recomCLIA HEV

High-performance Hepatitis E virus serology for routine use
Fast. Automated. Precise – for the highest standards in routine diagnostics on the KleeYa®

The Mikrogen recomCLIA HEV tests rely on state-of-the-art chemiluminescence immunoassay (CLIA) technology. We have developed our highly specific quantitative IgG and semi-quantitative IgM tests for this purpose. These enable a precise, reliable and modern diagnostic solution.
The specially developed antigen design ensures comprehensive coverage of relevant HEV genotypes and enables the reliable detection of both travel-related and zoonosis-associated infections.

The recomCLIA HEV assays are characterised by their precise detection of IgG and IgM antibodies, making them the ideal choice for screening and diagnostic support in cases of suspected HEV infection – always in conjunction with other laboratory and clinical findings.

Our product range for you

Reagents for 100 determinations
Article no.: 75004 Request
*recomCLIA Sample Diluent A is required for sample dilution.
Reagents for 100 Determinations*
Article no.: 75005 Request
Reagents for 2x50 determinations
Article no.: 75002 Request
Reagents for 2x50 determinations
Article no.: 75003 Request
2x200 sample dilutions
Article no.: 10120 Request

Why recomCLIA HEV?

  • State-of-the-art CLIA technology – fast, safe, accurate
  • Seamlessly compatible with the KleeYa® high-throughput system (random access)
  • Quantitative IgG or semi-quantitative IgM detection for maximum precision and reliability of results
  • Coverage of all relevant hepatitis E virus genotypes
  • Highest specificity and sensitivity based on our highly purified, recombinant antigen
  • Highest measurement accuracy through reliable calibration with long-term stability
  • IgG kit with two calibrators validated based on the WHO standard (National Institute for Biological Standards and Control [NIBSC] code 95/584)
  • LIS/middleware connection with bidirectional communication
  • IVDR-compliant and CE marked
Sample matrix:Serum, Plasma
Sample volumen:IgG: 13µl | IgM: 22µl (plus max. 150µl Dead volume in the device)
Sample throughput:up to 120 Tests/h
Sensitivity:IgG: 97.4% | IgM: 97.5%
Specifity:IgG: 100% | IgM: 94.7%
Stability:12 Month
Calibration:Every 14 days (IgG) or daily (IgM)
  

Flexible. Compatible. Efficient.

CLIA assay for open random access testing platform for up to 16 parallel assays with up to 120 tests/hour.

Simple. Fast. Secure.

Less than 10 minutes of hands-on time per day, first test result after 30 minutes, direct data transfer to the LIS

Ideal for...

Laboratories focusing on throughput, efficiency, and reproducibility.