Diagnostic Performance of a Novel Multiplex PCR Assay for Candidemia among ICU Patients

Abstract

Candidemia poses a major threat to ICU patients and is routinely diagnosed by blood culture, which is known for its low sensitivity and long turnaround times. We compared the performance of a novel, Candida-specific multiplex real-time PCR assay (Fungiplex® Candida IVD Real-Time PCR Kit) with blood culture and another established diagnostic real-time PCR assay (LightCycler SeptiFast Test) with respect to Candida detection from whole blood samples. Clinical samples from 58 patients were analyzed by standard blood culture (BC) and simultaneously tested with the Fungiplex Candida PCR (FP) and the SeptiFast test (SF) for molecular detection of Candida spp. Compared to BC, the FP test showed high diagnostic power, with a sensitivity of 100% and a specificity of 94.1%. Overall diagnostic accuracy reached 94.6%. Using SF, we found a sensitivity of 60%, a specificity of 96.1%, and an overall diagnostic accuracy of 92.9%. The Fungiplex Candida PCR has shown good sensitivity and specificity on clinical samples of high-risk patients for direct detection of Candida species in whole blood samples. Together with conventional diagnostics (BC and antigen testing), this new multiplex PCR assay may contribute to a rapid and accurate diagnosis of candidiasis.

Conventional and Molecular Identification of Mycotic Mastitis Caused by Candida in Farm Animals

“…Multiplex PCR technique can serve contribute rapid and precise diagnosis of candidiasis. (Fuchs et al 2019) and also (Susilawati et al 2019) assured that multiplex PCR assay is a quick alternative in discriminating Candida species due to its high specificity and high sensitivity.…”

Recent Advances and Novel Approaches in Laboratory-Based Diagnostic Mycology

“…Studies indicate the T2Candida is useful for predicting patient prognosis through source control, allowing de-escalation of treatment and determining treatment duration [ 14 , 15 , 16 ]. The availability of alternative commercial Candida PCR assays, although not automated, may be incorporated into current molecular diagnostic facilities with greater ease over the T2Candida and while initial performance of assays is good (Bruker Fungiplex Candida Se: 100%, Sp: 94%), further evaluation is required [ 17 ]. The fully automated detection of PcP has been performed using the BD MAX™ system, where a prospective evaluation of BAL fluid testing generated sensitivity/specificity of 93%/95% and provided Cq values that could differentiate colonization from infection [ 18 ].…”

Molecular Methods for the Diagnosis of Invasive Candidiasis

“…For DNA extraction, kits from Qiagen and Biomerieux are recommended, and the assay manual provides instrument settings for a number of different thermocyclers. In a small prospective study on ICU patients with suspected IC, the Fungiplex ® Candida detected eight out of eight patients with IC and reached a sensitivity of 100% and a specificity of 94.1% [ 49 ]. Bruker also offers the panfungal Fungiplex ® Universal RUO PCR Kit and the Fungiplex ® Candida Auris RUO PCR Kit for use with extracted DNA.…”