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Updated: Jul 12, 2026
Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
Published on: June 14, 2018
[Preparation of time-resolved fluoroimmunoassay kit for human alpha-fetoprotein detection]
Jian-Feng Hang1, Ying-Song Wu, Wei-Hong Yu
1Institute of Tropical Medicine, Southern Medical University, Guangzhou 510515, China. hangjianfeng_ren@163.com
Objective:
To prepare time-resolved fluoroimmunoassay (TRFIA) kit for detecting human alpha-fetoprotein (hAFP).
Methods:
Sandwich TRFIA kit for hAFP detection was developed using monoclonal antibody of anti-AFP.
Results:
AFP-TRFIA kit was capable of detecting AFP within the range of 1-1 000 U/ml with sensitivity of 0.17 U/ml and without cross-reactivity with CEA, CA12-5, CA15-3, or CA19-9. The intra- and inter-assay coefficients of variation were (3.3-5.9)% and (3.7-6.5)%, respectively. The prepared AFP-TRFIA reagent could withstand preservation at 4 degrees celsius; for 1 year and at 37 degrees celsius; for 7 days with the cutoff value of 12 U/ml in healthy subjects (n=426). The correlation coefficient of the detection results between this kit and commercially available AFP kit (Wallac OY, Finland) for 60 blood samples was 0.995.
Conclusion:
The prepared TRFIA kit for hAFP detection meets the demand of clinical application with good sensitivity, precision, specificity, stability and accuracy.
