• Zhen Huang, Min He, and Xiuyin Wang.
• Department of Laboratory Medicine, The Affiliated Traditional Chinese Medicine Hospital, Guangzhou Medical University, Guangzhou, China.
• Medicine (Baltimore). 2024 Oct 25; 103 (43): e40168e40168.

AbstractTo study the performance of the Siemens Atellica DL IM1600 automatic immune analyzer detection system for thyroid peroxidase antibodies (A-TPO) and anti-thyroglobulin antibodies (A-TG). Perform performance verification based on CNAS and CLSI related documents, including precision, accuracy, reference interval, and linearity. In precision validation, intra-batch imprecision coefficient of variation values of A-TG and A-TPO were 3.60%, 5.40%, and 3.20%, 2.20%, inter-batch imprecision coefficient of variation values were 5.40%, 4.40%, and 5.00%, 2.50%, all within the specified range. In the accuracy verification, the A-TG comparison values were -10.94%, -1.49%, -1.14%, -7.78%, -3.28%, and the A-TPO values were 21.20%, 6.42%, 14.63%, 12.40%, and 6.55%, The absolute values were all lower than the comparison requirements. The reference interval verifies that the A-TG and A-TPO test results of health patients were within the normal reference interval of 0 to 60 U/mL. In the linear range validation, A-TG linear regression y = 1.0145x - 10.093, correlation coefficient R2 = 0.9963 > 0.95, A-TPO linear regression y = 0.9985x - 18.172, correlation coefficient R2 = 0.9954 > 0.95, indicating linear linearity. The performance verification of Siemens Atellica DL IM1600 automatic immune analyzer detection system for A-TPO and A-TG was satisfactory, suitable for clinical application.Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.

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