Nanosphere has obtained the CE-IVD Mark for its gram-negative blood culture test (BC-GN) on the automated sample-to-result Verigene system.
The test expands Nanosphere’s infectious disease test capabilities to include rapid detection of bacteria that can cause deadly bloodstream infections.
With a single automated test, the Verigene BC-GN test provides rapid genus- and species-level detection for a broad panel of clinically significant gram-negative bacteria. The test also detects critical genetic markers of antimicrobial resistance, including KPC, NDM, CTX-M, OXA, VIM, and IMP.
The test, in less than two hours, provides identification of bacteria and resistance genes from gram-negative blood culture bottles. It automates the steps of bacterial DNA extraction, hybridization, and target detection on the Verigene system.
The BC-GN test is not FDA 510(k) cleared.
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