The Brazilian experience of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus infections in blood donors

• Published in: Transfusion (Philadelphia, Pa.) Pa.), 2018-04, Vol.58 (4), p.862-870
• Main Authors: Rocha, Daniele, Andrade, Elisabete, Godoy, Daniela T., Fontana‐Maurell, Marcela, Costa, Elaine, Ribeiro, Marisa, Ferreira, Antônio G.P., Brindeiro, Rodrigo, Tanuri, Amilcar, Alvarez, Patrícia
• Format: Article
• Language: English
• Subjects: Acids; Blood; Blood & organ donations; Blood donors; Diagnostic systems; Genotypes; Hepatitis; Hepatitis B; Hepatitis C; HIV; Human immunodeficiency virus; Infections; Nucleic acids; Reproducibility; Screening; Sensitivity; Sensitivity analysis; Viruses
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1111/trf.14478

BACKGROUND The history of the development and implementation of the Brazilian nucleic acid testing (NAT) platform to detect and discriminate among human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infections in blood donors is described here. The results for the sensitivity, reproducibility, and NAT yield of the platform since program implementation are provided. STUDY DESIGN AND METHODS The Brazilian NAT HIV, HCV, and HBV kit was developed and evaluated with regard to analytical sensitivity, specificity, intralot and interlot reproducibility, interfering substances, and genotype and diagnostic sensitivity. Additionally, a sample of identified NAT‐yield cases was characterized with regard to viral load. RESULTS The 95% limits of detection for HIV, HCV, and HBV were 68.02, 102.35, and 9.08 IU/mL, respectively. All replicates were detected with reproducibility assays between the acceptable values. A total of 13,610,536 blood donors was screened from 2010 to 2016, and 63 HIV‐yield cases and 28 HCV‐yield cases were detected. Among 5,795,424 blood donors screened for HBV from 2014 to 2016, 42 yield cases were found. CONCLUSION The Brazilian NAT HIV, HCV, and HBV kit is an automated NAT system suitable for routine blood donor screening in a completely traceable process. The analytical sensitivity as well as the diagnostic sensitivity fulfilled all requirements set by the health ministry for blood donor screening. A significant number of transmission cases were prevented by the implementation of this important program.