Maine Molecular Quality Controls, Inc. (MMQCI)’s mission is to provide high caliber quality controls to support the goal of achieving 100% accuracy of patient molecular test results. MMQCI designs, develops, manufactures, and distributes in vitro diagnostic (IVD) quality control products used to monitor clinical assays used for the diagnosis, management, and detection of DNA and RNA in blood, urine or other body fluids for genetic testing, disease status, cancer, transmissible agents, and pharmacogenetics on IVD manual, semi-automated and automated devices, including near patient/point of care IVD devices. As experts in quality assurance of laboratory medicine, MMQCI produces high caliber controls that provide confidence in test results with uniquely suited controls that monitor all phases of molecular testing as required by best practices and regulations. MMQCI designs and produces innovative, high-quality control products as needed for emerging nucleic acid technologies as they come into use by the molecular diagnostic community. MMQCI’s high caliber quality control products benefit clinical laboratory scientists by improving test result accuracy and efficiency, physicians & care givers by increased confidence in laboratory test results for best decision making, patients by improving healthcare with more accurate laboratory results, and our employees who can take pride in their contribution to healthcare through meaningful and rewarding employment.
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 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.
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.
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.
