Molecular

Alinity m SARS-CoV-2 Assay

Alinity m SARS-CoV-2 assay runs on the Alinity m system which offers workflow efficiency and the high throughput solution the laboratory requires today to meet the public health need:

Simple workflow with primary sample tube loading provides operational efficiencies to curb the increasing testing volume with the existing lab staff.
Dual target design within highly conserved target regions of the virus ensures detection of current strain and safeguards against viral evolution. (Learn more on the SARS-CoV-2 variant detection, click here)
Simple and clear result reporting to aid clinicians with patient management.

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Product Details

INTENDED USE

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.

specifications

ABBOTT ALINITY m SARS-CoV-2 ASSAY Specifications^1-4
Technology	Qualitative Multiplex 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)
Limitation 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).