NG-test®CARBA5 Carbapenemase Assay Kit (Colloidal Gold Immunochromatography)

NPMA Registration Certificate No.:	XXZZ 20200240171
Pack Size:	20 tests/kit
Sample Type:	Single bacterial colony/positive blood culture samples
Clinical Significance:	It is used by medical institutions for in vitro qualitative detection of KPC, NDM, OXA-48, VIM and IMP carbapenemases in single bacterial colony/positive blood culture samples, and rapid detection of one or more of the 5 carbapenemases in the samples; it is also clinically used to identify the tolerance of patients to carbapenem antibiotics
Principles and technology platform:	Colloidal Gold Immunochromatography

Comprehensive Projects

A single card could test five CRE indicators (KPC, NDM, IMP, VIM, OXA-48)

Appropriate for positive cultures of various clinical samples (including positive blood culture)
Quick and Convenient

Stored at room temperature. Any supporting instrument/equipment is unnecessary

It only takes 15 min to get the result
Accurate

Validated by more than 20 pieces of SCI literature at home and abroad and it is with excellent sensitivity and specificity, and its accuracy is comparable to the gold standard of molecular sequencing

The literature of CARBA5 has been quoted by the Expert Consensus Statement on Laboratory Detection and Clinical Report of Carbapenemases among Enterobacterales (2020) and the Expert Consensus on Strategies for Prevention and Control of Spread of Clinically Important Antimicrobial-resistant Organisms (2021)

Recommended by WHO documents
Multiple Certifications

EU CE Certification, US FDA Certification

NMPA Class II Marketing Authorization (the first colloidal gold product inspected by five items of CRE in China)

Comprehensive Projects