Performance Characteristics and Evaluation of an Automated-Developed and Quantitative, Immunochemical, Fecal Occult Blood Screening Test

Vilkin, Alex; Rozen, Paul; Levi, Zohar; Waked, Amal; Maoz, Eran; Birkenfeld, Shlomo; Niv, Yaron

doi:10.1111/j.1572-0241.2005.00231.x

Cited by 133 publications

(145 citation statements)

References 22 publications

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“…Completed FITs were returned to the hospital within 24 hours after collection and stored at À80 C until analysis with the OC-sensor MICRO Desktop Analyzer (Eiken Chemical Co.). Although several CRC screening studies used a 100 ng/mL cutoff value for the OC-sensor FIT (14-16), a cutoff value of 50 ng/mL (corresponding with 10 mg/g) has also been reported (7,17,18), resulting in a higher sensitivity for detection of advanced adenomas (16). Therefore, we decided to use a cutoff value of 50 ng/mL to determine positivity.…”

Section: Immunologic Fobtmentioning

confidence: 99%

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Bakker

Jonkers

Sanduleanu

et al. 2011

Cancer Prevention Research

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Given the current increase in colorectal cancer screening, information on performance of screening tests is needed, especially in groups with a presumed lower test performance. We compared test performance of immunologic fecal occult blood testing (FIT) and pseudosigmoidoscopy with colonoscopy for detection of advanced adenomas in an average risk screening population. In addition, we explored the influence of gender, age, and location on test performance. FIT was collected prior to colonoscopy with a 50 ng/mL cutoff point. FIT results and complete colonoscopy findings were available from 329 subjects (mean age: 54.6 AE 3.7 years, 58.4% women). Advanced adenomas were detected in 38 (11.6%) of 329 subjects. Sensitivity for advanced adenomas of FIT and sigmoidoscopy were 15.8% (95% CI: 6.0-31.3) and 73.7% (95% CI: 56.9-86.6), respectively. No sensitivity improvement was obtained using the combination of sigmoidoscopy and FIT. Mean fecal hemoglobin in FIT positives was significantly lower for participants with only proximal adenomas versus those with distal ones (P ¼ 0.008), for women versus men (P ¼ 0.023), and for younger (<55 years) versus older (!55 years) subjects (P ¼ 0.029). Sensitivities of FIT were 0.0% (95% CI: 0.0-30.9) in subjects with only proximal versus 21.4% (95% CI: 8.3-41.0) in those with distal nonadvanced adenomas; 5.3% (95% CI: 0.0-26.0) in women versus 26.3% (95% CI: 9.2-51.2) in men; 9.5% (95% CI: 1.2-30.4) in younger versus 23.5% (95% CI: 6.8-49.9) in older subjects. Sigmoidoscopy had a significantly higher sensitivity for advanced adenomas than FIT. A single FIT showed very low sensitivity, especially in subjects with only proximal nonadvanced adenomas, in women, and in younger subjects. This points to the existence of "low" FIT performance in subgroups and the need for more tailored screening strategies. Cancer Prev Res; 4(10); 1563-71. Ó2011 AACR.

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Section: Immunologic Fobtmentioning

confidence: 99%

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Bakker

Jonkers

Sanduleanu

et al. 2011

Cancer Prevention Research

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“…[7][8][9][10][11][12] The literature as well as data provided by the manufacturer show that the test results of the OC-Sensor 1 are reliable in the range from 50 to 2,000 ng/ml. 2 In a previous publication, we compared the guaiac FOBT Hemoccult 1 with the iFOBT OC-Sensor 1 . 1 In that publication, for generalizability with the previous studies, we presented data for the iFOBT with a cut-off value of 100 ng/ml.…”

Section: Immunochemical Fecal Occult Blood Testmentioning

confidence: 99%

“…The iFOBT kit contained written instructions and a single sampling tube, with 2 ml hemoglobin stabilizing buffer. The design of the tube regulates the amount of feces inserted into the sample bottle to 10 mg. 2 Participants performed the sampling for the test at home and were instructed to return the test as soon as possible by mail. They were asked to report the date of fecal sampling on the sample tube.…”

Section: Immunochemical Fecal Occult Blood Testmentioning

confidence: 99%

“…2,4,5 However, at higher temperatures, degradation of fecal hemoglobin could be more rapid, even under controlled laboratory circumstances. 5,6 Vilkin et al 2 performed a simulation study with a limited number of samples on the validity of the OC-Sensor. Indeed, they found a decrease over time of fecal hemoglobin concentrations especially at room temperature and above.…”

mentioning

confidence: 99%

“…1 Some iFOBT's are quantitative, and the fecal sample is stored in a sample bottle containing a hemoglobin stabilizing buffer. 2,3 However, the stability of fecal hemoglobin in the stabilizing buffer has not been studied comprehensively. Several factors may influence hemoglobin stability such as storage conditions and lag time before the fecal sample is analyzed.…”

mentioning

confidence: 99%

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False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening

Rossum

Rijn

Oijen

et al. 2009

Intl Journal of Cancer

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Delayed return of immunochemical fecal occult blood test (iFOBT) samples to a laboratory might cause false negatives because of hemoglobin degradation. Quantitative iFOBT's became increasingly more accepted in colorectal cancer screening. Therefore, we studied the effects of delay between sampling and laboratory delivery on iFOBT performance. IFOBT positivity ( ‡50 ng/ml hemoglobin) in colorectal cancer screening participants without delay between sampling and laboratory delivery (<5 days), was compared with positivity in participants with ‡5 and ‡7 days delay. Additionally, positive tests were stored at room temperature and retested 5 times within 10-14 days. The sampling date was reported by 61% (n 5 3,767) of the participants: in 19% delay was ‡5 days and in 5% ‡7 days. Compared with no-delay, the adenoma detection rate was already significantly decreased after ‡5 days delay (OR 0.6; 95%CI 0.4-0.9). We retested iFOBT samples of 170 positives of which 139 (82%) had a colonoscopy: 45 (32%) had advanced adenomas (not colorectal cancer) and 8 (6%) had colorectal cancer. Mean daily fecal hemoglobin decrease was 29 ng/ml (S.D. 38 and median 11 ng/ml). In patients with advanced adenomas, hemoglobin in the sample was <50 ng/ml in 5 (11%) 2-3 days after the initial test and in 16 (36%) after 10-14 days. Seven days after the initial test, 2 (25%) colorectal cancer patients became false negative. Both had stage I colorectal cancer and initial values below 100 ng/ml, where the average for stage I is 532 ng/ml. Delay in sample return increased false negative immunochemical FOBT's. Mainly precursor lesions, but also colorectal cancer, will be missed due to delayed sample return. ' 2009 UICC

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Cumulative evaluation of a quantitative immunochemical fecal occult blood test to determine its optimal clinical use

Rozen

Comaneshter²,

Levi

et al. 2010

Cancer

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BACKGROUND: Quantified, human hemoglobin (Hb)-specific, immunochemical fecal occult blood test (IFOBT) measurements are now used for colorectal cancer (CRC) screening. The objective was to evaluate sensitivity and specificity for CRC and advanced adenomatous polyps (APs) by the fecal Hb threshold used to determine a positive test and the number of IFOBTs prepared per test, so as to determine the least number of colonoscopies required to detect a neoplasm. METHODS: Cumulative data were analyzed from a prospective cross-sectional double-blind study of 1682 consecutive, ambulatory, nonbleeding colonoscopy patients who volunteered for IFOBTs, most of above average risk, from 3 ambulatory-endoscopy centers. Fecal Hb was measured in 3 samples and analyzed by an automated instrument, and the highest result !50 ng Hb/mL of buffer was related to findings. RESULTS: Colonoscopy identified CRC in 20 patients and advanced APs in 129. Sensitivity for either was best when any of 3 tests had !50 ng Hb/mL of buffer; sensitivity was 61.1% (95% confidence interval [CI], 53.2-68.9), and specificity was 87.8% (95% CI, 86.2-89.4). Positive tests identified 100% of CRCs and 55% of advanced APs every 3.1 colonoscopies. Sensitivity of a single test at the commonly used 100-ng Hb/mL threshold was lower at 31.5% (95% CI, 24.1-39.0) (P<.001), but specificity was higher at 96.4% (95% CI, 95.5-97.3) (P<.001). Positive tests identified 65% of CRCs and 26.4% of advanced APs every 2.2 colonoscopies. CONCLUSIONS: The fecal Hb cutoff chosen by the screener and the number of samples collected per patient determine sensitivity and specificity for CRC/advanced AP; these factors determine the number of colonoscopies needed for positive tests and neoplasia yield. This information provides guidelines for IFOBT screening. Limitations are 1-time screening and most examinees not being at average risk for CRC. Cancer 2010;116:2115-25.

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Performance Characteristics and Evaluation of an Automated-Developed and Quantitative, Immunochemical, Fecal Occult Blood Screening Test

Cited by 133 publications

References 22 publications

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas

False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening

Cumulative evaluation of a quantitative immunochemical fecal occult blood test to determine its optimal clinical use

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