High Frequency of False-Positive Hepatitis C Virus Enzyme-Linked Immunosorbent Assay in Rakai, Uganda

Mullis, Caroline E.; Laeyendecker, Oliver; Reynolds, Steven J.; Ocama, Ponsiano; Quinn, Jeffrey; Boaz, Iga; Gray, Ronald H.; Kirk, Gregory D.; Thomas, David L.; Quinn, Thomas C.; Stabinski, Lara

doi:10.1093/cid/cit602

Cited by 57 publications

(62 citation statements)

References 9 publications

(17 reference statements)

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“…[21] For these reasons, it may be most appropriate to use the LAg-Avidity as part of a MAA that also includes HIV viral load. [6] While misclassification was observed using either the LAg-Avidity alone, or the LAg-Avidity assay with exclusions based on viral load and/or CD4 cell count (this report and [30]), a recent study demonstrates that MAAs that include the LAg-Avidity assay with a second serologic assay, as well as other biomarkers, can provide accurate HIV incidence estimates in populations in the US. [6, 31] Further studies are needed to evaluate MAAs that include the LAg-Avidity in study populations with different prevalent HIV subtypes.…”

Section: Discussionmentioning

confidence: 85%

Incorrect identification of recent HIV infection in adults in the United States using a limiting-antigen avidity assay

Longosz

Mehta

Kirk

et al. 2014

Aids

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Objectives To evaluate factors associated with misclassification by the limiting-antigen avidity (LAg-avidity) assay among individuals with long-standing HIV infection. Design Samples were obtained from the Multicenter AIDS Cohort Study (MACS), and AIDS Linked to the IntraVenous Experience (ALIVE) cohort (1089 samples from 667 individuals, 595 samples collected 2–4 years and 494 samples collected 4–8 years after HIV seroconversion). Paired samples from both time points were available for 422 (63.3%) of the 667 individuals. Methods Samples were considered to be misclassified if the LAg-Avidity assay result was ≤1.5 normalized optical density (OD-n) units. Results Overall, 4.8% (52/1089) of the samples were misclassified, including 1.8% (16/884, 95% confidence intervals [CI]: 1.09%–3.06%) of samples from individuals with viral loads >400 copies/mL and 1.4% (10/705) of samples from individuals with viral loads >400 copies/mL and CD4 cell counts >200 cells/μl (95% CI: 0.68%–2.60%). Age, race, gender, and mode of HIV acquisition were not associated with misclassification. In an adjusted analysis, viral load <400 copies/mL (adjusted odds ratio [aOR]: 3.72, 95% CI: 1.61–8.57), CD4 cell count <50 cells/μl (aOR: 5.41, 95% CI: 1.86–15.74), and low LAg-Avidity result (≤1.5 OD-n) from the earlier time point (aOR: 5.60, 95% CI: 1.55–20.25) were significantly associated with misclassification. Conclusions The manufacturer of the LAg-Avidity assay recommends excluding individuals from incidence surveys who are receiving antiretroviral therapy, are elite suppressors, or have AIDS (CD4 cell count <200 cells/μl). The results of this study indicate that those exclusions do not remove all sources of assay misclassification among individuals with long-standing HIV infection.

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Section: Discussionmentioning

confidence: 85%

Incorrect identification of recent HIV infection in adults in the United States using a limiting-antigen avidity assay

Longosz

Mehta

Kirk

et al. 2014

Aids

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“…In particular, prevalence estimates of HCV co-infection in African HIV programmes vary widely across settings and are mainly based on studies that used serological tests with low specificity [8]. For instance, of 500 HIV-infected patients investigated for HCV infection in Rakai, Uganda, 31 (6.2%) had a positive HCV-antibody serology but no replicative HCV infection was found when using polymerase chain reaction (PCR) [9]. Similar discrepancies between HCV serology and PCR results were found in pregnant women in Southern Africa and outpatients in West Africa [10,11].…”

Section: Introductionmentioning

confidence: 99%

Hepatitis C in HIV‐infected individuals: a systematic review and meta‐analysis of estimated prevalence in Africa

Azevedo

Zwahlen

Rauch

et al. 2016

Journal of the International AIDS Society

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IntroductionAlthough hepatitis C virus (HCV) screening is recommended for all HIV-infected patients initiating antiretroviral therapy, data on epidemiologic characteristics of HCV infection in resource-limited settings are scarce.MethodsWe searched PubMed and EMBASE for studies assessing the prevalence of HCV infection among HIV-infected individuals in Africa and extracted data on laboratory methods used. Prevalence estimates from individual studies were combined for each country using random-effects meta-analysis. The importance of study design, population and setting as well as type of test (anti-HCV antibody tests and polymerase chain reactions) was examined with meta-regression.ResultsThree randomized controlled trials, 28 cohort studies and 121 cross-sectional analyses with 108,180 HIV-infected individuals from 35 countries were included. The majority of data came from outpatient populations (55%), followed by blood donors (15%) and pregnant women (14%). Based on estimates from 159 study populations, anti-HCV positivity prevalence ranged between 3.3% (95% confidence interval (CI) 1.8–4.7) in Southern Africa and 42.3% (95% CI 4.1–80.5) in North Africa. Study design, type of setting and age distribution did not influence this prevalence significantly. The prevalence of replicating HCV infection, estimated from data of 29 cohorts, was 2.0% (95% CI 1.5–2.6). Ten studies from nine countries reported the HCV genotype of 74 samples, 53% were genotype 1, 24% genotype 2, 14% genotype 4 and 9% genotypes 3, 5 or 6.ConclusionsThe prevalence of anti-HCV antibodies is high in HIV-infected patients in Africa, but replicating HCV infection is rare and varies widely across countries.

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“…HCV prevalence in Africa varies by country; estimates range from 1% to 10% ( 14 ). However, it is unclear whether HCV seroprevalence on the basis of antibody testing alone represents a true estimate because a high number of false-reactive results (compared to those for HCV RNA) have been reported in several HIV-prevalent populations in Africa ( 15 , 16 ). The rate of chronic HBV carriers in sub-Saharan Africa is estimated to be >8% ( 17 ).…”

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confidence: 99%

Seroprevalence for Hepatitis E and Other Viral Hepatitides among Diverse Populations, Malawi

Taha¹,

Rusie

Labrique³

et al. 2015

Emerg. Infect. Dis.

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High Frequency of False-Positive Hepatitis C Virus Enzyme-Linked Immunosorbent Assay in Rakai, Uganda

Cited by 57 publications

References 9 publications

Incorrect identification of recent HIV infection in adults in the United States using a limiting-antigen avidity assay

Incorrect identification of recent HIV infection in adults in the United States using a limiting-antigen avidity assay

Hepatitis C in HIV‐infected individuals: a systematic review and meta‐analysis of estimated prevalence in Africa

Seroprevalence for Hepatitis E and Other Viral Hepatitides among Diverse Populations, Malawi

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