Mashauri FM, Siza JE, Temu MM, et al. was validated in Bangladesh in 2005 and the guidelines [9] are in effect as at the time of this study. There are several limitations Stiripentol associated with the implementation of the national HIV rapid test algorithm with serum in Bangladesh. These limitations include the cost and delicate instrumentation required Stiripentol for serum-based testing, maintenance of cold chain, unstable source of electricity, and difficulties related to external quality assessment (EQA) [10]. These challenges contribute to the low coverage of HTC, especially among KAP in Bangladesh. In 2013, less than one in four KAP know their HIV status [11]. There is therefore, an immediate need to simplify the procedure for HTC to expand HIV diagnosis and linkage to HIV prevention, treatment, and care in Bangladesh. This study explored the operational Stiripentol feasibility of using whole blood as alternative to serum for rapid HIV testing in Bangladesh. The study was premise upon the WHO recommendation [12] to use whole blood or oral fluid as alternatives to serum for rapid testing of HIV. The authors assumed that using whole blood may reduce cost and ease the procedure of HTC support in Bangladesh. METHODS Study design and selection criteria The observational study was conducted between October and December 2014 and involved two categories of study participants. Overall, there were 400 study participants subdivided into 200 serologically confirmed HIV-positive individuals (group I) and another 200 individuals who were unfavorable for HIV antibody (group II). The sample size is consistent with the recommendation by WHO and UNAIDS [12] to collect approximately 100 HIV antibody-positive specimens and 200 HIV antibody-negative specimens per site for the evaluation of rapid HIV testing kits. All the study participants were selected from the national virology reference Stiripentol laboratory at the Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh. Blood specimen for study participants in group I were collected Rabbit Polyclonal to BTLA alongside laboratory test for measurement of CD4+ T lymphocyte from PLHIV presenting at the reference laboratory until the required sample was reached. In Bangladesh, CD4 T-lymphocyte count is a routine laboratory test to measure response to antiretroviral treatment in PLHIV. Specimens from the study participants of group II were collected from HIV-negative individuals who were referred from outpatient clinics to the reference laboratory. The specimens in group II were randomly selected and confirmed through anti-HIV ELISA test (ANI Lab systems, Finland). Determination of test performance and cost Whole blood specimens were collected from all the study participants and subjected to three HIV rapid test kits, that is, Alere Determine HIV-1/2 (Alere, United States) as A1, Uni-Gold Recombigen HIV-1/2 (Trinity Biotech, Ireland) as A2 and First Response HIV Test 1C2.0 (PMC Medical, India) as A3. The results were interpreted according to manufacturer’s instructions by a laboratory technologist followed by verification of a clinical virologist. In addition, we estimated the cost of providing rapid HIV test using serum and whole blood, and compared the costs of the two approaches. The cost items were classified into four categories, namely, permanent logistics, consumables, cost for EQA, and administrative cost. The permanent cost calculated in this study includes the cost of purchase of gear and materials required to establish an HTC support centre in Bangladesh. The salary of HIV Stiripentol counsellor and laboratory technologist was included as administrative cost. The analysis did not include the cost for utilities and maintenance of.