HIV Rapid Test Kits Suppliers & Bulk Manufacturers

Available Forms: Serum or Plasma-Based Test Kits

Available Strengths: sensitivity and specificity.: 99-100%

Reference Brands: -

Category: Rapid Test Kits

HIV-1/2 rapid test kits for serum or plasma, in vitro diagnostic immunoassays for laboratory and hospital testing programmes. For IVD distributors, ministries of health and donor-funded tender buyers.

Product Description:

HIV rapid test kits are in vitro diagnostic devices, not medicines. Most are lateral flow or flow-through immunoassays: serum or plasma runs across a membrane coated with HIV antigens, and antibodies to HIV-1 and HIV-2 produce a visible test line beside a control line. Some kits also detect p24 antigen to shorten the window period. This page covers kits validated for serum or plasma, suited to laboratories that already separate blood. Fingerstick whole-blood kits are separate products.

The result is read by eye at the time stated in the instructions for use; readings taken too early or too late are invalid. A reactive result is never a diagnosis on its own. National algorithms based on WHO guidance combine two or three different assays in sequence before anyone is told they are HIV positive. A non-reactive result soon after exposure may fall in the window period, so retesting rules apply. Users need training, a timer, gloves and biohazard waste disposal.

Sourcing notes. For UN, Global Fund and other donor-funded tenders, WHO prequalification of the IVD is usually the first criterion. Most countries also require national IVD registration; in the EU, HIV tests sit in the highest-risk class under the IVD Regulation. Take sensitivity and specificity only from the instructions for use and independent evaluations, not from offers. Storage range and shelf life vary by kit, so check transport needs for hot climates. Ask for a lot-specific CoA, the ISO 13485 certificate and the IFU in the local language. Specify sample type, pack size, accessories and quantity.