Comparative study on ELISA, CLIA and rapid diagnostic test in detecting HCV infection in blood donor at a tertiary care center

M.  Preethi; M. Saisudha; P.  Subhashini; Resmi P. R

doi:10.18231/j.joapr.2023.11.3.48.53

Authors

M. Preethi Department of Pathology, Sree Balaji Medical College and Hospital, Chennai, Tamil Nadu
M. Saisudha Department of Pathology, Sree Balaji Medical College and Hospital, Chennai, Tamil Nadu
P. Subhashini Department of Pathology, Sree Balaji Medical College and Hospital, Chennai, Tamil Nadu
Resmi P. R Department of Pathology, Sree Balaji Medical College and Hospital, Chennai, Tamil Nadu

DOI:

https://doi.org/10.18231/j.joapr.2023.11.3.48.53

Abstract

Background: The prevalence of blood screening assays for hepatitis C infection among blood donors remains comparatively low in line with WHO guidelines, especially when compared to developing nations. Various methodologies, such as ELISA, immunochromatography assays, RIBA, HCV RNA PCR, and CLIA, are employed to detect anti-HCV IgG antibodies in all patients with HCV infection. However, there is a significant scarcity of comparative data available regarding the evaluation of HCV infection screening among CLIA, ELISA, and RDT methods in their ability to detect anti-HCV antibodies effectively. This gap in knowledge highlights the need for further research and analysis in this critical area of healthcare. In this study we evaluate the technical performance between ELISA, CLIA and RDT in detection of HCV infection. Materials and method: A cross-sectional study was carried out, involving 70 blood donor samples. Subsequently, the samples were subjected to screening for Anti-HCV antibodies using three different methods: RDT, CLIA, and ELISA. The results obtained from these screenings were duly recorded. Results: Among the 70 patients included in the study, 63 (90%) were male, and 7 (10%) were female. The following performance metrics were calculated for each method where CLIA shows 100% sensitivity, Specificity 98%, PPV 100%, NPV 98.9%, Accuracy 100%, Kappa coefficient 0.932, p-value <0.001, in case of ELISA: Sensitivity 97.6%, Specificity 99.2%, PPV 100%, NPV 97.1%, Accuracy 99%, Kappa coefficient 0.97, p-value <0.001. followed by RDT: Sensitivity 89%, Specificity 87.9%, PPV 100%, NPV 90.2%, Accuracy 96%, Kappa coefficient 0.59, p-value <0.001. These results provide valuable insights into the performance of each method in screening for HCV antibodies, with CLIA and ELISA demonstrating higher sensitivity, specificity, and overall accuracy compared to RDT. Conclusion: In conclusion, the study suggests that the CLIA screening method for detecting HCV infections is considered superior to both ELISA and RDT in a Tertiary care center.

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References

Park Y, Lee JH, Kim BS, Kim DY, Han KH, Kim HS. New automated hepatitis C virus (HCV) core antigen assay as an alternative to real-time PCR for HCV RNA quantification. J Clin Microbiol 48, 2253-6 (2010)

Zameer M, Shazad F, Saeed M, Aziz S, Nazish, Hussain S. Comparison between ELISA and ICT techniques for the detection of Anti HCV antibody among blood donors. Biomedica 32(4), 281 – 284 (2016)

Hepatitis C [Internet]. www.who.int. Available from: http://www.who.int/mediacentre/factsheets/fs164/en

Kim S, Kim JH, Yoon S, Park YH, Kim HS. Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection. J Clin Microbiol 46, 3919-23 (2008)

Majumder P, Shetty AK. Comparison between ELISA and chemiluminescence immunoassay for the detection of Hepatitis C virus antibody. Indian Journal of Microbiology Research 4, 353 – 357 (2017)

Seitz WR. Immunoassay labels based on chemiluminescence and bioluminescence. Clin Biochem 17, 120-5 (1984)

Yu H, Raymonda JW, McMahon TM, Campagnari AA. Detection of biological threat agents by immunomagnetic microsphere-based solid phase fluorogenic- and electro-chemiluminescence. Biosens Bioelectron 14, 829-40 (2000)

Constantine NT, Kabat W, Zhao RY. Update on the laboratory diagnosis and monitoring of HIV infection. Cell Res 15, 870-6 (2005)

Sasano M, Kimura S, Maeda I, Hidaka Y. Analytical performance evaluation of the Elecsys® Cyclosporine and Elecsys® Tacrolimus assays on the cobas e411 analyzer. Pract Lab Med 8, 10-7 (2017)

Sommese L, Sabia C, Paolillo R, Parente D, Capuano M, Iannone C, Cavalca F, Schiano C, Vasco M, De Pascale MR, Casamassimi A, Napoli C. Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: evaluation of two chemiluminescent immunoassay systems. Scand J Infect Dis 46, 660-4 (2014)

Jinming O, Xiaoxu H, Yangtao J, Yanan W, Hong S. A comparative study on the clinical performance of three fourth generation HIV diagnostic reagents. Chinese Journal of Laboratory Medicine 36(10), 903 – 907 (2013)

Li L, Cai B, Tao C, Wang L. Performance Evaluation of CLIA for Treponema Pallidum Specific Antibodies Detection in Comparison with ELISA. J Clin Lab Anal 30, 216-22 (2016)

Madiyal M, Sagar S, Vishwanath S, Banerjee B, Eshwara VK, Chawla K. Comparing Assay Performance of ELISA and Chemiluminescence Immunoassay in Detecting Antibodies to Hepatitis B Surface Antigen. J Clin Diagn Res 10, DC22-DC25 (2016)

Olmeda MP, Balfagón P, Camacho J, Dafouz D, Fuente JDL, Murillo MA, Muñoz JL, García AF, Sanz JC, Ory FD. Comparative evaluation of assays for IgM detection of rubella and measles infections. Enfermedades Infecciosas y Microbiología Clínica 40(1), 22 – 27 (2022)

Wang T, Li D, Yan K, Yuan Y, Yang T, Du X, Yan X, Tao C, Wang L. Performance evaluation of a new fourth-generation HIV Ag/Ab combination electrochemiluminescence immunoassay - evaluation of a new HIV assay. Int J STD AIDS 25, 267-72 (2014)

Stramer SL, Townsend RL, Foster GA, Johnson R, Weixlmann B, Dodd RY. Discordant human T-lymphotropic virus screening with Western blot confirmation: evaluation of the dual-test algorithm for US blood donations. Transfusion 58, 638-40 (2018)

Kiely P, Stewart Y, Castro L. Analysis of voluntary blood donors with biologic false reactivity on chemiluminescent immunoassays and implications for donor management. Transfusion 43, 584-90 (2003)

Malm K, Kragsbjerg E, Andersson S. Performance of Liaison XL automated immunoassay platform for blood-borne infection screening on hepatitis B, hepatitis C, HIV 1/2, HTLV 1/2 and Treponema pallidum serological markers. Transfus Med 25, 101-5 (2015)

Kim S, Lee JH, Choi JY, Kim JM, Kim HS. False-positive rate of a "fourth-generation" HIV antigen/antibody combination assay in an area of low HIV prevalence. Clin Vaccine Immunol 17, 1642-4 (2010)

Kiely P, Wood E. Can we improve the management of blood donors with nonspecific reactivity in viral screening and confirmatory assays. Transfus Med Rev 19, 58-65 (2005)

Yang X, Liu YP, Zhou X, Gao C, Wang A. Investigation report of continuous improvement of clinical blood transfusion records. Chinese Journal of Blood Transfusion 27(9), 947–949 (2014)

Lin SB, Zheng ZX, Zhang R. [Application and Evaluation of Chemiluminescence Immunoassay in Blood Screening]. Zhongguo Shi Yan Xue Ye Xue Za Zhi 27, 569-72 (2019)

Lee K, Park HD, Kang ES. Reduction of the HIV seroconversion window period and false positive rate by using ADVIA Centaur HIV antigen/antibody combo assay. Ann Lab Med 33, 420-5 (2013)

Rao C, Wang T, Chen Q, An J, Feng S, Tao C, Wang L. Performance evaluation of a novel automated HIV Ag/Ab chemiluminescence immunoassay. Clin Chem Lab Med 54, e255-8 (2016)

Malhotra, S., Marwaha, N., Saluja, K. et al. Improving blood safety using fourth generation HIV ELISA as the screening tool in blood banks – an Indian experience. BMC Infect Dis 12 (Suppl 1), P89 (2012).