Aspergillus Polymerase Chain Reaction: Systematic Review of Evidence for Clinical Use in Comparison With Antigen Testing.

ABSTRACT

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 ß-d-glucan (2008), providing a minimal threshold when considering PCR. Categorical parameters and statistical performance were compared. RESULTS: When incorporated, GM-EIA and ß-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 ß-d-glucan testing, and that PCR is now mature enough for inclusion in the EORTC/MSG definitions.