Diagnostic performance of panfungal PCR on tissue specimens for the diagnosis of invasive fungal diseases: a systematic review and meta-analysis of the Fungal PCR Initiative (FPCRI)

Filippidis, Paraskevas, El Khoury, Céline, Cruciani, Mario, Alanio, Alexandre, Bialek, Ralf, Barnes, Rosemary A. and White, P. Lewis 2026. Diagnostic performance of panfungal PCR on tissue specimens for the diagnosis of invasive fungal diseases: a systematic review and meta-analysis of the Fungal PCR Initiative (FPCRI). Journal of Clinical Microbiology 64 (9) , pp. e00721-e00726. 10.1128/jcm.00721-26

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Abstract

Invasive fungal diseases are difficult to diagnose because of the limited sensitivity of culture. Panfungal PCR amplicon sequencing assays (targeting ribosomal RNA, such as 18S, 28S, ITS) are recommended for fungal identification in histopathology samples showing fungal elements. However, data describing its overall performance and consistency are lacking. This systematic literature review and meta-analysis assessed the performance of panfungal PCR on formalin-fixed paraffin-embedded (FFPE) and non-fixed (fresh or frozen) tissue samples. A systematic literature search was performed to include studies reporting the use of panfungal PCR for fungal identification in FFPE or non-fixed tissue samples. PCR sensitivity and specificity were assessed using the reference standard of histopathology showing fungal elements. Quality assessment was performed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Pooled estimates were obtained using random-effects meta-analysis. Twenty-eight studies were included. In FFPE samples (18 studies, 852 samples), sensitivity and specificity were 75.4% (95% confidence interval [CI], 59.2–86.6) and 93.5% (70.2–98.9), respectively. Sensitivity in non-fixed samples (13 studies, 207 samples) was 86.5% (74.7–93.3), while specificity could not be assessed (insufficient data). Comparative analyses showed a significantly higher sensitivity of panfungal PCR over culture (88.2%; 76–94.7 vs 52.2%; 39–65, P = 0.001). Sub-analyses could not demonstrate the superiority of one PCR target over another due to limited data. Panfungal PCR exhibited adequate sensitivity and good specificity in FFPE samples. Sensitivity was even higher in non-fixed samples and largely superior to culture. Nevertheless, large interstudy variability was observed, warranting interlaboratory studies to define the optimal PCR target and standardized protocols.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Schools > Medicine
Additional Information:	Full list of authors available at https://doi.org/10.1128/jcm.00721-26
Publisher:	American Society for Microbiology
ISSN:	0095-1137
Date of First Compliant Deposit:	27 August 2026
Date of Acceptance:	16 July 2026
Last Modified:	07 Oct 2026 13:00
URI:	https://orca.cardiff.ac.uk/id/eprint/189224

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