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MDx-Chex for BCY is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast by the Diasorin LIAISON PLEX Yeast Blood Culture assay on the LIAISON PLEX System. The MDx-Chex for BCY Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components.

Positive Control: Yeast: Candida albicans, Candida dubliniensis, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Candida auris, Candida kefyr, Candida lipolytica, Candida lusitaniae, Candida guilliermondii, Cryptococcus neoformans/gattii, Candida famata, Candida haemulonii/duobushamulonii.

Negative Control: buffered solution only.

This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex for BCY is a quality control kit consisting of two controls for the Diasorin LIAISON-PLEX Yeast Blood Culture Assay (BCY). The MDx-Chex for BCY Positive Control is positive for pathogens in the LIAISON-PLEX Yeast Blood Culture assay (See Table 1). The MDx-Chex for BCY Negative Control is negative for pathogen in the LIAISON-PLEX Yeast Blood Culture assay. Each control mix also contains and controls for blood and blood culture media components that have been identified as assay inhibitors, namely hemoglobin, leukocyte DNA, and anticoagulants.

MDx-Chex for BCY is also configured as a verification kit (MDx-Chex for BCY Verification Kit) for use at equipment installation, in the development of workflow procedures and for operator proficiency evaluation.

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