Mfinanga GS, Mutayoba B, Mbogo G, Kahwa A, Kimaro G, Mhame PP, Mwangi C, Malecela MN, Kitua AY. Quality of HIV laboratory testing in Tanzania: a situation analysis. Tanzan Health Res Bull. 2007 Jan;9(1):44-7.

UNAIDS/G.Pirozzi
Tanzania is scaling up prevention, treatment, care and support of individuals affected with HIV. There is therefore a need for high quality and reliable HIV infection testing and AIDS staging. The objective of this study was to assess laboratories capacities of services in terms of HIV testing and quality control. A baseline survey was conducted from December 2004 to February 2005 in 12 laboratories which were conveniently selected to represent all the zones of Tanzania. The questionnaires comprised of questions on laboratory particulars, internal and external quality control for HIV testing and quality control of reagents. Source and level of customer satisfaction of HIV test kits supply was established. Of 12 laboratories, nine used rapid tests for screening and two used rapid tests for diagnosis. In the 12 laboratories, four used double ELISA and five used single ELISA and three did not use ELISA. Confirmatory tests observed were Western Blot in three laboratories, DNA PCR in two laboratories, CD4 counting in seven laboratories, and viral load in two laboratories. Although all laboratories conducted quality control (QC) of the HIV kits, only two laboratories had Standard Operating Procedures (SOPs). Internal and external quality control (EQC) was done at varied proportions with the highest frequency of 55.6% (5/9) for internal quality control (IQC) for rapid tests and EQC for ELISA, and the lowest frequency of 14.3% (1/ 7) for IQC for CD4 counting. None of the nine laboratories which conducted QC for reagents used for rapid tests and none of the five which performed IQC and EQC had SOPs. HIV kits were mainly procured by the Medical Store Department and most of laboratories were not satisfied with the delay in procurement procedures. Most of the laboratories used rapid tests only, while some used both rapid tests and ELISA method for HIV testing. In conclusion, the survey revealed inadequacy in Good Laboratory Practice and poor laboratory quality control process for HIV testing reagents, internal and external quality control.
Editors’ note: The case of a man whose marriage plans were annulled as a result of a false positive HIV test result underscores the importance of observing Good Laboratory Practice and instituting quality control procedures. This type of situation analysis needs to be conducted in all countries.
Bell E, Mthembu P, O’sullivan S; on behalf of the International Community of Women Living with HIV/AIDS, Moody K; on behalf of the Global Network of People with HIV/AIDS. Sexual and reproductive health services and HIV testing: perspectives and experiences of women and men living with HIV and AIDS. Reprod Health Matters 2007;15:113-35.
All over the world HIV has been stigmatised, making it difficult for people living with HIV to access testing, treatment, care and counselling or even to act on a diagnosis or get advice and treatment, for fear of being judged. Prejudice in society has also often been reflected and reproduced by health care providers. A human rights approach, which positively incorporates sexual and reproductive rights, rather than a restricted medical view, is therefore essential for the achievement of true partnerships between health care providers and service users. This paper is about the experiences of HIV positive women and men in sexual and reproductive health services and HIV testing. It provides guidance not only on how things could and should be done but also on how they should not be done. It outlines the sexual and reproductive rights positive people consider crucial and gives examples of how these are being violated. It presents perceptions and implications of HIV testing and how health services can support people after a positive diagnosis. It analyses the importance of confidentiality, continuity of care, knowledge and information, and the role of support groups and home-based care. It calls on sexual and reproductive health services to address issues of stigma and discrimination when offering and carrying out HIV testing and counselling, and in providing treatment, care and support.
Editors’ note: This paper highlights perspectives of people living with HIV which can help guide best practices in HIV testing, treatment, care and support. Stigma is a huge barrier to care, treatment, and support worldwide, and addressing this barrier will allow improved access, not merely improved offering or availability, of care, treatment, and support.
Lee VJ, Tan SC, Earnest A, Seong PS, Tan HH, Leo YS. User acceptability and feasibility of self-testing with HIV rapid tests. J Acquir Immune Defic Syndr 2007;45:449-453.
Because HIV rapid tests are considered for self-testing, this study aims to determine the user acceptability and feasibility of self-testing. A cross-sectional study was performed on 350 systematically sampled participants across 2 Singapore HIV testing centers using the Abbott Determine HIV 1/2 blood sample rapid test (Abbott Laboratories, Abbott Park, IL). Participants were surveyed on knowledge of and attitudes toward rapid testing. To determine interrater agreement between self-testing and trained personnel testing, participants performed self-testing with visual instructions, followed by trained personnel testing. Ability to identify test outcomes was determined through interpretation of sample test results. Eighty-nine percent of participants preferred testing in private, but most indicated that confidential counselling by trained counsellors was necessary. Almost 90% found the kit easy to use and instructions easy to understand. Nevertheless, 85% failed to perform all steps correctly, especially blood sampling, and 56% had invalid results because of incorrect test performance. Interrater agreement between results from self-testing and trained personnel testing had a kappa value of 0.28. Twelve percent could not correctly determine results using sample tests, including 2% and 7% who read positive and negative samples, respectively, incorrectly. A substantial proportion could not perform self-testing or identify outcomes. Self-testing with the Determine HIV 1/2 kit in Singapore should be deferred.
Editors’ note: Although self-testing with rapid tests has the advantages of convenience and anonymity, high levels of inappropriate usage may cause more harm than good. In this study, most participants wanted the support of a trained counsellor which can reduce misunderstandings and alleviate stress/fear. Self-testing test performance will have to improve dramatically before it can be recommended.
Ou CY, Yang H, Balinandi S, Sawadogo S, Shanmugam V, Tih PM, Adje-Toure C, Tancho S, Ya LK, Bulterys M, Downing R, Nkengasong JN. Identification of HIV-1 infected infants and young children using real-time RT PCR and dried blood spots from Uganda and Cameroon. J Virol Methods. 2007 Jun 4; [Epub ahead of print]
Serodiagnosis of HIV infection in infants born to HIV-infected mothers is problematic due to the prolonged presence of maternal antibodies in infants. Nucleic acid-based amplification assays have been used to overcome this problem. Here a simplified, one-tube, real-time, duplex reverse transcription PCR (RT PCR) assay is shown to detect HIV-1 total nucleic acid (TNA) isolated from dried blood spots. The detection of TNA, as opposed to DNA alone, increases the HIV target molecules and thus makes the assay more robust. This method was used to detect HIV from the DBS collected from HIV-1 exposed infants and young children in Uganda (n=128) and Cameroon (n=315). The gold-standards used were a plasma viral assay in Uganda and Amplicor DNA assay in Cameroon. The concordance of this real-time assay and the gold standards was 99.2% (127/128) and 99.4% (313/315) with the Ugandan and Cameroonian samples, respectively. This simple and cost-effective assay is potentially useful for the diagnosis of paediatric HIV infection and for evaluating programs to reduce mother-to-child transmission of HIV-1.
Editors’ note: Early diagnosis of paediatric HIV infection permits tailored care with closer monitoring to determine eligibility for antiretroviral treatment, continuation of cotrimoxazole prophylaxis, and nutritional counselling.
August 12th, 2008 at 7:54 am