Maine Molecular Quality Controls, Inc. (MMQCI) Products & Reviews

Xpert FII & FV HET is intended for in vitro use as a quality control to monitor analytical performance of FII & FV detection on the GeneXpert® System. Xpert FII & FV HET is formulated to monitor the detection of mutations Factor II G20210A and Factor V Leiden G1691A, the most common genetic risk factors for thrombotic events.

Xpert BCR-ABL 0%IS is intended for in vitro diagnostic use as assayed external quality controls to monitor the performance of the in vitro quantitative detection of BCR-ABL1 translocation mRNA e14a2/b3a2 transcripts and the ABL1 endogenous control mRNA transcript.

The Xpert NPM1 Control Panel C194v1.1 is intended for use as an assayed external quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of the NPM1 Type A, Type B, and Type D mutant mRNA transcripts and ABL1 endogenous control mRNA transcript when analyzed using the Xpert® NPM1 Mutation assay on Cepheid GeneXpert® Instrument Systems.

The Xpert PML-RARA Control Panel C215 is an external reference material used to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of PML-RARA transcript isoforms, bcr1, bcr2, bcr3, and ABL1 endogenous control mRNA transcript when analyzed using the Xpert® PML-RARA assay on Cepheid GeneXpert® Instrument Systems.

The FilmArray® Ebola Control Panel M251 is intended for in vitro use as a quality control to monitor the presumptive detection of Ebola Zaire virus in whole blood specimens when tested by the FilmArray® BioThreat-E test on the FilmArray® instrument.

The Xpert PML-RARA Linearity Panel C221 is intended for use as a reference material to monitor the reportable range of in vitro laboratory nucleic acid testing procedures for the quantitative detection of PML-RARA transcript isoform bcr1 and ABL1 endogenous control mRNA transcript when analyzed using the Xpert® PML-RARA assay on Cepheid GeneXpert® Instrument Systems.

Xpert Bladder Cancer Panel C104 is intended for use as a quality control to monitor the performance of in vitro laboratory nucleic acid procedures for the qualitative detection of five RNA transcripts, CRH, IGF2, UPK1B, ANXA10, ABL1, performed on Cepheid GeneXpert® Systems with assays Xpert® Bladder Cancer Monitor and Xpert® Bladder Cancer Detection.

The SPOTFIRE® RSP Pos & Neg Controls kit is intended for use (as applicable) as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens.

The BioFire® JI Control Panel M420 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of gram-positive and gram-negative bacteria, antimicrobial resistance gene, and yeast pathogens included in the BioFire® Joint Infection (JI) Panel on the BioFire® systems.

FilmArray® Pneumonia/Pneumoniaplus Control is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of bacteria, antimicrobial resistance genes, and viruses included in the FilmArray® Pneumonia Panel or Pneumonia Panel plus assay performed on the FilmArray® systems.