A.Yashovardhan

Anju Verma

B. Suresh Babu

D.S. Jothi Bai

I.S.Chaitanya Kumar

K.V. Sreedhar Babu

The Journal of Clinical and Scientific Research

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110Blood transfusion services are a vital part ofmodern health care system. With every unit ofblood there is 1% chance of transfusion associatedproblems including transfusion transmittedinfectious disease acquisition.1 Transfusing infectedblood to patients in need amounts to a criminaloffence. It is mandatory to test  every unit of donorblood for antibodies to human immunodeficiencyvirus (HIV-1 and HIV- 2), syphilis, hepatitis C,hepatitis B and for malarial parasite.2 Hepatitis Cvirus (HCV) is an emerging infection in India andan important pathogen causing liver disease. Theprevalence of  HCV infection in voluntary or mixeddonors has beenobserved to be below 2%.3 Thehigh risk of chronicity of this blood-borne infectionand its association with hepatocellular carcinomaunderscores its public health importance. Bloodtransfusion and unsafe therapeutic interventions byinfected needles are two preventable modalitiesof spread of HCV infection.In modern blood banks, enzyme linkedimmunosorbent assay (ELISA) method is therecommended and preferred screening method fordetecting anti-HCV immunoglobulin G (IgG)antibodies. However, many blood banks in Indiado not have the facilities to carry out the ELISAtest for anti-HCV IgG antibodies and prefer touse “easy to perform”, “user friendly”immunochromatographic rapid screening testsinstead.4 A pilot study was therefore conducted inhealthy blood donors to study the performance ofimmunochromatographic (rapid) device test in thedetection of anti-HCV IgG antibodies, consideringELISA method as the ‘gold standard’.The study was carried out on 1002 blood samplescollected from apparently healthy voluntary as wellas replacement donors over a period of twomonths. All the samples were tested for anti-HCVIgG antibodies  by ELISA method (Hepano- sticaHCV Ultra; Beijing United BiomedicalCo.,LTD,Wales, UK) and  immunochromato-graphic (rapid) device test kit (SD BIOLINEHCV Standard Diagnostics. Inc., Kyongi-doKorea) simultaneously as per the manufacturer’sinstructions. Considering ELISA test as goldstandard,the sensitivity, specificity, positive-predictive value and negative-predictive value werecalculated (Table 1).The rapid immunochromatographic test was foundto have a sensitivity, specificity, positive-predictivevalue and a negative predictive value of 0%,99.9%,0% and 99.3% respectively. None of the8. Levey AS, Coresh J, Balk E, Kausz AT, Levin A,Steffes MW et al. National Kidney Foundationpractice guidelines for chronic kidney disease:evaluation, classification, and stratification. AnnIntern Med 2003;139:137-47.9. Cortas NK, Wakid NW. Determination ofinorganicnitrate in serum and urine by kineticcadmium  reduction  method.  Clin  Chem1990;36:1440-3.10. Rajendra W. High performance liquidchromatographic determination of amino acids inImmunochromatographic and ELISA methods in detection of Anti-HCV antibodies Sreedhar Babu et alTable 1: Performance characteristics of HCV ELISAand rapid test kits        ELISA             ELISA          Total      (reactive)   (non-reactive)Rapid (non-reactive) 7 994 1001Rapid (reactive) 0 1 1Total 7 995 1002HCV=Hepatitis C Virus; ELISA=enzyme linkedImmunosorbent Assaybiological samples by precolumn derivation with O-phthaldialdehyde. J Liq Chromatogr 1987;10:941-55.N. Sowjanya,1Aparna R. Bitla,1M.M. Suchitra,1V. Siva Kumar,2P.V.L.N. Srinivasa Rao.1Departments of  1Biochemistry and 2Nephrology Sri Venkateswara Institute of Medical Sciences,Tirupati.Received: 2 March, 2012.Sowjanya N, Bitla AR, Suchitra MM, Siva Kumar V,  Srinivasa Rao PVLN. Endothelial dysfunction in early stages ofchronic kidney disease: a pilot study. J.Clin Sci Res 2012; 1:109-10.Evaluation of immunochromatographic and ELISA methods in detection ofanti-HCV antibodies among healthy blood donors: a pilot study111samples that tested reactive by ELISA could bedetected by the  rapid method. Failure of the rapidkits to detect HCV reactive samples may be dueto inadequate coating of the antigens, nature ofthe antigens used or genetic heterogeneity of thevirus. Most of these rapid assays use recombinantproteins from the prototype virus alone. Studies4,5showed that variants of HCV may differsubstantially in nucleotide sequence from oneanother and show varied geographical andepidemiological distributions.Results of the present study showed that thesensitivity of rapid immunochromatographic testkits used for anti-HCV antibodies screening wassignificantly low and the rapid tests are inferiorcompared to ELISA. We strongly feel that  rapidimmunochromatographic test should not be usedin blood banks for screening blood donors forHCV infection. We also feel that stringent lawsneed to be introduced to address this problem.REFERENCES1. Garg S, Mathur DR, Garg DK. Comparison ofSeropositivity of HIV, HBV, HCV and syphilis involuntary and replacement blood donors in WesternIndia. Indian J Pathol Microbiol 2001;44:409-12.2. Nanu A, Sharma SP, Chatterjee K, Jyoti P. Markersfor transfusion-transmissible infections in northIndian voluntary and replacement blood donors:prevalence and trends 1989-1996. Vox sang1997;73:70-3.3. Mukhopadhya A. Hepatitis C in India. J Biosci2008;33:465-73.4. Kaur H, Dhanao J, Oberoi A. Evaluation of rapid kitsfor detection of HIV, HBsAg and HCV infections.Indian J Med Sci 2000;54:432-4.5. Raghuraman S, Subramanium T, Abraham P,Sridharan G. Evaluation of rapid assay for HCVantibody detection. Indian J Med Microbiol1999;7:140-1.K.V. Sreedhar Babu,I.S.Chaitanya Kumar,A.Yashovardhan,B. Suresh Babu,Anju Verma,D.S. Jothi Bai.Department ofImmunohaematology and Blood Transfusion,Sri Venkateswara Institute of Medical Sciences,Tirupati.Immunochromatographic and ELISA methods in detection of Anti-HCV antibodies Sreedhar Babu et alReceived: 28 February, 2012.Sreedhar Babu KV, Chaitanya Kumar IS, Yashovardhan A, Suresh Babu B, Verma A, Jothi Bai DS. Evaluation ofimmunochromatographic and ELISA methods in detection of anti-HCV antibodies among healthy blood donors: apilot study. J Clin Sci Res 2012; 110-1.

Evaluation of immunochromatographic and ELISA methods in detection of anti-HCV antibodies among healthy blood donors: a pilot study

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Evaluation of immunochromatographic and ELISA methods in detection of anti-HCV antibodies among healthy blood donors: a pilot study

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