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| “Top-down” and “bottom-up” methods were used to assess the measurement uncertainty of the same detection system for six tumor markers |
| LI Jing1 ZHANG Shaojun2 HUANG Tingrong1 XU Jixun1 |
1.Traditional Chinese Medicine Hospital of Huangshi City, Hubei Province, Huangshi 435000, China;
2.Xiaonan District Zhuhu Health Center of Xiaogan City, Hubei Province, Xiaonan 432100, China |
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Abstract Objective By evaluating the measurement uncertainty of six tumor markers, the applicability and differences of “top-down” and “bottom-up” evaluation methods in clinical laboratory were discussed. Methods Based on the Nordtest guideline for evaluating the uncertainty of the “top-down” approach, the internal quality control data of the six tumor markers were used as the source for introducing the uncertainty component of reproducibility in the laboratory. From 2015 to 2018, the return data of 6 external quality assessment of the ministry of health and the traceability data of calibration products were used as the source of the uncertainty component introduced by deviation, and the uncertainty of synthetic standard and relative standard were calculated. Guide to the expression of uncertainty in measurement (GUM) was used to assess the uncertainty of the “bottom-up” method. Reference laboratory technical reports, laboratory seven big sources of measurement uncertainty: repeatability of absorbance of equipment, temperature fluctuation of reagent chamber, temperature fluctuation of incubation plate, repeatability and accuracy of sampling system, system carrying pollution rate, fluctuation of environmental temperature and humidity, calibration of centrifuge was analyzed, and the synthesis standard uncertainty and relative uncertainty of each component were calculated. Results The relative synthesis uncertainty of the six tumor markers (α-fetoprotein, carcinoembryonic antigen, carbohydrate antigen 125, carbohydrate antigen 153, carbohydrate antigen 199 and total prostate-specific antigen) was assessed by the “top-down” method as 9.0%, 7.2%, 9.4%, 8.3%, 11.8%, and 9.8%, respectively. The results of the “bottom-up” method were 8.0%, 7.8%, 8.1%, 9.1%, 8.1% and 8.4%, respectively. There was no significant difference between the two methods (P ＞ 0.05). Conclusion Both “top-down” and “bottom-up” methods can be applied to the evaluation of uncertainty in the measurement of tumor markers in clinical laboratories.
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