However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in the package insert. The instruments and assay procedures reduce the risk of contamination by amplification product.Laboratories are required to report all positive results to the appropriate public health authorities.Use of the Abbott RealTi me SARS-CoV-2 assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Abbott m2000 System.§ 263a, that meet requirements to perform high complexity tests. This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Improvement Amendments of 1988 (CLIA), 42 U.S.C.The Abbott RealTi me SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.įor use under an Emergency Use Authorization only. The Abbott RealTi me 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. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The agent detected may not be the definite cause of disease. 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 respiratory specimens during the acute phase of infection. Results are for the identification of SARS-CoV-2 RNA. §263a, that meet requirements to perform high complexity tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. The Abbott RealTi me 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 SARS-CoV-2 in anterior nasal swabs, self-collected at a health care location or collected by a healthcare provider and mid-turbinate nasal swabs, nasopharyngeal (NP) and oropharyngeal (OP) swabs, and bronchoalveolar lavage fluid (BAL) collected by a healthcare provider, from individuals suspected of COVID-19 by their healthcare provider.
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