胃蛋白酶原光激化学发光免疫测定方法的建立

Quantitative Determination of Pepsinogen Using the Light Initiated Chemiluminescent Immunoassay

目的建立一种检测人血清胃蛋白酶原浓度的光激化学发光免疫测定方法。方法采用双抗体夹心法建立检测人血清中胃蛋白酶原Ⅰ和胃蛋白酶原Ⅱ浓度的方法,评估其分析灵敏度、回收率和批内精密度,并与雅培（化学发光法）进行比较。结果胃蛋白酶原Ⅰ/Ⅱ的分析灵敏度分别为0.8ng/mL和0.6ng/mL,回收率分别为100.3%、106.5%,批内变异系数（CV）为0.93%~4.1%、1.2%~4.3%,与化学发光法的相关性较好（r=0.99）。结论该方法测定胃蛋白酶原具有较高灵敏度、精密度和准确性,适用于临床。方法建立后可进一步进行长期稳定性试验。

Objective To develop a light initiated chemiluminescent immunoassay for human pepsinogen. Methads Double antibody sandwich immunoassay was used to develop to detect the concentrations of pepsinogen I and pepsinogen II in human sera respectively. Analytical sensitivity, recovery and within-run precision were evaluated and the results were compared with Abbott reagent（chemiluminescent immunoassay）. Results The analytical sensitivity ofpepsinogen ＇I and pepsinogen II were 0.8ng/mL and 0.6ng/mL, recovery of PG I and PG II were 100.3%, 106.5%, within-run precision were 0.93%-4.1%, 1.2%-4.3%. The coincidence rate with the chemiluminescent immunoassay was highly significant （r=0.99）. Conclusions The light initiated chcmiluminescent immtmoassay for pepsinogen have good sensitivity, precision, accuracy, and can be applied for clinical determination. It will be helpful to carry on the long-term stability test.