Author(s)

Yuping Kang ¹, Shaojin Zhang ¹, Kechao Cheng ¹

Affiliation(s)

¹ School of Medical Technology and Engineering, Gansu Health Vocational College, Lanzhou, Gansu, 730207, China

Corresponding Author

Yuping Kang

ABSTRACT

This study performed comprehensive clinical performance verification of CARBA-5 Rapid Test (Culture, REF OCAR-902, Hangzhou AllTest Biotech Co., Ltd.), an in vitro diagnostic rapid chromatographic immunoassay for the qualitative detection of carbapenemase enzymes [KPC (K), OXA-48-like (O), IMP (I), VIM (V), NDM (N)] in bacterial colonies. A leading commercial CARBA-5 rapid test was adopted as the reference standard to evaluate diagnostic performance, with a total of 200 clinical culture specimens consisting of 50 carbapenemase-positive isolates and 150 carbapenemase-negative isolates collected from symptomatic and asymptomatic hospitalized patients. The investigational test achieved a relative sensitivity of 96.0% (95% CI: 86.3%–99.5%), relative specificity of 99.3% (95% CI: 96.3%–>99.9%), and overall diagnostic accuracy of 98.5% (95% CI: 95.7%–99.7%). Limit of detection (LoD) testing using purified recombinant carbapenemase proteins demonstrated ultra-low analytical thresholds: KPC 0.3 ng/mL, OXA-48 0.5 ng/mL, VIM 0.6 ng/mL, IMP 4.6 ng/mL, NDM 1.0 ng/mL. Intra-assay and inter-assay precision assessments confirmed >99% consistent correct identification for negative and carbapenemase-positive specimen panels across three independent production batches. The assay exhibits straightforward operation, stable storage tolerance (2-30°C without freezing), and interpretable results within 10 minutes after sample loading, with readout validity limited within 20 minutes post-test initiation. This evaluation demonstrates that OCAR-902 CARBA-5 Rapid Test (Culture) delivers reliable, reproducible, and user-friendly point-of-laboratory detection of dominant carbapenemase variants, enabling rapid laboratory identification of carbapenemase-producing Enterobacterales and Pseudomonas aeruginosa to support timely hospital infection control and targeted antimicrobial stewardship.

KEYWORDS

Carbapenemase; KPC; NDM; OXA-48-like; Carbapenem-resistant Enterobacterales; Rapid Diagnostic Test; Nosocomial Infection Control

CITE THIS PAPER

Yuping Kang, Shaojin Zhang, Kechao Cheng. Performance Evaluation of CARBA-5 Rapid Test (Culture) OCAR-902 via Clinical Validation. MEDS Clinical Medicine (2026). Vol. 7, No. 3, 22-27. DOI: http://dx.doi.org/10.23977/medsc.2026.070304.

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