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

Kanjaksha Ghosh · Kanchan Kumar Mishra · Apeksha Trivedi · Sheetal Sosa

6 citations0/0 files storedBritish Journal of Biomedical Science

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Blood donation and transfusion practices Clinical Laboratory Practices and Quality Control Hepatitis C virus research

Abstract

BACKGROUND: Detection of human immunodeficiency virus type-1 (HIV-1), hepatitis-C (HCV) and hepatitis-B virus (HBV) in the blood donors is crucial. An efficient form of detection is nucleic acid testing (NAT) in blood screening. We assessed the suitability of commercial NAT testing in a developing country, focusing on the Altona RealStar assay and the method of Sacace Biotechnologies. METHODS: We have standardised and validated commercially available NAT kits with a semi-automated system for detection of HBV, HCV and HIV-1 in blood donations. The MP-NAT (mini-pool) assay consists of pooling of sample, virus extraction, amplification and detection with commercially available NAT kits. An internal control (IC) is incorporated in the assay to monitor the extraction, target amplification and detection process. RESULTS: The sensitivity of the Altona RealStar assay at 10-MP for each viral target was evaluated, HBV showed amplification in all diluted positive samples of 100, 50, 25, 10 and 5 IU/ml. HIV and HCV infected samples showed amplification in all diluted positive samples of 500, 100, 50 and 30 IU/ml. For HIV, out of six diluted samples of 30 IU/ml, five were amplified. A total of 14,170 seronegative blood samples were tested by RealStar PCR kit in 10-MP and 6 (0.042%) samples/pools were positive. A total of 65,362 seronegative blood donations were also tested by kits of Sacace Biotechnologies, in 10-MP and 45 (0.075%) pools were positive. The prevalence of combined NAT yield cases among routine donors was 1 in 1559 donations tested for all the 3 viruses. CONCLUSION: The semi-automated combined system for NAT screening assays is robust, sensitive, reproducible, and this gives an additional layer of safety with affordable cost.

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2004Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–Amplification Testing 2005A new strategy for estimating risks of transfusion‐transmitted viral infections based on rates of detection of recently infected donors 2011International survey on NAT testing of blood donations: expanding implementation and yield from 1999 to 2009 2005Estimates of the frequency of HBV, HCV, and HIV infectious donations entering the blood supply in the United Kingdom, 1996 to 2003 2005Blood safety and nucleic acid testing in Europe 2012Need for Nucleic Acid Testing in Countries with High Prevalence of Transfusion-Transmitted Infections 2013Individual donor nucleic acid testing for blood safety against HIV-1 and hepatitis B and C viruses in a tertiary care hospital.2010Nucleic acid testing (NAT) in high prevalence–low resource settings

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