Accuracy in HIV Rapid Testing among Laboratory and Non-laboratory Personnel in Zambia: Observations from the National HIV Proficiency Testing System

Mwangala, Sheila Monde; Musonda, Kunda; Monze, Mwaka; Musukwa, K.; Fýlkesnes, Knut

doi:10.1371/journal.pone.0146700

Cited by 23 publications

(28 citation statements)

References 32 publications

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“…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].…”

Section: Resultsmentioning

confidence: 99%

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

Johnson

Fonner

Sands

et al. 2017

Journal of the International AIDS Society

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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.

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Section: Resultsmentioning

confidence: 99%

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

Johnson

Fonner

Sands

et al. 2017

Journal of the International AIDS Society

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“…A study from Zambia found that the accuracy of HIV rapid tests was higher when testing was performed by trained laboratory personnel compared to non-laboratory personnel. 29 In this report, all testing was performed by experienced laboratory personnel under ideal testing conditions; the frequency of false-negative results in the setting of long-term ART suppression may be higher in other settings. In a previous study of children and adolescents who were virally suppressed on ART, the Uni-Gold rapid test performed better than the OraQuick rapid test.…”

Section: Discussionmentioning

confidence: 99%

Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays

Fogel¹,

Piwowar‐Manning²,

Debevec³

et al. 2017

JAIDS Journal of Acquired Immune Deficiency Syndromes

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BACKGROUND Antiretroviral therapy (ART) can down-regulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays. METHODS Samples were obtained from 207 participants in the HPTN 052 trial who were stably suppressed on ART for ≥4 years (Malawi sites; pre-ART CD4 cell count 350–550 cells/mm3 [early ART arm, N=180] or <250 cells/mm3 or an AIDS-defining illness [delayed ART arm, N=27]). Samples were tested with two HIV rapid tests and two HIV incidence assays; selected samples were also tested with two 4th-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result). RESULTS Ten (4.8%) samples had a non-reactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, p=0.13); one sample had non-reactive 4th-generation assay results and three had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher 4th-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection. CONCLUSIONS False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Down-regulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.

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“…HIV testing in these settings is mostly conducted by community health workers who are generally well trained and highly proficient in HIV testing. However, in a few instances, lower accuracy has been documented among community workers compared to laboratory staff [16]. The performance of rapid HIV testing has also been found to vary with the reference standard used for evaluation.…”

Section: Introductionmentioning

confidence: 99%

Misdiagnosis of HIV infection during a South African community‐based survey: implications for rapid HIV testing

Kufa

Kharsany

Cawood

et al. 2017

Journal of the International AIDS Society

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Introduction: We describe the overall accuracy and performance of a serial rapid HIV testing algorithm used in community-based HIV testing in the context of a population-based household survey conducted in two sub-districts of uMgungundlovu district, KwaZulu-Natal, South Africa, against reference fourth-generation HIV-1/2 antibody and p24 antigen combination immunoassays. We discuss implications of the findings on rapid HIV testing programmes. Methods: Cross-sectional design: Following enrolment into the survey, questionnaires were administered to eligible and consenting participants in order to obtain demographic and HIV-related data. Peripheral blood samples were collected for HIV-related testing. Participants were offered community-based HIV testing in the home by trained field workers using a serial algorithm with two rapid diagnostic tests (RDTs) in series. In the laboratory, reference HIV testing was conducted using two fourth-generation immunoassays with all positives in the confirmatory test considered true positives. Accuracy, sensitivity, specificity, positive predictive value, negative predictive value and false-positive and false-negative rates were determined. Results: Of 10,236 individuals enrolled in the survey, 3740 were tested in the home (median age 24 years (interquartile range 19–31 years), 42.1% males and HIV positivity on RDT algorithm 8.0%). From those tested, 3729 (99.7%) had a definitive RDT result as well as a laboratory immunoassay result. The overall accuracy of the RDT when compared to the fourth-generation immunoassays was 98.8% (95% confidence interval (CI) 98.5–99.2). The sensitivity, specificity, positive predictive value and negative predictive value were 91.1% (95% CI 87.5–93.7), 99.9% (95% CI 99.8–100), 99.3% (95% CI 97.4–99.8) and 99.1% (95% CI 98.8–99.4) respectively. The false-positive and false-negative rates were 0.06% (95% CI 0.01–0.24) and 8.9% (95% CI 6.3–12.53). Compared to true positives, false negatives were more likely to be recently infected on limited antigen avidity assay and to report antiretroviral therapy (ART) use. Conclusions: The overall accuracy of the RDT algorithm was high. However, there were few false positives, and the sensitivity was lower than expected with high false negatives, despite implementation of quality assurance measures. False negatives were associated with recent (early) infection and ART exposure. The RDT algorithm was able to correctly identify the majority of HIV infections in community-based HIV testing. Messaging on the potential for false positives and false negatives should be included in these programmes.

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Accuracy in HIV Rapid Testing among Laboratory and Non-laboratory Personnel in Zambia: Observations from the National HIV Proficiency Testing System

Cited by 23 publications

References 32 publications

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

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

Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays

Misdiagnosis of HIV infection during a South African community‐based survey: implications for rapid HIV testing

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