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Evaluation of clinical sensitivity and specificity of hepatitis B virus (HBV), hepatitis C virus, and human immunodeficiency Virus-1 by cobas MPX: Detection of occult HBV infection in an HBV-endemic area

 Jihye Ha  ;  Younhee Park  ;  Hyon-Suk Kim 
 JOURNAL OF CLINICAL VIROLOGY, Vol.96 : 60-63, 2017 
Journal Title
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Adult ; Aged ; Blood/virology* ; Female ; HIV/genetics ; HIV/isolation & purification* ; Hepacivirus/genetics ; Hepacivirus/isolation & purification* ; Hepatitis B virus/genetics ; Hepatitis B virus/isolation & purification* ; Humans ; Male ; Mass Screening/methods* ; Middle Aged ; Multiplex Polymerase Chain Reaction/methods* ; Reagent Kits, Diagnostic* ; Sensitivity and Specificity ; Young Adult
Blood donor screening ; Cobas MPX ; Multiplex PCR ; Occult HBV infection
BACKGROUND: Transfusion-transmitted infectious diseases remain a major concern for blood safety, particularly with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Nucleic acid testing (NAT) in donor screening shortens the serologically negative window period and reduces virus transmission. The cobas MPX (Roche Molecular Systems, Inc., Branchburg, New Jersey) is a recently developed multiplex qualitative PCR system that enables the simultaneous detection of HBV, HCV, and HIV with improved sensitivity and throughput using cobas 6800 and 8800 instruments. OBJECTIVES: The aim of this study was to conduct an evaluation of the clinical sensitivity and specificity of cobas MPX detection of HBV, HCV, and HIV in clinical specimens. STUDY DESIGN: Among samples referred for HBV, HCV, and HIV-1 quantification at Severance Hospital, Yonsei University College of Medicine, positive samples were selected to evaluate sensitivity. A total of 843 samples was tested using both cobas MPX and COBAS AmpliPrep/COBAS TaqMan Tests for HBV, HCV, and HIV-1 using the cobas 8800 system and a COBAS TaqMan 96 analyzer, respectively. Samples that showed discrepancies were confirmed by nested PCR. CONCLUSIONS: The cobas MPX achieved excellent sensitivity and specificity for the detection of HBV, HCV, and HIV-1 in clinical samples. We found that the lower limit of detection (LOD) of blood screening by NAT actually improves clinical sensitivity, and occult HBV infection prevalence among healthy employees of the hospital was rather high.
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1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hyon Suk(김현숙) ORCID logo https://orcid.org/0000-0001-5662-7740
Park, Youn Hee(박윤희) ORCID logo https://orcid.org/0000-0001-8458-1495
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