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 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 |
* Source: Abbott RealTime SARS-CoV-2 package insert 51-608442/R1
** Abbott data on file
Link to WHO's interim guidance on COVID-19 Testing:
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.
