Development and evaluation of a novel fast broad-range PCR and sequencing assay (FBR-PCR/S) using dual priming oligonucleotides targeting the ITS/LSU gene regions for rapid diagnosis of invasive fungal diseases: multi-year experience in a large Canadian healthcare zone

Table 4 Performance of molecular assay and standard methods for bronchoalveolar lavage specimens (Clinical and Contrived)^a

		Standard methods^b
		Positive	Negative	Total
FBR-PCR/S Assay^c	Positive	54	0	54
	Negative	7	11	18
	Total	61	11	72
^cSensitivity (88.5%, 54/61), specificity (100%, 11/11), PPV (100%, 54/54), NPV (61.1%, 11/18) and efficiency 90.2% (65/72)

		FBR-PCR/S Assay
		Positive	Negative	Total
Standard methods^d	Positive	54	7	61
	Negative	0	11	11
	Total	54	18	72
^dSensitivity (100%, 54/54), specificity (61.1%, 11/18), PPV (88.5%, 54/61), NPV (100%, 11/11) and efficiency 90.2% (65/72)

^aIncludes 39 clinical specimens and 33 contrived specimens inoculated with a variety of fungal isolates identified by the reference lab. The molecular assay detected and accurately identified all fungal isolates in contrived BALs. PPV positive predictive value, NPV negative predictive value
^bStandard methods: All isolates were recovered from fungal culture. Yeasts were identified by morphology and Vitek MS while molds were identified by morphology and conventional PCR targeted to the ITS1 and ITS2 gene regions

ISSN: 1471-2334