College of Food Science and Engineering, South China University of Technology, Guangzhou, 510640, China.
National & Local United Engineering Lab of Rapid Diagnostic Test, Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, 5l0663, China.
Anal Bioanal Chem. 2021 Jul;413(17):4493-4500. doi: 10.1007/s00216-021-03412-6. Epub 2021 May 26.
Pepsinogen I (PGI) can reflect the morphology and function of the gastric mucosa. Accordingly, the large-scale community health screening of PGI can dramatically increase the early diagnosis rate of gastric cancer. However, PGI testing can only be carried out in comprehensive hospitals and health examination centers. To ameliorate this issue, a point-of-care chemiluminescent immunoassay for PGI was developed in a fully automated miniaturized instrument. This instrument was especially developed for health check-ups in the grassroots communities; its volume of which is only 0.18 m. Critically, the entire detection process for a single sample only requires 20 min, and the samples can be loaded continuously, making the method suitable for high-throughput analysis. The assay displayed an excellent detection limit of 0.048 ng/mL with a broad detection range of 0-200 ng/mL. Furthermore, this assay exhibited high sensitivity and specificity, had low intra- and inter-assay coefficients of variation (<10%), and was not affected after storage at 37 °C for 7 days. The assay was used to detect PGI in 95 clinical serum samples, and the results were highly correlated with those that were clinically tested (correlation coefficient, R = 0.998). Hence, the method established in this work has great application value and can be broadly applied for the large-scale screening of gastric cancer in resource-limited areas.
胃蛋白酶原 I（PGI）可以反映胃黏膜的形态和功能。因此，大规模的社区卫生筛查 PGI 可以显著提高胃癌的早期诊断率。然而，PGI 检测只能在综合医院和健康检查中心进行。为了解决这个问题，我们在一个全自动的微型化仪器中开发了一种用于检测 PGI 的即时化学发光免疫分析方法。该仪器是专门为基层社区的健康检查而开发的；其体积仅为 0.18 立方米。关键的是，单个样本的整个检测过程仅需 20 分钟，并且可以连续加载样本，因此该方法适合高通量分析。该检测方法的检测限为 0.048ng/mL，检测范围为 0-200ng/mL。此外，该检测方法具有很高的灵敏度和特异性，批内和批间变异系数均小于 10%，在 37°C 下储存 7 天后也没有受到影响。该检测方法用于检测 95 份临床血清样本中的 PGI，与临床检测结果高度相关（相关系数，R=0.998）。因此，本工作中建立的方法具有很大的应用价值，可以广泛应用于资源有限地区的胃癌大规模筛查。
