A Performance Evaluation of Automatic Chemiluminescence Immunoanalyzer for Detecting Three Types of Thyroid Hormones
Objective To evaluate the performance of the eCL9000 automatic chemiluminescence immunoanalyzer for detecting thyrotropin(TSH),free triiodothyronine(FT3),and free thyroxine(FT4)items.By analyzing the consistency of Lifotronic eCL9000 and Roche Cobas e801 test results,to explore the application value of Lifotronic eCL9000 in thyroid function evaluation.Methods Referring to CLSI EP15-A3,CNAS-CL02 and other related documents,the accuracy,precision,linear range,reference interval and sensitivity of Lifotronic eCL9000 for detecting thyroid hormones were verified and evaluated,and the consistency and coincidence rate with the detection results of Roche Cobas e801 were verified by a methodological comparison.Results The intra batch precision variation coefficient(CV)of thyroid hormones was 0.52％to 3.75％,which was less than 1/4TEa,and the inter batch precision CV was 0.68％～3.75％,which was less than 1/3TEa.The accuracy comparison bias range of cach item was-2.32％to 2.77％,which was less than 1/2TEa.Linear validation slope of TSH was 1.0035 with R2≥0.990.95％of the healthy subjects tested were within the biological reference range marked by the manufacturer.The minimum detection limit complied with the specification.The analytical performance of Lifotronic eCL9000 for three types of thyroid hormones was consistent with the manufacturer's declaration,and met the requirements of Clinical Laboratory Improvement Amendments of 1988(CLIA'88)and ISO15189 laboratory accreditation standards.Using Roche Cobas e801 as a reference instrument,Lifotronic eCL9000 showed a decent correlation with Roche Cobas e801 for TSH,FT3 and FT4 detection results,and the deviation of detection results was within the clinically acceptable range.Conclusion Lifotronic eCL9000 meets clinical needs and can be used in clinical laboratories.
Lifotronic automatic chemiluminescence immunoanalyzer eCL9000Performance verificationThree thyroid function testsComparative analysis
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