Assessment of semi-automated nucleic acid testing programme in a Regional Blood Transfusion Centre

References

• Adeoti FM, Oyourou AO, Sirancy-Bogui L, et al. Evolution of the residual risk of transmitting HIV, HCV and HBV in the blood transfusion from 1998 to 2009 in Cote d’Ivoire. J. Vaccines Vaccin. 2012;3:1–4.
   Google Scholar
• Marwaha N. Voluntary blood donation in India: achievements, expectations and challenges. Asian J. Transfus. Sci. 2015;9:1–2.10.4103/0973-6247.157011
   PubMedGoogle Scholar
• Shyamala V, Sandison TG, Holmberg JA. Individual donation nucleic acid technology testing to minimize human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus transfusion transmitted infections. Asian J. Transfus. Sci. 2014;8:68.10.4103/0973-6247.126708
   PubMedGoogle Scholar
• Albertoni G. Mini review: current molecular methods for the detection and quantification of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus type-1. Int. J. Infect. Dis. 2014;25:145–149.10.1016/j.ijid.2014.04.007
   PubMed Web of Science ®Google Scholar
• Hans R, Marwaha N. Nucleic acid testing-benefits and constraints. Asian J. Transfus. Sci. 2014;8:2–3.10.4103/0973-6247.126679
   PubMedGoogle Scholar
• Stramer SL, Glynn SA, Kleinman SH, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. N. Engl. J. Med. 2004;351:760–768.10.1056/NEJMoa040085
   PubMed Web of Science ®Google Scholar
• Laperche S. Blood safety and nucleic acid testing in Europe. Euro Surveill. 2005;10:3–4.
   PubMedGoogle Scholar
• Stramer SL, Krysztof DE, Brodsky JP, et al. Sensitivity comparison of two Food and Drug Administration-licensed, triplex nucleic acid test automated assays for hepatitis B virus DNA detection and associated projections of United States yield. Transfusion. 2011;51:2012–2022.10.1111/trf.2011.51.issue-9
   PubMed Web of Science ®Google Scholar
• Stramer SL, Zou S, Notari EP, et al. Blood donation screening for hepatitis B virus markers in the era of nucleic acid testing: are all tests of value? Transfusion. 2012;52:440–446.10.1111/trf.2012.52.issue-2
   PubMed Web of Science ®Google Scholar
• Soldan K, Davison K, Dow B. Estimates of the frequency of HBV, HCV, and HIV infectious donations entering the blood supply in the United Kingdom, 1996 to 2003. Euro Surveill. 2005;10:17–19.
   PubMedGoogle Scholar
• El Ekiaby M, Lelie N, Allain J-P. Nucleic acid testing (NAT) in high prevalence-low resource settings. Biologicals. 2010;38:59–64.10.1016/j.biologicals.2009.10.015
   PubMed Web of Science ®Google Scholar
• Central Drug Standard Control Organisation. State wise list of the approval blood banks in the country up to no; 2014. Available from: http://www.cdsco.nic.in/forms/list.aspx?lid=1836&Id=8
   Google Scholar
• Department of Health Schedule. The drugs and cosmetics act, 1940 and the drugs and cosmetics rules, 1945, as amended up to 2005 June 30. [Last accessed on 2013 Apr 04]. Government of India. Ministry of Health and Family Welfare; p. 326. Available from: http://www.cdsco.nic.in
   Google Scholar
• 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.
   PubMedGoogle Scholar
• Chandra T. Implementation of Nucleic Acid Testing in a government blood bank setting in India. Vox sang. 2013;105:82–87.
   Google Scholar
• Jain R, Aggarwal P, Gupta GN. Need for nucleic acid testing in countries with high prevalence of transfusion-transmitted infections. ISRN Hematol. 2012;2012:5.
   Google Scholar
• Roth WK, Busch MP, Schuller A, et al. International survey on NAT testing of blood donations: expanding implementation and yield from 1999 to 2009. Vox Sang. 2012;102:82–90.10.1111/vox.2011.102.issue-1
   PubMed Web of Science ®Google Scholar
• Roth WK, Seifried E. The German experience with NAT. Transfus. Med. 2002;12:255–258.10.1046/j.1365-3148.2002.00383.x
   PubMed Web of Science ®Google Scholar
• Kleinman SH, Strong DM, Tegtmeier GGE. Hepatitis B virus (HBV) DNA screening of blood donations in minipools with the COBAS AmpliScreen HBV test. Transfusion. 2005;45:1247–1257.10.1111/j.1537-2995.2005.00198.x
   PubMed Web of Science ®Google Scholar
• Eiras A, Sauleda S, Planelles D, et al. HCV screening in blood donations using RT-PCR in mini-pool: the experience in Spain after routine use for 2 years. Transfusion. 2003;43:713–720.10.1046/j.1537-2995.2003.00420.x
   PubMed Web of Science ®Google Scholar
• Wendel S, Levi JE, Takaoka DT, et al. Primary screening of blood donors by NAT testing for HCV-RNA: development of an ‘in-house’ method and results. Rev. Inst. Med. Trop. Sao Paulo. 2007;49:177–185.
   PubMedGoogle Scholar
• Glaubitz J, Sizmann D, Simon CO, et al. Accuracy to 2nd International HIV-1 RNA WHO Standard: Assessment of three generations of quantitative HIV-1 RNA nucleic acid amplification tests. J. Clin. Virol. 2011;50:119–124.10.1016/j.jcv.2010.10.017
   PubMed Web of Science ®Google Scholar
• Yalamanchili N, Syed R, Chandra M, et al. A latest and promising approach for prediction of viral load in hepatitis B virus infected patients. Indian J. Hum. Genet. 2011;17:17–21.10.4103/0971-6866.83170
   PubMedGoogle Scholar
• Albertoni G, Castelo Girao MJ, Schor N. Mini review: current molecular methods for the detection and quantification of hepatitis B virus, hepatitis C virus, and human immunodeficiency virus type 1. Int. J. Infect. Dis. 2014;25:145–149.10.1016/j.ijid.2014.04.007
   PubMed Web of Science ®Google Scholar
• Makroo RN, Chowdhry M, Bhatia A, et al. Evaluation of the Procleix Ultrio Plus ID NAT assay for detection of HIV 1, HBV and HCV in blood donors. Asian J. Transfus. Sci. 2015;9:29–30.10.4103/0973-6247.150944
   PubMedGoogle Scholar
• Jackson JB, Smith K, Knott C, et al. Sensitivity of the Procleix HIV-1/HCV assay for detection of human immunodeficiency virus type 1 and hepatitis C virus RNA in a high-risk population. J. Clin. Microbiol. 2002;40:2387–2391.10.1128/JCM.40.7.2387-2391.2002
   PubMed Web of Science ®Google Scholar
• FDA approves Roche’s blood screening assay for simultaneous detection and identification of three major viral targets. Media Release, Basel, 2015 Jan 9. Available from: http://www.roche.com/media/store/releases/med-cor-2015-01-09.htm
   Google Scholar
• US Food and Drug Administration. Guidance for industry: use of nucleic acid tests on pooled and individual samples from donors of whole blood and blood components, including source plasma, to reduce the risk of transmission of hepatitis B virus. US FDA. 2012. Available from: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm327850.htm
   Google Scholar
• US Food and Drug Administration. Guidance for industry: nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry. Rockville, MD: US FDA. 2010.
   Google Scholar
• Chandrashekar S. Half a decade of mini-pool nucleic acid testing: cost-effective way for improving blood safety in India. Asian J. Transfus. Sci. 2014;8:35–38.10.4103/0973-6247.126688
   PubMedGoogle Scholar
• Busch MP, Glynn SA, Stramer SL, et al. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion. 2005;45:254–264.10.1111/trf.2005.45.issue-2
   PubMed Web of Science ®Google Scholar
• Galel SA. Infectious disease screening. Tech. Manual. AABB. 2011;17:239–270.
   Google Scholar
• Chatterjee K, Coshic P, Borgohain M, 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;25:207–209.
   PubMed Web of Science ®Google Scholar
• Pathak S, Chandrashekhar M. Nucleic acid testing: redefining safety in blood screening. e-Max Med. J. 2010; 1: 1.
   Google Scholar
• Makroo RN, Chowdhry M, Bhatia A, et al. Evaluation of the Procleix Ultrio Plus ID NAT assay for detection of HIV 1, HBV and HCV in blood donors. Asian J. Transfus. Sci. 2015;9:29–30.10.4103/0973-6247.150944
   PubMedGoogle Scholar
• Kumar R, Gupta S, Kaur A, et al. Individual donor-nucleic acid testing for human immunodeficiency virus-1, hepatitis C virus and hepatitis B virus and its role in blood safety. Asian J. Transfus. Sci. 2015;9:199–202.10.4103/0973-6247.154250
   PubMedGoogle Scholar
• Shyamala V. Factors in enhancing blood safety by nucleic acid technology testing for human immunodeficiency virus, hepatitis C virus and hepatitis B virus. Asian J. Transfus. Sci. 2014;8:13–18.10.4103/0973-6247.126682
   PubMedGoogle Scholar
• Chigurupati P, Murthy KS. Automated nucleic acid amplification testing in blood banks: An additional layer of blood safety. Asian J. Transfus. Sci. 2015;9:9–11.10.4103/0973-6247.150938
   PubMedGoogle Scholar