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TaqPath COVID-19 Combo kit

FACT FOR PATIENTS

You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) using the TaqPath COVID-19 Combo kit.
This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider.

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.

These tests are designed to detect the virus that causes COVID-19 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate swabs, nasopharyngeal aspirates, and bronchoalveolar lavage (BAL) specimens.

You were tested because your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or because:

  • You live in or have recently traveled to a place where transmission of COVID-19 is known to occur, or
  • You have been in close contact with an individual suspected of or confirmed to have COVID-19.

Testing of the samples will help find out if you may have COVID-19.

Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test result (see below for more information).

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and those you come in contact with.

If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. You should follow CDC guidance to reduce the potential transmission of disease.

There is a smaller possibility that this test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19. Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms

A negative test result means that the virus that causes COVID-19 was not found in your sample.

However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. You might test negative if the sample was collected early during your infection. You could also be exposed to COVID-19 after your sample was collected and then have become infected.

This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.

It is important that you work with your healthcare provider to help you understand the next steps you should take.

No. This test is not yet approved or cleared by the United States FDA, but it has been issued an Emergency Use Authorization (EUA). FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics, unless it is terminated or revoked by FDA (after which the test may no longer be used).

Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases.

A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Download TaqPath COVID-19 Combo kit FACT SHEET FOR PATIENTS

FACT FOR HEALTHCARE PROVIDERS

This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the TaqPath COVID-19 Combo Kit.
The TaqPath COVID-19 Combo Kit is authorized for use with certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat, new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID-19 please see the link provided in “Where can I go for updates and more information?” section.
Public health officials have identified cases of COVID-19 infection throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdictions website for the most up to date information.

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information?” section).

  • The TaqPath COVID-19 Combo Kit can be used to test nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate swabs, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens.
  • The TaqPath COVID-19 Combo Kit should be ordered for the detection of COVID-19 in individuals suspected of COVID-19 by their healthcare provider.
  • This test is also for use with the Everlywell COVID-19 Test Home Collection Kit when used consistent with its authorization.
  • The TaqPath COVID-19 Combo Kit is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high-complexity tests.

Specimens should be collected with appropriate infection control precautions. Current guidance is available at the CDC’s website (see links provided in “Where can I go for updates and more information?” section).

When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information?” section).

A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC guidelines.

The TaqPath COVID-19 Combo Kit have been designed to minimize the likelihood of false positive test results. However, it is still possible that this test can give a false positive result, even when used in locations where the prevalence is below 5%. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. It is possible to test a person too early or too late during SARS-CoV-2 infection to make an accurate diagnosis via TaqPath COVID-19 Combo Kit.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. 

If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing with an alternative method should be considered by healthcare providers in consultation with public health authorities. Additional testing may be helpful to ensure testing was not conducted too early.

Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

The performance of this test was established based on the evaluation of a limited number of clinical specimens. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA, by FDA can be found by searching the medical device databases here: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases.

A cleared or approved test should be used instead of a test made available under an EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Download TaqPath COVID-19 Combo Kit FACT SHEET FOR HEALTHCARE PROVIDERS

TaqPath COVID-19, FluA, FluB Combo Kit

FACT FOR PATIENTS

You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19), influenza A, and/or influenza B using the TaqPath™ COVID-19, FluA, FluB Combo Kit.
This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19 and/or influenza. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider.

You were tested because your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or because:

  • You live in or have recently traveled to a place where transmission of COVID-19 is known to occur, and/or
  • You have been in close contact with an individual suspected of or confirmed to have COVID-19.

Testing of the samples will help find out if you may have COVID-19.

COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.

Influenza (flu) is a contagious respiratory illness caused by influenza viruses. Influenza viruses can cause mild to severe illness. Serious outcomes of the flu can result in hospitalization or death. Some people, such as older people, young children, and people with certain underlying health conditions, are at higher risk for serious flu complications. There are two main types of influenza viruses: types A and B. Both type A and B influenza viruses regularly spread in people and are responsible for seasonal flu each year. Influenza viruses can be spread to others before and after a person shows signs and symptoms of being sick.

The test is designed to simultaneously detect three types of viruses: two types that cause influenza (type A and type B) and the virus that causes COVID-19 (SARS-
CoV-2) in nasopharyngeal and anterior nasal swab samples.

Potential risks include:

  • Possible discomfort or other complications that can happen during sample collection.
  • Possible incorrect test result (see below for more information).

Potential benefits include:

  • The results, along with other information, can help your healthcare provider make informed recommendations about your care.
  • The results of this test may help limit the spread of COVID-19 to your family and those you come in contact with.

If you have a positive test result for the presence of SARS-CoV-2, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. You should follow CDC guidance to reduce the potential transmission of disease.

There is a smaller possibility that this test can give a positive result that is wrong (a false positive result) particularly when used in a population without many cases of COVID-19 infection. Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms

If you have a positive test result for the presence of influenza A and/or influenza B viruses, it is very likely that you have the flu. If you have a positive result for an influenza virus, your healthcare provider will determine the best way to care for you based on the test results along with other factors in your medical history. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results, medical history, and your symptoms.

It is possible for an individual to be infected with SARS-CoV-2 virus, influenza A virus, and/or influenza B virus, at the same time. Your healthcare provider will work with you to determine how best to care for you based on these test results, your medical history, and your symptoms.

A negative test result for any of the viruses detected by this test means that these viruses were not found in your sample. For COVID-19 and influenza, a negative test result for a sample collected while a person has symptoms usually means that SARS-CoV-2, influenza A or influenza B viruses are unlikely to be the cause your current illness.

However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19 or influenza. You might test negative if the sample was collected early during your infection. You could also be exposed to COVID-19 or influenza after your sample was collected and then have become infected. Additionally, unobserved self-collected specimens from SARS-CoV-2, influenza A or influenza B positive individuals may yield negative results if the specimen was not collected properly.

Your healthcare provider will consider the test result together with your symptoms, possible exposures and other health information in deciding how to care for you. It is possible that your healthcare provider may collect another sample in order to repeat the test or conduct other tests.
It is important that you talk with your healthcare provider to help you understand what your results mean and the next steps you should take.

No. This test is not yet approved or cleared by the United States FDA, but it has been issued an Emergency Use Authorization (EUA). FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics, unless it is terminated or revoked by FDA (after which the test may no longer be used).

There are approved/cleared influenza tests, but there is not yet an approved available alternative test for influenza combined with COVID-19 in one test. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Download TaqPath COVID-19, FluA, FluB Combo Kit FACT SHEET FOR PATIENTS

FACT FOR HEALTHCARE PROVIDERS

This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the TaqPath™ COVID-19, FluA, FluB Combo Kit.
The TaqPath COVID-19, FluA, FluB Combo Kit is authorized for use with nasopharyngeal and anterior nasal swab specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat, new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID-19 please see the link provided in “Where can I go for updates and more information?” section.
Public health officials have identified cases of COVID-19 infection throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdictions website for the most up to date information.

The signs and symptoms of influenza usually develop suddenly and are similar to those of COVID-19. Common signs and symptoms of influenza are fever, cough, sore throat, runny/stuffy nose, body aches, headaches, and fatigue.

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information?” section).

  • The TaqPath COVID-19, FluA, FluB Combo Kit can be used to test nasopharyngeal and anterior nasal swab specimens.
  • The TaqPath COVID-19, FluA, FluB Combo Kit can be ordered for the detection and differentiation of RNA from SARS-CoV-2 virus, influenza A virus (Flu A), and/or influenza B virus (Flu B) in individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.
  • The TaqPath COVID-19, FluA, FluB Combo Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

Specimens should be collected with appropriate infection control precautions. Current guidance is available at the CDC’s website (see links provided in “Where can I go for updates and more information?” section).

When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information?” section).

A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC guidelines.

The TaqPath COVID-19, FluA, FluB Combo Kit has been designed to minimize the likelihood of false positive test results. However, it is still possible that this test can give a false positive result, even when used in locations where the prevalence is below 5%. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. It is possible to test a person too early or too late during COVID-19 infection to make an accurate diagnosis via the The TaqPath COVID-19, FluA, FluB Combo Kit.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative.

If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing with an alternative method should be considered by healthcare providers in consultation with public health authorities. Additional testing may be helpful to ensure testing was not conducted too early.

Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

The performance of this test was established based on the evaluation of a limited number of clinical specimens. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

A positive test result for influenza A virus and/or influenza B virus indicates that RNA from one or both of these viruses was detected, the patient is infected with the virus(es) and is presumed to be contagious. Laboratory test results should always be considered in the context of clinical findings and observations and/or epidemiological data in making a final diagnosis. Patient management decisions should be made by a healthcare provider and follow current CDC guidelines. Results (positive and negative) for influenza should be interpreted with caution. If an influenza result is inconsistent with clinical presentation and/or other clinical and epidemiological information, FDA-cleared Influenza NAATs are available for confirmation if clinically indicated.

The TaqPath COVID-19, FluA, FluB Combo Kit has been designed to minimize the likelihood of false-positive test results. However, in the event of a false-positive result, risks to individuals could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family of friends, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of an antiviral medication or other therapy, or other unintended adverse effects.

A negative test result for influenza viruses means that influenza A and/or B RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out influenza virus infection and should not be used as the sole basis for treatment or patient management decisions.

When diagnostic testing results are negative, the possibility of a false-negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with influenza. The possibility of a false-negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that influenza is likely, and diagnostic test results for other causes of illness (e.g., other respiratory illness) are negative. If influenza is still suspected based on exposure history and clinical findings, re-testing should be considered by healthcare providers in consultation with public health authorities.

Laboratory test results should always be considered in the context of clinical findings and observations and/or epidemiological data in making a final diagnosis. Patient management decisions should be made by a healthcare provider and follow current CDC guidelines. Results (positive and negative) for influenza should be interpreted with caution. If an influenza result is inconsistent with clinical presentation and/or other clinical and epidemiological information, FDA-cleared Influenza NAATs are available for confirmation if clinically indicated.

Risks to an individual from a false-negative TaqPath COVID-19, FluA, FluB Combo Kit result for influenza A or B include: delayed or lack of supportive treatment; lack of monitoring of infected patients and their household or other close contacts for symptoms, resulting in increased risk of spread of influenza within the community; or other unintended adverse events.

Yes, it is possible for an individual to be infected with influenza A virus, influenza B virus, and/or SARS-CoV-2 simultaneously. A positive test result for the viruses that cause COVID-19 and influenza A and/or B indicates that RNA from these viruses was detected, the patient may be co-infected, and is presumed to be contagious. Laboratory test results should always be considered in the context of clinical findings and observations and epidemiological data in making a final diagnosis. Patient management decisions should be made with a healthcare provider and follow current CDC guidelines.

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.

An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

FDA has approved/cleared certain influenza tests, however, there are no approved available alternative tests for the combined detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and/or influenza B viruses. FDA has issued EUAs for other tests that can be found at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

Download TaqPath COVID-19, FluA, FluB Combo Kit FACT SHEET FOR HEALTHCARE PROVIDERS