全自动粪便钙卫蛋白免疫分析提取装置的临床和分析验证。

Clinical and Analytical Verification of an Automated Fecal Calprotectin Immunoassay with Extraction Device.

机构信息

ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA.

Department of Pathology, University of Utah, Salt Lake City, UT, USA.

出版信息

J Appl Lab Med. 2021 Jul 7;6(4):931-941. doi: 10.1093/jalm/jfaa236.

DOI:10.1093/jalm/jfaa236

PMID:33582792

Abstract

BACKGROUND

Fecal calprotectin (FC) is a screening test for intestinal inflammation, and often used by clinicians to help identify and monitor patients with inflammatory bowel disease (IBD). Improvements in FC assays include moving to more automated immunoassays compared to ELISAs and simple-to-use extraction devices compared to manual weighing for the extraction process.

METHODS

A method comparison was performed between the PhiCal ELISA and LIAISON immunoassay for 53 stool samples, and the screening results were compared to the gold standard endoscopy with biopsy results. Clinical accuracy was assessed by comparing the FC results from each assay to the presence or absence of inflammation determined from the biopsy report. The performance of the extraction device was compared to manually weighing. Additional studies were completed to verify the manufacturer's claims.

RESULTS

The FC results were compared to the biopsy results for detecting inflammation. PhiCal ELISA had a sensitivity of 86% and specificity of 100%, while the LIAISON immunoassay had a sensitivity of 97% with specificity of 94%. Therefore, the LIAISON immunoassay performed better than the PhiCal ELISA. The extraction device performed well compared to manual weighing if stool samples were <800 μg/g, within Bristol stool types 2-6, and did not contain a significant amount of undigested material, fibrous material, or mucus.

CONCLUSION

The LIAISON immunoassay with extraction device has acceptable performance for clinical use in measuring fecal calprotectin.

摘要

背景

粪便钙卫蛋白（FC）是一种用于肠道炎症的筛查检测，临床医生常使用它来帮助识别和监测炎症性肠病（IBD）患者。FC 检测方法的改进包括与 ELISA 相比，更多地转向更自动化的免疫测定法，与手动称重的提取过程相比，更多地转向更简单易用的提取设备。

方法

对 53 份粪便样本进行 PhiCal ELISA 和 LIAISON 免疫测定之间的方法比较，并将筛查结果与内镜活检结果的金标准进行比较。通过比较每个检测方法的 FC 结果与活检报告中炎症的存在与否，评估临床准确性。还比较了提取设备与手动称重的性能。完成了其他研究以验证制造商的声明。

结果

FC 结果与活检结果进行了炎症检测的比较。PhiCal ELISA 的灵敏度为 86%，特异性为 100%，而 LIAISON 免疫测定的灵敏度为 97%，特异性为 94%。因此，LIAISON 免疫测定比 PhiCal ELISA 表现更好。如果粪便样本的 FC 含量<800μg/g，Bristol 粪便类型为 2-6，且不含有大量未消化的物质、纤维物质或黏液，则与手动称重相比，提取设备的性能良好。