Alinity m SARS-CoV-2 assay, for use under FDA Emergency Use Authorization only and run on the Alinity m system, offers workflow efficiency and the high throughput solution the laboratory requires today to help meet the public health need:
The Alinity m SARS-CoV-2 assay is a real-time reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal swabs, self-collected at a health care location or collected by a healthcare worker, nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare worker or bronchoalveolar lavage fluid (BAL) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, that meet requirements to perform moderate or high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase ofinfection. 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
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. The Alinity m SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
LIMITATIONS OF THE PROCEDURE
For use under an Emergency Use Authorization only.
This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.
|ABBOTT ALINITY m SARS-CoV-2 ASSAY Specifications1-4|
|Technology||Qualitative Multiplex RT-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 Linear Probe|
|Target Region||Dual Target, RdRp and N-genes|
Nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and bronchoalveolar lavage fluid (BAL)
|Result Interpretation||Positive / Negative|
|Minimum Sample Volume||Depending on tube type between 0.8 mL and 1.4 mL|
|Controls||One negative and one positive control|
|Internal Control||Armored RNA (Pumpkin), added to each specimen and control|
|Throughput||300 samples in ~8 hours; up to 1080 samples in 24 hours|
Below are links to CDC website on:
Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.
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.