粪便免疫化学检测（FIT）在巴西结直肠癌（CRC）筛查队列中 5090 名阳性出血和阴性出血受试者中的诊断准确性。

Diagnostic Accuracy of Fecal Immunochemical Test (FIT) in Bleed-positive and Bleed-negative Colorectal Cancer (CRC) Among a Cohort of 5,090 Subjects who Participated in the Colorectal Neoplasia (CRN) Screening in Brazil.

机构信息

Department of Surgery, Kuopio University Hospital and School of Medicine, University of Eastern Finland, Kuopio, Finland;

Department of Surgery, Kuopio University Hospital and School of Medicine, University of Eastern Finland, Kuopio, Finland.

出版信息

Anticancer Res. 2023 Apr;43(4):1569-1580. doi: 10.21873/anticanres.16307.

DOI:10.21873/anticanres.16307

PMID:36974786

Abstract

BACKGROUND/AIM: This study assessed the diagnostic accuracy (DA) of fecal immunochemical test (FIT) ColonView (CV) and guaiac-based fecal occult blood test (HemoccultSENSA) among bleed-positive (history or signs of intestinal bleeding) and bleed-negative participants (no history or signs of intestinal bleeding) (n=5,090) in colorectal neoplasia (CRN) screening in Brazil.

PATIENTS AND METHODS

The eligible patients for the study (n=506) collected three consecutive stool samples, to be analyzed by both assays (CV, SENSA). Finally, 421/5090 (8.3%) patients returned both samples, which were subjected to final analysis. Receiver operating characteristic (ROC) analysis with different cut-offs was performed to assess the DA.

RESULTS

The area under curve (AUC) values for i) visually analyzed (VA) CV for bleed-positive CRC, ii) automatically analyzed (AA) CV for bleed-positive CRC, iii) VA CV for bleed-negative CRC, and iv) AA CV for bleed-negative CRC as endpoints were as follows: i) AUC=0.864, ii) AUC=0.933, iii) AUC=0.836, and iv) AUC=0.892. In roccomp analysis, the differences in AUC values were: between i) and ii) p=0.068; between i) and iii) p=0.497; between i) and iv) p=0.488; between ii) and iii) p=0.0058; between ii) and iv) p=0.229; and between iii) and iv) p=0.138.

CONCLUSION

This is the first investigation where two modes of CV test, VA, and AA, for bleed-positive and bleed-negative CRC patients were used as the endpoint. The AA reading of the CV test showed higher DA in bleed-positive than in bleed-negative CRC patients.

摘要

背景/目的：本研究评估了粪便免疫化学检测（FIT） ColonView（CV）和基于愈创木脂的粪便隐血检测（HemoccultSENSA）在巴西结直肠癌（CRC）筛查中对阳性出血（有肠道出血史或体征）和阴性出血（无肠道出血史或体征）参与者（n=5090）的诊断准确性（DA）。

方法

本研究纳入了符合条件的 506 名患者，他们连续采集了 3 份粪便样本，由两种检测方法（CV、SENSA）进行分析。最终，有 421/5090（8.3%）名患者返回了两份样本，对其进行了最终分析。采用不同截断值的受试者工作特征（ROC）曲线分析来评估 DA。

结果

以阳性出血 CRC 为终点时，i）CV 视觉分析（VA）、ii）CV 自动分析（AA）、iii）CV 阴性出血 CRC 的 AUC 值分别为：i）AUC=0.864，ii）AUC=0.933，iii）AUC=0.836；以阴性出血 CRC 为终点时，i）CV 视觉分析（VA）、ii）CV 自动分析（AA）、iii）CV 阴性出血 CRC 的 AUC 值分别为：i）AUC=0.892。在 roccomp 分析中，AUC 值的差异为：i）与 ii）间 p=0.068；i）与 iii）间 p=0.497；i）与 iv）间 p=0.488；ii）与 iii）间 p=0.0058；ii）与 iv）间 p=0.229；iii）与 iv）间 p=0.138。