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The Abbott RealTime SARS-C0V-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acids from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients who are suspected of COVID-19 by their healthcare provider.
Abbott RealTime SARS-CoV-2 Instruction for Use
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:
Assay Specifications* | |
Technology | Qualitative Multiplex real time PCR |
Probe Design | Single Stranded Linear Probe |
Target Region | Dual Target, RdRp and N-genes |
Assay Runtime** |
Approximately 7 hours |
Throughput** | 470 patient samples in 24 hours |
Specimen type | Nasopharyngeal swabs, Oropharyngeal swabs |
Limit of Detection | 100 copies/mL |
Specificity | 100% |
Results Reporting | Detected / Not Detected |
Sample input volume | 0.5 mL |
Internal Control (IC) | Armored RNA (Pumpkin), Added to each specimen and control |
Controls | One negative and one positive control per run |
Link to WHO's interim guidance on COVID-19 Testing:
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