Clinical utility of pan-microbial PCR assays in the routine diagnosis of infectious diseases

The goals of the study were to examine the analytical properties and the clinical utility of pan-microbial PCR (PM-PCR) assays in a retrospective study conducted in 2014–2015 at the Tel-Aviv Sourasky Medical Center. PM-PCR included in-house assays for pan-bacterial, pan-fungal, and pan-mycobacterial PCR followed by sequencing. The clinical utility of the assays was decided based on defined criteria/categories. There were 585 PM-PCR tests performed on samples from 306 patients. The positivity rates of PM-PCR for bacterial, fungal, and mycobacterial infections were 72/316 (22.7%), 16/186 (8.6%), and 6/83 (7.2%), and the sensitivity values were 65%, 76%, and 85%, respectively. PCR results had influenced the management in 14/82 (17%) of PCR-positive cases and in 13/222 (5.8%) of PCR-negative cases (P = 0.005). The causes for the low clinical utility were related to lack of effect on the initial treatment in PCR-negative cases and concurrent positive cultures or presumed contamination in PCR-positive cases.