First Saliva COVID-19 Test Secures FDA Approval

One of the toughest parts of COVID-19 laboratory testing is the sample collection process. A swab must be inserted into each nostril, one at a time, to the nasopharynx at the back of the nasal cavity, followed by gentle scraping of the tissue to obtain the needed respiratory samples. The process poses at least three challenges:

• It is uncomfortable for patients;
• It requires a qualified health care professional to perform; and
• It directly exposes the professional to risk of infection thus requiring the use of personal protective equipment (PPE), including respiratory masks that are in short supply.

There must be a better way. Spit Over Swab On April 13, the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the first COVID-19 test cleared for use on saliva samples. The Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay test is based on the Thermo Fisher Scientific Applied Biosystems TaqPath COVID-19 Combo Kit previously approved for the detection of specific genomic regions of the SARS-CoV-2 nucleocapsid gene, spike gene and ORF1ab region in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage specimens. But it has now been modified for use on additional specimen types, including saliva. The test runs on the Thermo Fisher Applied Biosystems QuantStudio 5 Real-Time PCR System equipped with software v1.3 or the Applied Biosystems ViiA7 Real-Time PCR System with the Applied Biosystems QuantStudio 5 software v1.3. All the patient has to do is spit into a tube. However, it is not a home test. Under the terms of the EUA, the testing must still take place in a healthcare setting under the supervision of a qualified professional. But in addition to being less invasive, spitting significantly reduces the risk of infection to the sample taker, freeing up the use of desperately needed PPE and eliminating the use of swabs, which are also in short supply due to the COVID-19 crisis. Takeaway The EUA was provided under the FDA’s Policy A COVID-19 pathway for tests developed by high-complexity CLIA laboratories which allows for use only by the laboratory that develops them. Accordingly, the new saliva test can be performed only at Rutgers University Cell and DNA Repository (RUCDR) laboratories in New Jersey. However, you can expect other laboratories and test makers to develop their own versions of COVID-19 saliva tests in the very near future.