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 |
1
The 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.