*For In Vitro Diagnostic Use.
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:
INTENDED USE
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.
| ASSAY SPECIFICATIONS* | |
| Technology | Qualitative real time PCR |
| Probe Design | Single Stranded Linear Probe |
| Target Region | Dual Target, RdRp and N-genes |
| Throughput in an 8hr shift** | 94 results (7hrs 59 min) |
| Throughput at the end of two shifts** | 282 results (16hrs 39min) |
| Specimen type | Nasopharyngeal swabs, Oropharyngeal swabs |
| Limit of Detection | 100 copies/mL |
| Specificity | 100% |
| Results Reporting | Cycle Number / 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/R2
** 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.
