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Aspergillus Polymerase Chain Reaction: Systematic Review of Evidence for Clinical Use in Comparison With Antigen
P Lewis White1, John R Wingard2, Stéphane Bretagne3
1Public Health Wales, Microbiology Cardiff, United Kingdom.
Background:
Aspergillus polymerase chain reaction (PCR) was excluded from the European Organisation for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions of invasive fungal disease because of limited standardization and validation. The definitions are being revised.
Methods:
A systematic literature review was performed to identify analytical and clinical information available on inclusion of galactomannan enzyme immunoassay (GM-EIA) (2002) and β-d-glucan (2008), providing a minimal threshold when considering PCR. Categorical parameters and statistical performance were compared.
Results:
When incorporated, GM-EIA and β-d-glucan sensitivities and specificities for diagnosing invasive aspergillosis were 81.6% and 91.6%, and 76.9% and 89.4%, respectively. Aspergillus PCR has similar sensitivity and specificity (76.8%-88.0% and 75.0%-94.5%, respectively) and comparable utility. Methodological recommendations and commercial PCR assays assist standardization. Although all tests have limitations, currently, PCR is the only test with independent quality control.
Conclusions:
We propose that there is sufficient evidence that is at least equivalent to that used to include GM-EIA and β-d-glucan testing, and that PCR is now mature enough for inclusion in the EORTC/MSG definitions.
Insights
Aspergillus polymerase chain reaction (PCR) is now suitable for inclusion in invasive fungal disease definitions. This diagnostic test shows comparable performance to existing biomarkers like galactomannan enzyme immunoassay (GM-EIA) and beta-D-glucan.
Area of Science:
- Medical Mycology
- Infectious Diseases
- Diagnostic Microbiology
Background:
- European Organisation for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions previously excluded Aspergillus PCR due to standardization issues.
- These definitions for invasive fungal disease are currently undergoing revision.
Purpose of the Study:
- To evaluate the analytical and clinical data supporting the inclusion of Aspergillus PCR in diagnostic criteria.
- To compare the performance of PCR with established biomarkers, galactomannan enzyme immunoassay (GM-EIA) and beta-D-glucan.
Main Methods:
- Systematic literature review to gather information on Aspergillus PCR, GM-EIA, and beta-D-glucan.
- Comparison of categorical parameters and statistical performance metrics (sensitivity, specificity) of the diagnostic tests.
Main Results:
- Galactomannan enzyme immunoassay (GM-EIA) and beta-D-glucan demonstrated sensitivities of 81.6% and 76.9%, and specificities of 91.6% and 89.4%, respectively.
- Aspergillus PCR exhibited similar sensitivity (76.8%-88.0%) and specificity (75.0%-94.5%), with comparable diagnostic utility.
- Standardization efforts through methodological recommendations and commercial assays are improving PCR reliability, which uniquely offers independent quality control.
Conclusions:
- The evidence supporting Aspergillus PCR inclusion is equivalent to that for GM-EIA and beta-D-glucan.
- Aspergillus PCR has reached sufficient maturity and reliability for incorporation into the EORTC/MSG definitions of invasive fungal disease.
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