Description

The SARS-CoV-2 (COVID-19) Rapid Antigen Test enables fast decision making e.g. whether patients need to be put in quarantine, reducing the risk of further spreading. In addition to that it allows for screening of individuals after confirmed exposure to a SARS-CoV-2 (COVID-19) infected person or individuals at risk of exposure such as healthcare workers.

Included In Each Box (25 Packs Per Box)

Each kit contains 25 individually packaged, ready to use tests containing all equipment needed to perform a test, and comprises of:

▪ Test device – individual foil wrapped with desiccant
▪ Extraction buffer tube
▪ Sterile swab and Nozzle cap
▪ Film (to attach to test device to facilitate outdoor testing)
▪ Instructions for use and Quick Reference Guide

Technical Specification:

Test Sample Type: Nasopharyngeal

Detailed Technical Information –

SARS-CoV-2 Rapid Antigen Test characteristics

▪ Assay format: Lateral flow test / immunochromatographic
▪ Instrument: No
▪ Testing time: 15-30 minutes
▪ Specificity: 99.2%
▪ Sensitivity: 96.52% (Ct value ≤ 30)
▪ Antigen: N
▪ Sample material: Nasopharyngeal Swab
▪ Reagents: mAb anti-COVID19 antibody, mAb anti-Chicken IgY, mAb anti-COVID-19 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate

Tested against new variants
The Roche Antigen Tests have been checked against the new Indian variant including B.1.617.1 and B.1.617.2 and are suitable for detecting these SARS-CoV-2 variants. The tests have also been checked against Kent B.1.1.7 lineage, South Africa B.1.351 and Brazil P.1 lineage.

Meets requirements for Pre-Departure Testing
Roche confirm that the SARS‐CoV‐2 (COVID-19) Rapid Diagnostic Antigen Test meets the standards for pre-departure testing of ≥97% specificity, ≥80% sensitivity at viral loads above 100,000 copies/ml, when this test is provided by a Government approved test site.

Strictly for professional use only