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Method development and validation for the quantitative detection of soluble PD-L1 protein concentration in human serum
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En-hui GAO1, 2, 3, Rui-xia ZHANG4, Ying-feng HUANG4, Su-qin MAN2, 3, Yuan-guo CHENG1, 2
Chinese Journal of New Drugs | 2021, 30(15) : 1374 - 1380
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Chinese Journal of New Drugs | 2021, 30(15): 1374-1380
Method development and validation for the quantitative detection of soluble PD-L1 protein concentration in human serum
Full
En-hui GAO1, 2, 3, Rui-xia ZHANG4, Ying-feng HUANG4, Su-qin MAN2, 3, Yuan-guo CHENG1, 2
Affiliations
  • 1Shanghai University of Engineering Science, Shanghai 201620, China
  • 2National Shanghai Center for New Drug Safe Evaluation and Research, China State Institute of Pharmaceutical Industry, Shanghai 201203, China
  • 3Shanghai Innostar Biotech Co., Ltd., Shanghai 201320, China
  • 4Dragonboat Biopharmaceutical Co., Shanghai 201203, China
Published: 2021-08-15
Outline
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Objective:

To establish a high sensitivity, high specificity and rapid method for the determination of soluble PD-L1 (sPD-L1) concentration in human serum based on electrochemiluminescence, and to verify the method to meet the comprehensive purpose of a detection method.

Methods:

Based on the Meso Scale Discovery (MSD) technology platform, mouse anti-human PD-L1 antibody was used as the capture antibody, and biotinylated goat anti-human PD-L1 antibody was used as the detection reagent to quantitatively detect the concentration of sPD-L1 in human serum. The key parameters of the detection method was optimezed and the quantitative range, accuracy and precision, recovery, stability, dilution linearity, selectivity and other properties of the method were validated.

Results:

A high-sensitivity, high-specificity MSD method for rapid detection of sPD-L1 in human serum was established and the methodology was verified. The quantitative range of this method was 9.375~1 200 pg·mL-1, and the precision, accuracy, recovery, dilution linearity and selectivity are satisfactory. The samples remained stable placed at room temperature for 4.3 h, at test bench for 4.3 h after dilution treatment, and at the refrigerator (2 ℃~8 ℃) for 24.4 h, freeze-thaw for 3 times, and in an ultra-low temperature refrigerator (-90 ℃~-70 ℃) for 101 days.

Conclusion:

After validation, it suggested that this method could be used to quantitatively analyze the concentration of sPD-L1 in serum to provide a theoretical basis for the pharmacodynamic evaluation of PD-1/PD-L1 immune checkpoint related drugs in clinical research. It also has potential applications in personalized therapy and concomitant diagnosis.

soluble PD-L1  /  Meso Scale Discovery  /  methodology  /  validation
高恩惠, 张瑞霞, 黄应峰, 满素勤, 程远国. 定量检测人血清中可溶性PD-L1蛋白浓度的方法开发及验证. 中国新药杂志, 2021 , 30 (15) : 1374 -1380 .
En-hui GAO, Rui-xia ZHANG, Ying-feng HUANG, Su-qin MAN, Yuan-guo CHENG. Method development and validation for the quantitative detection of soluble PD-L1 protein concentration in human serum[J]. Chinese Journal of New Drugs, 2021 , 30 (15) : 1374 -1380 .
Year 2021 volume 30 Issue 15
25
7
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Article Info
  • Online Date:2026-10-28
  • Published:2021-08-15
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History
  • Accepted:2020-12-01
Funding
Affiliations
    1Shanghai University of Engineering Science, Shanghai 201620, China
    2National Shanghai Center for New Drug Safe Evaluation and Research, China State Institute of Pharmaceutical Industry, Shanghai 201203, China
    3Shanghai Innostar Biotech Co., Ltd., Shanghai 201320, China
    4Dragonboat Biopharmaceutical Co., Shanghai 201203, China
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表12种不同金属材料的力学参数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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