scholarly journals An evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer

2018 ◽  
Vol 56 (4) ◽  
pp. 625-633 ◽  
Author(s):  
Josep M. Auge ◽  
Cristina Rodriguez ◽  
Oihana Espanyol ◽  
Liseth Rivero ◽  
Silvia Sandalinas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Standard Deviation ◽  
Confidence Interval ◽  
Colorectal Neoplasia ◽  
Advanced Adenoma ◽  
Predictive Values ◽  
Advanced Colorectal Neoplasia ◽  
Two Samples ◽  
Analytical Imprecision ◽  
Carry Over

Abstract Background: An evaluation of SENTiFIT® 270 (Sentinel Diagnostics, Italy; Sysmex, Spain) analyser for the quantitation of faecal haemoglobin (f-Hb) was performed. Methods: The analytical imprecision, linearity, carry over and f-Hb stability were determined. Evaluation of the diagnostic accuracy was performed on 487 patients. Results: Within-run and between-run imprecision ranged 1.7%–5.1% and 3.8%–6.2%, respectively. Linearity studies revealed a mean recovery of 101.1% (standard deviation, 6.7%) for all dilutions. No carry over was detected below 7650 μg Hb/g faeces. Decay of f-Hb in refrigerated samples ranged 0.2%–0.5% per day. f-Hb in patients with advanced colorectal neoplasia (ACRN) (colorectal cancer [CRC] plus advanced adenoma [AA]) were significantly higher than from those with a normal colonoscopy. Sensitivity for ACRN at f-Hb cutoffs from 10 to 60 μg Hb/g faeces ranged from 28.9% (95% confidence interval [CI], 21.7%–37.2%) to 46.5% (95% CI, 38.1%–55%), the specificity ranged from 85% (95% CI, 82.3%–87.3%) to 93.2% (95% CI, 91.2%–94.8%), positive predictive values for detecting CRC and AA ranged from 11.6% (95% CI, 7.6%–17.2%) to 20.6% (95% CI, 13.3%–30.3%) and from 34.7% (95% CI, 28.1%–42%) to 42.3% (95% CI, 32.4%–52.7%), respectively, and the negative predictive value for ACRN ranged from 90.2% (95% CI, 87.9%–92.2%) to 88.4% (95% CI, 86%–90.4%). Using two samples per patient sensitivity increased with a slight decrease in specificity. Conclusions: The analytical and clinical performances of SENTiFIT assay demonstrate a specific and accurate test for detecting ACRN in symptomatic patients and those undergoing surveillance.

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

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3574
Author(s):  
Anton Gies ◽  
Tobias Niedermaier ◽  
Elizabeth Alwers ◽  
Thomas Hielscher ◽  
Korbinian Weigl ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Screening ◽  
Colorectal Cancer Screening ◽  
Diagnostic Performance ◽  
Colorectal Neoplasia ◽  
Predictive Values ◽  
Colonoscopy Screening ◽  
Advanced Colorectal Neoplasia ◽  
Faecal Samples

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.

scholarly journals One-Time Fecal Immunochemical Screening for Advanced Colorectal Neoplasia in Patients with CKD (DETECT Study)

2019 ◽  
Vol 30 (6) ◽  
pp. 1061-1072 ◽  
Author(s):  
Germaine Wong ◽  
Richard L. Hope ◽  
Kirsten Howard ◽  
Jeremy R. Chapman ◽  
Antoni Castells ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colorectal Neoplasia ◽  
Bowel Perforation ◽  
Disease Status ◽  
Performance Characteristics ◽  
Detection Rates ◽  
Predictive Values ◽  
Advanced Colorectal Neoplasia ◽  
And Performance

BackgroundIn patients with CKD, the risk of developing colorectal cancer is high and outcomes are poor. Screening using fecal immunochemical testing (FIT) is effective in reducing mortality from colorectal cancer, but performance characteristics of FIT in CKD are unknown.MethodsTo determine the detection rates and performance characteristics of FIT for advanced colorectal neoplasia (ACN) in patients with CKD, we used FIT to prospectively screen patients aged 35–74 years with CKD (stages 3–5 CKD, dialysis, and renal transplant) from 11 sites in Australia, New Zealand, Canada, and Spain. All participants received clinical follow-up at 2 years. We used a two-step reference standard approach to estimate disease status.ResultsOverall, 369 out of 1706 patients who completed FIT (21.6%) tested positive; 323 (87.5%) underwent colonoscopies. A total of 1553 (91.0%) completed follow-up; 82 (4.8%) had died and 71 (4.2%) were lost. The detection rate of ACN using FIT was 6.0% (5.6%, 7.4%, and 5.6% for stages 3–5 CKD, dialysis, and transplant). Sensitivity, specificity, and positive and negative predictive values of FIT for ACN were 0.90, 0.83, 0.30, and 0.99, respectively. Of participants who underwent colonoscopy, five (1.5%) experienced major colonoscopy-related complications, including bowel perforation and major bleeding.ConclusionsFIT appears to be an accurate screening test for patients with CKD, such that a negative test may rule out the diagnosis of colorectal cancer within 2 years. However, the risk of major complications from work-up colonoscopy are at least ten-fold higher than in the general population.

scholarly journals Long-Term Incidence of Advanced Colorectal Neoplasia in Patients with Serrated Polyposis Syndrome: Experience in a Single Academic Centre

Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1066
Author(s):  
Daniel Rodríguez-Alcalde ◽  
Guillermo Castillo-López ◽  
Jorge López-Vicente ◽  
Luis Hernández ◽  
Mercedes Lumbreras-Cabrera ◽  
...  
Keyword(s):  
Total Colectomy ◽  
Colorectal Neoplasia ◽  
Elevated Risk ◽  
Advanced Adenoma ◽  
Polyposis Syndrome ◽  
Serrated Polyp ◽  
Advanced Colorectal Neoplasia ◽  
Median Interval

Serrated polyposis syndrome (SPS) implies a slightly elevated risk of colorectal cancer (CRC) during endoscopic follow-up, but its natural course is still not well known. The main objective of this study was to describe the long-term risk of developing advanced neoplasia (AN) in these patients. Until October 2020, individuals who fulfilled 2010 WHO criteria I and/or III for SPS were retrospectively recruited. We selected those under endoscopic surveillance after resection of all lesions >3 mm in a high-quality colonoscopy. We excluded patients with total colectomy at diagnosis and those with any interval between colonoscopies >3.5 years. We defined AN as advanced serrated polyp (≥10 mm and/or with dysplasia), advanced adenoma, or CRC. In 109 patients, 342 colonoscopies were performed (median = 3, median interval = 1.8 years) during a median follow-up after colonic clearance of 5.0 years. Five-year cumulative incidences of AN were 21.6% globally, and 5.6%, 10.8%, and 50.8% in patients who fulfilled criterion I, III, and both, respectively (p < 0.001). No CRC was diagnosed and only 1 (0.9%) patient underwent surgery. In conclusion, cumulative incidences of AN could be lower than previously described, at least in patients who fulfil the 2010 WHO criterion III alone. Therefore, low-risk individuals might benefit from less stringent surveillance.

scholarly journals Faecal haemoglobin can define risk of colorectal neoplasia at surveillance colonoscopy in patients at increased risk of colorectal cancer

2020 ◽  
Vol 8 (5) ◽  
pp. 559-566
Author(s):  
Jayne Digby ◽  
Shirley Cleary ◽  
Lynne Gray ◽  
Pooja Datt ◽  
David R Goudie ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Diagnostic Accuracy ◽  
Limit Of Detection ◽  
Colorectal Neoplasia ◽  
Haemoglobin Concentration ◽  
Surveillance Colonoscopy ◽  
National Guidelines ◽  
Predictive Values ◽  
Advanced Neoplasia ◽  
Increased Risk

Background Quantitative faecal immunochemical tests measure faecal haemoglobin concentration (f-Hb), which increases in the presence of colorectal neoplasia. Objective We examined the diagnostic accuracy of faecal immunochemical test (FIT)in patients at increased risk of colorectal cancer (CRC) attending for surveillance colonoscopy as per national guidelines. Methods A total of 1103 consecutive patients were prospectively invited to complete a FIT before their scheduled colonoscopy in two university hospitals in 2014– 2016. F-Hb was analysed on an OC-Sensor io automated analyser (Eiken Chemical Co., Ltd, Tokyo, Japan) with a limit of detection of 2 µg Hb/g faeces. The diagnostic accuracy of f-Hb for CRC and higher-risk adenoma was examined. Results A total of 643 patients returned a faecal test. After excluding 4 patients with known inflammatory bowel disease, 639 (57.9%) remained in the study: age range: 25–90 years (median: 64 years, interquartile range (IQR): 55–71): 54.6% male. Of 593 patients who also completed colonoscopy, 41 (6.9%) had advanced neoplasia (4 CRC, 37 higher-risk adenoma). Of the 238 patients (40.1%) who had detectable f-Hb, 31 (13.0%) had advanced neoplasia (2 CRC, 29 higher-risk adenoma) compared with 10 (2.8%) in those with undetectable f-Hb (2 CRC, 8 higher-risk adenoma). Detectable f-Hb gave negative predictive values of 99.4% for CRC and 97.2% for CRC plus higher-risk adenoma. Conclusion In patients at increased risk of CRC under colonoscopy surveillance, a test measuring faecal haemoglobin can provide an objective estimate of the risk of advanced neoplasia, and could enable tailored scheduling of colonoscopy.

scholarly journals Analysis of A 6-Mirna Signature in Serum from Colorectal Cancer Screening Participants as Non-Invasive Biomarkers for Advanced Adenoma and Colorectal Cancer Detection

Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1542 ◽  
Author(s):  
María Marcuello ◽  
Saray Duran-Sanchon ◽  
Lorena Moreno ◽  
Juan José Lozano ◽  
Luis Bujanda ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Detection ◽  
Diagnostic Performance ◽  
Colorectal Neoplasia ◽  
Precancerous Lesion ◽  
Advanced Adenoma ◽  
Average Risk ◽  
Mirna Signature ◽  
Crc Screening ◽  
Non Invasive

Early detection of colorectal cancer (CRC) and its precancerous lesion, advanced adenomas (AA), is critical to improve CRC incidence and prognosis. Circulating microRNAs (miRNAs or miR) are promising non-invasive biomarkers for cancer detection. Our previous results showed that a plasma 6-miRNA signature (miR-15b-5p, miR-18a-5p, miR-29a-3p, miR-335-5p, miR-19a-3p and miR-19b-3p) could distinguish between CRC or AA and healthy individuals (controls). However, its diagnostic performance in serum is unknown. In this exploratory study we aim to evaluate the diagnostic performance of the 6-miRNA signature in serum samples in a cohort of individuals participating in Barcelona’s CRC Screening Programme. We prospectively collected serums from 264 faecal immunochemical test (FIT)-positive participants and total RNA was extracted. Finally, 213 individuals (CRC, 59, AA, 74, controls, 80) were included. MiRNA expression was quantified by real-time RT-qPCR and data analysis was performed by logistic regression. Faecal hemoglobin concentration (f(Hb)) from FIT of the same individuals was also considered. As previously described in plasma, serum from patients with AA or CRC presented significant differences in the 6-miRNA signature compared to controls. Moreover, when combined with f(Hb), the final signature showed high discriminative capacity to distinguish CRC from controls (area under the curve (AUC) = 0.88), and even AA (AUC = 0.81) that otherwise are poorly detected if we only consider f(Hb) (AUC = 0.64). Addition of the serum 6-miRNA signature to quantitative f(Hb) show high accuracy to detect patients with advanced colorectal neoplasia in average-risk individuals. A combination of these two non-invasive methods could be a good strategy to improve diagnostic performances of current CRC screening programmes.

Prevalence of advanced colorectal neoplasia according to risk categories at screening colonoscopy in a tertiary referral center.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 578-578
Author(s):  
Eduardo Negrete Carballo ◽  
Fidel David Huitzil Melendez
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Risk Stratification ◽  
Colorectal Neoplasia ◽  
Screening Colonoscopy ◽  
Average Risk ◽  
Moderate Risk ◽  
Advanced Colorectal Neoplasia ◽  
Advanced Neoplasm ◽  
Colorectal Screening

578 Background: Colorectal cancer (CRC) is the third most common cancer in the world. There is strong evidence that screening for colorectal cancer improves survival in conutries with high incidence. Although Mexico is considered a country with a low incidence of CRC, 4694 potentially preventable deaths occur every year. There is no established CRC screening program in our country, risk stratification of the target populations to be screened may bring potential advantages, making the strategy more cost-effective. The Asia-Pacific Colorectal Screening (APCS) score, is a validated risk-stratification tool that helps identify individuals at risk for advanced colorectal neoplasm amongst the asymptomatic population. Methods: We performed a retrospective, cross-sectional analysis of database records from 1172 patients who underwent screening colonoscopy betwen january 2013 and november 2014. Results: The prevalence of advanced colorectal neoplasia was 2.9%. Applying the APCS stratification, 91 subjects (7.8%) were in the average risk tier, 849 subjects (72.4%) in the moderate risk tier and 232 (19.8%) subjects in the high risk tier. The prevalence of advanced neoplasia in the average risk, moderate risk and high risk groups was 0%, 2.6% and 5.1%, respectively. The subjects in the high risk tier had 2.21-fold (p = 0.021) increased prevalence of advanced neoplasia than those in the average-moderate tier. Conclusions: The APCS score is a simple risk stratification index for colorectal advanced neoplasm that uses elementary clinical information on age, gender, family history and smoking to stratify the risk of colorectal advanced neoplasm in asymptomatic subjects for priority of colorectal screening.

scholarly journals Detection of advanced colorectal neoplasia and relative colonoscopy workloads using quantitative faecal immunochemical tests: an observational study exploring the effects of simultaneous adjustment of both sample number and test positivity threshold

2020 ◽  
Vol 7 (1) ◽  
pp. e000517
Author(s):  
Graeme P Young ◽  
Richard J Woodman ◽  
Erin Symonds
Keyword(s):  
Observational Study ◽  
Colorectal Neoplasia ◽  
Haemoglobin Concentration ◽  
Advanced Adenoma ◽  
Sample Number ◽  
Test Parameters ◽  
Advanced Colorectal Neoplasia ◽  
Advanced Adenomas ◽  
Simultaneous Adjustment ◽  
The Relationship

ObjectiveWhen screening for colorectal cancer (CRC) using quantitative faecal immunochemical tests (FIT), test parameters requiring consideration are the faecal haemoglobin concentration (f-Hb) positivity cut-off and the number of stools sampled. This observational study explored variation in f-Hb between samples and the relationship between sensitivity for advanced neoplasia (AN, cancer or advanced adenoma) and colonoscopy workload across a range of independently-adjusted parameter combinations.DesignQuantitative FIT data (OC-Sensor) were accessed from individuals undergoing personalised colonoscopic screening with an offer of 2-sample FIT in the intervening years. We estimated variation in f-Hb between samples in 12 710 completing 2-sample FIT, plus test positivity rates (colonoscopy workload) and sensitivity for AN according to parameter combinations in 4037 instances where FIT was done in the year preceding colonoscopy.ResultsThere was large within-subject variability between samples, with the ratio for the second to the first sample f-Hb ranging up to 18-fold for all cases, and up to 56-fold for AN cases. Sensitivity for AN was greatest at lower f-Hb cut-offs and/or using 2-sample FIT. Colonoscopy workload varied according to how parameters were combined. Using different cut-offs for 1-sample FIT and 2-sample FIT to return similar sensitivity, workload was less with 2-sample FIT when the sensitivity goal exceeded 35%.ConclusionVariation in f-Hb between samples is such that both parameters are crucial determinants of sensitivity and workload; independent adjustment of each should be considered. The 2-sample FIT approach is best for detecting advanced adenomas as well as CRC provided that the colonoscopy workload is feasible.

Sign in / Sign up

Export Citation Format

Share Document