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  • Leading Controls Manufacturer
    Leading Controls Manufacturer
    Controls   Definition Substance, material, or article intended by its manufacturer to be used to verify the performance characteristics of an IVD medical device.   Performance Characteristics One of the parameters used to define the analytical or clinical performance of an IVD medical device.   Basic Features of Control Materials The composition of the quality control product shall be similar or identical to the substrate used to test the patient samples. Quality control products should be uniform and stable. Quality control products must be tested in the same manner as the patient sample.   Internal quality control Internal Quality Control (IQC) is a function of quality control to monitor and evaluate the work quality of the laboratory. A series of inspection and control measures are adopted by each laboratory. IQC is important for improvement of the laboratory quality management system, as it is a measure of laboratory performance.   External quality assessment External Quality Assessment (EQA) is used to describe a method that allows for comparison of a laboratory's testing to a source outside the laboratory.  Allows comparison of performance and results among different test sites  Provides early warning for systematic problems associated with kits or operations  Provides objective evidence of testing quality  Indicates areas that need improvement  Identifies training needs   QC rules Our quality control methods are based on Westgard rules. Based on this rule system, two kinds of quality control methods are established: L-J quality control and X-B quality control. L-J quality control curve is a straight line in an ideal state, with a fluctuation no more than 2 SD.   Getein QC Products   Classification Item Cardiac Marker cTnI  TnT CK-MB H-FABP NT-proBNP  CK-MB/cTnI/Myo  BNP Inflammation PCT CRP SAA IL-6 Coagulation D-Dimer Diabetes HbA1c Fertility HCG+β LH FSH Prog PRL AMH Renal Function mAlb NGAL CysC β2-MG Tumor tPSA fPSA AFP CEA Infectious Disease HBsAg Anti-HCV Metabolic Marker 25-OH-VD Thyroid Function TSH T3 T4 COVID-19 SARS-CoV-2 Antigen Other Ferritin   *Cooming soon: Anti-HCV, Anti-HIV, Total IgE     

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