Efficacy of Nucleic Acid Amplification Test (NAT) over Enzyme Linked Immuno Sorbent Assay (ELISA) in Detecting Transfusion Transmissible Infections (TTI) among Blood Donors at a Tertiary Care Centre
A Comparative Study
Keywords:
Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus, Nucleic Acid Amplification Test, Enzyme Linked Immuno Sorbent Assay, Transfusion Transmissible Infections
Abstract
Background: Background: Blood safety in India becomes prime importance with a large number of blood donors. The donated blood is screened for transfusion transmissible infections (TTI) using immunoassays and nucleic acid amplification Test (NAT). However the risk of infection during window period (WP) might be missed by the immunoassay, which are responsible for most of the TTI. Zero window period might provide complete blood safety. Aim: 1) To study sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy (efficacy) of NAT over enzyme linked immuno sorbent assay (ELISA) methods in detecting TTI among blood donors 2)To assess the impact of introduction of individual donor – nucleic acid amplification test (ID-NAT) by all the blood banks and this study was conducted at blood bank, Gadag institute of medical sciences (GIMS), Gadag, Karnataka, India. Methods: Over a period of 1year & 6 months, a total number of 6000 blood donors, samples were subjected to ELISA and NAT.4th generation ELISA and NAT testing using, transcription mediated amplification(TMA) was used. The results were tabulated in an excel format and data was analyzed using Statistical Package for Social Sciences (SPSS) Software 21st version. Sensitivity, specificity, positive predictive value (PPV), negative predictive value(NPV) and diagnostic accuracy(efficacy) were calculated using Galen and Gambino method. Result: A total of 6000 donors, blood samples were subjected to ELISA and NAT, among them 60 were seroreactive. 52 were NAT reactive and seronegative. The NAT yield was 1 in 113. The present study showed 53.57%, 100%,100%, 99.12% and 99.13% of sensitivity, specificity, PPV, NPV and diagnostic accuracy respectively. Conclusion: NAT could detect human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) cases in blood donor samples those that were undetected by immunoassays. Thus, NAT provides an additional layer of blood safety and provides safest blood pack for donation.References
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15. Makroo RN, Choudhury N, Jagannathan L, Parihar-Malhotra M, Raina V, Chaudhary RK, et al. Multicenter evaluation of individual donor nucleic acid testing (NAT) for simultaneous detection of human immunodeficiency virus -1 & hepatitis B & C viruses in Indian blood donors. Indian J Med Res. 2008;127:140–7.
2. Chigurupati P, Murthy KS. Automated nucleic acid amplification testing in blood banks: an additional layer of blood safety. Asian J Transfus Sci. 2015;9:9–11.
3. Dodd RY, Notari EP 4 th, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 2002;42:975-9.
4. Kapoor D, Saxena R, Sood B, Sarin SK. Blood transfusion practices in India: Results of a national survey. Indian J Gastroenterol 2000;19:64-7.
5. Garg S, Mathur DR, Garg DK. Comparison of seropositivity of HIV, HBV, HCV and syphilis in replacement and voluntary blood donors in western India. Indian J Pathol Microbiol.2001;44:409–12.
6. Busch MP, Kleinman SH, Jackson B, Stramer SL, Hewlett I, Preston S. Committee report. Nucleic acid amplification testing of blood donors for transfusion-transmitted infectious diseases: Report of the Interorganizational Task Force on Nucleic Acid Amplification Testing of Blood Donors. Transfusion. 2000;40:143–59.
7. Chatterjee K, Coshic P, Borgohain M, Premchand, Thapliyal RM, Chakroborty S, et al. Individual donor nucleic acid testing for blood safety against HIV-1 and hepatitis B and C viruses in a tertiary care hospital. Natl Med J India. 2012;25:207–9.
8. Palla P, Vatteroni ML, Vacri L, Maggi F, Baicchi U. HIV-1 NAT minipool during the pre-seroconversion window period: Detection of a repeat blood donor. Vox Sang.2006;90:59–62.
9. Weusten J, Vermeulen M, van Drimmelen H, Lelie N. Refinement of a viral transmission risk model for blood donations in seroconversion window phase screened by nucleic acid testing in different pool sizes and repeat test algorithms. Transfusion. 2011;51:203–15.
10. Jain R, Perkins J, Johnson ST, Desai P, Khatri A, Chudgar U, et al. A prospective study for prevalence and/or development of transfusion-transmitted infections in multiply transfused thalassemia major patients. Asian J Transfus Sci. 2012;6:151–4.
11. Chaurasia R, Zaman S, Das B, Chatterjee K. Screening donated blood for transfusion transmitted infections by serology along with NAT and response rate to notification of reactive results: An Indian experience. J Blood Transfus. 2014;2014:412105.
12. Agarwal N, Chatterjee K, Coshic P, Borgohain M. Nucleic acid testing for blood banks: An experience from a tertiary care centre in New Delhi, India. Transfus Apher Sci 2013;49:482-4.
13. Chandra S T. Rizvi F N, Agarwal D . Nucleic acid testing in blood donors of northern india: a single centre experience. International Journal of Contemporary Medical Research 2016;3(6):1818-1821.
14. Jain R, Aggarwal P, Gupta GN. Need for nucleic acid testing in countries with high prevalence of transfusion-transmitted infections. ISRN Hematol 2012. 2012 718671.
15. Makroo RN, Choudhury N, Jagannathan L, Parihar-Malhotra M, Raina V, Chaudhary RK, et al. Multicenter evaluation of individual donor nucleic acid testing (NAT) for simultaneous detection of human immunodeficiency virus -1 & hepatitis B & C viruses in Indian blood donors. Indian J Med Res. 2008;127:140–7.
Published
2019-05-01
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