This SARS-CoV-2 RT-PCR test is a laboratory developed test using TaqPath™ COVID-19 Combo Kit. This real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) test is designed for the Qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens. APC Health, LLC (CLIA # 45D2184695) is a CAP (College of American Pathologists) accredited high complexity lab and operates under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
A "Not Detected" result does not preclude the possibility of SARS-CoV-2 infection since the adequacy of sample collection and/or low viral burden may result in the presence of viral RNA below the analytical sensitivity of this test method. A “Not Detected” result should not be used as the sole basis for patient management decisions and must be combined with clinical observation, patient history, and epidemiological information.
Positive results are indicative of the presence of SARS-CoV-2 RNA but do not rule out bacterial infection or co-infection with other viruses. Test results should be used with caution and in conjunction with other clinical and laboratory data in making the diagnosis.
Inconclusive results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Inconclusive results must be combined with clinical observations, patient history, and epidemiological information. The healthcare provider should conduct additional confirmation testing with a new specimen, if clinically indicated.
Samples must be collected, transported, and stored using appropriate procedures and conditions. Improper collection, transport, or storage of specimens may hinder the ability of the assay to detect the target sequences.