Vela Sentosa™ SA vanAvanB PCR Test

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

VELA OPERATIONS SINGAPORE PTE. LTD.

Class:

Class C IVD

Manufactured by:

VELA OPERATIONS SINGAPORE PTE. LTD.

Therapeutic area:

Microbiology

Therapeutic indications:

The Sentosa™ SA vanA/vanB PCR Test is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test, for the qualitative detection and differentiation of vancomycin resistance (vanA and vanB) genes that can be associated with Vancomycin-Resistant Enterococcus (VRE). It detects vanA and vanB genotypes in rectal and / or perianal swab samples from patients at risk for nosocomial drug resistance infections, together with clinical and epidemiological risk factors. This in vitro diagnostic test is validated for use on the Sentosa™ SX101 instrument, with the Sentosa™ SX Bacteria gDNA Kit v2.0, in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. The test results can be used as supplementary data for diagnosis, or large scale screening of vancomycin resistant colonization in healthcare settings. Negative results do not preclude VRE infection and should not be used as a sole basis for treatment and other patient management decisions.

Product summary:

Models: Sentosa™ SA vanA/vanB PCR Test (4x8) - 300015, Sentosa™ SA vanA/vanB PCR Test (4x24) - 300016, Sentosa™ SX Bacteria gDNA Kit (4x8) v2.0 - 300033, Sentosa™ SX Bacteria gDNA Kit (4x24) v2.0 - 300034, Sentosa™ SX101 instrument - 400089, Rotor-Gene Q MDX 5plex HRM Platform - 400046, Sentosa SX101 Software - 460018, Rotor-Gene Q MDx 5plex HRM Platform Software - 500131

Authorization date:

2015-07-15