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Consistent Major Differences in Sex- and Age-Specific Diagnostic Performance among Nine Faecal Immunochemical Tests Used for Colorectal Cancer Screening.

ABSTRACT: Evidence on diagnostic performance of faecal immunochemical tests (FITs) by sex and age is scarce. We aimed to evaluate FIT performance for detection of advanced colorectal neoplasia (AN) by sex and age across nine different FIT brands in a colonoscopy-controlled setting. The faecal samples were obtained from 2042 participants of colonoscopy screening. All eligible cases with AN (n = 216) and 300 randomly selected participants without AN were included. Diagnostic performance for detection of AN was assessed by sex and age (50-64 vs. 65-79 years for each of the nine FITs individually and for all FITs combined. Sensitivity was consistently lower, and specificity was consistently higher for females as compared with males (pooled values at original FIT cutoffs, 25.7% vs. 34.6%, p = 0.12 and 96.2% vs. 90.8%, p < 0.01, respectively). Positive predictive values (PPVs) were similar between both sexes, but negative predictive values (NPVs) were consistently higher for females (pooled values, 91.8% vs. 86.6%, p < 0.01). Sex-specific cutoffs attenuated differences in sensitivities but increased differences in predictive values. According to age, sensitivities and specificities were similar, whereas PPVs were consistently lower and NPVs were consistently higher for the younger participants. A negative FIT is less reliable in ruling out AN among men than among women and among older than among younger participants. Comparisons of measures of diagnostic performance among studies with different sex or age distributions should be interpreted with caution.

SUBMITTER: Gies A

PROVIDER: S-EPMC8306133 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesQuantitative faecal immunochemical tests (FITs) are widely used for colorectal cancer (CRC) screening in the Western countries, whereas qualitative FITs are preferred in China. The present study aimed to compare the screening yield between one-sample quantitative FIT and two-sample qualitative FIT for CRC screening.DesignA cross-sectional study.SettingA population-based CRC screening programme was conducted in 28 communities in Haining City, Zhejiang Province, China.ParticipantsConsecutive participants aged 40-74 years were invited to undergo the CRC screening programme. Two-sample qualitative FITs were offered between January 2019 and December 2019, and one-sample quantitative FIT was offered between August 2019 and February 2020.Primary and secondary outcome measuresPrimary outcomes were detection rates of advanced neoplasms, including CRCs and advanced adenomas. Secondary outcomes were positivity rates and colonoscopy resource demand for the two FITs. The positivity thresholds were 20 µg and 1-5 µg haemoglobin per gram of faeces for the quantitative and qualitative FITs, respectively.ResultsA total of 19 131 and 28 804 invitees were assigned to the two-sample qualitative and one-sample quantitative groups, respectively. Positivity rates were 14.2% for the two-sample qualitative FIT and 5.4% for the one-sample quantitative FIT. Detection rates of advanced colorectal neoplasms at colonoscopy using one-sample quantitative FIT and two-sample qualitative FIT were 17.6% (95% CI: 14.6% to 20.6%) and 10.5% (95% CI: 8.7% to 12.4%), respectively. Both detection rates of cancer and advanced adenoma were higher in the one-sample quantitative FIT group than those in the two-sample qualitative FIT group. Moreover, one-sample quantitative FIT significantly reduced the colonoscopy load for detection of one advanced neoplasm case (5, 95% CI: 5 to 7) than the two-sample qualitative FIT (10, 95% CI: 8 to 11).ConclusionsThe one-sample quantitative FIT for CRC screening increases the detection rate of advanced neoplasia and reduces the colonoscopy workload compared with the two-sample qualitative FIT.

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Consistent Major Differences in Sex- and Age-Specific Diagnostic Performance among Nine Faecal Immunochemical Tests Used for Colorectal Cancer Screening.

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