Review Article

An Overview of the Molecular Methods in the Diagnosis of Gastrointestinal Infectious Diseases

Table 1

Molecular tests for detection of toxigenic Clostridioides difficile.

AssayManufacturerDevise/analyzerTargets/methodology

AmpliVue®C. difficileFDA/CEQuidel Diagnostics, San Diego, CA, USAHand-held Disposable cassettetcdA, isothermal helicase-dependent
Illumigene (Alethia) C. difficileFDA/CEMeridian Bioscience, Cincinnati, OH, USAIncubator/readertcdA, loop-mediated isothermal amplification (LAMP)
ProGastro Cd testFDA/CEHologic, San Diego, CA, USASmartCyclertcdB, real-time PCR
Lyra®C. difficileFDA/CEQuidel, San Diego, CA, USASmartCycler, ABI 7500, QuantStudiotcdA and tcdB, real-time PCR
SimplexaC. difficileFDA/CEFocus Dx, Cypress, CA, USA3M Integrated CyclertcdB, real-time PCR
BD MaxC. difficileFDA/CEBecton Dickinson & Co., Sparks, MD, USABD Max SystemtcdB, real-time PCR
Cobas® Liat CdiffFDA/CERoche Diagnostics, Indianapolis, IN, USACobas Liat SystemtcdB, real-time PCR
GenePOC CDiff assayFDA/CEMeridian Bioscience, Cincinnati, OH, USARevogene integrated analyzertcdB, real-time PCR
ARIES®C. difficileFDA/CELuminex, Austin, TX, USAARIES systemtcdA, tcdB, real-time PCR
GeneXpert®C. difficile/EpiFDA/CECepheid, Sunnyvale, CA, USAGeneXpert systemtcdB, Δ117tcdC (BI/NAP1/027, real-time PCR
Verigene®C. difficileFDA/CELuminex, Austin, TX, USAVerigene processor and readertcdA, tcdB, Δ117tcdC (BI/NAP1/027), multiplex PCR/nanoparticle array hybridization
Qiagen® artus C. difficile QS-RGQFDA/CEQiagen, Hilden, GermanyQIAsymphony rotor-gene Q instrumentstcdA, tcdB, real-time PCR
EntericBio real-time®C. difficileCE-IVDSerosep, Limerick, IrelandABI 7500, LightCycler 480tcdB, real-time PCR