RESUMO
Objective To evaluate the performance of Mindray TSH chemiluminescence immunoassay ,including imprecision , limit of detection ,functional sensitivity ,interference ,cross-reaction ,and calibration consistency .The purpose was to confirm Mind-ray TSH assay meets the criteria of IFCC standardization and harmonization of thyroid functional tests .Methods The CLSI guide-lines defined in EP documents have been followed to measure the limit of detection ,functional sensitivity ,specificity ,imprecision and calibration consistency of Mindray TSH immunoassay on CL2000i system .Results Limit of detection was 0 .001 5 μIU/mL ,func-tional sensitivity was 0 .013 μIU/mL ,the correlation coefficient of linearity was 0 .999 in the range of 0-98 .95 μIU/mL .Mindray TSH calibrator C0 spiked with luteinizing hormone (LH) up to 500 mIU/mL ,follicle stimulating hormone (FSH) up to 500 mIU/mL ,or human chorionic gonadotropin (HCG) up to 200 000 mIU/mL detected no cross reactivity (detected TSH was less than 0 .2μIU/mL) .Hemoglobin up to 500 mg/dL ,bilirubin up to 10 mg/dL ,triglycerides up to 1 800 mg/dL ,and protein up to 10 g/dL showed -6 .91% ~8 .60% bias in TSH measurement .The total imprecision of two controls (high and low levels) and three serum specimens were in the range of 3 .24% and 5 .34% .Calibration consistency which had been demonstrated with high and low controls were measured between -6 .58% and 5 .26% .Conclusion The performance of Mindray thyroid-stimulating hormone assay meets the criteria for IFCC standardization and harmonization of thyroid function tests .
RESUMO
Objective To implement the harmonization of thyroid-stimulating hormone(TSH) of Mindray assay system by par-ticipating in harmonization research program of International Federation of Clinical Chemistry (IFCC)-Standardization of Thyroid Function Tests(C-STFT ) .Methods A total of three combinations of TSH reagents and calibrators were used to measure 20 serum samples of healthy human .Within-run precision and batch-to-batch variation were assessed .The concept of harmonization was dem-onstrated by comparing our test results with All Procedure Trimmed Mean (APTM ) provided by IFCC and recalibrating with Mater Calibrators .Results The within-run precision was 1 .96% ,batch-to-batch variation was 0 .47% - 1 .15% ,depending on the level of TSH analyte .There existed a positive bias compared to APTM values .After recalibration with Mater Calibrators and Passing &Bablok regression ,the slope of method comparison was 1 .0 ,and correlation coefficient was more than 0 .975 .Conclusion By using a panel of real human specimen and recalibration based on APTM ,the test results of Mindray assay system could be harmonized with mainstream manufacturers globally .
RESUMO
Objective As a collaborator of Beijing Institute of Medical Device Testing for value assignment of state standard ma-terial candidate Cystatin-C ,we have used the internationally accepted reference material to assign value for state standard material candidate Cystatin-C ,and help Beijing Institute of Medical Device Testing get Cystatin-C national standard material certificate . Methods According to the target value and operational procedure of international reference material ERM-DA471 ,We have tested 6 dilutions of standard material candidate Cystatin-C on calibrated Hitachi 7180 immunoassay system .Results The results demon-strate good repeatability and commutability ,and have been accepted in calculating the final value for the candidate standard materi-al ,our data has assisted Beijing Institute of Medical Device Testing in passing the criteria and obtaining Cystatin-C national standard material certificate .Conclusion Compared to the data from all participating collaborators ,our results hit right on the target value , and no significant matrix effects have been observed .