Key Words: NewScen HCV Antibody Rapid Test, CE IVDD HCV Rapid Test Kit, HCV Rapid Test Kit Manufacturer China
Sample type: Serum, Plasma, or Whole Blood
Detection type method: Qualitative Colloidal Gold
Usage/Application: For professional laboratory use only
Format: Cassette
Certificate: CE (EU IVDD | IVDR in Progress) / NMPA (China) / ISO 13485
Sensitivity: 99.76%
Specificity: 100.00%
Reading time: 15-30 minutes
Packaging Details: 1 / 40 Tests per Kit (customizable)
Description
1. Product Advantages:
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CE certified by TÜV SÜD — highest regulatory standard for HCV rapid tests
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IVDR clinical evaluation: 99.76% sensitivity, 100.00% specificity
WHO evaluation result: 100.00% sensitivity, 98.70% specificity -
Technical Superiority — simultaneously detect IgG, IgM, IgA
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Early detection — detects infection as early as 7 days, eariler than the benchmark assay
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Room-temperature storage (4–30 °C), no instrument required — easy to use and ideal for field screening
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Multiple formats (1 / 40 tests) available for professional use
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ISO 13485 & NMPA certified manufacturing quality
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Proven performance in CDC and government screening programs
2. For more detailed information, please refer to the NewScen Product Catalogue [2026]
