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      Low and Decreasing Prevalence and Rate of False Positive HIV Diagnosis — Chókwè District, Mozambique, 2014–2017

      research-article
      , MD 1 , , MPH 2 , , DrPH 2 , , , PhD 3 , , MPH 1 , , MD 3 , , PhD 2 , , MS 2 , 3 , 4 , 3 , , MD 3 , , PhD 2 , , PhD 2 , , MD 2 , , MD 2 , , MD 5 , , MD 5 , , MPH 6 , , MD 7 , 7 , , PhD 1 , 1 , , MD 1 , , MD 1 , , MD 1 , , PhD 1
      Morbidity and Mortality Weekly Report
      Centers for Disease Control and Prevention

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          Abstract

          In 2017, rapid human immunodeficiency virus (HIV) testing services enabled the HIV diagnosis and treatment of approximately 15.3 million persons with HIV infection in sub-Saharan Africa with life-saving antiretroviral therapy (ART) ( 1 ). Although suboptimal testing practices and misdiagnoses have been reported in sub-Saharan Africa and elsewhere, trends in population burden and rate of false positive HIV diagnosis (false diagnosis) have not been reported ( 2 , 3 ). Understanding the population prevalence and trends of false diagnosis is fundamental for guiding rapid HIV testing policies and practices. To help address this need, CDC analyzed data from 57,655 residents aged 15–59 years in the Chókwè Health and Demographic Surveillance System (CHDSS) in Mozambique to evaluate trends in the rate (the percentage of false diagnoses among retested persons reporting a prior HIV diagnosis) and population prevalence of false diagnosis. From 2014 to 2017, the observed rate of false diagnosis in CHDSS decreased from 0.66% to 0.00% (p<0.001), and the estimated population prevalence of false diagnosis decreased from 0.08% to 0.01% (p = 0.0016). Although the prevalence and rate of false diagnosis are low and have decreased significantly in CHDSS, observed false diagnoses underscore the importance of routine HIV retesting before ART initiation and implementation of comprehensive rapid HIV test quality management systems ( 2 , 4 , 5 ).

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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

          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.
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            Low Specificity of Determine HIV1/2 RDT Using Whole Blood in South West Tanzania

            Objective To evaluate the diagnostic performance of two rapid detection tests (RDTs) for HIV 1/2 in plasma and in whole blood samples. Methods More than 15,000 study subjects above the age of two years participated in two rounds of a cohort study to determine the prevalence of HIV. HIV testing was performed using the Determine HIV 1/2 test (Abbott) in the first (2006/2007) and the HIV 1/2 STAT-PAK Dipstick Assay (Chembio) in the second round (2007/2008) of the survey. Positive results were classified into faint and strong bands depending on the visual appearance of the test strip and confirmed by ELISA and Western blot. Results The sensitivity and specificity of the Determine RDT were 100% (95% confidence interval  = 86.8 to 100%) and 96.8% (95.9 to 97.6%) in whole blood and 100% (99.7 to 100%) and 97.9% (97.6 to 98.1%) in plasma respectively. Specificity was highly dependent on the tested sample type: when using whole blood, 67.1% of positive results were false positive, as opposed to 17.4% in plasma. Test strips with only faint positive bands were more often false positive than strips showing strong bands and were more common in whole blood than in plasma. Evaluation of the STAT-PAK RDT in plasma during the second year resulted in a sensitivity of 99.7% (99.1 to 99.9%) and a specificity of 99.3% (99.1 to 99.4%) with 6.9% of the positive results being false. Conclusions Our study shows that the Determine HIV 1/2 strip test with its high sensitivity is an excellent tool to screen for HIV infection, but that – at least in our setting – it can not be recommended as a confirmatory test in VCT campaigns where whole blood is used.
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              Characterization of human immunodeficiency virus type-1 from HIV-1 seropositive cases with undetectable viremia

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                Author and article information

                Journal
                MMWR Morb Mortal Wkly Rep
                MMWR Morb. Mortal. Wkly. Rep
                WR
                Morbidity and Mortality Weekly Report
                Centers for Disease Control and Prevention
                0149-2195
                1545-861X
                14 December 2018
                14 December 2018
                : 67
                : 49
                : 1363-1368
                Affiliations
                CDC Country Office, Maputo, Mozambique; Division of Global HIV and TB, Center for Global Health, CDC; Chókwè Health Research and Training Center, National Institute of Health, Chókwè, Mozambique; Jhpiego, Johns Hopkins University, Maputo, Mozambique; Chókwè District Public Health Directorate, Chókwè, Mozambique; FHI 360, Maputo, Mozambique; Mozambique Ministry of Health, Maputo, Mozambique.
                Author notes
                Corresponding author: Duncan MacKellar, DMackellar@ 123456cdc.gov , 404-639-6199.
                Article
                mm6749a3
                10.15585/mmwr.mm6749a3
                6300074
                30543600
                d7debe3e-9423-4fc1-b9b5-5ef6aac6abdf

                All material in the MMWR Series is in the public domain and may be used and reprinted without permission; citation as to source, however, is appreciated.

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