Evaluation of an External Quality Assessment Program for HIV Testing in Tigray North Ethiopia 2016

Point-of-care diagnostic tests (POCTs) are increasingly used in both developing and developed countries ¹. They allow same day testing and treatment at remote locations where no laboratory support is available. Quality control measures, which are routinely used in laboratories, have not been widely implemented for POCTs. The World Health Organization and US Centers for Disease Control and Prevention advocates the implementation of POCT with a quality assurance method in place ².

The World Health Organization (WHO) defines External Quality Assessment (EQA) as a system for objectively checking a laboratory’s performance using an external agency or facility ³. EQA participation is associated with improved laboratory performance over time and is a requirement for accreditation ⁴. However, many professionals in Sub-Saharan Africa (SSA) countries are unable to effectively implement quality improvement programs and many countries remain without an accredited clinical laboratory ⁵. Establishing, maintaining and demonstrating the accuracy of diagnostic tests is a major challenge for most laboratories in SSA, and the complexity and cost of setting up and main training quality assurance systems mean that very few laboratories, mainly tertiary or privately owned, can achieve these standards ^{6, 7}. The common perception that EQA is costly or unnecessary has hindered the widespread enrolment of laboratories into EQA programs ⁸.EQA can be applied in three main ways, each with advantages and disadvantages: 1) Proficiency testing (PT), where an external provider sends samples of undisclosed results to laboratories or individual testers and provides feedback on results; 2) Rechecking or retesting samples in higher level or peer laboratories (inter-laboratory comparison); 3) On-site assessment by approved evaluators ³.

Health service utilization to human immunodeficiency (HIV) has expanded rapidly in Ethiopia. National efforts to scale up care and treatment services for individuals with HIV depend on efficient laboratory services, including HIV testing, which is the main entry point to access to care and treatment. In spite of increased access to HIV counseling and testing in developed countries, most people living with HIV in low and middle-income countries are unaware of their aerostats ⁹.

 While available rapid diagnostic tests (RDTs) for HIV have high sensitivity and specificity when performed correctly, incorrect use can result in incorrect results, with serious consequences ¹⁰. EQA is critical to assess the quality of laboratory performance and to ensure accuracy and reliability of laboratory results ¹¹.This aimed to assess the integrity of the entire laboratory testing process, to educate and improve performance in quality of HIV rapid testing.

A total of 145 testing points from governmental health facilities (hospitals and health centers) participated in the study. Among the participated testing points 41% have no designated area, 40% have no clean water for hand washing and 51% have no national test algorithm (Table 1).

External quality assessments is a method used for assessing laboratory and health care professionals’ performance and allows for the evaluation of inter-laboratory proficiency tests and the identification of related problems. Accordingly, it affords grounds for corrective and preventive actions on a regular basis ¹⁰. Measures to control the quality of result in HIV diagnostic laboratories are extremely important, because of the consequence of either false Positive or false negative results are huge ⁹.

This study demonstrates low (56%) coverage of HIV training in the testing points. This is different from a study conducted in south Ethiopia which was 85% ¹¹. This difference may be due to difference in sample size and characteristics of study participants, our study participants were laboratories and other health professionals whom perform HIV rapid test in TB clinic, VCT, ANC but their study participants were only laboratory and their samples were only 20 health facilities. From the assessed testing points, 64 (44%) health professionals’ who conduct HIV testing were found to have no trained in HIV testing. This is incomparable with study conducted in Ethiopia, which reported only14% were found to have no trained in HIV testing ¹¹. In this study 12% study participants didn’t follow national test algorithm. This is in line with study conducted in Ethiopia, which demonstrates 10% of the study participants didn’t follow national test algorithm. Our finding demonstrated that 50% testing points have no SOP for each testing points. In contrast to this findings study conducted in Ethiopia and South East Asia reported that from assessed laboratories 0% and 8% did not have SOPs respectively ^{11, 12}.

The average score of the testing points were 92.7%. Figure 1 This slightly lower than nine year survey conducted in Africa WHO region which indicated that 98.9% ¹³. This deference may be due to study participant difference and method used for HIV testing. Because our study participants included all testing points and they performed HIV testing using HIV rapid test but their study participants’ only laboratory professionals and they used HIV rapid test and ELISA to perform HIV rapid testing. Our findings demonstrated that 82.8% of testing points score 80 and above this lower than study conducted by Jean Louis and his colleagues which was 97.5% ¹⁴.

Figure 1.Average performance of testing points in %

High quality test results underpin accurate diagnosis and appropriate treatment for patients. But in the study area the score of PT result and coverage of training is slightly low comparing to other findings. Therefore following national testing algorithm to report client test results, training and monitoring are critical points to improve the PT score of testing points.

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