南京市精液分析质量控制的初步研究

目的:调查并分析南京市各家医院对精液分析项目中的精子浓度、精浆果糖、α葡糖苷酶及酸性磷酸酶(ACP)的检测结果,为进一步开展省内乃至全国范围内的精液分析的外部质量控制打下基础。方法:制备低、高浓度的4种检测项目的质控品8份,分装后检测每份质控品的结果并计算变异系数(CV)。质控品分发至南京市11家医院,收集并分析质控品回收结果。以分装后检测结果为参考值,计算不同实验室测得的质控品结果的总相对误差(RE)。结果:8份质控品分装后检测的CV为3.83%~11.16%。11家医院回报的精子浓度结果11份,精浆α葡糖苷酶、果糖和ACP结果5份。不同实验室高、低浓度精浆果糖的检测结果差异最小(CV分别为8.99%和3.95%),其次为α葡糖苷酶(CV分别为16.66%和18.41%),而精浆ACP的检测结果差异最大,CV分别为54.12%和65.58%。RE亦有相同的趋势,不同实验室精浆果糖检测的总RE分别为11.99%和20.31%,α葡糖苷酶为22.92%和27.26%,而ACP为7.34%和318.35%,即高浓度ACP检测结果的RE最大。11家医院中,6家用计算机辅助精液分析(CASA)系统检测精子浓度,5家用改良牛鲍血球计数池的方法检测。血球计数池计数的精子浓度结果[分别为(62.74±16.63)×106/m l和(163.32±36.24)×106/m l]和RE值(分别为148.47%和187.59%)显著高于CASA系统检测的结果分别为[(24.88±4.16)×106/m l和(54.24±23.06)×106/m l]和RE值(分别为13.97%和10.48%)。结论:目前男科学实验室精浆α葡糖苷酶和果糖的检测方法比较稳定,结果的变异在可接受的范围内,而ACP检测的方法可能不适合于临床常规使用,尚需进一步改进。血球计数池明显高估精子浓度,不适合用作精子浓度分析。

Primary Investigations on the Quality Control for Semen Analysis in Nanjing City

OBJECTIVE: To investigate and analyze the results of the determination of sperm concentration, fructose concentration, alpha-glucosidase and acid phosphatase (ACP) activities in the seminal plasma from different hospitals in the city of Nanjing, so as to provide a basis for the external quality control (EQC) of semen analysis within Jiangsu Province or even the whole country. METHODS: Eight samples of quality control products for low and high concentrations sperm count, fructose, alpha-glucosidase and ACP determination were prepared and divided, each detected for the sperm concentration, fructose, alpha-glucosidase and ACP activity, and the coefficient variances (CVs) were calculated. The products were then distributed to 11 hospitals in the city, and the results were collected and analyzed. In addition, the total relative errors (REs) for each product was calculated based on the results after dividing as reference values. RESULTS: The CVs from the 8 samples after dividing were 3.83% - 11.16%. Collected from the 11 hospitals attending EQC were 11 reports of the results of sperm concentration, and 5 the results of fructose, alpha-glucosidase and ACP in seminal plasma. Among the results from different laboratories, those of fructose determination showed the minimal difference (CVs: 8.99% and 3.95% for low and high concentrations, respectively) , next came alpha-glucosidase (CVs: 16.66% and 18.41% for low and high activities, respectively), and ACP determination showed the maximal difference (CVs: 54.12% and 65.58% for low and high activities, respectively). Moreover, the same trend was observed in RE values, as shown in the total REs, which were 11.99% (low concentration) and 20.31% (high concentration) for the determination of fructose in seminal plasma, 22.92% and 27.26% for alpha-glucosidase, 7.34% and 318.35% for ACP in different laboratories, and the maximal RE value was detected in the result of the high-activity ACP sample. Of the 11 hospitals, 6 determined sperm concentration with the computer-assisted semen analysis (CASA) system, and the other 5 with the modified hemocytometer. RE values (148.47% and 187.59% for low and high concentration samples, respectively) and sperm concentrations ([62.74 +/- 16.63] x 10(6)/ml and [163.32 +/- 36.24] x 10(6)/ml) counted with the hemocytometer were significantly higher than those with the CASA system (REs 13.97% and 10.48%; sperm concentrations [24.88 +/- 4.16] x 10(6)/ml and [54.24 +/-23.06] x 10(6)/ml ). CONCLUSION: The methods of seminal alpha-glucosidase and fructose determination were relatively stable in current andrology laboratories, and the variance range could be accepted. However, the method of seminal ACP determination might be unadaptable to clinical application, and needs to be further improved. Hemocytometer, which significantly overestimated sperm concentration, could not be applied to the assay of sperm concentration.