Prospective evaluation of the SeptiFAST multiplex real‐time PCR assay for surveillance and diagnosis of infections in haematological patients after allogeneic stem cell transplantation compared to routine microbiological assays and an in‐house real‐time PCR method

We prospectively evaluated a multiplex real‐time PCR assay (SeptiFast, SF) in a cohort of patients undergoing allo‐BMT in comparison to an in‐house PCR method (IH‐PCR). Overall 847 blood samples (mean 8 samples/patient) from 104 patients with haematological malignancies were analysed. The majority of patients had acute leukaemia (62%) with a mean age of 52 years (54% female). Pathogens could be detected in 91 of 847 (11%) samples by SF compared to 38 of 205 (18.5%) samples by BC, and 57 of 847 (6.7%) samples by IH‐PCR. Coagulase‐negative staphylococci (n=41 in SF, n=29 in BC) were the most frequently detected bacteria followed by Escherichia coli (n=9 in SF, n=6 in BC). Candida albicans (n=17 in SF, n=0 in BC, n=24 in IH‐PCR) was the most frequently detected fungal pathogen. SF gave positive results in 5% of samples during surveillance vs in 26% of samples during fever episodes. Overall, the majority of blood samples gave negative results in both PCR methods resulting in 93% overall agreement resulting in a negative predictive value of 0.96 (95% CI: 0.95‐0.97), and a positive predictive value of 0.10 (95% CI: ?0.01 to 0.21). SeptiFast appeared to be superior over BC and the IH‐PCR method.