High-throughput SARS-CoV-2 Antigen Assay

High-throughput SARS-CoV-2 Antigen Assays

Lab-based antigen testing for virus detection: Time to first result in as little as 26 minutes

The COVID-19 pandemic has placed immense pressure on clinical laboratories on the front line of diagnosing SARS-CoV-2 infections. Shortages in diagnostic resources, tools, and capacity have limited the amount of testing labs can offer to their communities. Due to the highly contagious nature of this virus, and particularly the Omicron variant, and the mode of transmission, the need for additional, less-complex testing solutions is clear.

SARS-CoV-2 antigen testing has emerged as a potential tool to support molecular RT-PCR diagnostic testing in the fight against COVID-19, and high-throughput SARS-CoV-2 antigen testing can help laboratories increase their SARS-CoV-2 diagnostic testing capacity to identify currently infected persons.


Now available on the Atellica® IM Analyzer and ADVIA Centaur® XP/XPT Systems*, with over 9,000 high-throughput analyzers worldwide1

  • Gain back time, confidence, and resources while increasing testing capacity.
  • Quickly detect positive case, allowing protective measures and appropriate follow up.
Atellica IM 1300 Analyzer,  Atellica IM 1600 Analyzer

Atellica IM SARS-CoV-2 Antigen Assay

Time to first result: 26 minutes2
200 tests per hour3

ADVIA Centaur XPT Immunoassay System

ADVIA Centaur SARS-CoV-2 Antigen Assay

Time to first result: 28 minutes2
125 tests per hour3

Anterior nasal swab samples from symptomatic patients

System

Reactive

Nonreactive

Sensitivity

95% Interval

Atellica IM Analyzer

40

7

85.11%

72.31-92.59%

ADVIA Centaur XP/XPT Systems

40

7

85.11%

72.31-95.59%

Anterior nasal swab samples from symptomatic patients

System

Reactive

Nonreactive

Sensitivity

95% Interval

Atellica IM Analyzer

0

119

100%

96.78-100%

ADVIA Centaur XP/XPT Systems

0

119

100%

96.85-100%

Clinical Agreement

Positive percent agreement and negative percent agreement were determined by testing a total of 166 anterior nasal (AN) swab samples in accordance with CLSI Document EP12-A2. Samples were collected from 68 male and 98 female symptomatic individuals suspected of COVID-19, with one or more confirmed symptoms based on CDC guidelines, and were enrolled sequentially (all-comers). All samples were collected between January and February 2022. Of the 47 RT-PCR positive samples, 44 were confirmed as the Omicron variant using next-generation sequencing and 3 samples failed sequencing due to an insufficient quantity of viral material.

The samples were collected in Sample Inactivation Media refrigerated from the time of collection and tested with the Atellica IM CoV2Ag assay (n=166) and ADVIA Centaur CoV2Ag assay (n=165) using respectively the Atellica IM Analyzer and the ADVIA Centaur XP/XPT systems. The results were compared to FDA EUA RT-PCR results.

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