Brief Summary
The video provides an overview of carbapenem-resistant Enterobacterales (CRE), which are challenging to treat due to their resistance to last-line antibiotics. The rapid NG Test Carba 5, distributed by Hardy Diagnostics, can identify the five most common types of carbapenemases in just 15 minutes, offering phenotypic results that support therapeutic decisions. The device is user-friendly, cost-effective, and has proven high sensitivity and specificity in clinical trials.
- Carbapenem-resistant Enterobacterales (CRE) are resistant to critical antibiotics.
- The NG Test Carba 5 quickly identifies the five main carbapenemases.
- The test is easy to use and provides dependable results without requiring specialized training.
Carbapenem-resistant Enterobacterales (CRE) are a group of Gram-negative bacteria that resist last-line antibiotics. They often develop this resistance through the production of enzymes known as carbapenemases, which deactivate carbapenem antibiotics. It is essential to identify the specific type of carbapenemase for effective treatment and infection control, as different enzymes necessitate tailored antibiotic regimens, and some can spread easily within healthcare facilities.
Infections caused by CRE have an alarming mortality rate of up to 50%. Thus, quick and accurate identification of the carbapenemase being produced is critical for handling these infections effectively. The video highlights that understanding which carbapenemase is present can help prevent outbreaks and guide appropriate antibiotic therapies.
Hardy Diagnostics offers the NG Test Carba 5, a rapid multilex lateral flow assay that detects five main carbapenemases in Enterobacterales and Pseudomonas aeruginosa within 15 minutes. This FDA-cleared test utilises colonies from various agars, such as Hardy Chrome CR, blood agar, or MacConkey agar, requiring only one minute of hands-on time. The quick results are integral for guiding clinical decisions.
The Carba 5 test has several advantages over traditional molecular methods: it detects the enzyme directly, indicating its expression, while molecular assays only assess the presence of genes. Carba 5 is easy to use, requires no specialised training or equipment, and has lower maintenance costs, boasting a shelf life of two years at room temperature.
The video compares Carba 5 with other detection methods, such as the SIM and EIM assays, which can differentiate between major groups of carbapenemases but fail to identify specific enzymes or may mask the presence of Metallo-beta-lactamases. The Carba NP test also has similar limitations. Carba 5 is positioned as a solution that identifies and distinguishes multiple carbapenemases efficiently.
The video outlines the procedure for using the NG Test Carba 5, which requires adding buffer to a suspension of bacterial colonies, vortexing it, and dispensing it into the test device. The test results are obtained promptly, allowing for timely clinical decision-making.
The performance of the Carba 5 test was evaluated in a multi-centre clinical trial, demonstrating 100% sensitivity and specificity with bacterial colonies from Enterobacterales and Pseudomonas aeruginosa. Extensive data from over 8,000 isolates tested worldwide show a sensitivity of 98.4% and a specificity of 99.6%, reinforcing Carba 5’s dependability for clinical microbiology labs.
The video concludes by inviting viewers to seek more information on the Carba 5 test, including supportive documents, instructions for use, and other resources available on Hardy Diagnostics' website.
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0:02 carbapenam resistant enterobacterales or CR are a group of gr negative bacteria that are resistant to lastline antibiotics and are very challenging to treat these microorganisms May confer their resistance via the production of a carbapenamase an enzyme that inactivates carbapenam antibiotics the five most common types of carbapenemases are KPC oxy 48 like Vim imp and NDM knowing the type of carbapenamase is crucial for therapeutic purposes infection control and for preventing outbreaks different enzymes require
0:47 different antibiotic regimens and some enzymes can more easily spread through hospitals or networks of hospitals leading to an epidemic spread of antimicrobial resistance genes CR infections have an estimated mortality rate of up to 50% therefore it is imperative to know if and what type of carbapenamase is being produced by a pathogen quickly and accurately Hardy Diagnostics is the exclusive distributor in the United States of the rapid multilex lateral flow assay the NG test carba 5 in just 15 minutes Cara 5 is able to detect and
1:34 differentiate the big five carbapenemases produced by enterobacterales and pomonis orinsa this FDA cleared device delivers phenotypic results in 15 minutes using colonies from Hardy Chrome CR augur blood augur or makoni augur with about 1 minute of Hands-On time and results in 15 minutes per test NG test carbo 5 naturally fits into any laboratory workflow unlike molecular methods Cara 5 detects the carbapenamase enzyme which
2:21 is crucial to aiding therapeutic decisions additionally Cara 5 has been able to detect several variants of carbapenemases undetected by predicate PCR methods this lateral flow assay is incredibly easy to use and requires no specialized training or additional equipment unlike molecular assays there are no maintenance costs associated with the device and the product is stable at room temperature with a 2-year shelf life each kit of NG test Cara 5 comes with all of the equipment required for use Cara 5 can be used in place of molecular detection methods molecular
3:08 methods require specialized technician training are very expensive per test and can take about two to 3 hours for a result additionally molecular assays detect the presence of particular genes but do not indicate whether or not the gene is being expressed Cara 5 did detects and differentiates carbapenemases produced by microorganisms to deliver a phenotypic result MIM and eim assays detect and differentiate between the two major groups of carbopac serene betalactamases like KPC and oxa 48 like and Metallo betalactamases like Vim imp and
3:55 NDM however Sim tests are unable to further different differentiate specific enzymes additionally in the msim and eim assay Serene beta lactamases will mask Metallo betalactamases if the enzymes are co-produced the carbon NP test another phenotypic assay has similar limitations to sim test methods in that it does not differentiate the specific carbapenamase that is produced Cara 5 solves this problem by detecting and differentiating multiple carbapenemases in a single assay per test Cara 5 is more economical than molecular methods and the test can
4:42 be reimbursed for up to five CPT codes using Cara 5 is easy simply add five drops of extraction buffer to the [Music] tube using a a 1 microl Loop touch three colonies and inoculate the tube with buffer Vortex until the suspension is homogeneous this is important to ensure that these cells have liced open the myar pouch containing the carb 5 lateral flow device using the supplied transfer pipet
5:27 draw the sample until it reaches the 100 microl L black line dispense the sample into the sample well labeled s and start your timer allow the sample to diffuse along the test [Music] strip in a multicentric US clinical trial the carboi performance was evaluated from bacterial colonies of enterobacterales and pomonis orosa grown on 5% sheep blood augur and makoni augur the resulting data supported a
6:14 sensitivity of 100% And A specificity of 100% after discrepant analysis additionally bacterial colonies were also tested from Hardy Chrome CR and resulting data supported a sense sensitivity and specificity of 100% after discrepant analysis in addition to the US clinical trial there are more than 100 peer-reviewed Publications and posters evaluating the performance of carba 5 since 2018 published results from over 30 different countries with more than 8,000 isolates tested support a sensitivity of 98.4% and a specificity of
7:01 99.6% all of this data indicates that Cara 5 is an accurate and dependable device for use in all clinical microbiology labs for more information regarding Cara 5 supportive documents ifus and much more please visit Hardy diagnostics.com cara5 [Music] thank you for your time to view this video if you have any questions at all please do not hesitate to reach
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