The Ezplex SARS-CoV-2 G Kit is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, and sputum specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing in the U.S. is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
This test (CE IVD and MFDS versions only) is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled specimens containing up to five individual nasopharyngeal or oropharyngeal swabs where each specimen is collected by a healthcare provider using individual vials containing transport media from individuals suspected of COVID-19 by their health care provider. 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 if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive, inconclusive, or invalid result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in specimen pools due to the decreased sensitivity of pooled testing.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Ezplex SARS-CoV-2 G Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Ezplex SARS-CoV-2 G Kit is only for use in the United States under the Food and Drug Administration’s Emergency Use Authorization.