Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing

Abstract

Rapid antibody tests for the detection of human immunodeficiency virus (HIV) offer an effective means of providing a timely result of HIV serostatus to individuals. The increased use of rapid HIV antibody tests outside the laboratory has highlighted the need for new, cost-effective quality assurance methods to be developed for use in nonlaboratory-based and resource-limited settings. Photographed rapid HIV test results were used in a modified external quality assessment scheme to assess the interpretation proficiency and, therefore, to assess the feasibility of using this method as a basis for a quality assessment program for nonlaboratory-based testing. Participants (n ‫؍‬ 148), both experienced and inexperienced in the performance and interpretation of rapid HIV testing, interpreted the photographed results of five rapid HIV assays. These were scored according to the degree of technical discordance. Error scores were grouped according to each participant's technical experience. The accuracy of interpretation for four of the five assays was between 80 and 97%, indicating that the photographed results of samples, including those difficult to read or borderline difficult to read, can be used to assess the proficiency of test operators in interpreting results. Participants had greater difficulty in interpreting samples of weak reactivity; this was consistent across the five assays. Experience played an important role in accurate interpretation, with experienced laboratory participants exhibiting greater proficiency (P < 0.05) in interpreting the results of three of the five rapid HIV assays. It was established that photographed results of rapid HIV assays could be interpreted with accuracy and demonstrated that prior experience resulted in a more accurate interpretation performance.

To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status

“…There were also four multi-country/regional studies [26,27,38,40]. Samples varied by size and unit of measurement, including clients ( n  = 38 studies, range: 303,010 to 1 clients), specimens ( n  = 15 studies, range: 9419 to 16 specimens), health workers performing HIV tests ( n  = 5 studies, range: 3835 to 39 personnel) and sites where HIV testing was performed ( n  = 12 studies, range: 602 to 4 sites).…”

“…User errors, incorrectly performing the test procedure or incorrectly interpreting results, defined as human errors, were reported in 25 studies [7,8,11,14,26–28,31,33,34,37,40,42,46,52,54,57,60,65–68,70,72,73]. Errors identified included users having difficulty with specimen collection [14,28,68], performing RDTs [31,73], interpreting test results [10,24,27,30,32,40,42,48,62,65,66,74], reading test results too early [7] and not using the correct reagents/buffer [7].…”

“…Errors identified included users having difficulty with specimen collection [14,28,68], performing RDTs [31,73], interpreting test results [10,24,27,30,32,40,42,48,62,65,66,74], reading test results too early [7] and not using the correct reagents/buffer [7]. …”

“…A study, which assessed the proficiency of laboratory technicians, found that specimens with very weak levels of HIV-1/2 antibodies were less accurately reported [40]. In Uganda, two studies found that the majority of false reactive results came from weak reactive RDTs [32,36].…”

Using electronic readers to monitor progress toward elimination of mother‐to‐child transmission of HIV and syphilis: An opinion piece

“…One of the key challenges for large-scale screening programs is the need to ensure the quality of RDTs and implement comprehensive sustainable quality assurance [12]. Lateral flow RDTs are read with the naked eye and may be prone to human error and inter-user variability, especially in remote settings where healthcare providers receive limited initial or refresher training and where ongoing supervision and quality assurance (e.g.…”