Evaluation of the Sentinel-FOB gold faecal immunochemical test for the presence of haemoglobin using the automated Roche Cobas 8000 system.

OBJECTIVES: Faecal immunochemical tests (FIT) for the detection of haemoglobin are widely used in the diagnostic pathway of colorectal cancer (CRC) in patients presenting with lower abdominal symptoms. Several quantitative immunochemical tests are available, however only a few tests are available on high throughput automated analyzers. Here we report the analytical and clinical evaluation of the Sentinel-FOB Gold assay on the Roche Cobas 8000 automated system. DESIGN: and Methods: The assessment of the analytical performance of the assay on the Roche Cobas analyzer comprised determination of imprecision, accuracy, limit of detection, linearity, carryover and prozone effect. In the clinical evaluation part of the study 163 patients presenting for coloscopy with lower abdominal symptoms were included in the study. Diagnostic accuracy and optimal cutoff of the FIT-assay were determined by comparing faecal haemoglobin (f-Hb) concentrations with coloscopy findings as reference. RESULTS: We confirmed good analytical performance of the assay on the Roche Cobas system. Patients with CRC had significant higher f-Hb concentrations than patients with non-advanced adenomas and patients with normal findings by coloscopy. When applying a cutoff of 10 µg/g the sensitivity and specificity were 96.2% and 51.8%, respectively for CRC and 84.6% and 57.7% for CRC and advanced adenoma. CONCLUSION: The Sentinel-FOB Gold assay is appropriate for application on the automated Roche Cobas 8000 analyzer. The assay shows good analytical performance on the system. With regard to early detection of significant colorectal diseases a cutoff of 10 µg/g seems to be optimal.

Development and Validation of a Simple Ultrasound Activity Score for Crohn's Disease.

BACKGROUND AND AIMS: To improve management of patients with Crohn's disease, objective measurements of disease activity are needed. Ileocolonoscopy is the current reference standard but has limitations that restrict repeated use. Ultrasonography is potentially useful for activity monitoring, but no validated sonographic activity index is currently in widespread use. Thus, we aimed to construct and validate a simple ultrasound score for Crohn's disease. METHODS: Forty patients were prospectively examined with ultrasound and endoscopy in the development phase. The Simple Endoscopic Score for Crohn's Disease [SES-CD] was used as a reference standard. Seven ultrasound variables [bowel wall thickness, length, colour Doppler, stenosis, fistula, stratification and fatty wrapping] were initially included, and multiple linear regression was used to select the variables that should be included in the final score. Second, the ultrasound data from each patient were re-examined for interobserver assessment using weighted kappa and intraclass correlation. Finally, the activity index was validated in a new cohort of 124 patients. RESULTS: Length, fistula and stenosis were excluded. The combination of the remaining variables provided a multiple correlation coefficient of r = 0.78. Interobserver analysis revealed poor agreement for stratification and fatty wrapping and these were thus excluded. There was excellent interobserver agreement for the remaining score consisting of wall thickness and colour Doppler. In both patient cohorts, the ultrasound score correlated well with SES-CD [Development cohort: rho = 0.83, p < 0.001, Validation cohort: rho = 0.78, p < 0.001]. A receiver operating characteristic curve analysis revealed an area under the curve of 0.92 and 0.88 for detecting endoscopic activity and moderate endoscopic activity, respectively. CONCLUSIONS: A simple ultrasound activity index for Crohn's disease consisting of bowel wall thickness and colour Doppler was constructed and validated and correlated well with endoscopic disease activity.ClinicalTrials. gov ID: NCT03481751.

[Whipple's disease]. / Whipples sykdom.

BACKGROUND: Whipple's disease is a rare infectious disease. This review describes the clinical picture, diagnostic aspects and treatment options. MATERIAL AND METHODS: Based on a clinical case, a literature study was performed by searching PubMed (unlimited) with the words "whipples disease" combined with " TROPHERYMA WHIPPELII: " (118 hits) and " TROPHERYMA WHIPPLEI:" (65 hits). Titles and abstracts were used to identify other relevant articles. RESULTS AND INTERPRETATION: Whipple's disease may affect several organ systems and thus causes a wide range of symptoms. The most common ones are weight loss, abdominal pain, diarrhoea and arthralgia. The diagnosis is based on PAS-POSITIVE MATERIAL: in duodenal biopsies and identification of gene fragments from the bacterium TROPHERYMA WHIPPLEI:. Presence of the bacterium may be confirmed by sensitive polymerase chain reaction assays. Left without treatment the disease may be lethal. Proper antibiotic treatment is imperative to heal the disease.

[Hepatic and renal haemodynamic changes in congestive heart disease]. / Hemodynamiske forandringer i lever og nyre ved høyresidig hjertesvikt.

BACKGROUND: Increased right ventricular pressure in congestive heart disease is transmitted to the inferior caval vein and the hepatic veins and is essential to our understanding of haemodynamic changes in congestive liver disease. By ultrasonography we aimed to reveal haemodynamic changes within the renal parenchyma as well. MATERIAL AND METHODS: In 23 patients with serious congestive heart disease we ultrasonographically measured portal pulsatility ratio, maximal velocity in the hepatic vein during atrial contraction and in systole, the vena cava inferior diameter and collapsibility index, and renal resistive and pulsatility indexes. In a control group, ultrasonography was performed in 23 patients without heart disease. RESULTS: Statistically significant differences between the groups were found on all parameters measured at ultrasonography. In patients with congestive heart disease, the serum creatinine was higher than in the control group. INTERPRETATION: Congestive heart disease causes caval hypertension and thus increased pressure within the renal vein. Patients with congestive heart disease have increased renal resistive and pulsatility indexes, which can be explained by increased venous pressure within then renal parenchyma.

[Ultrasonography in acute transient ischaemic colitis]. / Ultrasonografi ved akutt transitorisk iskemisk kolitt.

BACKGROUND: Acute transient ischaemic colitis gives abdominal pain and blood per rectum; the symptoms disappear in the course of a few days. The diagnosis is made by clinical signs and symptoms, endoscopy and histology. MATERIAL AND METHODS: During the last tree years this diagnosis has been made in 12 patients in our department. In an attempt at evaluating the extent to which transabdominal ultrasonography could give diagnostic information, the patients were examined in the acute state and at control a few days later; then the data were compared. RESULTS: At admission the bowel wall echotexture was non-stratified; proximal to the ischaemic damage was fluid or air within the bowel lumen in all patients. During the observation period the thickness of the bowel wall was reduced from 9.0 +/- 1.7 to 4.2 +/- 0.7 mm (p < 0.0005). At the same time, mural resistive index was reduced from 0.72 +/- 0.08 to 0.62 +/- 0.09 (p = 0.010), while systolic acceleration time was reduced from 0.144 +/- 0.054 to 0.070 +/- 0.023 ms (p = 0.001), the same value as was found in the great mesenteric vessels (p = 0.969). INTERPRETATION: In acute transient ischaemic colitis, transabdominal ultrasonography may reveal pathological haemodynamic conditions and bowel wall thickness, both of which normalise within a few days.

[Ultrasonography in inflammatory bowel diseases--preliminary results]. / Ultrasonografi ved inflammatoriske tarmsykdommer--foreløpige erfaringer.

BACKGROUND: After installing an ultrasound machine within the gastroenterologic unit at Alesund Hospital in February 2001, we wanted to evaluate its usefulness in inflammatory bowel diseases compared with endoscopy. MATERIAL AND METHODS: We describe findings in 22 patients investigated from February to December 2001. Ultrasonography was performed using a combination of B-mode, power Doppler and duplex Doppler ultrasound techniques. The bowel disease was diagnosed by histology in all patients. RESULTS: Ultrasonography revealed wall thickness, disease extent and hyperaemia within the pathological segment of the bowel in all patients. Furthermore, the method demonstrated several pathological conditions related to the bowel disease which were not revealed by colonoscopy. INTERPRETATION: Transcutaneous abdominal ultrasonography gives additional information to endoscopy in patients with inflammatory bowel diseases.