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qPCR Is a Sensitive and Rapid Method for Detection of Cytomegaloviral DNA in Formalin-fixed, Paraffin-embedded Biopsy Tissue
Published on: July 9, 2014
Multicenter evaluation of PCR methods for detecting CMV DNA in blood donors
J D Roback1, C D Hillyer, W L Drew
1Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia 30322, USA. jroback@emory.edu
Transfusion
|October 19, 2001
Summary
Evaluating seven cytomegalovirus (CMV) PCR assays for blood donor screening revealed significant variability in sensitivity and specificity. Five assays showed adequate performance, aiding in selecting optimal CMV DNA detection methods for blood safety.
Area of Science:
- Virology
- Molecular Diagnostics
- Blood Transfusion Safety
Background:
- Cytomegalovirus (CMV) DNA screening is crucial for identifying infectious blood donations.
- Current serologic tests have limitations, and no consensus exists on optimal CMV DNA detection assays for donors.
Purpose of the Study:
- To evaluate the performance of seven CMV PCR assays for blood donor screening.
- To compare the sensitivity, specificity, and reproducibility of different CMV DNA detection methods.
Main Methods:
- A blinded, multicenter evaluation of seven CMV PCR assays was conducted.
- Five laboratories tested coded analytical controls and donor blood samples.
Main Results:
- Five of seven CMV PCR assays demonstrated sufficient sensitivity for donor screening (≥25 CMV genome equivalents).
- Two sensitive nested PCR assays and one commercial assay showed high specificity, detecting no CMV DNA in seronegative donors.
- Other assays showed occasional or high detection rates in seronegative samples, indicating potential false positives.
Conclusions:
- Significant variations in sensitivity, specificity, and reproducibility exist among CMV PCR assays.
- These findings aid in selecting appropriate assays for blood donor screening to enhance blood safety.
- Results may explain discrepancies in previous studies on CMV DNA prevalence in blood donors.
