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NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production when grown on the following media: - 5% sheep blood agar or MacConkey agar (16-24 hours) - HardyCHROM™ ESBL agar (18-24 hours) The NG-Test® CTX-M MULTI is intended as an aid for infection control in the detection of CTX-M enzymes-producing organisms (Enterobacterales) in healthcare settings. NG-Test® CTX-M MULTI is not intended to guide or monitor treatment. A positive or negative NG-Test® CTX-M MULTI test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test® CTX-M MULTI should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production after culturing on agar and processed in an extraction buffer. The device consists of a sample port, sample and conjugate pad, and nitrocellulose test strip, which are contained within a plastic cassette, in addition to reagents for liquid extraction. The result can be read 15 minutes after adding the sample to the sample well. A positive result on the NG-Test® CTX-M MULTI occurs when two red lines appear, one on the control (C) region and one on the test (T) region. A negative result occurs when only the control line is observed and indicates the sample does not contain any target CTX-M enzymes, or the CTX-M enzymes are present at a non-detectable level. If the control line does not appear, the test result is invalid. Monoclonal antibodies that recognize the five major CTX-M groups are immobilized on a nitrocellulose membrane. Free monoclonal antibodies are present in the conjugate pad and labeled with colloidal gold. Upon addition of the processed sample to the sample pad, the capillary action of the nitrocellulose draws the sample through the mobile antibodies in the conjugate pad and the immobile antibodies on the test strip. The immobilized control antibodies capture any mobile antibodies that do not bind to the test line.

NG-Test CARBA 5 is an in vitro rapid and visual multiplex immunochromatographic assay for the qualitative detection and differentiation of five common carbapenemases (KPC, OXA-48-like, VIM, IMP and NDM) from carbapenem non-susceptible pure bacterial colonies when grown on the following media: - 5% sheep blood agar or MacConkey agar (16-24 hours) for testing Enterobacteriaceae and Pseudomonas aeruginosa - HardyCHROM™ CRE agar (18-24 hours) for testing E. coli and KES (Klebsiella aerogenes, . Klebsiella oxytoca, Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens). The NG-Test CARBA 5 is intended as an aid for infection control in the detection of carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa in healthcare settings. NG-Test CARBA 5 is not intended to guide or monitor treatment for carbapenem non-susceptible bacterial infections. A positive or negative NG-Test CARBA 5 test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test CARBA 5 should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

NG-Test CARBA 5 is an in vitro rapid and visual multiplex immunochromatographic assay that detects one or more of the five common types of carbapenemase enzymes (KPC (K), OXA-48-like (O), IMP (I), VIM (V), NDM (N)) in bacterial colonies. Liquid extraction buffer is used as a cell lysing solution when mixed with colonies. Monoclonal antibodies that individually recognize each of the five carbapenemases are immobilized on a nitrocellulose membrane. Free monoclonal antibodies are present in the sample pad and labelled with colloidal gold. Upon addition of colonies mixed with extraction buffer to the sample pad, the capillary action of the nitrocellulose draws the sample the mobile antibodies and immobile antibodies on the test strip. The immobilized control antibodies capture any mobile antibodies that run through the sample pad and nitrocellulose without binding to other test lines. A positive result occurs when a red line appears on the control region and one or more lines appear in the test regions (K. O. V. I. or N) and indicates that the sample contains one or more carbapenemases. A negative result occurs when only the control line is observed and indicates that the sample does not contain any of the five carbapenemases. If the control line does not appear, the test result is invalid. The sample pad, and nitrocellulose strip are contained within a plastic cassette. After addition of colonies in extraction buffer to the sample port, a result can be read after 15 minutes.

RAPIDEC® CARBA NP is a phenotypic (colorimetric) in vitro diagnostic test for the qualitative detection of carbapenemase enzymes in Enterobacteriaceae and Pseudomonas aeruginosa colonies that have elevated MIC values to any carbapenem. RAPIDEC® CARBA NP is performed on pure colonies grown on non-selective sheep blood agar culture media. RAPIDEC® CARBA NP is intended as an aid in the prevention and control of infection caused by carbapenemase-producing Enterobacteriaceae and Pseudomonas aeruginosa. RAPIDEC® CARBA NP is not intended to guide or monitor the treatment for these bacterial infections. A negative result does not preclude the presence of carbapenemase enzymes. The ability of RAPIDEC® CARBA NP to detect carbapenemase enzymes encoded by genetic markers other than KPC, NDM, OXA-48, VIM, and IMP has not been established. RAPIDEC® CARBA NP testing should be used in conjunction with other laboratory tests including antimicrobial susceptibility testing.

The RAPIDEC® CARBA NP strip is composed of 5 wells prepared with premeasured portions of the necessary substrates for the reactions. In addition, the kit contains the necessary accessories for performing the test. In order to rehydrate the dry reagents and initiate the reactions, wells a, b and c are filled with 100 uL of API Suspension Medium (purified water). The strip is left at room temperature for 4-10 minutes to allow the dry reagents to reconstitute in the wells. The bacterial inoculum suspension is prepared in well c until the turbidity equals well b. Well c contains the lysis buffer. In order to achieve lysis of the inoculum suspension, which enables the extraction of the enzyme, the strip is left at room temperature for additionally 30 minutes. As the next step, 25 uL of the lysed inoculum suspension is transferred to wells d and e and 25 µL from well a (phenol red solution) is also transferred to wells d and e. The strip is incubated for 30 minutes at 33-38°C to allow for the hydrolysis to occur and change in color of the phenol red solution in case of presence of a carbapenemase enzyme. The initial reading is performed after 30 minutes of incubation. In case of a negative or doubtful reaction, the strip is re-incubated for an additional 1 hour and 30 minutes before performing the final reading. The hydrolysis acidifies the medium which results in the change in color of the pH indicator. Reading is performed by comparing the colors in wells d and e. The test is positive when a significant variation in color is observed between the two wells. For example, the control well is red and the test well has changed to yellow.