Protocol for the collection, storage and transportation of samples to evaluating laboratory (MHL & CIIMS ARC) and the conduct of the clinical and analytical performance evaluation of immunochromatographic assay - HIV 1 & 2 Antibody Test Kit, Hepatitis B Surface Antigen (HBsAg) Test Kit, Syphilis Antibody Test Kit.

The study will include participants from various categories and clinical conditions, ensuring that the IVD test is evaluated across a broad spectrum of cases. This will include subjects with confirmed positive results for HIV-1, HIV-2, HBsAg and Syphilis. Additionally, the study will involve negative samples from pregnant women, subjects with autoimmune diseases such as rheumatoid factor or systemic lupus erythematosus, and those with other cross-reacting agents. Hospitalized subjects and unselected blood donors, including first-time donors, will also be included. Participants will be screened by healthcare professionals to ensure they meet the study’s inclusion and exclusion criteria for their respective disease group (HIV, HBsAg, or Syphilis). Eligibility will be determined based on relevant risk factors or clinical indicators, and informed consent will be obtained before participation. Upon enrollment, trained phlebotomists will collect blood samples from each participant following standard venipuncture procedures. The blood samples will be collected using EDTA, citrate, or heparin tubes for plasma separation, ensuring the prevention of clotting, and plain tubes for serum collection. Each specimen will be clearly labeled with a unique patient identification code, along with the date of collection, to ensure proper traceability throughout the study. Once collected, the blood samples will be transported to a MHL laboratory under strict temperature-controlled conditions. The MHL laboratory will be equipped with necessary resources to maintain the appropriate storage and processing environment, ensuring that the samples remain viable for testing. Upon arrival, the samples will be logged into the laboratory management system, where the unique identification numbers will be used to track the specimens throughout the testing process. In the MHL Laboratory the validation process will be initiated.