*For use under an Emergency Use Authorization (EUA) Only
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 SARS-CoV-2 in mid-turbinate nasal, anterior nasal, nasopharyngeal (NP) and oropharyngeal (OP) swabs, and bronchoalveolar lavage (BAL) specimens collected from individuals suspected of COVID-19 by their healthcare provider (HCP), as well as mid-turbinate nasal, anterior nasal, NP and OP swabs collected from any individual, including individuals without symptoms or other reasons to suspect COVID-19 infection. Testing of non-pooled specimens 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.
This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples containing up to 5 individual upper respiratory specimens (i.e., mid-turbinate nasal, anterior nasal, NP, and OP swabs) that are collected by an HCP using individual vials containing transport media. Testing of pooled specimens is limited to laboratories certified under CLIA, 42 U.S.C §263a, that meet requirements to perform 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 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. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all 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. Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
The Alinity m SARS-CoV-2 assay is intended for use by qualified and trained 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|
|Specimen Types||Nasal, nasopharyngeal (NP) and oropharyngeal (OP) swabs, and bronchoalveolar lavage (BAL) specimens collected from individuals suspected of COVID-19 by their healthcare provider (HCP), as well as nasal, NP and OP swabs collected from any individual, including individuals without symptoms or other reasons to suspect COVID-19 infection. Pooled samples containing up to 5 individual upper respiratory specimens (i.e., nasal, NP, and OP swabs) that are collected by an HCP|
|Result||Cycle number/not detected|
|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|
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