HIV Rapid Test Kits

Form: Serum or Plasma-Based Test Kits

Strength: sensitivity and specificity.: 99-100%

Reference Brands: Bio-Rad HIV 1/2, Abbott Architect, Gallo HIV Combo(US)

Category: Rapid Test Kits

HIV serum/plasma-based tests in the EU and US require strict regulatory approval. In the EU, these tests must comply with CE marking standards, ensuring safety and efficacy. In the US, FDA approval or Emergency Use Authorization (EUA) is mandatory. A comprehensive dossier, including clinical validation data, manufacturing details, and quality assurance, is essential for approval. Reliable test kits enhance early HIV detection, improving patient outcomes. For expert guidance on regulatory compliance and to access validated products, visit Pharmatradz. Ensuring adherence to these standards helps manufacturers succeed in global markets while maintaining high quality and safety standards.