A public health approach to addressing and preventing misdiagnosis in the scale‐up of HIV rapid testing programmes

Johnson, Cheryl; Dalal, Shona; Baggaley, Rachel; Taegtmeyer, Miriam

doi:10.7448/ias.20.7.22190

Cited by 18 publications

(11 citation statements)

References 32 publications

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“…Also, in our analysis, retesting for verification was defined as repeating the same testing algorithm. And, retesting can rule out possible technical or clerical errors, including specimen mix-up through mislabeling and transcription errors, as well as random error by either the provider or the test device, though retesting for verification will not exclude misdiagnosis related to poor choice of a testing algorithm or cross-reactivity[18]. However, this risk should be reduced assuming the testing algorithm used is validated[20, 69, 70].…”

Section: Resultsmentioning

confidence: 99%

“…However, a variety of factors, including but not limited to: user error, poor recordkeeping, inadequate management and supervision, use of incorrect testing algorithms, cross-reactivity and over-interpretation of weak reactive results, contribute to HIV misdiagnoses [10–12]. In global settings, studies have reported HIV misdiagnosis rates ranging from less than 1% to more than 10% [13–18].…”

Section: Introductionmentioning

confidence: 99%

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Cost implications of HIV retesting for verification in Africa

et al. 2019

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Introduction HIV misdiagnosis leads to severe individual and public health consequences. Retesting for verification of all HIV-positive cases prior to antiretroviral therapy initiation can reduce HIV misdiagnosis, yet this practice has not been not widely implemented. Methods We evaluated and compared the cost of retesting for verification of HIV seropositivity ( retesting ) to the cost of antiretroviral treatment (ART) for misdiagnosed cases in the absence of retesting ( no retesting ), from the perspective of the health care system. We estimated the number of misdiagnosed cases based on a review of misdiagnosis rates, and the number of positives persons needing ART initiation by 2020. We presented the total and per person costs of retesting as compared to no retesting , over a ten-year horizon, across 50 countries in Africa grouped by income level. We conducted univariate sensitivity analysis on all model input parameters, and threshold analysis to evaluate the parameter values where the total costs of retesting and the costs no retesting are equivalent. Cost data were adjusted to 2017 United States Dollars. Results and discussion The estimated number of misdiagnoses, in the absence of retesting was 156,117, 52,720 and 29,884 for lower-income countries (LICs), lower-middle income countries (LMICs), and upper middle-income countries (UMICs), respectively, totaling 240,463 for Africa. Under the retesting scenario, costs per person initially diagnosed were: $40, $21, and $42, for LICs, LMICs, and UMICs, respectively. When retesting for verification is implemented, the savings in unnecessary ART were $125, $43, and $75 per person initially diagnosed, for LICs, LMICs, and UMICs, respectively. Over the ten-year horizon, the total costs under the retesting scenario, over all country income levels, was $475 million, and was $1.192 billion under the no retesting scenario, representing total estimated savings of $717 million in HIV treatment costs averted. Conclusions Results show that to reduce HIV misdiagnosis, countries in Africa should implement the WHO’s recommendation of retesting for verification prior to ART initiation, as part of a comprehensive quality assurance program for HIV testing services.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Cost implications of HIV retesting for verification in Africa

et al. 2019

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“…To prevent enrolling misdiagnosed persons into lifelong ART, the WHO recommends the retesting of all clients determined to be HIV positive with a second specimen prior to ART initiation (57). Factors often attributed to misdiagnosis include staff inexperience due to high turnover rates, the use of a suboptimal algorithm, clerical errors, inadequate training and competency assessments, and a lack of supervisory oversight (158)(159)(160). Improper or inadequate documentation of testing records could also lead to erroneous result reporting and is often found in lower-level health care facilities.…”

Section: Ensuring Quality Of Testing Current Status Of Quality Assuramentioning

confidence: 99%

Diagnosis of Human Immunodeficiency Virus Infection

Parekh

Fonjungo

et al. 2018

Clin Microbiol Rev

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SUMMARY HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission “hot spots,” thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control.

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“…In richer countries self-tests can cost as much as $40; in lower income countries, price guarantees and promises of large volumes have meant the price is likely to be below $10 a test (and possibly only $1–3 for large government contracts), but this is substantially more than < $1 for current “rapid” tests used within clinics. However, concerns have recently been aired that these technologies may lose sensitivity to detect infection in “breakthrough” infections ( 18 , 19 ).…”

Section: Integration Within Normal Clinic Flowmentioning

confidence: 99%

Pre-exposure Prophylaxis: The Delivery Challenge

Venter

2018

Front. Public Health

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HIV pre-exposure prophylaxis (PrEP), despite its efficacy, has been slow in uptake throughout the world. This article discusses the operational and service delivery complexity, based on early real-world experience, with some recommendations on how this promising intervention could be made more available. Currently, access to PrEP is made complex by restricting delivery to dedicated health facilities, as well as requirements around HIV testing and toxicity monitoring. Expanding to verticalized services that focus on well-defined populations where HIV testing and treatment programmes already exist, has proven relatively simple. Providing PrEP outside of this environment has yet to be demonstrated at any scale, and will likely require innovative thinking addressing the regulatory and clinical environment, so as to ensure easier access to this promising HIV prevention tool.

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A public health approach to addressing and preventing misdiagnosis in the scale‐up of HIV rapid testing programmes

Cited by 18 publications

References 32 publications

Cost implications of HIV retesting for verification in Africa

Cost implications of HIV retesting for verification in Africa

Diagnosis of Human Immunodeficiency Virus Infection

Pre-exposure Prophylaxis: The Delivery Challenge

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