Field evaluation of rapid HIV serologic tests for screening and confirming HIV-1 infection in Honduras

Hc, Stetler; Tc, Granade; Ca, Nunez; Meza, Rita I; Terrell, Scott P.; Amador, L. Baquerizo; George, .

doi:10.1097/00002030-199703110-00015

Cited by 88 publications

(55 citation statements)

References 10 publications

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“…Most studies were carried out in Africa ( n = 48) [5,7,10–14,16,22–25,29,30,32–34,36,37,39,41,43,44,46,47,49,51,52,54–59,61–65,67–72,74,75], followed by in the Americas ( n = 7) [28,31,42,50,53,60,66], Asia ( n = 4) [8,35,45,73] and Europe ( n = 1) [48]. There were also four multi-country/regional studies [26,27,38,40].…”

Section: Resultsmentioning

confidence: 99%

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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%

“…Sixteen studies reported clerical errors [8,11,26,28,29,31,34,35,45,50,63–65,67,73,75]. Errors included poor record-keeping [35], data reporting problems, labelling and transcription mistakes [73] and specimen mix-ups.…”

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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“…Capillus is used first is because it has higher sensitivity but low specificity while Determine has higher specificity but low sensitivity. Moreover, these rapid tests are cheap, easy to perform and results are obtained within a short time as compared to ELISA test (Stetler, 1997). However, one health facility reported to be using Determine first in HIV testing.…”

Section: Discussionmentioning

confidence: 99%

Assessment of quality assurance in HIV testing in health facilities in Lake Victoria zone, Tanzania

Mashauri¹,

Siza²,

Temu³

et al. 2007

Tanzania J Hlth Res

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Tanzania is currently implementing the antiretroviral treatment programme, and has a target of putting about 400,000 eligible HIV infected individuals on treatment by 2008. This will involve screening a large number of people, which will require non-laboratory personnel to be involved in doing HIV testing. In order to guarantee reliable and quality HIV test results, there is a need to ensure that quality assurance (QA) procedures are followed from specimen collection, testing and reporting of results. In light of the above a survey was conducted to assess QA in HIV testing in health facilities in Lake Victoria zone, Tanzania. A total of 89 health facilities (29 hospitals, 34 health centres, 9 dispensaries and 17 voluntary and counselling testing centres) were surveyed. Only three (10.3%) health facilities reported performing Uniform II ELISA for HIV diagnosis. All other health facilities reported to be using HIV rapid tests Capillus and Determine. Five (5.6%) of health facility laboratories performed CD4 counts. Internal quality control (IQC) were performed in 21 (63.6%) of the hospitals. Kits for HIV testing were reported to be readily available by 54 (60.7%) of the facilities. Only 16 (18%) of the health facilities had standard operating procedures in place. Systems of equipment calibration were reported by 13 (14.6%) of the health facilities. Counselling services were available in all health facilities and all counsellors had received the 6-week mandatory training course. These findings show that most of health facilities in the Lake Victoria zone do not adhere to QA procedures in HIV testing. There is therefore, a need to establish a monitoring system to laboratories performing HIV testing for the purpose of ensuring QA procedures are done. Personnel doing HIV testing should be re-trained at a regular basis to cope with new techniques and ensure QA procedures are followed. ___________________________________________________________________________________________________________

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“…For example, until recently there has not been much interest in the United States in rapid tests and thus few expensive large-scale evaluation trials necessary for Food and Drug Administration approval (Kassler et al 1995) have been done. Yet in less developed international settings, several authors have stressed the urgent need for rapid tests requiring minutes or hours and a single visit vs. two visits over several weeks required with regular testing (Mashu et al 1997;McKenna et al 1997;Ray et al 1997;Stetler et al 1997). To address such demand for simple nonlaboratory tests, governments in the developing world will need to encourage manufactures to produce low-cost HIV tests not intended for developed country markets, but be aware that the accuracy of the test must be locally evaluated, as must quality control over time.…”

Section: Discussionmentioning

confidence: 99%

“…Stetler and associates have shown that two tests (i.e. UNAIDS Strategy II) worked well in rural Honduras, even in low-prevalence populations (Stetler et al 1997), while Wilkinson et al (1997) have suggested, based on their findings in South Africa, that one rapid test may be sufficient, especially in resource-poor settings. We concur with Wilkinson et al (1997) that multiple testing strategies should be questioned and evaluated, taking into account cost and feasibility, and the consequences of not testing those who carry the virus.…”

Section: Discussionmentioning

confidence: 99%

Local evaluation of a rapid HIV assay for use in developing countries

Myint¹,

Frerichs²,

Oo³

et al. 1999

Tropical Med Int Health

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SummaryWe present a research scheme for evaluating inexpensive HIV rapid tests in a developing country setting and assess the field validity of the SeroؒStrip HIV 1/2 rapid test. The research design features the random allocation of 100 true HIV-positive and 100 true HIV-negative serum specimens to 4 groups, followed by blind testing for HIV status. After one short training session, laboratory technicians at 4 township hospitals (25-35 beds) located 20-50 km from Yangon, Myanmar were sent 800 sera labelled with only an identification number and divided into four groups of 200 specimens each, half being HIV-positive and half HIVnegative. Testing was done in the field with the SeroؒStrip HIV 1/2. Determination of the test's validity was based on 399 true HIV positive and 401 true HIV negative sera. All true positives were correctly identified, as were all but two of the true negatives. The sensitivity (% of true positives that test positive) was 100%, and the specificity (% of true negatives that test negative) was 99.5%. The research was completed by in-country scientists who are best suited to evaluate the validity of HIV tests conducted in local environments.

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Field evaluation of rapid HIV serologic tests for screening and confirming HIV-1 infection in Honduras

Cited by 88 publications

References 10 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

Assessment of quality assurance in HIV testing in health facilities in Lake Victoria zone, Tanzania

Local evaluation of a rapid HIV assay for use in developing countries

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