Alinity m SARS-CoV-2 Assay
For more information, contact Abbott.
For more information, contact Abbott.
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The Alinity m 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 collected by a healthcare provider, from patients who are suspected of COVID-19 infection.
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 Alinity m 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.
To learn more about Alinity m SARS-CoV-2 Assay please visit: https://www.molecular.abbott/int/en/alinity-m-sars-cov-2-assay
| ABBOTT ALINITY m SARS-COV-2 ASSAY SPECIFICATIONS | |
| Technology | Qualitative real-time PCR |
| Assay Run Time | < 115 min time to first results (12 results), 12 more results 16 min thereafter (assumption 100% efficiency) |
| Probe Design | Single Stranded Probe |
| Target Region | Dual Target, RdRp and N-genes |
| Specimen Types |
Nasopharyngeal and oropharyngeal swabs |
| Result Interpretation | Positive / Negative |
| Minimum Sample Volume | Depending on tube type between 0.8 mL and 1.4 mL (see package insert for details) |
| Controls | One negative and one positive control per 48 hours |
| Internal Control | IC target armored RNA from pumpkin gene, added to each specimen and control |
| Throughput | Up to 1080 samples in 24 hours (Number of actual samples per 24-hour period may vary based on laboratory practice and workflow) |
| Limit of Detection | The lowest concentration level with observed positive rates ≥ 95% was 100 virus Copies/mL. LOD estimated from probit analysis was 0.0037 TCID50/mL (95% CI: 0.0022-0.0099). |
1. Alinity m SARS-CoV-2 AMP kit Package Insert (PI): 53-608193/R3.
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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.