The GenePOC/Revogene Carba C assay is a highly efficient, FDA-approved diagnostic tool that detects and differentiates carbapenemase genes directly from bacterial colonies in just 70 minutes. Clinical evaluations show 100% sensitivity and specificity for major resistance markers like KPC, NDM, and OXA-48, making it a powerful, rapid solution for managing antimicrobial resistance without the need for prior DNA isolation.

The Revogene® Carba C assay is a highly reliable, rapid, and user-friendly tool for detecting the five major carbapenemase genes (NDM, VIM, IMP, KPC, and OXA-48) in Gram-negative bacteria. With 100% sensitivity and specificity, the platform provides accurate results in approximately 70 minutes, successfully identifying even complex double-carbapenemase producers. Despite its focus on specific targeted genes, its speed and diagnostic precision make it an excellent choice for microbiology laboratories to improve infection control and guide timely clinical decisions.

"In conclusion, both assays showed excellent sensitivity and specificity for detection of the four most common carbapenemases. The GenePOC Carba assay showed greater sensitivity (100%) for the detection of IMP variants than did the Xpert Carba-R assay (44.4%), which is interesting for regions in which this carbapenemase is prevalent. Given its user friendliness and short time to result, the GenePOC Carba assay is a suitable test for microbiology laboratories for the identification of CPE."

"Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women."

"Analysis of the technical features, environmental requirements and results of validation studies of the eight diagnostic molecular platforms summarized in this review show very promising potential for mobile microbiology applications. It is particularly encouraging that several molecular diagnostic instruments that are commercially available or in the launching stage have been specifically designed to be portable and suitable even for extreme environmental conditions, most importantly extreme temperatures and humidity. As of September 2019, the main areas of clinical applications of the reviewed instruments include early infant diagnosis of HIV-1/2 (Alere q), diagnosis of tuberculosis and analysis of rifampicin resistance (GeneXpert Edge and Omni), diagnostic work-up of chronic hepatitis C (Genedrive), diagnosis of respiratory infections (cobas Liat, ID Now) and diagnosis of gastrointestinal infection (PanNAT, Revogene, cobas Liat) infections. Future developments and optimization of portable molecular diagnostic instruments should be directed toward providing a broader range of diagnostic molecular assays per instrument, multiplexing, reducing the frequency of invalid results and price cutting."

"The easy-to-use Revogene® GBS DS assay provides a valuable tool for the detection of GBS colonization at the beginning of labor. The sensitivity and turn-around time are adequate. The high number of invalid results needs to be addressed before the Revogene® GBS DS test can be expected to replace the current screening-based approach."

"The rapid detection of carbapenemase-producing microorganisms is crucial for clinical and infection control purposes. Here we evaluated Revogene®Carba C assay on 154 carbapenemase-producing and -nonproducing Gram-negatives. Up to 8 samples per 70 minutes were processed by Revogene®Carba C assay which showed excellent performances with 100% sensitivity, 99.5% specificity,100% NPV, and 97.8% positive predictive value."

"In summary, our results demonstrate a promising performance of the intrapartum Revogene GBS DS test, which now needs to be confirmed in a real-time (“24/7”) clinical practice (evaluation ongoing). In our experience, the Revogene GBS DS test required minimal training with easy-to-use workflow. The Revogene instrument was user-friendly and intuitive to operate, it had a small footprint but the lack of on-demand testing may require placements of 2 (or more) units in obstetrical wards with high..."

The Revogene Carba C assay is a highly effective tool for the rapid detection of the "big 5" carbapenemase families (KPC, OXA-48-like, NDM, VIM, and IMP) in Gram-negative bacteria. With a sensitivity of 98.90% and the ability to identify challenging variants like blaKPC-33 and blaIMP-13/14, it outperforms several established molecular and immunochromatographic tests. Despite rare challenges with co-harboured genes, its speed (70 minutes) and ease of use make it a valuable asset for clinical laboratories in guiding targeted antimicrobial therapy and enhancing infection control.

The multicenter study confirms that the Revogene C. difficile system is a highly effective molecular platform for the rapid detection of the toxin B (tcdB) gene in clinical stool specimens. With an overall sensitivity of 85.0% and a specificity of 97.2%, the assay demonstrates performance comparable to other established PCR methods, even when measured against a rigorous reference standard involving enriched toxigenic cultures. With a short turnaround time of approximately 70 minutes and minimal hands-on preparation, the system is well-suited for routine clinical use. It facilitates early diagnosis, which is essential for optimizing patient management, reducing healthcare costs, and preventing the nosocomial spread of infections.

"In conclusion, the revogene C. difficile molecular assay for detection of the tcdB gene of toxigenic Clostridioides difficile is a high quality and simple to use diagnostic test providing reliable results in approximately an hour. This makes the revogene assay suitable for implementation as diagnostic utility, either as frontline/confirmatory test in a multistep algorithm or as stand-alone method if used with proper institutional criteria for collection of CDI-suspected stool specimens."

The Revogene Carba C assay is a rapid, multiplex PCR test that demonstrates excellent sensitivity and specificity (100% in Enterobacterales) for detecting the five major carbapenemase families: KPC, NDM, VIM, IMP, and OXA-48. While the assay is highly effective for routine screening of Enterobacterales and P. aeruginosa, its utility for A. baumannii is limited (approx. 12.5% sensitivity in the French epidemiological context) because it does not target the prevalent OXA-23-like enzymes. Despite this, its short turnaround time (ca. 85 minutes) and ability to identify difficult-to-detect IMP variants make it a powerful tool for infection control in clinical laboratories.

"Overall, the Revogene Strep A assay is highly sensitive and specific, easy to perform, and provides reproducible results among different users in different clinical settings. These aspects make it a useful diagnostic tool and an attractive alternative to other rapid diagnostic tests for GAS pharyngitis."