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COVID-19 Antibody Test

  • Product Features
  • Serological testing for the presence of IgG and IgM antibodies against SARS-CoV-2 is an important step to determine if an individual has had prior exposure to the virus which causes Covid-19.1
  • The Realy Tech Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG & IgM antibodies specifically against SARS-CoV-2 in human whole blood, serum or plasma.
  • Point-of-care finger prick test
  • CE marked
  • Manufactured by Hangzhou Realy Tech, China Independently validated using positive & negative blood samples against CMIA reference method
  • Sensitivity IgG 99%, IgM 98%
  • Specificity IgG 100%, IgM 99%
  • 10-15 minute result
  • Virus Tracing App included

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The Realy Tech Rapid Test Device has been independently clinically validated and has shown very high levels of Sensitivity,
(IgG 99%, IgM 98%)2 and Specificity (IgG 100%, IgM 99%)3 indicating it’s suitability as a reliable test method.
The test has also been analytically validated with favourable results for precision, stability, robustness and cross reactivity,
among others.4
The test has been produced in an ISO13485 approved factory and carries the CE mark of approval. In
accordance with the European Commission working document on the performance of Covid-19 test methods, (16th April
2020) the most critical performance parameter for identifying persons who have developed an immune response against
SARS CoV-2 is diagnostic specificity.5
The Realy Tech Rapid Test Device performs strongly against the European guideline
with Specificities of 99% IgM and 100% IgG, thereby minimising the possibility of false positive test results

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