| Background:The histological characteristics and anatomical structure of the adrenal gland are special,and the adrenal gland lesions are highly heterogeneous,therefore,adrenal diseases are easily missed or misdiagnosed.At present,the diagnosis and treatment of adrenal diseases has become a major difficulty in clinical work.Adrenal cortex and urinary metabolites can reflect the secretion of adrenal cortex hormones,glucocorticoids and gonads,and can be used to evaluate the function of adrenal hormones on the adrenal gland,Which has great value to identification of adrenal diseases.Objective:The purpose of this study is to evaluate the performance of homogeneous enzyme immunoassay kits for 17-hydroxycorticosteroids(17-OHCS),17-ketosterols(17-KS),vanilla mandelic acid(VMA)and other related indicators of adrenal gland and to explore the changes in diseases:①Weather 17-KS,17-OHCS,and VMA can have diagnostic value for the identification of adrenal diseases.②The general rule of the expression of adrenal medullary urinary metabolites in different types of adrenal diseases and the value of auxiliary diagnosis.@The general rule of urinary vanillic acid and urinary adrenaline,norepinephrine,dopamine and other factors in the urine of patients with pheochromocytoma and its application value as an auxiliary diagnostic indicator for pheochromocytoma.Methods:(1)Method traceability:the necessary laboratory performance of the correctness,precision,linear range and reference interval for homogeneous enzyme immunoassay kits of 17-KS,17-OHCS,and VMA was made,according to the relative document.(2)Inclusion criteria and grouping:a total of 214 24-hour urine samples from patients with adrenal-related diseases affiliated to our hospital from January 2017 to May 2017 were collected,including 93 males and 121 females;the minimum age was 15 years old.The maximum age is 89 years old and the average age is 48 years old.According to the specific disease types,patients with adrenal diseases were divided into 35 cases of pheochromocytoma group,36 cases of Cushing syndrome group,58 cases of primary aldosteronism group,37 cases of nonfunctioning adenoma group,and 48 cases of other disease groups.(including 20 cases of adrenocortical adenoma 5 cases of adrenal gland neuroblastoma 9 cases of adrenal cysts,3 cases of adrenal schwannomas,etc.).All diseases have been confirmed by imaging and pathological examination,and confirmed according to their respective diagnostic criteria,no surgery has been performed.The 17-KS,17-OHCS,and VMA of the urine samples were measured and statistically analyzed according to different diseases of the adrenal gland.(3)214 subjects were divided into two groups:pheochromocytoma group and other adrenal diseases.The contents of E,NE and DA in urine samples were collected,combined with VMA index,these four indicators were analyzed in combined diagnostic efficacy in pheochromocytoma.Results:(1)Performance Verification Experiment Results:The accuracy test showed that the bias of the five levels of the 17-KS,17-OHCS and VMA calibrator was less than 1/2Tea,which met the verification criteria.The precision experiments show that the in-batch and total precision values are less than the manufacturer’s statsed value of the low-and high-value samples of 17-KS,17-OHCS and VMA;linear experiments show:the linear of 17-KS,17-OHCS and VMA reagents were clinically acceptable first-order linearity and linear reliable.The reference interval validation experiment showed that the average level of 17-KS,17-OHCS and VMA in 20 apparent normal subjects was within the normal reference interval set by the manufacturer.Kit performance verification meets the requirements.(2)The diagnostic value of 17-KS,17-OHCS and VMA in adrenal diseases:There were statistical differences in 17-KS and VMA levels in acidic and neutral urine.The median level of 17-KS in primary aldosteronism group was 6.52 mg/24h,the level of 17-KS in adrenal diseases group was significantly different(P<0.01);the median level of 17-OHCS in Cushing syndrome was 5.36 mg/24h,and the level of 17-OHCS in adrenal disease group was significantly different(P<0.01).The median level of VMA in pheochromocytoma group was 21.05 mg/24h,and the level of VMA in adrenal disease group was significantly different(P<0.01).(3)A comparative study on the application value of 24 hour urine VMA,E,NE and DA in clinical diagnosis of pheochromocytoma:The levels of urinary VMA,E,NE and DA in pheochromocytoma group were significantly higher than those in other adrenal diseases group(P<0.05).The area under ROC curve of VMA in the diagnosis of pheochromocytoma was 0.857,the sensitivity was 78.9%,and the specificity was 92.6%.VMA was significantly better than E,NE and DA in the diagnosis of pheochromocytoma.There was no significant difference in the diagnostic efficiency between the combined detection of E+DA and VMA.Conclusions:(1)The accuracy,precision and linear verification results of homogeneous enzyme immunoassay 17-KS,17-OHCS and VMA kits independently developed in China conform to the requirements.Reference interval validation is within the scope of the reagent manufacturer.The validation is successful and can be used for the detection of clinical samples.(2)Homogeneous immunoassay 17-KS,17-OHCS,and VMA have certain clinical significance in the differential diagnosis of adrenal diseases.(3)24h urine VMA test results can be used as a potential indicator for the diagnosis of pheochromocytoma. |
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