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Evaluation of the Methodology for Thyrotropin Receptor Antibody Measurement with Roche Electro Chemiluminescence System

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  • Center of Laboratory Medicine, Shanghai Eighth People’s Hospital, Shanghai 200235, China

Received date: 2014-03-29

  Online published: 2015-01-25

Abstract

Objective To evaluate the method for thyrotropin receptor antibody(TRAb)measurement with Roche Electro chemiluminescence (ECL) system and to establish the reference range in our laboratory. Methods The within-run and between-day imprecision was performed with high and low lever mixed serum. The analytic measure range (AMR) was evaluated with serially diluted serums. Limit of quantity (LoQ) was evaluated with continuous detection of low level serums. 20 normal sera were random taken to verify the reference range. 50 normal human serum and 50 patient’s serum samples were used to verify the specificity and sensitivity of method. Results The imprecision of within-run for high and low concentration of TRAb sample were 0.63% and 6.13%. The imprecision of between-day for high and low value concentration of TRAb sample were 4.15% and 9.55%. Reportable low limit was 1.20IU/L. The analytical measurement range (AMR) was 2.72-33.66 IU/L. the reference range was less than 1.24 IU/L. The specificity and sensitivity of measurement were 94% and 92% respectively. The bias of two detection system measurement data was less than the acceptable biases of the laboratory. Conclusion The Electro chemiluminescence system for the TRAb measurement meets the requirement of CAP.

Cite this article

DAI Yue, WU Wen-qing . Evaluation of the Methodology for Thyrotropin Receptor Antibody Measurement with Roche Electro Chemiluminescence System[J]. Labeled Immunoassays and Clinical Medicine, 2015 , 22(1) : 52 . DOI: 10.11748/bjmy.issn.1006-1703.2015.01.017

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