Ortho SARS-CoV-2 Antigen Test CE Marking

Ortho Clinical Diagnostics is proud to announce the availability of VITROS® Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack and Calibrator* available on VITROS® XT 7600/5600 Integrated Systems and VITROS® 3600 Immunodiagnostic Systems. Ortho has achieved CE Mark for this test and is now available to order.

Laboratories across the world have been tasked with the responsibility of delivering critical test results during the most important health crisis in a generation.  At the beginning of this pandemic, Ortho leveraged its legacy of developing best-in-class infectious disease tests and brought to you two COVID-19 antibody tests (Total and IgG) that help assess immune response.  Now, Ortho is answering the call for high-throughput infection testing by introducing the VITROS® SARS-CoV-2 Antigen test for diagnosing infection in both symptomatic and asymptomatic individuals.

This highly accurate test delivers excellent sensitivity and specificity and is now available on the high-throughput, random access, fully automated VITROS® Systems.  The VITROS® SARS-CoV-2 Antigen test is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen to identify infection and offers:

This highly accurate test delivers excellent sensitivity and specificity and is now available on the high-throughput, random access, fully automated VITROS® Systems. The VITROS®SARS-CoV-2 Antigen test is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen to identify infection and offers:

  • High Sensitivity: 97.8% (95% CI: 88.5-100%) tested on 46 RT-PCR confirmed positive samples collected from 1-5 days of symptom onset and 100% (95% CI: 92.0-100%)concordance to <32 CT (PCR Cycle Count) -making it a viable alternative to PCR testing.
  • High Specificity: 99.2% specificity (95% CI: 95.8%-100%) tested on 131 RT-PCR confirmed negative samples –so results can be trusted.
  • Simple Sample Preparation: for Nasopharyngeal (NP) swabs in transport media for symptomatic patients and mid-turbinate swabs for asymptomatic patients.
  • Easy Results Interpretation: with reactive and non-reactive results and no gray zone or repeat testing -to significantly impact workflow advantages during the pandemic.

Test performance is enhanced by the proprietary technologies and the benefits are ONLY available on VITROS® Systems, enabling consistently fast, accurate and reliable results.

 

Enclosure: Assay Readiness Guide

*Product Availability Subject to Regulatory Approval

Ref. CL2020-295_ce_announcment