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 |
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| Institution: | 1. Department of Laboratory Medicine, Pusan National University Hospital, Busan, Republic of Korea;2. Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea;1. Centre for Blood Research, University of British Columbia, 2350 Health Sciences Mall, Vancouver, British Columbia V6T 1Z3, Canada;2. Canadian Blood Services, 1800 Alta Vista Dr., Ottawa, ON K1G 4J5, Canada;3. Canadian Blood Services, 2350 Health Sciences Mall, Vancouver, BC V6T1Z3, Canada;1. Sorbonne Université, INSERM, Institut Pierre Louis d''Epidémiologie et de Santé Publique IPLESP, AP-HP, Hôpital Pitié-Salpêtrière, Laboratoire de virologie, Paris, France;2. Université de Paris, Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Paris, France;3. INSERM UMR 976, Université de Paris, Paris, France;4. Université de Paris, Assistance Publique – Hôpitaux de Paris, Service de virologie, Hôpital Bichat, Paris, France;5. UMR 1137-IAME, DeSCID: Decision SCiences in Infectious Diseases control and care, INSERM, Université de Paris, Paris, France;6. INSERM UMR 944, Université de Paris, Paris, France;1. Virologie, AP-HP, Hôpital Paul Brousse, Villejuif, 94804, France;2. INSERM U1193, Villejuif, 94804, France;3. Univ Paris-Sud Villejuif, 94804, France;1. EA3064, Faculty of medicine of Saint-Etienne, University of Lyon, 42023 Saint-Etienne, France;2. Institut national de la transfusion sanguine, 75015 Paris, France;3. University Clinic Hospital, Institute of Hematologic and Oncologic Diseases, Haemotherapy and Haemostasis Department, Villarroel 170, 08036 Barcelona Catalonia, Spain;4. University of Barcelona, IDIBAPS, Villarroel 170, 08036 Barcelona Catalonia, Spain |
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| Abstract: | BackgroundTransfusion-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.ObjectivesThe 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 designAmong 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.ConclusionsThe 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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| Keywords: | Cobas MPX Blood donor screening Occult HBV infection Multiplex PCR |
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