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Comparative evaluation of a triplex nucleic acid test for detection of HBV DNA, HCV RNA, and HIV-1 RNA, with the Procleix Tigris System
- Source :
- Journal of virological methods. 187(2)
- Publication Year :
- 2012
-
Abstract
- Nucleic acid testing (NAT) is valuable for screening blood donors for occult hepatitis B virus (HBV) infection and infection during the window period in countries where HBV is endemic, such as China. An “in-house” NAT (Triplex NAT) was developed for screening for HBV DNA, hepatitis C virus (HCV) RNA, and the human immunodeficiency virus type 1 (HIV-1) RNA. Using the Triplex NAT, a head-to-head comparative clinical evaluation was carried out against the most common commercial NAT used for blood screening in China: the Procleix Tigris System. A total of 33,025 specimens which were negative for Hepatitis B surface antigen, HCV antibody and HIV-1 antibody/antigen from potential blood donors were tested for HBV DNA, HCV RNA, and HIV-1 RNA by both the in-house Triplex assay and the commercially available Procleix Tigris System. Eleven specimens were detected as HBV positive by both NATs. Twelve specimens were detected as HBV positive by the Procleix Ultrio assay and the discriminatory assays, and not the Triplex. Twenty-eight specimens were detected as HBV positive by the Triplex and not the Procleix Ultrio. This study, combined with other data obtained in China, suggest that at least 50% HBV surface antigen negative but DNA-positive blood donations would be undetected using the current commercial NATs because of their insufficient sensitivity and/or Mini-Pool formatting strategies.
- Subjects :
- China
Hepatitis B virus
Hepatitis C virus
HIV Infections
Window period
Hepacivirus
medicine.disease_cause
Sensitivity and Specificity
Antigen
Virology
medicine
Humans
biology
medicine.diagnostic_test
virus diseases
RNA
Nucleic acid test
Hepatitis B
Molecular biology
Hepatitis C
digestive system diseases
Molecular Diagnostic Techniques
Nat
DNA, Viral
biology.protein
HIV-1
RNA, Viral
Antibody
Subjects
Details
- ISSN :
- 18790984
- Volume :
- 187
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Journal of virological methods
- Accession number :
- edsair.doi.dedup.....51d51ad063340538c35869de8524b912