In Stock

Roche SARS‐CoV‐2 (COVID-19) Rapid Diagnostic Antigen Test x25

Rating:
98.462% of 100
SKU:
ROC-09327592190
MPN:
09327592190
£206.40 £172.00
  • 2 Qty £204.00 £170.00
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  • 5 Qty £201.60 £168.00
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  • 10 Qty £198.00 £165.00
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  • 25 Qty £194.40 £162.00
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Same day delivery is available for London and the South East.  Please email sales@primarycaresupplies.co.uk for a quote.

This Roche Antigen testing kit facilitates the detection of COVID-19 with rapid return of results.

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.

 

Benefits

  • Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result
  • Easy handling which does not require specific training
  • No instrument required
  • Allowing decentralized testing or access to testing in areas where laboratory testing is not available

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

Features 

  • Five simple steps, with results after 15 minutes
  • Quick and Easy to read result
  • Excellent performance, Sensitivity 96.52% (Ct Value ≤ 30) and Specificity 99.2% 
  • CE Marked and MHRA approved test kits

Sensitivity: the ability of a test to correctly identify patients with a disease

Specificity: the ability of a test to correctly identify people without the disease

This product is strictly intended for professional use.

 

UK Government Tested

This product has been evaluated by the Government against the new Covid-19 variant summarising that the Roche test detects the new variant containing four amino acid changes from the original viral sequence.

https://www.gov.uk/government/publications/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-vui-20201201/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-vui-20201201

 

External Clinical Evaluations

The main objective of the below presentation is to summarize key publications that deal with real world performance of the SARS-CoV-2 Rapid Antigen Test.

Additionally, factors that influence assay performance are described.

This presentation will be updated regularly.

SARS-CoV-2 Rapid Antigen Assay Clinical Performance

Summary of Conclusions:

  • 14 studies presented with over 9’300 patient samples
  •  The sensitivity of the Roche / SD Biosensor POC Antigen assay was between 96.2 to 100% with a CT that is
    considered to be associated with culture positive results. *
  •  If the specimens are obtained ≤7 days after symptom onset for use with the Rapid Antigen test, it can help to
    filter out the infected persons and prevent spread to the others.
  • First real world performance data confirms the primary use case for POC assay, however, more and larger
    studies are needed

*The data from Uganda are not considered due to great discrepancy of the Ct values and categorization compared to all other republications.

This item line is exempt from our usual returns policy. This item is non-returnable or exchangeable.

Technical Specification

Brand - Roche
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.  https://www.gov.uk/guidance/travel-abroad-from-england-during-coronavirus-covid-19

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