Validation of the BetaStar® Advanced for Tetracyclines Test Kit for the Screening of Bulk Tank and Tanker Truck Milks for the Presence of Tetracycline Drug Residues.

A validation study was conducted for an immunochromatographic method (BetaStar® Advanced for Tetracyclines) for detection of tetracycline antibiotic residues in raw, commingled bovine milk. The assay was demonstrated to detect tetracycline, chlortetracycline, and oxytetracycline at levels below the FDA tolerance levels but above the maximum sensitivity thresholds established by the National Conference on Interstate Milk Shipments. Results of internal and independent laboratory dose-response studies employing spiked samples were in agreement. All three drugs at the approximate 90/95% sensitivity levels were detected in milk collected from cows that had been treated with the specific drug. Selectivity of the assay was 100%, as no false-positive results were obtained in testing 881 control milk samples. Testing the estimated 90/95 sensitivity level for tetracycline (213 ppb), chlortetracycline (272 ppb), and oxytetracycline (180 ppb) and at 1000 ppb for each antibiotic resulted in 100% positive tests for each tetracycline. Results of ruggedness experiments established the operating parameter tolerances for the test. Results of cross-reactivity testing established that the assay detects certain other tetracycline drugs but does not cross-react with any of 32 drugs belonging to seven different drug classes. Abnormally high bacterial or somatic cell counts (SCC) in raw milk produced no assay interference.

Clinical features of ileal pouch polyps in patients with underlying ulcerative colitis.

PURPOSE: Polypoid lesions rarely occur in the ileal pouch in ulcerative colitis patients after restorative proctocolectomy. Clinical features, malignant potential, and management of pouch polyps have not been characterized. METHODS: We identified 23 ulcerative colitis patients with large polyps (size> or =1 cm) of the ileal pouch from our 2,512-case ulcerative colitis pouch database. Demographic, clinical, endoscopic, and histologic data were reviewed. The Pouchitis Disease Activity Index symptom score (range, 0-6) was used to quantify patients' symptoms before and after polypectomy. RESULTS: Of the 23 patients, 95.7 percent (22 patients) had pouch endoscopy indicated for the evaluation of symptoms when polyps were detected, and 60.9 percent of patients had the polyps in the pouch, 26.1 percent in the anal transitional zone, and 21.7 percent in the afferent limb. The mean size of pouch polyps was 1.9 cm +/- 1 cm. Twenty-one patients (91.3 percent) had concomitant pouchitis, cuffitis, or Crohn's disease. On histology, 21 patients (91.3 percent) had inflammatory-type polyps, and 2 (8.7 percent) had dysplastic or malignant polyps. In 18 patients who had endoscopic polypectomy with concurrent medical therapy, the prepolypectomy and postpolypectomy mean symptom scores were 3.4 +/- 1.7 and 1.1 +/- 1.2 points, respectively (P = 0.015). Two patients (8.7 percent) had pouch excision for malignancy or for concomitant chronic refractory pouchitis. CONCLUSIONS: The majority of patients with large ileal pouch polyps were symptomatic. These polyps were typically detected on the background of pouchitis, cuffitis, or Crohn's disease. Although the majority of polyps were inflammatory type, polyps in two patients were dysplastic or malignant. Endoscopic polypectomy with concomitant medical therapy seemed to improve patients' symptom scores.