Performance evaluation of Mindray TSH assay on CL2000i system-pre-requisite for IFCC standardization and harmonization of thyroid function tests / 国际检验医学杂志

ABSTRACT

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 .