Home    中文  
 
  • Search
  • lucene Search
  • Citation
  • Fig/Tab
  • Adv Search
Just Accepted  |  Current Issue  |  Archive  |  Featured Articles  |  Most Read  |  Most Download  |  Most Cited

Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2015, Vol. 03 ›› Issue (04): 244-248. doi: 10.3877/cma.j.jssn.2095-5820.2015.04.012

Special Issue:

• Clinical Research • Previous Articles     Next Articles

Methodological evaluation of high-throughput enzyme-linked immunosorbent assay for serum alpha fetoprotein

Juan Chen, Hua Yu, Rong Zhang, Ziyun Zhao, Aifeng Zhou, Xiaofeng Mu   

  • Received:2015-10-27 Online:2015-11-28 Published:2015-11-28
  • Contact: Xiaofeng Mu
  • About author:
    Corresponding author: Mu Xiaofeng, Email:

Abstract:

Objective

To analyze the methodology of serum alpha fetoprotein (AFP) assay by high-throughput enzyme-linked immunosorbent assay (ELISA) and appraise its clinical value.

Methods

A total of 170 serum samples of patients (hepatic carcinoma, hepatitis and hepatic cirrhosis patients) and 200 serum samples of healthy people were recruited from Qingdao Central Hospital from March to December 2013 in this study. The linear range, precision, accuracy, reference interval and diagnostic performance for primary liver cancer were estimated in accordance with EP5-A2 files and EP15-A2 files from the American association of Clinical Laboratory Standards Institute and related literatures. Compared with the electrochemical luminescence assay was performed to evaluated the detection accuracy and clinical value of high-throughput ELISA.

Results

The linear range of high-throughput ELISA for AFP was 0.0-200.0μg/L. The intra-batch coefficient of variation (CV ) of different concentrations (low, medium and high) were 4.9%, 3.1%, 3.7% respectively, the inter-batch CVs of different concentrations were 3.8%, 1.5%, 2.1% respectively, while total CVs of different concentrations were 5.0%, 6.0%, 5.0% respectively. Compared with the results of the electrochemical luminescence, the relative bias was 7.9%. The recovery rate was 91%-109%, 97.76% on average. The reference interval of serum AFP detected by high-throughput ELISA in our laboratory was 0.00~7.20 μg/L. The diagnostic threshold of primary liver cancer was 195.7μg/L, with sensitivity of 39.5% and specificity of 93.3%.

Conclusions

This study established standard operating procedures for the quantitative detection of serum AFP by a high-throughput ELISA method. High-throughput ELISA assay for quantitation of serum AFP is an accurate, stable performance in diagnosis of primary liver cancer.

Key words: High-throughput enzyme-linked immunosorbent assay, Alpha fetoprotein, Methodological evaluation

京ICP 备07035254号-20
Copyright © Chinese Journal of Clinical Laboratory Management(Electronic Edition), All Rights Reserved.
Tel: 020-81341720 Fax: 020-37103505 E-mail: clinlab@cma.org.cn
Powered by Beijing Magtech Co. Ltd