Genetron SARS-CoV-2 RNA Test

The Genetron SARS-CoV-2 RNA Test, is a real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 nucleic acid in
oropharyngeal swab, nasopharyngeal swabs, anterior nasal swab and mid-turbinate nasal swab, and sputum samples from patients
suspected of COVID-19 by their healthcare providers. Testing is limited to laboratories - certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA, which is generally detected in oropharyngeal, nasopharyngeal, anterior nasal and
mid-turbinate nasal swab specimens and sputum specimens during the acute phase of the 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 positive 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 treatment or other patient
management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Genetron SARS-CoV-2 RNA Test is intended for use by qualified clinical laboratory personnel specifically instructed and trained in
the techniques of real-time PCR and in vitro diagnostic procedures. The Genetron SARS-CoV-2 RNA Test is only for use under the Food
and Drug Administration’s Emergency Use Authorization.