Performance evaluation of glycerol as stabilizer for the preparation of seminal plasma biochemical quality control products

doi:10.3969/j.issn.1673-8640.2022.12.020

Abstract

Abstract:

Objective To evaluate the performance of seminal plasma biochemical quality control products prepared with glycerol as stabilizer，in order to determine a high quality seminal plasma biochemical quality control product preparation method. Methods Group A used glycerol as stabilizer to prepare seminal plasma biochemical quality control products，and group B used seminal plasma biochemical quality control products directly into seminal plasma. The 2 groups were determined for fructose and neutral alpha-glucosidase，and the homogeneity and stability were evaluated. Daily quality control test and analysis were performed to compare the precisions of the 2 biochemical quality control products. The 2 biochemical quality control products were determined daily，and the precisions of the 2 methods were compared. Results In the homogeneity evaluation test，the F values of seminal plasma fructose and neutral alpha-glucosidase of the 2 groups were <F_{critical value} [F_{0.05（9，10）}=3.02]. The homogeneity was good. In the stability evaluation test，the fructose of group A had t<t_{critical value} [t_0.05（5）=2.57] within 29 d after preparation，and the stability was good. The fructose of group B had t>2.57 at the 8th day. The stability was lower than that of group A. The neutral alpha-glucosidase of group A had t<2.57 within 85 d，and the stability was good. The neutral alpha-glucosidase of group B had t<2.57 within 29 d after preparation. The stability was lower than that of group A. The daily quality control results showed that the seminal plasma biochemical quality control results of the 2 groups（above 95%） were distributed within ±2s，and the coefficient of variation（CV） of the quality control data of the 2 items between the 2 groups was <10%. Conclusions The seminal plasma biochemical quality control product formulated with glycerol as stabilizer is more stable than seminal plasma stock solution，and it can be used as a stabilizer of seminal plasma biochemical quality control product.

Key words: Glycerol, Seminal plasma biochemical determination, Quality control product, Homogeneity, Stability

CLC Number:

R446.1

ZHANG Chen, LI Ting, MENG Qinghao, XIE Nan, ZHANG Weimin, ZHAO Fei, LI Min, GAO Xuan, YANG Sijie. Performance evaluation of glycerol as stabilizer for the preparation of seminal plasma biochemical quality control products[J]. Laboratory Medicine, 2022, 37(12): 1200-1203.

组别	果糖/ （μmol/mL）	中性α-葡萄糖苷酶/ （mU/mL）
A组	9.78±1.26	13.25±1.55
F值	0.36	2.908
B组	11.92±0.74	22.33±6.03
F值	0.18	1.085

组别	果糖/ （μmol/mL）	中性α-葡萄糖苷酶/ （mU/mL）
A组	9.78±1.26	13.25±1.55
F值	0.36	2.908
B组	11.92±0.74	22.33±6.03
F值	0.18	1.085

项目	精浆果糖		精浆中性α-葡萄糖苷酶
项目	A组	B组	A组	B组
第1天与第8天	0.02	3.11	1.53	0.39
第1天与第15天	1.16	2.06	0.44	2.22
第1天与第22天	0.28	0.29	1.71	0.09
第1天与第29天	0.22	6.37	0.08	0.24
第1天与第36天	2.94	4.76	0.7	3.05
第1天与第43天	2.87	3.01	0.76	5.67
第1天与第50天	7.33	5.14	1.35	3.84
第1天与第57天	6.68	4.27	0.44	1.79
第1天与第64天	5.83	1.85	1.26	6.34
第1天与第71天	5.15	1.60	1.2	6.51
第1天与第78天	1.52	0.17	1.76	5.41
第1天与第85天	2.1	0.74	2.23	2.8

项目	精浆果糖		精浆中性α-葡萄糖苷酶
项目	A组	B组	A组	B组
第1天与第8天	0.02	3.11	1.53	0.39
第1天与第15天	1.16	2.06	0.44	2.22
第1天与第22天	0.28	0.29	1.71	0.09
第1天与第29天	0.22	6.37	0.08	0.24
第1天与第36天	2.94	4.76	0.7	3.05
第1天与第43天	2.87	3.01	0.76	5.67
第1天与第50天	7.33	5.14	1.35	3.84
第1天与第57天	6.68	4.27	0.44	1.79
第1天与第64天	5.83	1.85	1.26	6.34
第1天与第71天	5.15	1.60	1.2	6.51
第1天与第78天	1.52	0.17	1.76	5.41
第1天与第85天	2.1	0.74	2.23	2.8

组别	果糖/ （μmol/mL）	中性α-葡萄糖苷酶/ （mU/mL）
A组	8.85±0.83	16.55±0.79
CV	9.43%	4.79%
B组	12.58±1.21	23.50±1.05
CV	9.65%	4.46%
P值	0.670	0.688

Performance evaluation of glycerol as stabilizer for the preparation of seminal plasma biochemical quality control products

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组别	例数	果糖/ （μmol/mL）	中性α-葡萄糖苷酶/ （mU/mL）
A组	116	8.40±1.20	16.28±1.31
CV/%		14.30	8.05
B组	97	13.01±2.52	23.79±2.69
CV/%		19.37	11.31
P值		0.341	0.469

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