What exactly does Fulgent’s molecular COVID-19 test look for?

Fulgent uses diagnostic RT-PCR testing to identify whether any SARS-CoV-2 viral RNA is present in the provided sample. In other words, the analysis performed amplifies targeted viral RNA from the COVID-19 virus, which can inform us whether the person who provided the sample is currently infected with COVID-19. Molecular tests are also called RT-PCR tests or nucleic acid amplification tests (NAATs).

Does Fulgent’s molecular COVID-19 test assess anything other than COVID-19?

The test is also able to identify the presence of influenza A and B, however, testing for influenza is a separate opt-in option. The ordering provider or institution may choose to include this analysis or not. Any testing beyond this scope is not possible, as no DNA is extracted from COVID-19 RT-PCR samples, so there is no human genetic analysis performed.

Is my genetic information collected or studied during the lab analysis?

Fulgent’s lab only looks for the presence of the COVID-19 virus in the samples received for COVID-19 testing. No human DNA is extracted or analyzed during the process. As a result we do not obtain any genetic information specific to you from our COVID-19 tests.

What medical information does Fulgent collect as part of the molecular COVID-19 testing process?

Individuals that submit test samples will participate in a brief health screening that includes yes or no questions pertaining to recent hospitalization, pregnancy, and whether a participant is currently symptomatic. These questions are generally required by the U.S. Department of Health & Human Services or other public agencies as part of the COVID testing and reporting process. Participants may decline to answer any of these questions without penalty.

What information from each molecular COVID-19 test does Fulgent retain, and where?

Generally individuals that submit test samples are asked to provide certain personal and demographic information including their name, birth date, relevant contact information, home address, race, ethnicity, and gender. This information is required to be collected by laboratories issuing reports to public health authorities and will be retained by Fulgent for such purposes. Questions for race, ethnicity, and gender have a “Prefer Not to State’’ option, and there are no consequences for selecting that answer.

Apart from the above, the only additional information that Fulgent retains is the final diagnostic result of any tests submitted. All information is securely stored in our web portal. Test records are also securely maintained in the Fulgent laboratory information management system.

What else does Fulgent use molecular COVID-19 test data for?

Test data is used for testing and reporting purposes only. The samples we receive for COVID-19 testing are only processed for viral RNA detection and/or viral strain/variant identification. No human DNA is extracted or analyzed, and the samples are discarded once a result report has been generated (usually within two days after receipt). Discarded samples are scheduled to be picked up daily and incinerated off-site by our biological waste disposal contractor.

What entities does Fulgent share molecular COVID-19 test information with?

We take the privacy of your personal health information very seriously. We are a CLIA-certified clinical laboratory, and therefore your individually identifiable health information, including your test results, are protected by HIPAA and in some cases similar state laws. We may share information with third parties as permitted by these laws, or with your permission.

Our lab is cooperating with federal and state public reporting agencies as appropriate regarding reportable COVID-19 cases. We may also share your health information for treatment purposes including the ordering physician/institution, in connection with obtaining payment for your test, to meet certain legal obligations such as complying with court orders, and in certain other cases as further discussed in our HIPAA Notice of Privacy Practices.

Our lab has also been engaged by certain institutions and organizations to provide testing to individuals. For example, we provide testing for workplace health and safety programs and various agencies and municipalities offering community testing. Such institutions or organizations may have access to certain health information regarding testing and results. If you are testing through an institution or organization, please speak to your group administrator or contact clientservices@fulgentgenetics.com for more information.

How long will Fulgent retain information gathered as part of the molecular COVID-19 testing process?

Test results and associated protected health information will remain in our laboratory information system for a minimum of 3 years, per guidelines for clinical laboratories. The test samples themselves are disposed of by incineration after 48 hours.