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

Clinical Infectious Diseases, Dec 2013

The prevalence of hepatitis C virus (HCV) infection in sub-Saharan Africa remains unclear. We tested 1000 individuals from Rakai, Uganda, with the Ortho version 3.0 HCV enzyme-linked immunosorbent assay. All serologically positive samples were tested for HCV RNA. Seventy-six of the 1000 (7.6%) participants were HCV antibody positive; none were confirmed by detection of HCV RNA.

A PDF file should load here. If you do not see its contents the file may be temporarily unavailable at the journal website or you do not have a PDF plug-in installed and enabled in your browser.

Alternatively, you can download the file locally and open with any standalone PDF reader:

https://cid.oxfordjournals.org/content/57/12/1747.full.pdf

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

CID High Frequency of False-Positive Hepatitis C Virus Enzyme-Linked Immunosorbent Assay in Rakai, Uganda Caroline E. Mullis 2 3 4 Oliver Laeyendecker 1 2 3 Steven J. Reynolds 1 2 3 Ponsiano Ocama 0 2 Jeffrey Quinn 2 3 Iga Boaz 2 7 Ronald H. Gray 2 6 Gregory D. Kirk 2 6 David L. Thomas 2 3 Thomas C. Quinn 1 2 3 Lara Stabinski 1 2 5 0 Department of Medicine, Makerere University , Kampala 1 Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland 2 Received 27 June 2013; accepted 10 September 2013; electronically published 18 Septem- ber 2013 3 Department of Medicine, School of Medicine, Johns Hopkins University , Baltimore 4 Present affiliation: New York Medical College , Valhalla , New York 5 Present affiliation: Office of the Global AIDS Coordinator, US State Department , Washington, District of Columbia. 538A, Baltimore, MD 6 Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University , Baltimore, Maryland 7 Rakai Health Sciences Program , Entebbe , Uganda The prevalence of hepatitis C virus (HCV) infection in subSaharan Africa remains unclear. We tested 1000 individuals from Rakai, Uganda, with the Ortho version 3.0 HCV enzyme-linked immunosorbent assay. All serologically positive samples were tested for HCV RNA. Seventy-six of the 1000 (7.6%) participants were HCV antibody positive; none were confirmed by detection of HCV RNA. - hepatitis C virus; ELISA; Africa. Chronic hepatitis C virus (HCV) infection is a leading cause of hepatocellular carcinoma and cirrhosis [1, 2]. Estimates of the burden of HCV infection in sub-Saharan Africa vary widely, but the overall seroprevalence is estimated at 3.0%, compared to <1%2% in developed countries [2]. Understanding the burden of HCV in sub-Saharan Africa is of particular importance because of the high human immunodeficiency virus (HIV) prevalence and the increased rate of complications arising from HIV and HCV coinfection [1, 3]. As more HIVinfected individuals in sub-Saharan Africa gain access to highly active antiretroviral therapy (HAART) with resulting declines in AIDS-related complications, liver disease associated with hepatitis B virus (HBV) and HCV could become an increasingly important cause of morbidity and mortality [4]. Additionally, knowledge of HCV seroprevalence is critical for screening the blood supply [3, 5]. In sub-Saharan Africa, HCV prevalence has primarily been estimated by HCV antibody screening, without confirmatory virologic testing because of the high cost associated with the latter tests [1, 3, 4]. In Uganda, HCV seroprevalence estimates range from 0.0% to 14.6% [1], but the observed variation may reflect the performance of HCV antibody tests in this setting [5]. Despite high sensitivity and specificity in US populations [6], HCV antibody tests have been shown to have high falsepositive misclassification in African populations, suggesting that the reported seroprevalence may be inflated [7, 8]. Infection with malaria, syphilis, or HIV, malnutrition, and various chronic diseases have been hypothesized to increase the false positivity of HCV antibody tests, although these associations remain speculative [7]. MATERIALS AND METHODS We report analyses conducted on 500 HIV-infected individuals enrolled in HIV care with the Rakai Health Sciences Program frequency-matched by age, sex, and community to 500 HIV-uninfected participants of the Rakai Community Cohort Study [9]. Data collection included a structured interview focusing on exposures potentially associated with liver disease, collection of blood specimens, and a transient elastography (Fibroscan, Echosense, Paris, France) examination to noninvasively quantify liver fibrosis [9]. Methods for determining HIV type 1 (HIV-1) status and CD4 nadir were previously described [9]. Presence of HBV surface antigen and antibodies to schistosomiasis were determined using an ETI-EKB s Plus enzyme-linked immunosorbent assay (ELISA; Diasorin, Vercelli, Italy) and Schisto-96 soluble egg antigen ELISA (IVD Research Inc, Carlsbad, California), respectively [9]. All participants provided informed consent. Institutional review board approval for this study was received from the National Institute of Allergy and Infectious Diseases, the Johns Hopkins Medical Institutions, the Western Institutional Review Board (Olympia, Washington), the Scientific and Ethics Committee of the Uganda Virus Research Institute, and the Uganda National Council for Science and Technology. Serum samples were tested manually using the Ortho HCV version 3.0 ELISA Test System (Ortho Clinical Diagnostics, Raritan, New Jersey). All samples were tested in a single well, with initially reactive samples being retested in duplicate before final interpretation. Any sample upon retesting that was reactive for HCV antibody in either or both wells was then considered repeatedly reactive and classified as HCV ELISA positive for (...truncated)


This is a preview of a remote PDF: https://cid.oxfordjournals.org/content/57/12/1747.full.pdf

Caroline E. Mullis, Oliver Laeyendecker, Steven J. Reynolds, Ponsiano Ocama, Jeffrey Quinn, Iga Boaz, Ronald H. Gray, Gregory D. Kirk, David L. Thomas, Thomas C. Quinn, Lara Stabinski. High Frequency of False-Positive Hepatitis C Virus Enzyme-Linked Immunosorbent Assay in Rakai, Uganda, Clinical Infectious Diseases, 2013, pp. 1747-1750, 57/12, DOI: 10.1093/cid/cit602