By comparing the performance of two detection systems, imported A and domestic B, in the six detection items of sex hormones, to evaluate whether the automatic chemiluminescence instrument of domestic B meets the clinical requirements and the application value of domestic chemiluminescence analyzer in the detection of sex hormones, and to explore the market advantages of domestic chemiluminescence analyzer.

The domestic B was used to verify the precision and linear range of progesterone (P), estradiol (E₂), luteoprohormone (LH), follicle stimulating hormone (FSH), prolactin (PRL), testosterone (T). Domestic B compares the correlation, recovery test and anti-interference performance with the reference system. The reference system is an imported instrument (imported A) and its supporting reagents.

Domestic B instruments P, E₂, LH, FSH, PRL and T were 0.832~3.586, CV (%) 1.290~3.876,1/4 TEa (±6.25%), total inprecision 1/3 TEa (±8.33%). Linear range validation met the requirements (see Table 2). Correlation coefficient between domestic B and imported A instruments was 0.98~0.99 and R²≥0.95. The recovery rate of domestic B is 96%~107%, imported A is 97%~108%, imported A is slightly better than domestic B, both are within the acceptable range of ±10%; the interference test results of imported A and domestic B meet the requirements of the manufacturer.

The results between imported A and domestic B, which can meet the clinical needs. Domestic chemiluminescence instrument equipment technology to reach a high level, has a unique market advantage.