Screening of blood donations by hepatitis C virus polymerase chain reaction (HCV-PCR) improves safety of blood products by window period reduction

Introduction of the nucleic acid amplification technique (NAT) as a screening test for blood donors to detect HCV RNA became mandatory on 1 April 1999. Few automated commercial systems are available for HCV RNA detection at the moment. The Cobas Amplicor HCV 2.0 System is able to perform fully autom...

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Bibliographic Details
Published inClinical laboratory (Heidelberg) Vol. 47; no. 5-6; p. 219
Main Authors Hitzler, W E, Runkel, S
Format Journal Article
LanguageEnglish
Published Germany 2001
Subjects
Autoanalysis
Blood Donors
Drug Stability
Hepacivirus - genetics
Hepatitis C - prevention & control
Hepatitis C - transmission
Humans
Polymerase Chain Reaction
Quality Control
Reproducibility of Results
RNA, Viral - blood
Safety
Sensitivity and Specificity
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Summary:Introduction of the nucleic acid amplification technique (NAT) as a screening test for blood donors to detect HCV RNA became mandatory on 1 April 1999. Few automated commercial systems are available for HCV RNA detection at the moment. The Cobas Amplicor HCV 2.0 System is able to perform fully automated amplification and detection of nucleic acids. A concentration of 98 IU HCV RNA/ml can be detected by the Cobas Amplicor HCV 2.0 System (n = 233, in 100% of the cases). With a pool size of 40 donor samples, the guidelines of the Paul-Ehrlich-Institute concerning sensitivity (5,000 IU HCV RNA per mL in a single donation) were followed. One whole blood donation was identified as HCV-RNA positive (anti-HCV IgG negative, GPT < 30 U/L) during a period of 5 months. No false positive test results could be observed. The internal control and the run control are primarily helpful to monitor methodological problems.
ISSN:1433-6510