The Fact Sheets inform 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 on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.
All patients whose specimens are tested with this assay will receive the Fact Sheet for Patients: TaqPath™ COVID-19 Combo Kit.
Where can I go for updates and more information?
The most up-to-date information on COVID-19 is available at the CDC General webpage. In addition, please also contact your healthcare provider with any questions/concerns.
Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 4 days.
Public health officials have identified cases of COVID-19 infection in the United States, which may pose risks for public health. There also are reports of human to human transmission through close contact with an individual confirmed to be ill with COVID-19, in the United States and globally. Please check the CDC webpage 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 upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and nasopharyngeal aspirate) and bronchoalveolar lavage (BAL) specimens.
Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section).
Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 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 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 in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines.
The TaqPath™ COVID-19 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 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, the 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 confirmatory 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. A negative result does not exclude the possibility of COVID-19.
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 should be considered in consultation with public health authorities.
Risks to a patient of a false negative 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 United States (U.S.) 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 the detection of the virus that causes 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).
CDC WEBPAGES
General: https://www.cdc.gov/COVID19
Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/index.html
FDA WEBPAGES
General: www.fda.gov/novelcoronavirus
EUAs:(includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Thermo Fisher Scientific
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Contact number and/or email: 1-866-356-0354
Website: www.thermofisher.com
COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness, was first idenitifed in Wuhan, China, and has now spread globally, including the United States. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, sneezing, difficulty breathing, etc.).
The test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal or oral swabs.
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:
Testing of the samples will help find out if you may have COVID-19.
Potential risks include:
Potential benefits include:
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. 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 along with other factors of your medical history, and your symptoms, possible exposures, and geographic location of places you have recently traveled.
A negative test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness.
However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, duration of illness, 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. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). 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 emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 or by calling 1-800-FDA-1088
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