Testing for COVID-19

 

Commitment To Delivering Essential COVID-19 Testing
Accurate and fully automated testing is critical in the fight against the coronavirus disease (COVID-19) – and key to quickly identifying who is infected and subsequently helping alleviate the spread of this novel virus.

Hologic is proud to offer COVID-19 testing across all 50 states with multiple sample types. Hologic is committed to delivering more than 1 million new COVID-19 tests to our laboratory partners per week.

Hologic COVID-19 Tests
Hologic COVID-19 tests should be ordered for the detection of coronavirus in individuals who are suspected of having COVID-19.* Download our specimen collection guides for more information:

*Specimens should be collected with the appropriate infection control precautions. Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19.
† Nasal wash/ aspirate sample is indicated for Aptima® SARS-CoV-2 assay.
‡ Lower respiratory tract specimen sample is indicated for Panther Fusion® SARS-CoV-2 assay.

Test Results 
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 Hologic COVID-19 tests have 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 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.

What does it mean if the specimen tests negative for the virus that causes COVID-19? 
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 by healthcare providers 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 Hologic COVID-19 tests are only authorized for use in laboratories in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. 

The United States (U.S.) 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.2
References: 1. Coronavirus (COVID-19). Centers for Disease Control and Prevention. Accessed May 27, 2020. https://www.cdc.gov/coronavirus/2019-ncov/index.html  2. HHS. Emergency Use Authorization of Medical Products and Related Authorities. Published January 2017. Accessed May 27, 2020. https://www.fda.gov/media/97321/download 
For the most up to date information on COVID-19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage at www.cdc.gov/COVID19