Quality of HIV laboratory testing in Tanzania: a situation analysis

Abstract

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.

Keywords: HIV, diagnosis, laboratory tests, quality control, Tanzania

Tanzania Health Research Bulletin Vol. 9 (1) 2007: pp.44-47