Overview of current detection methods and microRNA potential in Clostridioides difficile infection screening

Table 2 Selected Food and Drug Administration-approved molecular assays

Assay name	Developer	Target	Method	Sensitivity/specificity (%)
AmpliVue C. difficile assay[70]	Quidel	tcdA	Isothermal nucleic acid amplification	93.6/94.1
ARIES C. difficile assay[71,72]	Luminex	tcdA and tcdB	qRT-PCR	90-98/92-98
ARTUS C. difficile QS-RGQ MDX Kit[73]	QIAGEN, GMBH	tcdA and tcdB (+ tcdBv)	qRT-PCR	100/90-100
BD Diagnostics BD MAX C. diff assay[71,74-77]	GeneOhm Sciences	tcdB	TaqMan probe-based qRT-PCR	86-98/89-100
BD GeneOhm C. diff assay[78-82]	BD Diagnostics/GeneOhm Sciences	tcdB	Beacon probe-based PCR	91-95/96-100
Cobas C. diff Nucleic Acid Test For Use On The Cobas Liat System[83,84]	Roche	tcdB	TaqMan probe-based qRT-PCR	93/99
GenePOC C. diff[85]	GenePOC	tcdB of toxigenic C	TaqMan probe-based qRT-PCR	81/97
ICEPlex C. diff Kit1[86]	PrimeraDx	tcdB	qRT-PCR + capillary electrophoresis-based detection	90/97
Illumigene C. diff DNA Amplification assay[77]	Meridian Bioscience	tcdA	Loop-mediated isothermal DNA amplification	82-100/94-100
IMDx C. difficile for Abbott m2000[76,77]	Intelligent Medical Devices	tcdA and tcdB (+ tcdBv)	Probe-based qRT-PCR	62-84/94-99
Portrait Toxigenic C. difficile assay[87,88]	Great Basin Scientific	tcdB	Primer-mediated helicase-dependent amplification + chip-based detection	98.2/92.8
ProGastro Cd assay[81,89]	Prodesse	tcdB	Probe-based qRT-PCR	77-100/94-99
Quidel Molecular Direct C. difficile assay[70,90]	Quidel	tcdA and tcdB	TaqMan probe-based qRT-PCR	82-96/97-100
Simplexa C. difficile Universal Direct assay[70,91]	Focus Diagnostics	tcdB	qRT-PCR + bifunctional fluorescent primer-probes	87-98/99-100
Solana C. difficile assay1[92]	Quidel	tcdA	Helicase-dependent amplification	93/99
Verigene C. difficile Nucleic acid Test[91,93,94]	Nanosphere	tcdA, tcdB, cdt and tcdCΔ117	PCR + nanoparticle-based array	94-96/96-98
X/Pert C. difficile/Epi[71,77,95,96]	Cepheid	tcdA, tcdB, cdt and tcdCΔ117	TaqMan probe-based qRT-PCR	90-100/93-99

¹The sensitivity and specificity were provided by the manufacturer.

tcdCΔ117: The tcdC deletion nt 117; tcdBv: tcdB variant; cdt: Binary toxin; C. difficile or C. diff: Clostridioides difficile; qRT: Quantitative real-time.