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

Abstract

Introduction: In accordance with global testing and treatment targets, many countries are seeking ways to reach the "90-90-90" goals, starting with diagnosing 90% of all people with HIV. Quality HIV testing services are needed to enable people with HIV to be diagnosed and linked to treatment as early as possible. It is essential that opportunities to reach people with undiagnosed HIV are not missed, diagnoses are correct and HIV-negative individuals are not inadvertently initiated on life-long treatment. We conducted this systematic review to assess the magnitude of misdiagnosis and to describe poor HIV testing practices using rapid diagnostic tests.

Methods: We systematically searched peer-reviewed articles, abstracts and grey literature published from 1 January 1990 to 19 April 2017. Studies were included if they used at least two rapid diagnostic tests and reported on HIV misdiagnosis, factors related to potential misdiagnosis or described quality issues and errors related to HIV testing.

Results: Sixty-four studies were included in this review. A small proportion of false positive (median 3.1%, interquartile range (IQR): 0.4-5.2%) and false negative (median: 0.4%, IQR: 0-3.9%) diagnoses were identified. Suboptimal testing strategies were the most common factor in studies reporting misdiagnoses, particularly false positive diagnoses due to using a "tiebreaker" test to resolve discrepant test results. A substantial proportion of false negative diagnoses were related to retesting among people on antiretroviral therapy. Conclusions HIV testing errors and poor practices, particularly those resulting in false positive or false negative diagnoses, do occur but are preventable. Efforts to accelerate HIV diagnosis and linkage to treatment should be complemented by efforts to improve the quality of HIV testing services and strengthen the quality management systems, particularly the use of validated testing algorithms and strategies, retesting people diagnosed with HIV before initiating treatment and providing clear messages to people with HIV on treatment on the risk of a "false negative" test result.

Keywords: HIV; HIV testing; diagnostic error; false positive; healthcare; misclassification; misdiagnosis; patient safety.

Figure 1.

Study selection process. RDT: rapid diagnostic test; WB: Western blot; EIA: enzyme immunoassay.

Figure 2.

Rates of false positive diagnostic error rates diagnosis (n = 30 studies, 43 reports). LP: low prevalence; HP: high prevalence; ZAM: Zambia; VL: visceral Leishmaniasis; Data reported include reports of misdiagnosis of HIV-positive statuses. False positive diagnoses were reported in 30 studies (43 reports), total positive diagnoses n = 16,777. Kufa et al. 2017 reported proportion misdiagnosed by did not report full sample size. In studies where all participants were known to be HIV positive and/or on ART at the beginning of the study, the full study population was used as the denominator.

Figure 3.

False negative diagnostic error rates (n = 28 studies, 40 reports). LP: low prevalence; HP: high prevalence; SA: South Africa, discrepant results; ZAM: Zambia, discrepant results; VL: visceral Leishmaniasis; Data reported includes reports of misdiagnosis of HIV-negative statuses. Misdiagnoses of HIV-negative statuses were reported 28 studies (40 reports), total negative = 55, 626. Kufa et al. 2017 reported proportion misdiagnosed but did not report full sample size information. Note Olaru et al. was exclusively among people with HIV on ART, accounting for the high rate of false negative diagnoses.