Site-specific Performance of ColonView (CV) Fecal Immunochemical Test (FIT) With Differences Between Proximal and Distal Colorectal Adenoma.

BACKGROUND/AIM: The aim of this study was to assess the diagnostic accuracy (DA) of a ColonView (CV) test in proximal versus distal colorectal adenoma (pCRA versus dCRA). PATIENTS AND METHODS: The colorectal neoplasia (CRN) screening cohort included 5,090 individuals and 506/5,090 (10%) were eligible for the study. Finally, only 127/506 were included in the CRA analysis and hierarchical summary ROC (HSROC) curves were used to show the pooled overall DA of visually analyzed (VA) and automatically analyzed (AA) techniques in pCRA and dCRA detection. RESULTS: The overall specificity (Sp) of the AA technique for the pCRA and dCRA endpoint was 46% and 43%, respectively. The most sensitive AA test in pCRA patients showed 76% sensitivity (Se) versus 58% Se in dCRA patients. In the HSROC analysis, area under the curve (AUC) values were as follows: i) VA in pCRA: AUC=0.503, ii) AA in pCRA: AUC=0.560, iii) VA in dCRA: AUC=0.552 and iv) AA in dCRA: AUC=0.486. In Roccomp analysis, the statistically significant AUC values were available between VA and AA reading modes in pCRA (p=0.044) and in AA reading between pCRA and dCRA (p=0.024). CONCLUSION: As compared with the CRC endpoint, the DA value of the CV test is far inferior for the CRA endpoint, as determined by the AUC values.

The ColonView (CV) Quick Test for Fecal Occult Blood Shows Significantly Higher Diagnostic Accuracy in Detecting Distal than Proximal Colorectal Cancer.

AIM: The present study compared the accuracy of ColonView (CV) quick test in detecting proximal versus distal colorectal cancer (CRC). A traditional guaiac-based fecal occult blood test (gFOBT) (Hemoccult SENSA) was used as a reference. PATIENTS AND METHODS: A cohort of 368 colonoscopy-referral patients were asked to collect 3 consecutive fecal samples, to be analyzed by both assays (CV, SENSA). Receiver operating characteristic (ROC) analysis was used to find the optimal cut-off values for both Hb and Hb/Hp of the CV test. Summary hierarchical ROC (HSROC) curves were used to visualize the pooled overall accuracy of visually analysed (VA) and automatically analyzed (AA) reading modes in proximal and distal CRC detection. RESULTS: The overall specificity (Sp) of the AA reading mode for the proximal CRC and distal CRC endpoint was 73% and 76%, respectively. For proximal CRC, the two most sensitive AA tests showed 90% sensitivity (Se), while for distal CRC, the two most sensitive AA tests showed 100% Se. In the HSROC analysis, the AUC values were as follows: i) VA in proximal CRC: 0.765, ii) AA in proximal CRC: 0.878, iii) VA in distal CRC: 0.955 and iv) AA in distal CRC: 0.961. In roccomp analysis, AUC values were significantly different in: VA vs. AA in proximal CRC p=0.009; VA in proximal vs. VA in distal CRC p<0.0001; VA in proximal vs. AA in distal CRC p<0.0001; AA in proximal vs. VA in distal CRC p=0.021; AA in proximal CRC vs. AA in distal CRC p=0.006. CONCLUSION: The applicability of the CV test (a new-generation FIT) in CRC screening was confirmed. The AA reading was superior to VA (or SENSA) in its diagnostic accuracy in detecting proximal CRC patients. Distal CRCs were more accurately detected than proximal CRCs by both reading modes.

The Automatically Analyzed (AA) ColonView (CV) Quick Test for Fecal Occult Blood Shows Higher Diagnostic Accuracy in Detection of Colorectal Adenoma than Visually Analyzed Tests.

BACKGROUND/AIM: The present study compared the accuracy of visually analyzed (VA) and automatically analyzed (AA) ColonView (CV) quick test; a new-generation fecal immunochemical test (FIT) for hemoglobin (Hb) and hemoglobin/haptoglobin (Hb/Hp) (Biohit Oyj, Helsinki, Finland) in subjects participating in colorectal neoplasia (CRN) detection in Brazil. A traditional guaiac-based fecal occult blood test (gFOBT) test (HemoccultSENSA) was used as a reference. PATIENTS AND METHODS: A cohort of 509 colonoscopy-referral patients were asked to collect three consecutive fecal samples, to be analyzed by both CV and SENSA. RESULTS: In ROC analysis for the AA reading, the optimal cut-off value for CV Hb was ≥8.0912 and that for CV Hb/Hp was ≥1.8983. With these cut-offs, the sensitivity (Se), specificity (Sp), and efficiency of CV AA in detecting colorectal adenoma (CRA) were: 64.2%/78.6%, 53.4%/35.3%, and 58.6%/56.5%, for Hb and Hb/Hp, respectively. In the HSROC analysis, the AUC values for i) VA and ii) AA modes were as follows: i) AUC=0.551 (95%CI=0.500-0.602), ii) AUC=0.606 (95%CI=0.550-0.662). The difference between these AUC values was statistically significant (p=0.0160). CONCLUSION: The present study confirms the previous results on the applicability of the ColonView quick test in CRN screening. Of the two optional reading modes, the AA reading showed significantly better diagnostic accuracy as compared to the VA reading (or SENSA), in detecting the CRA endpoint in colonoscopy-referral patients.

The New Generation Immunochemical Test for Fecal Occult Blood (ColonView Quick Test) Shows a High Diagnostic Accuracy in Colorectal Cancer Detection.

BACKGROUND/AIM: The present study compared the accuracy of visually analyzed (VA) and automatically analyzed (AA) ColonView (CV) quick test; a new-generation immunochemical test (FIT) for Hb and Hb/Hp (Biohit Oyj, Helsinki, Finland) in subjects participating in colorectal cancer (CRC) detection in Brazil. A traditional gFOBT test (HemoccultSENSA) was used as a reference. PATIENTS AND METHODS: A cohort of 368 colonoscopy-referral patients were asked to collect 3 consecutive fecal samples, to be analysed by both assays (CV, SENSA). RESULTS: In receiver operating characteristic (ROC) analysis for the AA reading, the optimal cut-off value for CV Hb AA (test AA 3) was ≥117 and that for CV Hb/Hp AA (test AA 4) was ≥48. In the hierarchical summary receiver operating characteristic (HSROC) analysis for pooled accuracy of CV with AA and VA reading, the AUC values for i) VA and ii) AA were as follows: i) AUC=0.859 (95%CI=0.839-0.879), ii) AUC=0.931 (95%CI=0.920-0.942). The difference between these AUC values (Roccomp analysis) was statistically significant (p=0.0024). CONCLUSION: The present study confirms the previous studies on the applicability of the ColonView quick test (a new-generation FIT) in CRC screening.

Serological Biomarker Test (GastroPanel®) in the Diagnosis of Functional Gastric Disorders, Helicobacter pylori and Atrophic Gastritis in Patients Examined for Dyspeptic Symptoms.

BACKGROUND/AIM: The GastroPanel® test (Biohit Oyj) is interpreted by the GastroSoft® application distinguishing eight biomarker profiles, of which five profiles have a morphological equivalent in the Updated Sydney System (USS) classification of gastritis, and 3 others specify functional disorders of the stomach: 1) high acid output, 2) low acid output, and 3) effects of proton pump inhibitor (PPI) medication. This study evaluated the prevalence of these biomarker profiles in dyspeptic patients. PATIENTS AND METHODS: A cross-sectional study was designed to assess the point prevalence of these biomarker profiles in a random sample of 500 subjects derived from our archives of GastroPanel® samples. RESULTS: Reflux symptoms were reported by 35.2% and use of PPI medication by 36.8% of the study subjects. Biomarker profile 2 (high acid output) was the second most common GastroPanel® profile in this cohort; 31.2%, second only (33.6%) to profile 1 (healthy stomach). Hp-infection was detected in 25.0% of the subjects. Profiles related to use of PPI (low acid output, PPI effect) were found in 7.4% of the cases. AG was uncommon, diagnosed in 14 patients only (2.8%). CONCLUSION: These data are derived from the population with the highest frequency of dyspepsia, and the results might have widespread implications in diagnostic and screening practices.

GastroPanel® Biomarker Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review.

BACKGROUND/AIM: Several clinical conditions seriously hamper the diagnostic accuracy of the commonly used tests for Helicobacter pylori (Hp), 13C-urea breath test (UBT) and stool antigen test (SAT). The present communication is a critical review of the potential limitations of UBT and SAT, and describes the approach on how these can be avoided. Drawbacks of the Hp tests: False-negative results are most often due to low bacterial load in the stomach due to: i) use of proton pump inhibitor medication; ii) use of antibiotics; iii) presence of atrophic gastritis and hypoacid stomach; iv); bleeding peptic ulcer; v) gastric cancer (GC) and vi) mucosal-associated lymphatic tissue lymphoma. The UBT also gives false-positive results when urease-producing bacterial species, other than Hp colonize an acid-free stomach. Importantly, neither UBT nor SAT are capable of diagnosing atrophic gastritis, thus missing the patients at highest risk for GC. GastroPanel® (Biohit Oyj, Finland) circumvents these shortcomings with a serological test consisting of a panel of stomach-specific biomarkers: pepsinogen I, pepsinogen II, gastrin-17 and Hp antibodies. GastroPanel® is a tool for non-invasive examination of i) dyspeptic patients for exclusion or diagnosis of Hp or atrophic gastritis, also disclosing the status of gastric acid output; ii) for screening of asymptomatic individuals at risk of GC; and iii) for comprehensive diagnosis of Hp infection. GastroSoft® application integrates the biomarker profile with the patient's medical information, accurately classifying the biomarker profiles into eight diagnostic categories. CONCLUSION: Given that Hp is the single most important risk factor of GC, the non-invasive diagnosis and screening of Hp should be based on more accurate and more comprehensive testing than UBT or SAT alone. The GastroPanel® is such test, being completely devoid of the known serious shortcomings of UBT and SAT.