Evaluation of Analytical and Preliminary Clinical Performance of Myconostica MycAssay Aspergillus When Testing Serum Specimens for Diagnosis of Invasive Aspergillosis
Open Access
- 1 June 2011
- journal article
- research article
- Published by American Society for Microbiology in Journal of Clinical Microbiology
- Vol. 49 (6), 2169-2174
- https://doi.org/10.1128/jcm.00101-11
Abstract
Diagnosis of invasive aspergillosis remains a significant problem. PCR testing may aid diagnosis but is not yet included in disease-defining criteria due to a lack of standardization of assays and methodologies. This study investigated the analytical performance and the clinical sensitivity and specificity of the Myconostica MycAssay Aspergillus PCR (MAP) assay compared to those of a validated in-house Aspergillus PCR (IHP) test when testing serum specimens. Serum specimens spiked with Aspergillus genomic DNA had a limit of detection equivalent to 5 genomes and a linear dynamic range of 5 to >5 × 10 4 genomes for both assays. When testing clinical specimens ( n = 170), the MAP assay had a sensitivity of 60 to 70% and a specificity of 90.5 to 100%. The IHP assay had a sensitivity of 50 to 80% and a specificity of 100%. A commercially available Aspergillus PCR assay provides a methodology that is standardized and reagents that are quality controlled. This facilitates multicenter evaluation of the clinical utility of PCR diagnosis. The performance of the MAP assay is comparable to that of the IHP assay and to those in previously reported studies evaluating commercial tests (galactomannan enzyme-linked immunosorbent assay).Keywords
This publication has 21 references indexed in Scilit:
- Critical Stages of Extracting DNA from Aspergillus fumigatus in Whole-Blood SpecimensJournal of Clinical Microbiology, 2010
- Aspergillus PCR: One Step Closer to StandardizationJournal of Clinical Microbiology, 2010
- Dynamics of extracellular release of Aspergillus fumigatus DNAand galactomannan during growth in blood and serumJournal of Medical Microbiology, 2010
- Strain-Dependent Variation in 18S Ribosomal DNA Copy Numbers in Aspergillus fumigatusJournal of Clinical Microbiology, 2009
- The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR ExperimentsClinical Chemistry, 2009
- Revised Definitions of Invasive Fungal Disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus GroupClinical Infectious Diseases, 2008
- Development and optimization of quantitative PCR for the diagnosis of invasive aspergillosis with bronchoalveolar lavage fluidBMC Infectious Diseases, 2008
- In Vitro Release by Aspergillus fumigatus of Galactofuranose Antigens, 1,3-β- d -Glucan, and DNA, Surrogate Markers Used for Diagnosis of Invasive AspergillosisJournal of Clinical Microbiology, 2006
- The Evolution and Evaluation of a Whole Blood Polymerase Chain Reaction Assay for the Detection of Invasive Aspergillosis in Hematology Patients in a Routine Clinical SettingClinical Infectious Diseases, 2006
- Polymerase Chain Reaction for Diagnosing Invasive Aspergillosis: Getting Closer but Still a Ways to GoClinical Infectious Diseases, 2006