The COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate) collected from individuals suspected of COVID-19 by their healthcare provider (HCP), as well as upper respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, nasal swabs, or mid-turbinate swabs) collected from any individual, including for testing of individuals without symptoms or other reasons to suspect COVID-19 nfection.
The COVID-19 RT-PCR test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples, using a matrix pooling strategy (i.e., group pooling strategy), containing up to five individual upper respiratory swab specimens (nasopharyngeal, mid-turbinate, nasal or oropharyngeal swabs collected using individual vials containing transport media) per pool and 25 specimens per matrix. Nasal swab specimens are collected in individual vials containing transport media either under observation by a HCP or self-collected using a home collection kit authorized for use with this test (see indication above). Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result or results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools where the positive sample cannot be identified using the matrix must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.