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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 quality control study for human cytomegalovirus DNAemia quantification
Daniele Lilleri1, Tiziana Lazzarotto, Valeria Ghisetti
1Servizio di Virologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
The New Microbiologica
|October 23, 2009
Summary
Standardized human cytomegalovirus (HCMV) DNA quantification methods show acceptable variability for monitoring transplanted patients. Consistent results are achieved for clinically significant viral loads, improving pre-emptive therapy surveillance.
Area of Science:
- Virology
- Molecular Diagnostics
- Transplantation Medicine
Background:
- Human cytomegalovirus (HCMV) infection surveillance is critical for transplanted patients on pre-emptive therapy.
- Standardized virological monitoring protocols are essential for accurate HCMV infection surveillance.
Purpose of the Study:
- To evaluate the performance of different HCMV-DNA quantification methods in a quality control program.
- To assess the variability and reliability of in-house and commercial assays for HCMV-DNA detection.
Main Methods:
- Fifteen Italian diagnostic laboratories participated in an external Quality Control Programme.
- Two in-house and five commercial methods were used for HCMV-DNA quantification.
- Assays were evaluated for specificity, sensitivity, and variability across different viral loads.
Main Results:
- All methods demonstrated 100% specificity.
- Sensitivity reached 100% for samples with > 1,000 copies/ml HCMV-DNA.
- Variability decreased with increasing HCMV-DNA concentrations, with acceptable ranges (> 5,000 copies/ml).
Conclusions:
- An acceptable level of variability exists among methods for quantifying clinically significant HCMV-DNA levels.
- Standardized cutoffs for pre-emptive therapy can yield comparable clinical and virological results across transplantation centers.
- Method standardization is crucial for reliable HCMV monitoring in immunocompromised patients.
