QIAstat-Dx Respiratory SARS-CoV-2 Panel Intended Use
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid real-time PCR test intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID 19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.
SARS-CoV-2 RNA and nucleic acids from the other respiratory viral and bacterial organisms identified by this test are generally detectable in nasopharyngeal swabs (NPS) during the acute phase of infection. Positive results are indicative of the presence of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the test, or lower respiratory tract infection that is not detected by a nasopharyngeal swab. The agent detected may not be the definite cause of disease.
For SARS-CoV-2 positive specimens; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Laboratories within the United States and its territories are required to report all SARS-CoV-2 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 treatment or other patient management decisions. Negative SARS-CoV-2 results must be combined with clinical observations, patient history, and epidemiological information. Negative results for other organisms identified by the test may require additional laboratory testing (eg, bacterial and viral culture, immunofluorescence and radiography) when evaluating a patient with possible respiratory tract infection.
Testing with the QIAsta-Dx Respiratory SARS-CoV-2 Panel is intended for use by qualified and trained operators who are proficient in performing the tests using the QIAstat-Dx Analyzer System. The QIAstat-Dx Respiratory SARS-CoV-2 Panel is only for use under the Food and Drug Administration’s Emergency Use Authorization.