Comparative evaluation of ELISA & CLIA screening assays in the effective detection of HIV infection in blood donor samples

An observational study from a blood bank in tertiary health center

https://doi.org/10.53730/ijhs.v6nS1.8291

Authors

  • F.K. Jasima Nilofer Tutor, Department of Pathology, Sree Balaji Medical College and Hospital, Chennai
  • P. Subhashini Associate Professor, Department of Pathology, Sree Balaji Medical College and Hospital, Chennai

Keywords:

Specificity, accuracy, screening assay, sensitivity, HIV infection, ELISA, CLIA

Abstract

Background: Since the set-up of the first blood bank in India in 1939, by the Bengal Red Cross Society, screening for transfusion transmissible infections in donated blood has been improvising steadily in the country. Currently it is either done by rapid diagnostic tests (RDTs) or the more common enzyme linked immunosorbent assay (ELISA) or the latest available sensitive assay namely, chemiluminescence immunoassay (CLIA). Aim: The prime objective of this analytical study was to assess the degree of performance of the readily available CLIA against two different ELISA testing methods for the serological screening of HIV. Methods: We have included 850 samples obtained from serial blood donors who donated blood dating from March 2021 to March 2022. All the collected blood samples were screened by two different ELISA testing methods & CLIA analyzer. The results were then computed and evaluated. Results: Out of 850 samples, 98 were ultimately confirmed to be HIV positive by qPCR testing. As far as sensitivity is considered, both CLIA and ELISA methods hadn’t shown much disparity.

Downloads

Download data is not yet available.

References

Chinese Center for Disease Control and Prevention, “National center for AIDS/STD control and prevention, national AIDS/STD epidemic in December of 2017,” Chinese Journal of AIDS & STD, vol. 24, no. 2, p. 111, 2018.

J. Wang, J. Liu, Y. Huang et al., “An analysis of risk factors for human immunodeficiency virus infection among Chinese blood donors,” Transfusion, vol. 53, no. 10pt2, pp. 2431–2440, 2013.

J. Wang, J. Liu, F. Yao et al., “Prevalence, incidence, and residual risks for transfusion-transmitted human immunodeficiency virus Types 1 and 2 infection among Chinese blood donors,” Transfusion, vol. 53, no. 6, pp. 1240–1249, 2013.

H. Xia, W. Qiang, T. Weiguo, and L. Hongwen, “A systematic review of HIV infection prevalence among volunteer blood donors in China,” Chinese Journal of Blood Transfusion, vol. 25, no. s1, pp. 152-153, 2012.

G. Weiland, “The enzyme-linked immunosorbent assay (ELISA)–a new serodiagnostic method for the detection of parasitic infections (author’s transl),” MMW Munch Med Wochenschr, vol. 120, no. 44, pp. 1457–1460, 1978.

W. R. Seitz, “Immunoassay labels based on chemiluminescence and bioluminescence,” Clinical Biochemistry, vol. 17, no. 2, pp. 120–125, 1984.

H. Yu, J. W. Raymonda, T. M. McMahon, and A. A. Campagnari, “Detection of biological threat agents by immunomagnetic microsphere-based solid phase fluorogenic- and electro-chemiluminescence,” Biosensors Bioelectronics, vol. 14, no. 10-11, pp. 829–840, 2000.

A. Darko, W. Kabat, N. Constantine, and R. Y. Zhao, “Update on the diagnosis and monitoring of HIV-1 infection,” US Infectious Disease, vol. 2007, pp. 2–5, 2007.

M. Sasano, S. Kimura, I. Maeda, and Y. Hidaka, “Analytical performance evaluation of the Elecsys Cyclosporine and Elecsys Tacrolimus assays on the cobas e411 analyzer,” Practical Laboratory Medicine, vol. 8, pp. 10–17, 2017.

L. Sommese, C. Sabia, R. Paolillo et al., “Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: evaluation of two chemiluminescent immunoassay systems,” Scandinavian Journal of Infectious Diseases, vol. 46, no. 9, pp. 660–664, 2014.

O. Jinming, H. Xiaoxu, J. Yangtao, W. Yanan, and S. Hong, “A comparative study on the clinical performance of three fourth generation HIV diagnostic reagents,” Chinese Journal of Laboratory Medicine, vol. 36, no. 10, pp. 903–907, 2013.

L. Li, B. Cai, C. Tao, and L. Wang, “Performance evaluation of CLIA forTreponema Pallidum specific antibodies detection in comparison with ELISA,” Journal of Clinical Laboratory Analysis, vol. 30, no. 3, pp. 216–222, 2016.

M. Madiyal, S. Sagar, S. Vishwanath, B. Banerjee, V. K. Eshwara, and K. Chawla, “Comparing assay performance of ELISA and chemiluminescence immunoassay in detecting antibodies to hepatitis B surface antigen,” Journal of Clinical and Diagnostic Research: JCDR, vol. 10, no. 11, pp. dc22–dc25, 2016.

A. Sampedro, J. Rodr´ıguez-Granger, C. Gomez, A. Lara, ´ J. Gutierrez, and A. Otero, “Comparative evaluation of a new chemiluminiscent assay and an ELISA for the detection of IgM against measles,” Journal of Clinical Laboratory Analysis, vol. 27, no. 6, pp. 477–480, 2013.

T. Wang, D. Li, K. Yan et al., “Performance evaluation of a new fourth-generation HIV Ag/Ab combination electrochemiluminescence immunoassay - evaluation of a new HIV assay,” International Journal of STD & AIDS, vol. 25, no. 4, pp. 267–272, 2013.

S. L. Stramer, R. L. Townsend, G. A. Foster, R. Johnson, B. Weixlmann, and Y. Dodd, “Discordant human T-lymphotropic virus screening with Western blot confirmation: evaluation of the dual-test algorithm for US blood donations,” Transfusion, vol. 58, no. 3, pp. 638–640, 2018.

P. Kiely, Y. Stewart, and L. Castro, “Analysis of voluntary blood donors with biologic false reactivity on chemiluminescent immunoassays and implications for donor management,” Transfusion, vol. 43, no. 5, pp. 584–590, 2003.

K. Malm, E. Kragsbjerg, and S. Andersson, “Performance of Liaison XL automated immunoassay platform for bloodborne infection screening on hepatitis B, hepatitis C, HIV 1/2, HTLV 1/2 and Treponema pallidum serological markers,” Transfusion Medicine, vol. 25, no. 2, pp. 101–105, 2015.

S. Kim, J.-H. Lee, J. Y. Choi, J. M. Kim, and H.-S. Kim, “False-positive rate of a “Fourth-Generation” HIV antigen/antibody combination assay in an area of low HIV prevalence,” Clinical and Vaccine Immunology, vol. 17, no. 10, pp. 1642–1644, 2010.

P. Kiely and E. Wood, “Can we improve the management of blood donors with nonspecific reactivity in viral screening and confirmatory assays?” Transfusion Medicine Reviews, vol. 19, no. 1, pp. 58–65, 2005.

X. Yang, Y. P. Liu, X. Zhou, C. Gao, and A. Wang, “Investigation report of continuous improvement of clinical blood transfusion records,” Chinese Journal of Blood Transfusion, vol. 27, no. 9, pp. 947–949, 2014.

S. B. Lin, Z. X. Zheng, and R. Zhang, “Application and evaluation of chemiluminescence immunoassay in blood screening,” Zhongguo Shi Yan Xue Ye Xue Za Zhi, vol. 27, no. 2, pp. 569–572, 2019.

L. Kyunghoon, P. Hyung-Doo, and E.-S. Kang, “Reduction of the HIV seroconversion window period and false positive rate by using ADVIA centaur HIV antigen/antibody combo assay,” Annals of Laboratory Medicine, vol. 33, no. 6, pp. 420–425, 2013.

C. Rao, T. Wang, Q. Chen et al., “Performance evaluation of a novel automated HIV Ag/Ab chemiluminescence immunoassay,” Clinical Chemistry and Laboratory Medicine (CCLM), vol. 54, no. 9, pp. e255–e258, 2016.

S. Malhotra, N. Marwaha, K. Saluja, and R. R. Sharma, “Improving blood safety using fourth generation HIV ELISA as the screening tool in blood banks – an Indian experience,” BMC Infectious Diseases, vol. 12, no. S1, p. 1, 2012.

H. Wang, Y. Yin, and W. Wei, “Evaluation of the 4th ELISA kits for HIV antibody in the STD clinic,” China Journal of Leprosy & Skin Diseases, vol. 26, no. 6, pp. 392–394, 2010. 8 Canadian Journal of Infectious Diseases and Medical Microbiology

P. Nuttall, R. Pratt, L. Nuttall, and C. Daly, “False-positive results with HIV ELISA kits,”

Published

01-06-2022

How to Cite

Nilofer, F. K. J., & Subhashini, P. (2022). Comparative evaluation of ELISA & CLIA screening assays in the effective detection of HIV infection in blood donor samples: An observational study from a blood bank in tertiary health center. International Journal of Health Sciences, 6(S1), 13149–13156. https://doi.org/10.53730/ijhs.v6nS1.8291

Issue

Section

Peer Review Articles