Table 1.

Product Performance Data for Selected Tests for Laboratory Diagnosis of CDI When Compared with the Results of CCCN and TC

Type and name of test	Sensitivity		Specificity		Predictive value of positive result		Predictive value of negative result
	CCCN	TC	CCCN	TC	CCCN	TC	CCCN	TC
CCCN2,26,27
Laboratory-developed cytotoxin		76		100		100		97
TechLab (Wampole)		64–67		99		93		94
EIA for toxins2,7,28–30
Meridian AB	96–99	48–58	94–97	95–98	51–88	69–88	99	87–92
TechLab AB	60–96		87–99		96		92
Remel Xpect	96	48	99	84	95	46	99	85
Lateral flow for toxins7,28,29,31
TechLab	43–80		99		94	97	76	97
Meridian Immunocard	96	48	99	99	95	91	99	87
GDH2,6,7,28,31,32
Marion latex (no longer available)		68		95		59		96
Biocite Triage		32–80		100		100		84–95
TechLab		83–94		97		83–88		97–98
NAATs26,27,33–37
Gen-Probe ProGastro (PCR)	85–92	77	95–96	98	69	94	98	96
BD GeneOhm (PCR)	84–96	84–94	95	98	65–70	84–90	99	97–99
Cepheid Xpert (PCR)		94–96		96–97		80–84		98–99
Meridian Illumigene (LAMP)		92–98		98–99		92		99

CCCN and TC were the reference methods.

TechLab, Blacksburg, VA; Meridian Biosciences, Inc., Cincinnati, OH; Remel, Lenexa, KS; Biocite, Inc, San Diego, CA; Gen-Probe, San Diego, CA; BD GenOhm, La Jolla, CA; Cepheid, Sunnyvale, CA.

CCCN, cell culture cytotoxin neutralization; TC, toxigenic culture.