便潜血免疫乳胶凝集试剂的研制及初步应用

Research and primary application of reagent for detecting fecal occult blood by immune latex agglutination reaction

目的 为了早期发现、诊断直、结肠癌，建立了一种检测便潜血的新方法。方法 利用免疫学原理，乳胶颗粒作为指示剂，检测粪便中的血红蛋白。结果 该方法灵敏度为40μgHb／g（粪便），与动物血、组织、人血清无交叉反应；测定范围；40～8000μg Hb／g粪便；对直、结肠癌诊断的灵敏度为100%。结论 与日本同类产品相比，特异性无明显差异（P〉0．05），灵敏度差异有统计学意义（P〈0．01）。临床应用结果表明，该法简便、快速，优于联苯胺法。由于此法具有较高的临床应用价值，建议使用此法进行粪便潜血检测，以取代传统的化学检测方法。

Objective To establish a new method detecting fecal occult blood for diagnosing early colorectal cancer. Methods The principle of immunology was used. Hemoglobin was detected by using immune latex agglutination reaction as the indication. Results The sensitivity of the method was 40 μg Hb/gr （feces）. There was no cross reaction among the animal blood, tissue and human serum. The detection range was 40-8 000 μg Hb per gram of feces. It showed the sensitivity of 100% for detection of coloreetal cancer. Conclusion Compared with the same kind of product made in Japan,the specificity of this product was not significantly different（P〉0.05） ,but its sensitivity was remarkably different（P〈0.01）. The results of clinical application imply the method is superior to Benzidine assay. The procedure is rapid and simple. Since this method is high value of application in clinical practice,it is suggest that the traditional chemical methods should be replaced by this method.