Comparison of Two Different Serological Viral Marker Testing Assays for Screening of Apheresis Donors: Which Assay Provides Optimum Safety for Transfusion?
Anti-HCV
Anti-HIV
CLIA
HBsAg
RDT
Journal
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion
ISSN: 0971-4502
Titre abrégé: Indian J Hematol Blood Transfus
Pays: India
ID NLM: 9425818
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
31
05
2021
accepted:
20
06
2022
pmc-release:
01
04
2024
medline:
4
4
2023
entrez:
3
4
2023
pubmed:
4
4
2023
Statut:
ppublish
Résumé
While whole blood testing has evolved over the years, viral marker testing for plateletpheresis donors is still performed by Rapid Diagnostic Tests (RDT). Aim of this study was to compare diagnostic accuracy of RDT and Chemiluminescence Immunoassay (CLIA) in serological testing for HBsAg, anti-HCV and anti-HIV antibodies. A prospective, analytical study was conducted in the department of Transfusion Medicine at a tertiary healthcare center in India between September 2016 and August 2018. Samples were simultaneously tested by CLIA, RDT and a confirmatory test. Sensitivity, specificity, negative and positive predictive values and mean time taken to report results were calculated. A total of 102 (1.48%) of the 6883 samples were found to be reactive by either or both the assays. A total of 74 (1.08%) samples were HBsAg reactive, 23 (0.33%) were reactive for anti-HCV antibodies and 5 (0.07%) were reactive for anti-HIV I and II antibodies. A combined sero-prevalence of 1.05% (72) was observed; 0.78% (54) for HBsAg, 0.26% (18) for anti-HCV antibodies and none for anti-HIV I and II antibodies. Four (3.85%) reactive samples were missed by RDT and therefore sensitivity of RDT was quite less as compared to CLIA. RDT and CLIA both were found to have a statistically significant shorter turnaround time than confirmatory tests. There is increasing need to develop a safe donor screening strategy for plateletpheresis. CLIA offers an excellent alterative to RDT for viral marker testing in terms of sensitivity.
Identifiants
pubmed: 37006975
doi: 10.1007/s12288-022-01553-x
pii: 1553
pmc: PMC10064355
doi:
Types de publication
Journal Article
Langues
eng
Pagination
300-307Informations de copyright
© The Author(s), under exclusive licence to Indian Society of Hematology and Blood Transfusion 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
Déclaration de conflit d'intérêts
Conflict of interestThe authors declare no conflict of interest.
Références
Indian J Pathol Microbiol. 2017 Jul-Sep;60(3):313-318
pubmed: 28937364
West Afr J Med. 2011 Jul-Aug;30(4):292-5
pubmed: 22669836
ISRN Hematol. 2012;2012:718671
pubmed: 23008779
Virol J. 2012 Nov 26;9:290
pubmed: 23181517
Transfusion. 2010 Jul;50(7):1495-504
pubmed: 20345570
Transfusion. 2013 Oct;53(10 Pt 2):2449-58
pubmed: 23607261
Indian J Pathol Microbiol. 2020 Apr-Jun;63(2):255-257
pubmed: 32317526
Transfusion. 2009 Jun;49(6):1115-25
pubmed: 19309474
Indian J Anaesth. 2014 Sep;58(5):558-64
pubmed: 25535417
J Virol Methods. 2019 Dec;274:113726
pubmed: 31479692
Indian J Med Sci. 2000 Oct;54(10):432-4
pubmed: 11262859
Blood Transfus. 2014 Apr;12(2):172-9
pubmed: 24333061
Indian J Med Microbiol. 2008 Jul-Sep;26(3):284-5
pubmed: 18695340
Indian J Med Res. 2017 Nov;146(5):642-645
pubmed: 29512607