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.
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.
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.
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.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 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 |