High-throughput SARS-CoV-2 Antigen AssaysLab-based antigen testing for rapid virus detection: Time to first result in as little as 26 minutes
SARS-CoV-2 antigen testing has emerged as an important tool to support molecular RT-PCR diagnostic testing in the fight against COVID-19. High-throughput antigen assays help to verify infection quickly so that healthcare providers can begin treatment immediately or initiate isolation precautions to prevent further spread of infection. Improve your confidence in SARS-CoV-2 mass screening with a high-throughput, central lab-based antigen assay that can quickly provide accurate results in at-risk individuals, including patients who are asymptomatic or in the early stage of the disease.
The SARS-CoV-2 Antigen Assays are now available on the Atellica® IM Analyzer and ADVIA Centaur® XPT/XPT Systems:- Helps you gain time, confidence, and resources back while increasing testing capacity.
- Quickly detects positive cases, allowing timely follow-up and implementation of protective measures.
- Protects your laboratory staff by inactivating the virus with a pretreatment.
Assay Details
**Dependent on test mix
Clinical Sensitivity†
Comparative PCR Method (Ct<30)
Clinical Specificity†
Comparative PCR Method (Ct<30)
Why Antigen Testing
Since the beginning of the COVID-19 pandemic, nucleic acid amplification tests (NAATs) such as PCR tests have been used to detect the virus. But in many countries, shortages of laboratory-based molecular testing have been challenging, and prolonged turnaround times for NAATs may preclude their clinical utility.
High-throughput SARS-CoV-2 antigen (Ag) assays:
- Play a significant role in early detection and isolation of positive cases
- Reduce the time to reportable results compared to lab-based PCR testing
- Can be used as an alternative method if PCR is not available
We are committed to support frontline and healthcare professionals and help them to deliver high-value critical care to patients at each stage of COVID-19 disease management: diagnosis, prognosis, therapy, and follow-up. Learn more.
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†Nasopharyngeal swab samples were collected in UTM or VTM and stored frozen between the time of collection and testing. Samples were thawed and inactivated using the CoV2Ag Sample Lysis Reagent and tested with the CoV2Ag assay using the Atellica IM Analyzer and ADVIA Centaur XP/XPT Systems. Relative sensitivity was determined by comparing the CoV2Ag assay using the Atellica IM Analyzer and the ADVIA Centaur XP/XPT systems to the comparative FDA EUA RT-PCR method for a population of samples from symptomatic and asymptomatic patients that tested positive with the comparative RT-PCR method.
PCR-negative nasopharyngeal swab samples obtained in tubes containing VTM, UTM, or liquid Amies transport medium were tested with the Atellica IM and ADVIA Centaur CoV2Ag assay, using the Atellica IM Analyzer and ADVIA Centaur XP/XPT Systems. Relative specificity was determined by comparing the CoV2Ag assay using the Atellica IM Analyzer and the ADVIA Centaur XP/XPT Systems to the comparative RT-PCR method.
* This test has not been reviewed by the FDA. In the U.S., use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements
References
1. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: interim guidance. https://apps.who.int/iris/handle/10665/334253. 11 Sept 2020.