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  • RAPIDEC CARBA NP

RAPIDEC® CARBA NP

Rapid, reliable test for Carbapenemase-producing bacteria

NEW, high medical value test confirms Carbapenemase-producing bacteria in agar cultures. The test gives reliable results in under 2 hours, making it the quick and easy way to control carbapenemase producers and meet diagnostics and screening challenges, improving patient management and controlling HAI.

  • Results in 30 mins-2 hours
  • Cost-effective, all-in-one solution
  • Highly specific and sensitive

The Carbapenemase global burden

Rising antimicrobial drug resistance is one of the most urgent challenges facing the field of healthcare today. Carbapenem antibiotics are a last-resort drug used to treat bacterial infections. However, strains of Carbapenem-resistant bacteria, particularly Enterobacteriaceae, are rapidly emerging. There are 2 types of resistance to Carbapenems. If resistance results from impermeability or efflux, it is not transmissible and there is no need to isolate patients. If it is caused by carbapenemase enzyme production, it is transmissible and preventative action is necessary. Infection caused by carbapenemase producers is therefore very difficult to treat, has a higher rate of mortality and can easily spread between humans via contact, food and water – leading to greater risk of outbreaks of healthcare-associated infections (HAI). In Antibiotic Resistance Threats 2013, the CDC classes Carbapenem resistance in its most serious category – urgent threat – meaning it is “an immediate public health threat that requires urgent and aggressive action”1.

Detection of resistance to Carbapenem, particularly when due to transmissible Carbapenemase -producing bacteria, is critical to properly orient antibiotic therapy, implement appropriate isolation measures, and conduct screening. Most methods for detection and confirmation have long time-to-results and/or are complicated and costly. What’s more, some tests lack sensitivity and specificity, making results less reliable.
 

RAPIDEC® CARBA NP: the new solution

The new RAPIDEC® CARBA NP offers high medical value as a cost-effective, all-in-one solution providing rapid results – between 30 minutes and two hours. The RAPIDEC® CARBA NP test is based on the direct detection of Carbapenem hydrolysis by Carbapenemase-producing bacteria. Therefore, it distinguishes only Carbapenem resistance that is transmissible, avoiding unnecessary patient isolation. With its high specificity and sensitivity (both 97.8%*), the test can contribute to better patient management and controlling the spread of HAI. 

RAPIDEC® CARBA NP is rapid and reliable enough to confirm diagnosis and help orient patient treatment, yet economical enough to be used for screening.

  • Adaptable to any lab
    • Easy to use
    • Cost-effective
       
  • Rapid time to result
     
  • Manage infection risk:
    • Reliable, specific and sensitive
    • Discriminates transmissible resistance

 

Leading the charge on carbapenemase
Compared to other methods,
RAPIDEC® CARBA NP is…

 …easy to implement
 …easy to interpret
 …rapid, accurate
 (versus other phenotype methods)


 …less costly
 ...able to detect new potential resistance mechanisms
 (versus PCR)

What makes RAPIDEC® CARBA NP different is how it works. It was developed in collaboration with international experts P. Nordmann and L. Poirel, based on the principle they described along with colleague L. Dortet 2,3. The RAPIDEC® CARBA NP test detects Carbapenem hydrolysis by Carbapenemase-producing bacteria: EnterobacteriaceaePseudomonas aeruginosa and Acinetobacter baumannii. Hydrolysis acidifies the medium which results in the change in color of the pH indicator – indicating specifically the presence of transmissible Carbapenem resistance.

RAPIDEC® CARBA NP detects (without distinction) all 3 types of produced Carbapenemase:

  • Class A: KPC is the main representative
  • Class B: Metallo ß-Lactamases (MBL). NDM-1, VIM and IMP
  • Class D: OXA Carbapenemases
     

Ready-to-use kit

The ready-to-use RAPIDEC® CARBA NP kit contains all you need to conduct the test in a few easy steps.

  • After bacterial lysis, which enables the extraction of the enzyme, the lysate is added to a detection solution which contains…

  • After incubation, readings are done by visually comparing a control well, starting at 30 minutes, and after no more than 2 hours. 

RAPIDEC® CARBA NP offers the flexibility of two packaging options in ready-to-use kits: one for management of sporadic situations and one for outbreaks.

Kits contain:

  • Test strips
  • Ampules of API® Suspension Medium, 2 mL
  • Incubation lids
  • 1 pack of stirring sticks
  • Two-colored (black and white) support
  • 1 package insert, also downloadable from www.biomerieux.com/techlib
  • 1 reading guide downloadable from www.biomerieux.com/techlib
     

Easy protocols for both screening and diagnostics

click to enlarge

 

 

1. Antibiotic Resistance Threats in the United States, CDC 2013

2. NORDMANN P., POIREL L., DORTET L. Rapid detection of carbapenemase-producing Enterobacteriaceae.Emerging Infectious Diseases, www.cdc.gov/eid, 2012, vol. 18, n°9, 1503-1507.

3. DORTET L., POIREL L., NORDMANN P. Rapid identification of carbapenemase types using a biochemical test in Enterobacteriaceae and Pseudomonas. Antimicrobial. Agents Chemother., 2012, vol. 56, n°12, 6437-6440.

RAPIDEC® CARBA NP Kit reference numbers

Kit for 10 tests (ref. 415418)

  • 10 test strips
  • 10 ampules of API® Suspension Medium, 2 mL.
  • 10 incubation lids.
  • 1 sachet of stirring sticks.
  • 1 two-colored (black and white) support.
  • 1 package insert provided in the kit or downloadable from www.biomerieux.com/techlib
  • 1 reading guide downloadable from www.biomerieux.com/techlib

 

Kit for 25 tests (ref. 417498)

  • 25 test strips
  • 25 ampules of API® Suspension Medium, 2 mL.
  • 25 incubation lids.
  • 1 sachet of stirring sticks.
  • 1 two-colored (black and white) support.
  • 1 package insert provided in the kit or downloadable from www.biomerieux.com/techlib
  • 1 reading guide downloadable from www.biomerieux.com/techlib

Please contact your local bioMérieux representative for product availability

 

*Performance

The RAPIDEC® CARBA NP test performance was established at two European sites using 275 collection strains or routinely encountered strains.

The RAPIDEC® CARBA NP test was performed after culture of bacteria on the Mueller Hinton E medium for 18-24 hours.

The standard procedure for preparation of the sample or the specific procedure for hypermucoid strains was followed.

Reading was performed after 30 minutes and if necessary after 2 hours of incubation at 33-38°C.

The evaluation was conducted using strains of EnterobacteriaceaePseudomonas aeruginosa and Acinetobacter baumannii, among which:

  • 136 possessed a carbapenemase, characterized by PCR. Its expression was confirmed by the results obtained from the study of meropenem and ertapenem susceptibility, according to EUCAST recommendations (7): KPC (40); OXA-48 (27); NDM (29); VIM (17); IMP (7); OXA-23 (5); OXA-24 (4); GES-5 (2); OXA-58 (1), IMI (1); NDM+OXA-48 (2); OXA-23+OXA-51 (1).
     
  • 139 did not possess a carbapenemase after characterization by PCR.

All of the tests gave an interpretable result (non response rate = 0%). 

 

Sensitivity results 

Sensitivity at 95% Confidence Interval Total number of positive samples

Number of samples detected positive with the RAPIDEC® CARBA NP test

Sensitivity

95% Confidence Interval

136

133

97.8%

[93.7 ; 99.2]%

The 3 strains which were not positive with the RAPIDEC® CARBA NP test are the following: Klebsiella pneumoniae, OXA-48; Acinetobacter baumannii, OXA-23; Acinetobacter baumannii, OXA-24. 

 

Specificity results

Specificity at 95% Confidence Interval Total number of negative samples

Number of samples detected negative with the RAPIDEC® CARBA NP test

Specificity

95% Confidence Interval

139

136

97.8%

[93.8 ; 99.3]%

The 3 strains which were not negative with the RAPIDEC® CARBA NP test are the following: Enterobacter cloacae (AmpC + impermeability); Pseudomonas aeruginosa (loss of porin + efflux); Klebsiella oxytoca (Ceftazidimase + impermeability). 

 

Limitations of the method

  • Some OXA-type carbapenemase-producing Acinetobacter baumannii strains may not be detected using the RAPIDEC® CARBA NP test.
  • The positive tests are frequently obtained after only 30-40 minutes of incubation. After this time, there is a risk that the test will become negative. It is therefore imperative to perform the first reading after 30 minutes of incubation.

Pioneering diagnostics