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.
Positive percent agreement with FDA EUA RT-PCR method (47 positive samples)
Anterior nasal swab samples from symptomatic patients
Negative percent agreement with RT-PCR method (negative samples)
Anterior nasal swab samples from symptomatic patients
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.