Clinical Diagnostics Products & Reviews

AUTOMATION REINVENTED, FLEXIBILITY REDEFINED In the United States, the GLP systems Track is FDA cleared and approved. Orderability is pending for certain modules and features.

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.

The FilmArray® BCID2 Control Panel M416 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 antimicrobial resistance genes, Gram positive and Gram negative bacteria, and yeast pathogens included in the BioFire® Blood Culture Identification 2 Panel on the BioFire® FilmArray® systems.

Xpert BCR-ABL1 p190 Control Panel C183 is intended for use as reference material to monitor the performance of the in vitro quantitative detection of p190 BCR-ABL1 translocation mRNA transcript and the ABL1 endogenous control mRNA transcript.

Xpert FII & FV NOR/MUT Control 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 NOR/MUT Control 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 IS Panel C130 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.

BioFire® ME Control Panel M262 is intended for in vitro use as a quality control to monitor the performance of laboratory nucleic acid testing procedures for the qualitative detection of all pathogens included in the BioFire FilmArray® Meningitis/Encephalitis (ME) Panel assay performed on BioFire FilmArray systems.

Xpert FII & FV Genotype Panel G109 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 Genotype Panel G109 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.

The Xpert BCR-ABL IS p210 Linearity Panel C207 is intended for use as an assayed external quality control 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 when analyzed using the Xpert® BCR-ABL Ultra assay on Cepheid GeneXpert® Instrument Systems.

The Xpert NPM1 Linearity Panel C225 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 mutant mRNA transcript and ABL1 endogenous control mRNA transcript when analyzed using the Xpert® NPM1 Mutation assay on Cepheid GeneXpert® Instrument Systems.

BioFire® RP2.1/RP2.1plus Control Panel M441 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 all pathogens including in the BioFire® Respiratory Panel 2.1, BioFire® Respiratory Panel 2.1plus and BioFire® Respiratory Panel 2.1-EZ assays.

The FilmArray® GI Control Panel M238 is intended for in vitro use as a quality control to monitor the detection and identification of multiple gastrointestinal pathogens as performed by the FilmArray® Gastrointestinal (GI) Panel assay on the FilmArray® instrument. Detection of the viruses, bacteria and protozoa listed in Table 1 is an important aid to the diagnosis of gastrointestinal illness.

Automated Capper and Decapper

Determination of total anti-infliximab antibodies Infliximab is a recombinant protein used to treat inflammatory bowel disease (IBD). The protein can induce humoral immune responses and lead to anti-drug antibody formation, a major cause of loss of drug response. IDKmonitor Infliximab Total Anti-drug ELISA kit is a ‘drug tolerant’ assay that enables the detection of anti-drug antibodies in the presence of circulating drug.

Determination of total anti-adalimumab antibodies Adalimumab is a recombinant protein used to treat inflammatory bowel disease (IBD). This protein can induce humoral immune responses and lead to anti-drug antibody formation, a major cause of loss of drug response. The IDKmonitor Adalimumab Total Anti-drug ELISA kit is a ‘drug tolerant’ assay that enables the detection of anti-drug antibodies in the presence of circulating dru…

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