The Abbott RealTime SARS-C0V-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories, using real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria.
Abbott RealTime SARS-CoV-2 assay provides a fully automated solution to help laboratories address the urgent need for automated, high-volume patient testing during the Coronavirus (COVID-19) pandemic.
The assay is engineered with:
The Abbott RealTime SARS-CoV-2 assay in combination with the RealTime m2000 system allow scalable, automated process for flexible testing volume (24-96 samples) and up to 470 patient samples in 24 hours.
Below are links to CDC website on:
Important Safety Information
The Abbott RealTime 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 nasal swabs, self-collected at a health care location or collected by a healthcare worker, and nasopharyngeal (NP) and oropharyngeal (OP) swabs, and bronchoalveolar lavage fluid (BAL) collected by a healthcare worker, from individuals 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, that meet requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasal, nasopharyngeal and oropharyngeal swabs 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. 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 management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Abbott RealTime 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. The Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
LIMITATIONS OF PROCEDURE
For use under an Emergency Use Authorization only.
This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.
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