Negative results must be combined with clinical observations, patient history, and epidemiological information.ĪBBOTT ALINITY m SARS-COV-2 ASSAY SPECIFICATIONS 1-4 Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses. 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. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection. Results are for the identification of SARS-CoV-2 RNA. The Alinity m SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare provider, from patients who are suspected of COVID-19 infection. The Alinity m SARS-CoV-2 assay 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. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing. Specimens included in pools with a positive result must be tested individually prior to reporting a result. If patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Negative results from pooled testing should not be treated as definitive. Negative results must be combined with clinical observations, patient history, and epidemiological information. The SARS-CoV-2 RNA is generally detectable during the acute phase of infection.
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