A variety of fecal immunochemical tests (FITs) for hemoglobin (Hb) are used in colorectal cancer (CRC) screening. It is unclear to what extent differences in reported sensitivities and specificities reflect true heterogeneity in test performance or differences in study populations or varying pre-analytical conditions. We directly compared the sensitivity and specificity values with which 9 quantitative (laboratory-based and point of care) FITs detected advanced neoplasms (AN) in a single CRC screening study.
Pre-colonoscopy stool samples were obtained from participants of screening colonoscopy in Germany from 2005 through 2010 and frozen at -80°C until analysis. The stool samples were thawed, homogenized, and used for 9 different quantitative FITs in parallel. Colonoscopy and histology reports were collected from all participants and evaluated by 2 independent, trained research assistants who were blinded to the test results. Comparative evaluations of diagnostic performance for AN were made at preset manufacturers´ thresholds (range: 2.0-17.0μg Hb/g feces), at a uniform threshold (15 μg Hb/g feces), and at adjusted thresholds yielding defined levels of specificity (99%, 97%, and 93%).
Of the 1667 participants who fulfilled the inclusion criteria, all cases with AN (n=216) and 300 randomly selected individuals without AN were included in the analysis. Sensitivities and specificities for AN varied widely when we used the preset thresholds (21.8%-46.3% and 85.7%-97.7%, respectively) or the uniform threshold (16.2%-34.3% and 94.0%-98.0%, respectively). Adjusting thresholds to yield a specificity of 99%, 97%, or 93% resulted in almost equal sensitivities for detection of AN (14.4%-18.5%, 21.3%-23.6%, and 30.1%-35.2%, respectively) and almost equal positivity rates (2.8%-3.4%, 5.8%-6.1% and 10.1%-10.9%, respectively).
Apparent heterogeneity in diagnostic performance of quantitative FITs can be overcome to a large extent by adjusting thresholds to yield defined levels of specificity or positivity rates. Rather than simply using thresholds recommended by the manufacturer, screening programs should choose thresholds based on intended levels of specificity and manageable positivity rates.
This research output has an Altmetric Attention Score of 39. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 February 2022.
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