Application evaluation of detection system based on microfluidic technology in initial screening of blood donors
10.13303/j.cjbt.issn.1004-549x.2024.04.013
- VernacularTitle:基于微流控技术的检测系统在献血初筛中的应用评估
- Author:
Liqiang FU
1
;
Lieyong SANG
1
;
Qin WANG
1
;
Bo YU
2
;
Kaijun ZHANG
2
;
Yixiang ZHAO
2
;
Hejin WU
2
Author Information
1. Shaoxing Central Blood Station, Shaoxing 312000, China
2. Zhejiang Pushkang Biotechnology Co Ltd
- Publication Type:Journal Article
- Keywords:
centrifugal microfluidics;
pre-donation testing;
Hb;
ALT;
performance verification
- From:
Chinese Journal of Blood Transfusion
2024;37(4):449-454
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To evaluate the screening efficacy and practical value of the portable microfluidic biochemical analyzer in the detection of blood donors before blood donation. 【Methods】 Blood donor samples, clinical blood samples and constant quality control products were collected. Referring to the documents of ISO15189 and National Health Industry Standard, the precision and accuracy of hemoglobin (Hb) and alanine aminotransferase (ALT) were verified and compared with other detection systems. 【Results】 The MS200 biochemistry instrument has an intra-batch precision of 1.40% to 1.46%, inter-batch precision of 1.91% to 1.94%, and correctness bias of -0.9% to -1.3% for Hb test, and an intra-batch precision of 3.77% to 4.86%, inter-batch precision of 4.92% to 6.02%, and correctness bias of -3.0% to -4.8% for ALT test, which were within the range of quality requirements of industry standard. Comparison of Hb test results between MS200 biochemistry and Hb201 analyser on 1 189 peripheral blood samples from donors showed no statistically significant difference (P>0.05). 65 samples showed positive correlation between MS200 biochemistry and XS-900i automated hematology analyzer on Hb test results (R2=0.986, P=0.000). Correlation analysis of all the results of ALT detection by MS200 biochemical analyzer and AU480 biochemical analyzer in 1 065 samples showed a positive correlation (R2=0.965, P=0.000). The elevated ALT samples did not affect the Hb test results, and the samples with abnormal Hb value did not affect the ALT test results, with no interference between the two items in the detection. 【Conclusion】 The MS200 biochemical analyzer based on microfluidic technology has reliable methodological performance and can meet the need of pre-donation testing.
