Current knowledge on the laboratory diagnosis of Clostridium difficile infection

Table 1 General recommendations for Clostridium difficile testing

Recommendation	Ref.
C. difficile testing is recommended only for stool samples from patients with diarrhea	[23,24]
The testing of asymptomatic patients is not recommended	[23]
Perirectal swabs are not accepted for C. difficile testing unless the patient has developed ileus	[23,24]
Repeated testing of C. difficile does not improve detection and does not change the result	[23,24]
Retesting, as a proof of cure, remains controversial	[23,24]

C. difficile: Clostridium difficile.

Table 2 Sensitivity and specificity of nucleic acid amplification test assays for the detection of Clostridium difficile

Assay	Sensitivity	Specificity	Ref.
Cepheid Xpert C. difficile	90%-100%	92.9%-98.6%	[87,89,91]
IMDx C. difficile for Abbott m2000 Assay	62.1%-92.8%	99.4%-100%	[92,93]
BD Max Cdiff Assay	81.6%-96.9%	95%-95.8%	[92,93]
Portrait Toxigenic C. difficile Assay	98.2%	92.8%	[95]
Quidel Lyra Direct C. difficile Assay	82.1%-85.7%	96.9%-98.3%	[96]
Verigene C. difficile nucleic acid test	95.2%-98.7%	87.5%-99.4%	[97,128]
Simplexa C. difficile Universal Direct real time PCR	87%-98%	100%	[99,128]
AmpliVue C. difficile assay	91%-96%	89%-100%	[99,100]
Illumigene C. difficile assay	93.3%-100%	95.1%-100%	[95,101]
BD GeneOhm Cdiff assay	89.6%-97.4%	96.7%-98.5%	[95,103]
ProGastro Cd assay	77.93%-100%	93.4%-99.2%	[103,104]

C. difficile: Clostridium difficile.

Table 3 Summary of non Food and Drug Administration-approved multiplex assays that detect Clostridium difficile

Assay	Company	Pathogens detected	Technology	Ref.
Gastrofinder Smart 17 Fast	PathoFinder	9 bacteria, 4 viruses and 4 parasites	Multiplex Real-time PCR	[129]
EasyScreen Enteric assays	Genetic Signature	7 bacteria, 8 viruses and 5 parasites	3base Technology	[130]
RIDA®GENE	R-BioPharma AG	11 bacteria, 4 viruses and 4 parasites	Multiplex Real-time PCR	[131]
FTD® Bacterial Gastroenteritis	Fast-Track Diagnostics	9 bacteria, 5 viruses and 3 parasites	Multiplex Real-time PCR	[132]
CLART EnteroBac panel	Genomica	19 bacteria	Low-density microarray	[133]
Faecal Bacteria	AusDiagnostics	8 bacteria, 4 viruses and 3 parasites	Multiplex Tandem PCR technology	[134]
Seeplex Diarrhea ACE	Seegene	10 bacteria and 4 viruses	Dual priming oligonucleotide technology	[135]