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ALINITY m SARS-CoV-2 ASSAY

ALINITY m SARS-CoV-2 ASSAY image
ALINITY m SARS-CoV-2 ASSAY image
ALINITY m SARS-CoV-2 ASSAY image

Alinity m SARS-CoV-2 assays run on the Alinity m system which offer workflow efficiency and the high throughput solution for testing specimens from symptomatic and asymptomatic patients the laboratory requires today.  Together with broad sample type claims including pooling, laboratories are empowered to meet their public health needs to diagnose or screen for COVID-19.

  • Simple workflow with primary sample tube loading and true random access powered by ReadiFlex Technology provide operational efficiencies to address fluctuating testing demands 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.
VIEW ORDERING INFORMATION
INTENDED USE (09N78-091)

The Alinity m SARS-CoV-2 assay is a reverse transcription polymerase chain reaction (RT-PCR) test for use with automated Alinity m System for the qualitative detection of nucleic acid from SARS-CoV-2 from patients with or without signs and symptoms of COVID-19 infection in the following specimen types:

  • individual nasopharyngeal (NP) swabs and oropharyngeal (OP) swabs collected by a healthcare provider (HCP)
  • individual nasal swabs self-collected under HCP supervision or collected by HCP
  • individual saliva specimens collected under HCP supervision, and 
  • pooled samples containing aliquots of transport media from up to 5 individual nasal, NP, and OP swabs specimens.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable 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. Negative results from pooled testing should not be treated as definitive. If 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 clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

INTENDED USE (09N78-090)

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.

ABBOTT ALINITY m SARS-COV-2 ASSAY SPECIFICATIONS1-4
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)
Assay Design Dual-target, single-stranded linear probe
Target Region RdRp and N-genes
Specimen Types

09N78-091 - Nasopharyngeal swabs, oropharyngeal swabs, nasal swabs, saliva, and pooled samples containing aliquots of transport media from up to 5 individual nasal, NP, and OP swabs. (Symptomatic and asymptomatic patients)

09N78-090 Nasopharyngeal and oropharyngeal swabs (Symptomatic patients)
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 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

09N78-091 Recombinant Virus in SNM and Saliva*: 100 virus copies/mL; CGIV** in NP and Nasal Swab: 0.009; TCID50 /mL (or 55 GE/mL); CGIV** in Saliva: 55 GE/mL

09N78-090 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/R1.  2. Alinity m SARS-CoV-2 CTRL Kit PI: 53-608194/R1. 3. Alinity m Operations Manual 54-605001/R10. 4. Alinity m SARS-CoV-2 AMP Kit with Claim Extension PI 53-608278/R1.
* Simulated Nasal Matrix  ** Cultured Gamma-Irradiated Virus

Link to WHO's interim guidance on COVID-19 Testing:  

https://apps.who.int/iris/handle/10665/331329

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