Evaluation of the performance of 44 assays used in countries with limited resources for the detection of antibodies to hepatitis C virus

Scheiblauer, Heinrich; El-Nageh, Mohamed; Nick, Sigrid; Fields, Howard A.; Prince, Alfred M.; Díaz, S. Pedraza

doi:10.1111/j.1537-2995.2006.00789.x

Cited by 39 publications

(39 citation statements)

References 12 publications

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“…In our study both assays showed no problems concerning their specificity neither with the investigated routine samples nor with the additionally tested samples from pregnant women or with samples positive for IgM-antibodies. The ARCHITECT results were highly comparable to those of the Ortho assay, which has proved to be highly specific and sensitive as shown in other studies (Oethinger et al, 2005;Zachary et al, 2005;Scheiblauer et al, 2006;Watterson et al, 2007). Analysis of the 38 samples that were discordant between the Ortho and ARCHITECT assays revealed a great variance in the two supplemental immunoblot assays (Inno-LIA and RIBA).…”

Section: Discussionsupporting

confidence: 69%

Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions

Berger

Rabenau

Allwinn

et al. 2008

Journal of Clinical Virology

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Section: Discussionsupporting

confidence: 69%

Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions

Berger

Rabenau

Allwinn

et al. 2008

Journal of Clinical Virology

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“…The quality of test kits used for anti-HCV testing may be a reason for concern, since some test kits used in limited-resource countries including India has been found to be unsatisfactory. 131,132 Use of nucleic acid testing (NAT) has been evaluated for preventing transmission of HCV as well as other blood borne pathogens (human immunodeficiency virus-1 and hepatitis B virus) in Indian blood donors has been proposed. It has been estimated that NAT could interdict 3272 infections annually among nearly 5 million annual donations.…”

Section: Provision Of Safe Blood and Blood Productsmentioning

confidence: 99%

Consensus Statement of HCV Task Force of the Indian National Association for Study of the Liver (INASL). Part I: Status Report of HCV Infection in India

Puri

Anand

Saraswat

et al. 2014

Journal of Clinical and Experimental Hepatology

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Globally, around 150 million people are infected with hepatitis C virus (HCV). India contributes a large proportion of this HCV burden. The prevalence of HCV infection in India is estimated at between 0.5% and 1.5%. It is higher in the northeastern part, tribal populations and Punjab, areas which may represent HCV hotspots, and is lower in western and eastern parts of the country. The predominant modes of HCV transmission in India are blood transfusion and unsafe therapeutic injections. There is a need for large field studies to better understand HCV epidemiology and identify high-prevalence areas, and to identify and spread awareness about the modes of transmission of this infection in an attempt to prevent disease transmission. ( J CLIN EXP HEPATOL 2014;4:106-116)

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“…In US populations, the sensitivity and specificity of anti-HCV detection is considered to be very high using third generation assays that require multiple antigens including HCV NS5 protein and these assays have been standard of care for some time [Allain, 1998;Ghany et al, 2009]. The performance of EIAs in Africa has not been well defined [Rouet et al, 2004;Hladik et al, 2006;Scheiblauer et al, 2006;Desbois et al, 2008]. The price and requirement for complex equipment significantly limit wider use of EIA in the developing world.…”

Section: Introductionmentioning

confidence: 98%

Poor performance of hepatitis C antibody tests in hospital patients in Uganda

Seremba

Ocama

Opio

et al. 2010

Journal of Medical Virology

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Most hepatitis C testing in Uganda is performed using commercial rapid strip assays (RSA) to detect antibodies to hepatitis C virus (anti-HCV), rather than enzyme immunoassays (EIA). The prevalence of hepatitis C antibodies in a Ugandan hospital population was determined using both methods to test their accuracy using nucleic acid testing (NAT) as a reference. Sera from 380 consecutive hospitalized Ugandan patients were tested for anti-HCV using an RSA in Uganda, with subsequent automated third-generation EIA testing in the United States, followed by NAT. Recombinant immunoblot assays (RIBA) were used as a supplementary test to detect anti-HCV epitopes. Overall, anti-HCV was detected in 48/380 (13%) by one or both antibody tests. Anti-HCV was detected in 19 (5.0%) patients by RSA and in 33 (8.7%) patients by EIA; only four patients were anti-HCV positive by both methods. Fourteen of the 48 anti-HCV positive patients had detectable serum HCV RNA, 7 each by bDNA assay or by PCR. RSA detected only 7 of 14 HCV RNA positive sera. Of 29 RNA negative but anti-HCV positive patients tested by RIBA, only two were anti-HCV positive; 27 were anti-HCV negative or indeterminate. Anti-HCV testing by RSA and/or EIA was neither sensitive nor specific for detection of ongoing HCV infection in hospitalized Ugandan patients. Our findings underscore the importance of confirmatory nucleic acid testing, which, despite its increased cost, appears essential to manage African patients with HCV.

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Evaluation of the performance of 44 assays used in countries with limited resources for the detection of antibodies to hepatitis C virus

Cited by 39 publications

References 12 publications

Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions

Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions

Consensus Statement of HCV Task Force of the Indian National Association for Study of the Liver (INASL). Part I: Status Report of HCV Infection in India

Poor performance of hepatitis C antibody tests in hospital patients in Uganda

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