Key Words: NewScen HIV (1+2) Tri-Line Rapid Test, CE IVDR Class D HIV Rapid Test Kit, HIV Rapid Test Kit Manufacturer China
Sample type： Serum, Plasma, or Whole Blood
Detection type method： Qualitative Colloidal Gold
Usage/Application: For professional use in clinical laboratories, hospitals, private clinics, pathology centers, public health programs, community screening projects, and government tenders or procurement channels.
Format: Cassette, Uncut sheet for OEM
Certificate: CE (IVDR Class D, EU) / NMPA (China) / ISO 13485
Sensitivity: 100%
Specificity: 99.82%
Reading time: 15-30 minutes
Packaging Details: 1 / 2 / 5 / 25 / 40 Tests per Kit (customizable)
Description
1. Product Advantages:
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CE IVDR Class D certified by TÜV SÜD — highest regulatory standard for HIV rapid tests.
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IVDR clinical evaluation: 100% sensitivity, 99.8% specificity
WHO evaluation report: 100% sensitivity, 100% specificity -
Tri-line differentiation design distinguishes HIV-1, HIV-2, and dual infections.
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Early detection — detects infection as early as 7 days, ahead of most competitors
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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 / 2 / 5 / 25 / 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 detailed test procedure, interpretation, and precautions, please refer to the Instructions for Use
