multiple sectors, including U.S. government departments and agencies, foreign ministries of health, foreign embassies, state and local public health departments, hospitals, laboratories, and cruise ship companies.”
SOURCE: Moriarty LF et al. MMWR. 2020 Mar 23;69[early release]:1-6.
FROM MMWR
CDC coronavirus testing decision likely to haunt nation for months to come
As the novel coronavirus snaked its way across the globe, the Centers for Disease Control and Prevention in early February distributed 200 test kits it had produced to more than 100 public health labs run by states and counties nationwide.
Each kit contained material to test a mere 300-400 patients. And labs, whether serving the population of New York or tiny towns in rural America, apparently received the same kits.
The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.
A woman in South Dakota with mild symptoms and no fever readily got the test and the results. Meanwhile, political leaders and public officials in places like New York, Boston, Seattle, and the San Francisco Bay area – all in the throes of serious outbreaks – couldn’t get enough tests to screen ill patients or, thereby, the information they needed to protect the general public and stem the outbreak of the virus, whose symptoms mimic those of common respiratory illnesses.
Rapid testing is crucial in the early stages of an outbreak. It allows health workers and families to identify and focus on treating those infected and isolate them.
Yet health officials in New York and such states as New York, Washington, Pennsylvania, and Georgia confirmed that they each initially got one test kit, calling into question whether they would have even stood a chance to contain the outbreaks that would emerge. They would soon discover that the tests they did receive were flawed, lacking critical components, and delivering faulty results.
During those early weeks, the virus took off, infecting thousands of people and leading to nationwide social distancing and sheltering in place. Public health officials are just beginning to grapple with the fallout from that early bungling of testing, which is likely to haunt the country in the months to come.
Too little too late
The first shipment to Washington state arrived more than 2 weeks after officials there announced the first U.S. case of coronavirus, and at a moment when deadly outbreaks of the disease were already festering in places like the Life Care Center in Kirkland. Within weeks, three dozen people infected with COVID-19 would die at the nursing home in the suburbs of Seattle.
The spread of COVID-19 would not take long to overwhelm the state, which as of March 20, 2020, had more than 1,300 cases.
The Trump administration in recent days has attempted to speed testing for the virus after early missteps hampered the government’s response to contain the contagion, and officials have had to respond to a barrage of criticism from public health experts, state officials, and members of Congress.
Federal health officials have eased the process for university and commercial labs to perform their own tests, and they are ramping up their capacity. As of March 16, public and private labs in the United States had the ability to test more than 36,000 people a day, according to estimates compiled by the American Enterprise Institute, a conservative-leaning think tank in Washington, a figure expected to rapidly escalate in coming weeks. That figure, however, can vary considerably by state and does not indicate how many tests are actually given to patients.
“We are now beginning to see that they have spread out in a prioritized way. We asked them to prioritize the regions that were mostly affected,” Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, said March 18 of private labs’ testing, without elaboration.
The scaling up of testing is set to take place after weeks of faltering and hundreds, if not thousands, of undiagnosed people spreading the virus. For example, New York’s state health department received a faulty CDC test kit on Feb. 8 for 800 patient specimens, an amount that’s consistent with other states, according to a spokesperson. It later began testing patients with a test that state officials developed based on the CDC protocol and has significantly increased testing – as of March 20, more than 7,200 people had tested positive statewide.
In New York City, the first batch was obtained on Feb. 7.
“The other state and local public health laboratories got test kits as they became available,” said Eric Blank, chief program officer of the Association of Public Health Laboratories.
Places in the middle of the country with no outbreaks had the luxury of time to plan. For example, Missouri officials have had about 800 tests to work with, leading to only 395 performed so far in the region by public health labs – 26 of which were positive. When private lab tests are accounted for, as of March 20 there were 47 confirmed cases.
Health care providers and public health staff in the state, however, benefited from the fact that there is less international travel to the region, according to infectious disease expert Steven Lawrence, MD, of Washington University, St. Louis.
“This is very similar to 1918 with the influenza pandemic – St. Louis had more time to prepare and was able to put measures in place to flatten the curve than, say, Philadelphia,” Dr. Lawrence said. “Seattle didn’t have an opportunity to prepare as much in advance.”
While commercial labs are coming online, strict restrictions are limiting testing capabilities, Dr. Lawrence said.
“The state has had their hands tied,” he added.
Waiting And wondering
Because of a widespread lag in testing, it is still a mystery for thousands of people to know whether they’ve come into contact with an infected person until well after it happens. As of March 20, the pandemic had killed more than 11,000 globally. More than 16,000 Americans were confirmed infected and at least 216 have died.
“CDC will distribute tests based on where they can do the most good. But without hospital-based testing and commercial testing, it will not be possible to meet the need,” said Tom Frieden, who led the CDC during President Obama’s administration and is a former commissioner of the New York City Health Department.
In California, public school teacher Claire Dugan, whose state was among the hardest hit in the initial wave of U.S. coronavirus cases, was told she didn’t qualify for testing because she had not traveled abroad to any country with an outbreak of the virus or been in contact with an infected person. Ms. Dugan, who lives in the San Francisco Bay area and is already medically fragile after a stray bullet nearly killed her while driving 4 years ago, sought a test from her doctor after registering a temperature of 100.7° F earlier this month.
“There are a lot of layers as to why this is so messed up,” said Ms. Dugan, who relies on a feeding tube and said she sought a test not only to protect herself but her students. “It’s community spreading right now, so it’s kind of silly we’re still insisting on [the early criteria for testing]. How would I know?”
Since the CDC’s initial distribution, states have been reordering more tests through the office’s International Reagent Resource – a long-standing tool that public health labs have relied on. They have also revised testing protocols to use only one sample per person, which boosts the number of people screened.
Yet problems still abound with tests or other materials needed to be able to detect the virus. California Gov. Gavin Newsom (D) said on March 12 that county public health labs can’t use all of the 8,000 test kits the state has because they are missing key components.
In Pennsylvania, state officials weren’t able to begin testing until March 2 because of problems with the CDC’s initial kit, according to Nate Wardle, a spokesperson at its department of health. New York received two newly manufactured CDC test kits on Feb. 29 and also began performing tests March 2, according to its health department.
“We are still limited on extraction kits,” Mandy Cohen, the Health & Human Services secretary in North Carolina, said in an interview in mid-March. Officials earlier this month could test only 300 patients because of shortages in the extraction materials needed to register whether the novel coronavirus is present.
In North Dakota, Loralyn Hegland wrote her physician’s practice an email on March 10 with the subject line “dry cough,” wondering if she should come in for testing after learning that was one symptom of COVID-19. The recommendation she got echoes those of countless others across the United States, saying her risk of being exposed was very low because she hadn’t traveled outside the United States and had not come into contact with a person who had been “definitely” diagnosed with the virus.
Ms. Hegland, who lives in Fargo, didn’t have a fever but decided to shelter herself, anyway, out of caution.
Would she push to get a test?
“What’s the point?” she said. “You can’t know what you don’t know. It’s just that simple. How else do you explain it to people when you’re not testing?”
KHN Midwest correspondent Lauren Weber in St. Louis contributed to this article.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
As the novel coronavirus snaked its way across the globe, the Centers for Disease Control and Prevention in early February distributed 200 test kits it had produced to more than 100 public health labs run by states and counties nationwide.
Each kit contained material to test a mere 300-400 patients. And labs, whether serving the population of New York or tiny towns in rural America, apparently received the same kits.
The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.
A woman in South Dakota with mild symptoms and no fever readily got the test and the results. Meanwhile, political leaders and public officials in places like New York, Boston, Seattle, and the San Francisco Bay area – all in the throes of serious outbreaks – couldn’t get enough tests to screen ill patients or, thereby, the information they needed to protect the general public and stem the outbreak of the virus, whose symptoms mimic those of common respiratory illnesses.
Rapid testing is crucial in the early stages of an outbreak. It allows health workers and families to identify and focus on treating those infected and isolate them.
Yet health officials in New York and such states as New York, Washington, Pennsylvania, and Georgia confirmed that they each initially got one test kit, calling into question whether they would have even stood a chance to contain the outbreaks that would emerge. They would soon discover that the tests they did receive were flawed, lacking critical components, and delivering faulty results.
During those early weeks, the virus took off, infecting thousands of people and leading to nationwide social distancing and sheltering in place. Public health officials are just beginning to grapple with the fallout from that early bungling of testing, which is likely to haunt the country in the months to come.
Too little too late
The first shipment to Washington state arrived more than 2 weeks after officials there announced the first U.S. case of coronavirus, and at a moment when deadly outbreaks of the disease were already festering in places like the Life Care Center in Kirkland. Within weeks, three dozen people infected with COVID-19 would die at the nursing home in the suburbs of Seattle.
The spread of COVID-19 would not take long to overwhelm the state, which as of March 20, 2020, had more than 1,300 cases.
The Trump administration in recent days has attempted to speed testing for the virus after early missteps hampered the government’s response to contain the contagion, and officials have had to respond to a barrage of criticism from public health experts, state officials, and members of Congress.
Federal health officials have eased the process for university and commercial labs to perform their own tests, and they are ramping up their capacity. As of March 16, public and private labs in the United States had the ability to test more than 36,000 people a day, according to estimates compiled by the American Enterprise Institute, a conservative-leaning think tank in Washington, a figure expected to rapidly escalate in coming weeks. That figure, however, can vary considerably by state and does not indicate how many tests are actually given to patients.
“We are now beginning to see that they have spread out in a prioritized way. We asked them to prioritize the regions that were mostly affected,” Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, said March 18 of private labs’ testing, without elaboration.
The scaling up of testing is set to take place after weeks of faltering and hundreds, if not thousands, of undiagnosed people spreading the virus. For example, New York’s state health department received a faulty CDC test kit on Feb. 8 for 800 patient specimens, an amount that’s consistent with other states, according to a spokesperson. It later began testing patients with a test that state officials developed based on the CDC protocol and has significantly increased testing – as of March 20, more than 7,200 people had tested positive statewide.
In New York City, the first batch was obtained on Feb. 7.
“The other state and local public health laboratories got test kits as they became available,” said Eric Blank, chief program officer of the Association of Public Health Laboratories.
Places in the middle of the country with no outbreaks had the luxury of time to plan. For example, Missouri officials have had about 800 tests to work with, leading to only 395 performed so far in the region by public health labs – 26 of which were positive. When private lab tests are accounted for, as of March 20 there were 47 confirmed cases.
Health care providers and public health staff in the state, however, benefited from the fact that there is less international travel to the region, according to infectious disease expert Steven Lawrence, MD, of Washington University, St. Louis.
“This is very similar to 1918 with the influenza pandemic – St. Louis had more time to prepare and was able to put measures in place to flatten the curve than, say, Philadelphia,” Dr. Lawrence said. “Seattle didn’t have an opportunity to prepare as much in advance.”
While commercial labs are coming online, strict restrictions are limiting testing capabilities, Dr. Lawrence said.
“The state has had their hands tied,” he added.
Waiting And wondering
Because of a widespread lag in testing, it is still a mystery for thousands of people to know whether they’ve come into contact with an infected person until well after it happens. As of March 20, the pandemic had killed more than 11,000 globally. More than 16,000 Americans were confirmed infected and at least 216 have died.
“CDC will distribute tests based on where they can do the most good. But without hospital-based testing and commercial testing, it will not be possible to meet the need,” said Tom Frieden, who led the CDC during President Obama’s administration and is a former commissioner of the New York City Health Department.
In California, public school teacher Claire Dugan, whose state was among the hardest hit in the initial wave of U.S. coronavirus cases, was told she didn’t qualify for testing because she had not traveled abroad to any country with an outbreak of the virus or been in contact with an infected person. Ms. Dugan, who lives in the San Francisco Bay area and is already medically fragile after a stray bullet nearly killed her while driving 4 years ago, sought a test from her doctor after registering a temperature of 100.7° F earlier this month.
“There are a lot of layers as to why this is so messed up,” said Ms. Dugan, who relies on a feeding tube and said she sought a test not only to protect herself but her students. “It’s community spreading right now, so it’s kind of silly we’re still insisting on [the early criteria for testing]. How would I know?”
Since the CDC’s initial distribution, states have been reordering more tests through the office’s International Reagent Resource – a long-standing tool that public health labs have relied on. They have also revised testing protocols to use only one sample per person, which boosts the number of people screened.
Yet problems still abound with tests or other materials needed to be able to detect the virus. California Gov. Gavin Newsom (D) said on March 12 that county public health labs can’t use all of the 8,000 test kits the state has because they are missing key components.
In Pennsylvania, state officials weren’t able to begin testing until March 2 because of problems with the CDC’s initial kit, according to Nate Wardle, a spokesperson at its department of health. New York received two newly manufactured CDC test kits on Feb. 29 and also began performing tests March 2, according to its health department.
“We are still limited on extraction kits,” Mandy Cohen, the Health & Human Services secretary in North Carolina, said in an interview in mid-March. Officials earlier this month could test only 300 patients because of shortages in the extraction materials needed to register whether the novel coronavirus is present.
In North Dakota, Loralyn Hegland wrote her physician’s practice an email on March 10 with the subject line “dry cough,” wondering if she should come in for testing after learning that was one symptom of COVID-19. The recommendation she got echoes those of countless others across the United States, saying her risk of being exposed was very low because she hadn’t traveled outside the United States and had not come into contact with a person who had been “definitely” diagnosed with the virus.
Ms. Hegland, who lives in Fargo, didn’t have a fever but decided to shelter herself, anyway, out of caution.
Would she push to get a test?
“What’s the point?” she said. “You can’t know what you don’t know. It’s just that simple. How else do you explain it to people when you’re not testing?”
KHN Midwest correspondent Lauren Weber in St. Louis contributed to this article.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
As the novel coronavirus snaked its way across the globe, the Centers for Disease Control and Prevention in early February distributed 200 test kits it had produced to more than 100 public health labs run by states and counties nationwide.
Each kit contained material to test a mere 300-400 patients. And labs, whether serving the population of New York or tiny towns in rural America, apparently received the same kits.
The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.
A woman in South Dakota with mild symptoms and no fever readily got the test and the results. Meanwhile, political leaders and public officials in places like New York, Boston, Seattle, and the San Francisco Bay area – all in the throes of serious outbreaks – couldn’t get enough tests to screen ill patients or, thereby, the information they needed to protect the general public and stem the outbreak of the virus, whose symptoms mimic those of common respiratory illnesses.
Rapid testing is crucial in the early stages of an outbreak. It allows health workers and families to identify and focus on treating those infected and isolate them.
Yet health officials in New York and such states as New York, Washington, Pennsylvania, and Georgia confirmed that they each initially got one test kit, calling into question whether they would have even stood a chance to contain the outbreaks that would emerge. They would soon discover that the tests they did receive were flawed, lacking critical components, and delivering faulty results.
During those early weeks, the virus took off, infecting thousands of people and leading to nationwide social distancing and sheltering in place. Public health officials are just beginning to grapple with the fallout from that early bungling of testing, which is likely to haunt the country in the months to come.
Too little too late
The first shipment to Washington state arrived more than 2 weeks after officials there announced the first U.S. case of coronavirus, and at a moment when deadly outbreaks of the disease were already festering in places like the Life Care Center in Kirkland. Within weeks, three dozen people infected with COVID-19 would die at the nursing home in the suburbs of Seattle.
The spread of COVID-19 would not take long to overwhelm the state, which as of March 20, 2020, had more than 1,300 cases.
The Trump administration in recent days has attempted to speed testing for the virus after early missteps hampered the government’s response to contain the contagion, and officials have had to respond to a barrage of criticism from public health experts, state officials, and members of Congress.
Federal health officials have eased the process for university and commercial labs to perform their own tests, and they are ramping up their capacity. As of March 16, public and private labs in the United States had the ability to test more than 36,000 people a day, according to estimates compiled by the American Enterprise Institute, a conservative-leaning think tank in Washington, a figure expected to rapidly escalate in coming weeks. That figure, however, can vary considerably by state and does not indicate how many tests are actually given to patients.
“We are now beginning to see that they have spread out in a prioritized way. We asked them to prioritize the regions that were mostly affected,” Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, said March 18 of private labs’ testing, without elaboration.
The scaling up of testing is set to take place after weeks of faltering and hundreds, if not thousands, of undiagnosed people spreading the virus. For example, New York’s state health department received a faulty CDC test kit on Feb. 8 for 800 patient specimens, an amount that’s consistent with other states, according to a spokesperson. It later began testing patients with a test that state officials developed based on the CDC protocol and has significantly increased testing – as of March 20, more than 7,200 people had tested positive statewide.
In New York City, the first batch was obtained on Feb. 7.
“The other state and local public health laboratories got test kits as they became available,” said Eric Blank, chief program officer of the Association of Public Health Laboratories.
Places in the middle of the country with no outbreaks had the luxury of time to plan. For example, Missouri officials have had about 800 tests to work with, leading to only 395 performed so far in the region by public health labs – 26 of which were positive. When private lab tests are accounted for, as of March 20 there were 47 confirmed cases.
Health care providers and public health staff in the state, however, benefited from the fact that there is less international travel to the region, according to infectious disease expert Steven Lawrence, MD, of Washington University, St. Louis.
“This is very similar to 1918 with the influenza pandemic – St. Louis had more time to prepare and was able to put measures in place to flatten the curve than, say, Philadelphia,” Dr. Lawrence said. “Seattle didn’t have an opportunity to prepare as much in advance.”
While commercial labs are coming online, strict restrictions are limiting testing capabilities, Dr. Lawrence said.
“The state has had their hands tied,” he added.
Waiting And wondering
Because of a widespread lag in testing, it is still a mystery for thousands of people to know whether they’ve come into contact with an infected person until well after it happens. As of March 20, the pandemic had killed more than 11,000 globally. More than 16,000 Americans were confirmed infected and at least 216 have died.
“CDC will distribute tests based on where they can do the most good. But without hospital-based testing and commercial testing, it will not be possible to meet the need,” said Tom Frieden, who led the CDC during President Obama’s administration and is a former commissioner of the New York City Health Department.
In California, public school teacher Claire Dugan, whose state was among the hardest hit in the initial wave of U.S. coronavirus cases, was told she didn’t qualify for testing because she had not traveled abroad to any country with an outbreak of the virus or been in contact with an infected person. Ms. Dugan, who lives in the San Francisco Bay area and is already medically fragile after a stray bullet nearly killed her while driving 4 years ago, sought a test from her doctor after registering a temperature of 100.7° F earlier this month.
“There are a lot of layers as to why this is so messed up,” said Ms. Dugan, who relies on a feeding tube and said she sought a test not only to protect herself but her students. “It’s community spreading right now, so it’s kind of silly we’re still insisting on [the early criteria for testing]. How would I know?”
Since the CDC’s initial distribution, states have been reordering more tests through the office’s International Reagent Resource – a long-standing tool that public health labs have relied on. They have also revised testing protocols to use only one sample per person, which boosts the number of people screened.
Yet problems still abound with tests or other materials needed to be able to detect the virus. California Gov. Gavin Newsom (D) said on March 12 that county public health labs can’t use all of the 8,000 test kits the state has because they are missing key components.
In Pennsylvania, state officials weren’t able to begin testing until March 2 because of problems with the CDC’s initial kit, according to Nate Wardle, a spokesperson at its department of health. New York received two newly manufactured CDC test kits on Feb. 29 and also began performing tests March 2, according to its health department.
“We are still limited on extraction kits,” Mandy Cohen, the Health & Human Services secretary in North Carolina, said in an interview in mid-March. Officials earlier this month could test only 300 patients because of shortages in the extraction materials needed to register whether the novel coronavirus is present.
In North Dakota, Loralyn Hegland wrote her physician’s practice an email on March 10 with the subject line “dry cough,” wondering if she should come in for testing after learning that was one symptom of COVID-19. The recommendation she got echoes those of countless others across the United States, saying her risk of being exposed was very low because she hadn’t traveled outside the United States and had not come into contact with a person who had been “definitely” diagnosed with the virus.
Ms. Hegland, who lives in Fargo, didn’t have a fever but decided to shelter herself, anyway, out of caution.
Would she push to get a test?
“What’s the point?” she said. “You can’t know what you don’t know. It’s just that simple. How else do you explain it to people when you’re not testing?”
KHN Midwest correspondent Lauren Weber in St. Louis contributed to this article.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
AMA offers resources for front-line physicians
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The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.
“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.
The COVID-19 physician and practice resources released by the AMA include:
- A Physicians Guide to COVID-19 .
- An AMA COVID-19 online resource center and a COVID-19 FAQ.
- A Quick Guide to Telemedicine in Practice.
- Ethical guidance for physicians .
- Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
- CME for physicians through the JAMA Network’s JN Learning website.
.
The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.
“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.
The COVID-19 physician and practice resources released by the AMA include:
- A Physicians Guide to COVID-19 .
- An AMA COVID-19 online resource center and a COVID-19 FAQ.
- A Quick Guide to Telemedicine in Practice.
- Ethical guidance for physicians .
- Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
- CME for physicians through the JAMA Network’s JN Learning website.
.
The literature include news, advocacy, and other information to help front-line physicians provide care to patients and keep themselves safe “in a rapidly changing environment,” the organization said in a statement.
“The AMA continues to forcefully advocate for [personal protective equipment] and critical policy and regulatory changes needed to address our public health and health system needs. Because so many of the challenges of the pandemic are felt at a practice level, we are also providing new tools and information to help physicians respond,” AMA President Patrice A. Harris, MD, said in the statement.
The COVID-19 physician and practice resources released by the AMA include:
- A Physicians Guide to COVID-19 .
- An AMA COVID-19 online resource center and a COVID-19 FAQ.
- A Quick Guide to Telemedicine in Practice.
- Ethical guidance for physicians .
- Evidence-based resources from the The JAMA Network COVID-19 Resource Center.
- CME for physicians through the JAMA Network’s JN Learning website.
How texting unites Seattle’s critical care departments
One of a smartphone’s simplest features has become a powerful communication and coordination tool for metro Seattle’s critical care departments.
Anne B. Lipke, MD, is the medical director of Swedish Medical Center’s Issaquah, Wash., campus in suburban Seattle. In an audio interview, Dr. Lipke explains how texting has become a fast, effective component of Seattle’s critical care response to COVID-19. And she offers lessons for physicians across the country who may soon be seeing situations similar to Seattle’s.
One of a smartphone’s simplest features has become a powerful communication and coordination tool for metro Seattle’s critical care departments.
Anne B. Lipke, MD, is the medical director of Swedish Medical Center’s Issaquah, Wash., campus in suburban Seattle. In an audio interview, Dr. Lipke explains how texting has become a fast, effective component of Seattle’s critical care response to COVID-19. And she offers lessons for physicians across the country who may soon be seeing situations similar to Seattle’s.
One of a smartphone’s simplest features has become a powerful communication and coordination tool for metro Seattle’s critical care departments.
Anne B. Lipke, MD, is the medical director of Swedish Medical Center’s Issaquah, Wash., campus in suburban Seattle. In an audio interview, Dr. Lipke explains how texting has become a fast, effective component of Seattle’s critical care response to COVID-19. And she offers lessons for physicians across the country who may soon be seeing situations similar to Seattle’s.