Causes of false-positive HIV rapid diagnostic test results

Klarkowski, Derryck; O’Brien, D. P.; Shanks, Leslie; Singh, Kasha

doi:10.1586/14787210.2014.866516

Cited by 83 publications

(87 citation statements)

References 81 publications

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“…As the median time between initial test and enrolment of the study was 392 days (IQR: 45, 1587) and there is a lack of data from the time of the initial HIV test, we are unable to determine the cause of the misdiagnosis. However, systematic reviews have identified several potential causes of misdiagnosis [3,17]. In a WHO report on misdiagnosis, user error, suboptimal testing strategy, cross-reactivity and poor management, and supervision practices were suggested as factors related to less than optimal test specificity [3].…”

Section: Resultsmentioning

confidence: 99%

Identification of misdiagnosed HIV clients in an Early Access to ART for All implementation study in Swaziland

Khan

Mafara

Pasipamire

et al. 2017

Journal of the International AIDS Society

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Introduction: Rapid diagnostic testing has made HIV diagnosis and subsequent treatment more accessible. However, multiple factors, including improper implementation of testing strategies and clerical errors, have been reported to lead to HIV misdiagnosis. The World Health Organization has recommended HIV retesting prior to antiretroviral therapy (ART) initiation which has become pertinent with scaling up of Early Access to ART for All (EAAA). In this analysis, misdiagnosed clients are identified from a subgroup of clients enrolled in EAAA implementation study in Swaziland. Methods: The subgroup to assess misdiagnosis was identified from enrolled EAAA study clients, who had an undetectable viral load prior to ART initiation between September 1, 2014 and May 31, 2016. One hundred and five of 2533 (4%) clients had an undetectable viral load prior to initiation to ART (pre-ART). The HIV status of clients was confirmed using the Determine HIV 1/2 and Uni-Gold HIV 1/2 rapid tests performed serially as recommended by the national testing algorithm. The status of clients on ART was additionally confirmed by fourth-generation HIV Ag/Ab combo tests, Architect and Genscreen Ultra. Results: Fourteen of the 105 (13%) clients were false positive (HIV negative) on confirmation testing, of whom five (36%) were still in pre-ART care, while nine (64%) were in ART care. Overall, proportion of false positive was 0.6% (14/2533). The false-positive clients had a median CD4 of 791 cells/ml (interquartile range (IQR): 628, 967) compared to 549 cells/ml (IQR: 387, 791) for true positives (HIV positive) (p = 0.0081) and were nearly 20 years older (p = 0.0008). Conclusions: Overall 0.6% of all enrolled EAAA clients were misdiagnosed, and 64% of misdiagnosed clients were initiated on ART. With adoption of EAAA guidelines by national governments, ART initiation regardless of immunological criteria, strengthening of proficiency testing and adoption of retesting prior to ART initiation would allow identification of misdiagnosed clients and further reduce potential of initiating misdiagnosed clients on ART.

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Section: Resultsmentioning

confidence: 99%

Identification of misdiagnosed HIV clients in an Early Access to ART for All implementation study in Swaziland

Khan

Mafara

Pasipamire

et al. 2017

Journal of the International AIDS Society

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“…This is a major cause of false positivity with rapid diagnostic tests (RDT). 17 A study sample of 1517 patients in south-western Uganda revealed 43.9% false positive rates that used a 'tie-breaker' algorithm (129/295 positive results) similar to NACO guidelines prevalent in India. 18 During interaction with sister laboratories in the city, we have been apprised that a major confusion exists due the false positive reports in this platform though the precise data is unavailable.…”

Section: Discussionmentioning

confidence: 99%

Occurrence of false positivity in a fourth generation (Ag/Ab) HIV screening assay: horns of a dilemma

Roy¹,

Ruchi²,

Rawat³

et al. 2018

Int J Res Med Sci

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Background: Universal screening for HIV with Ag/Ab combo assays has reduced the window period significantly due to its high sensitivity. However, occurrence of false positives is common and in a country like India, it may lead to social distress and loss of livelihood. We wanted to ascertain the occurrence of false positives in our laboratory.Methods: There were 21817 samples analysed retrospectively from Jan 2015 to Jul 2017 (31 months). Architect HIV Ag/Ab Combo (Abbott Laboratories, Abbott Park, IL) was used as the first test. Repeatedly reactive samples with a signal to cutoff (S/CO) ratio greater than or equal to 1.00 was considered reactive. Strategy III (3 test algorithm) of NACO guidelines was followed uniformly.Results: In this study, 147 samples tested reactive (0.67%) and 40 samples tested false positive (repeatedly reactive; 0.18%). 6 samples were indeterminate (0.027%). Overall, the sensitivity of the Architect HIV Ag/Ab Combo was 100%, the specificity varied between 99.74% and 99.91%. The PPV from June 2016 to July 2017 was 68.63% (32 false positives). The S/CO values of 72.8% (117/147) reactive samples ranged between 201- 800, whereas 72% (29/40) of false positive samples, the S/CO values ranged between 1.0-2.0. The specificity of the test improved to 99.98% when S/CO value was adjusted at 2 and 100% when adjusted at 5. Similarly, the PPV too improved to 93.04% and 98.66% at S/CO values of 2 and 5 respectively.Conclusions: Further studies are needed to ascertain the optimal or ‘grey-zone’ S/CO values for India to minimise the false positive results and avoid further supplemental tests routinely.

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“…In addition, exposure to parasites may produce polyclonal B-cell activation responsible for the high rate of false-positive immunoassays results reported in African patients. 19 Vairo and others have estimated that although sensitivity of IgG enzyme immunoassay test for dengue is nearly 100%, specificity could be substantially diminished in African populations. 20 Taken all together, these data suggest that prevalence studies using anti-dengue IgG antibodies in the African continent may be overestimating dengue infection and should be interpreted cautiously.…”

Section: Discussionmentioning

confidence: 99%

Imported Dengue Infection in a Spanish Hospital with a High Proportion of Travelers from Africa: A 9-Year Retrospective Study

Toro¹,

Trevisi²,

López-Quintana³

et al. 2017

The American Society of Tropical Medicine and Hygiene

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Abstract. Epidemiological data on dengue in Africa are still scarce. We investigated imported dengue infection among travelers with a high proportion of subjects from Africa over a 9-year period. From January 2005 to December 2013, blood samples from travelers with clinical suspicion of dengue were analyzed. Dengue was diagnosed using serological, antigen detection, and molecular methods. Subjects were classified according to birthplace (Europeans versus non-Europeans) and last country visited. Overall, 10,307 serum samples corresponding to 8,295 patients were studied; 62% were European travelers, most of them from Spain, and 35.9% were non-Europeans, the majority of whom were born in Africa (mainly Equatorial Guinea) and Latin America (mainly Bolivia, Ecuador, and Colombia). A total of 492 cases of dengue were identified, the highest number of cases corresponding to subjects who had traveled from Africa (N = 189), followed by Latin America (N = 174) and Asia (N = 113). The rate of cases for Africa (4.5%) was inferior to Asia (9%) and Latin America (6.1%). Three peaks of dengue were found

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Causes of false-positive HIV rapid diagnostic test results

Cited by 83 publications

References 81 publications

Identification of misdiagnosed HIV clients in an Early Access to ART for All implementation study in Swaziland

Identification of misdiagnosed HIV clients in an Early Access to ART for All implementation study in Swaziland

Occurrence of false positivity in a fourth generation (Ag/Ab) HIV screening assay: horns of a dilemma

Imported Dengue Infection in a Spanish Hospital with a High Proportion of Travelers from Africa: A 9-Year Retrospective Study

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