Quality of HIV laboratory testing in Tanzania: a situation analysis.

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.

Quality of HIV laboratory testing in Tanzania: a situation analysis

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 tnternal 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

The determination of safety of Muhanse M4, a traditional herbal preparation used to treat HIV/AIDS-related conditions and diseases in Tanzania.

Muhanse M4 is a traditional herbal preparation that has been in use in Tanzania for the past 17 years to improve the quality of life among people living with HIV/AIDS. This study was carried out to determine the safety of the extract Muhanse M4 in animal models. The qualitative test to identify alkaloids and saponins compounds was carried out. The toxicity tests in Swiss albino mice and rats were done according to WHO guidelines of 1993. Muhanse M4 was dissolved homogeneously in distilled water and was administered both intraperitonially and orally for 14 days for sub-acute test and 24 hours for acute test. Qualitatively, the extract was found to contain no alkaloids or saponins. In rats intraperitoneal doses that caused 100% lethality were 758.55 mg/kg and 553.7415mg/kg when administered singly and repeated, respectively. Single oral dose up to 3034.200mg/kg did not cause any death in the tested mice or rats. NOEL during intraperitoneal repeated doses for liver in rats was 424.788mg/kg, and NOAEL was 455.130mg/kg. In rats LD10%, LD50% and LD100% were 485.472mg/kg, 526.4337mg/kg and 553.7415mg/kg, respectively. In conclusion, Muhanse M4 extract is considered to be safe in laboratory animals.