Abbott RealTime SARS-CoV-2 assay provides a fully automated solution to help laboratories address the urgent need for patient testing during the Coronavirus (COVID-19) pandemic.
The assay is engineered with:
- Dual target assay for RdRp and N-genes
- Qualitative detection of nucleic acids from SARS-CoV-2
- maxRatio data analysis removes operator subjectivity
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 the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients who are suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in 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.
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.