Testing Importance

Testing plays a key role in our efforts to contain and mitigate the COVID-19 pandemic by identifying infected individuals to help prevent further person-to-person transmission of COVID-19.

Hologic’s COVID Tests

The Hologic COVID-19 tests detect the virus from a respiratory specimen taken via a nose or throat swab. Hologic’s COVID tests are running on Hologic instruments at labs across all 50 states.

Why was I tested for COVID-19?

You may have been tested because:

• Your healthcare provider believes you have signs or symptoms suggestive of COVID-19 (e.g. fever, cough, difficulty, breathing, etc.)
• You live in or have recently traveled to an area where the transmission of COVID 19 is high
• You have been in close contact with an individual suspected or confirmed to have COVID-19

Are there any risks to the test?

• Discomfort or other complications are possible during specimen collection via nasal or throat swab

What are the benefits of the test?

• The results of your COVID-19 test, along with other information, can help your healthcare provider make informed decisions about your care
• Being tested for COVID-19 may help limit the spread of COVID-19 to your family and others in your community

What does it mean if I have a positive test result?

If you have a positive test result, it is extremely likely that you have an active case of COVID-19. Therefore, it is also likely that you will be asked to quarantine to avoid spreading the virus to others. 

While very rare, it is possible that your positive result could be an inaccurate false positive result. Your healthcare provider will work with you to determine how best to care for you based on test results, symptoms, and medical history. 

What does it mean if I have a negative test result?

A negative test result means that the virus that causes COVID-19, SARS-CoV-2, was not detected in the specimen collected from your nose or throat. 

For COVID-19, a negative test result indicates that any COVID-19 type of symptoms you may be experiencing such as cough, fever, fatigue, etc. are likely due to some other type of illness, such as the flu or the common cold.

While very rare, it is possible that your negative result could be an inaccurate false negative result. This means that you could possibly still have COVID-19, even if there was no virus detected in your specimen. Your healthcare provider will consider your test result along with all other aspects of your medical history, including symptoms, possible exposure, and geographical locations of places you have recently traveled, as he or she decides how best to care for you. 

Where can I find more information about COVID-19 symptoms and how it is transmitted?

For the most up-to-date information visit the CDC COVID-19 webpage at www.cdc.gov/COVID19

The United States FDA has made the HOLOGIC COVID-19 tests available under an emergency access mechanism called an Emergency Use Authorization (EUA).

* Information about the Aptima® and Panther Fusion® SARS-CoV-2 assays:

• These tests have not been FDA cleared or approved;

• These tests have been authorized by FDA under an EUA for use by authorized laboratories;

• These tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

• These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The Panther Fusion SARS CoV-2 assay is available for EUA use in the United States, Australia, New Zealand and Canada. EUA does not apply to the European Union. The Aptima SARS-CoV-2 assay is available for EUA use in the United States. 

Emergency Use Authorization (EUA)

EUAs issued under a Health and Human Services (HHS) declared emergency are valid until the HHS secretary determines the emergency is over, or a product is cleared or approved with the same technology and intended use as other EUA products on the market. In this case, the EUAs for the products where there is now a cleared or approved alternative are terminated.¹

Reference: 1. HHS. Emergency Use Authorization of Medical Products and Related Authorities. Published January 2017. Accessed March 10, 2020. https://www.fda.gov/media/97321/download