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MDx-Chex for BCP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Diasorin LIAISON PLEX Gram-Positive Blood Culture assay on the LIAISON PLEX System. The MDx-Chex BCP 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: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium; genus: Bacillus spp., Listeria spp., Staphylococcus spp., Streptococcus spp.; antimicrobial resistance genes: mecA/mecC, vanA, and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex® for BCP is a quality control kit consisting of two controls for the Diasorin LIAISON-PLEX Gram-Positive Blood Culture Assay (BCP). The MDx-Chex for BCP Positive Control is positive for pathogens and resistance mechanisms in the LIAISON-PLEX Gram-Positive Blood Culture assay (See Table 1). The MDx-Chex for BCP Negative Control is negative for pathogen and antimicrobial resistance genes in the LIAISON-PLEX Gram-Positive 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 BCP is also configured as a verification kit (MDx-Chex® for BCP Verification Kit) for use at equipment installation, in the development of workflow procedures and for operator proficiency evaluation.

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