Product Data for. Colon Polyps Prevention Test

Transcription

1 roduct Data for Colon olyps revention Test - an immunochromatographic assay for qualitative determination of human Hemoglobin in feces Introduction Test principle Interpretation Limitation erformance Sensitivity Specificity and cross-reactions Correlation Colon olyps revention Test vs. Haemoccult vs. colonoscopy Real Time Stability Data

2 References Introduction: The Colon olyps revention Test is a rapid, convenient and practically very hygienic method for detecting fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn s disease, ulcerative colitis, and colon polyps. RICILES OF THE ROCEDURE Colon olyps revention Test incorporates a monoclonal antibody-colloidal gold conjugate specific to -hhb to bind to hhb and a surface coated with monoclonal antibodies specific to -hhb to capture the complex. As the test strip in the test cassette is in contact with the specimen buffer mixture, the antibody coated surface captures intact hhb bound to the antibody-colloidal gold conjugate forming a complex and giving a colored test line. In the absence of intact hhb in the sample, independent unbound conjugate binds to an antibody in the control area and appears as purple color band confirming the correct test performance. Detection Limit: Incubation time: 0,05 g hhb / ml Buffer resp. ~0,03 mg hhb / g Stuhl RESULTS 5 MIUTES AFTER ALICATIO OF SECIME Active Ingredients: Bovine Serum Albumin Goat Anti-(Rabbit IgG) olyclonal Antibody Anti- -hhb Monoclonal Antibody Rabbit IgG Colloidal Gold Conjugate Anti- -hhb Monoclonal Antibody-Colloidal Gold Conjugate Buffer: Bovine Serum Albumin Sodium Azide Sodium Dibasic hosphate Sodium Chloride Fib erg la ss ~ 7 mm sample pad Adhesive ~ mm Test-Line Control-Line Y Fib e rg la ss ~ 9 mm coated with gold-conjugates Human Hb Antigen (from stool) Vinyl ~ 60 mm itrocellulose ~ mm coated with Test- and Control-Line Anti- -hhb Monoclonal Antibody-Colloidal Gold Konjugat Y Anti- -hhb-monoclonal Antibody Goat Anti-(Rabbit IgG) olyclonal Antibody Rabbit IgG Antibody-Colloidal Gold Conjugate Strip dimensions: length: 60 mm + /- width: 3.8 mm + /-0.5

3 ASSAY ROCEDURE: Given in instructions. ITERRETATIO OF RESULTS: Samples are recorded as positive if two rose-pink color bands appear in the test area of the test-cassette. Specimens that give only one color band in the test area of the test-cassette should be recorded as negative. The absence of a purple color band in the test area, or its discoloration, after the correctly carried out test procedure, indicates an invalid test result. Do not read results later than 5 min. after test performance, because some time after performing the test both bands will become visible independent of the test result. ITERFERIG SUBSTACES: o interference from ascorbic acid (Vitamin C) and iron has been observed. LIMITATIOS: The test is limited to the detection of hhb. It does not allow to differentiate between different sources of hhb. erformance Study The analytical sensitivity of Colon olyps revention Test was determined using HB in different concentrations: Test Results Comments 0 g hhb / ml buffer egative ASS 0,0 g hhb / ml buffer egative ASS 0,05 g hhb / ml buffer Weak pos. ASS 0, g hhb / ml buffer ositive ASS 0, g hhb / ml buffer ositive ASS 00 g hhb / ml buffer ositive ASS 500 g hhb / ml buffer ositive ASS Moreover human hemoglobin-positive samples, with varying concentrations of hhb, were prepared by homogenizing human hemoglobin into hemoglobin-negative fecal samples. The results are tabulated below: hhb (mg/g stool) ,3 0,03 0,003 Results

4 Conclusions: The minimum detectable concentration of hhb is 0,05 g / ml buffer or ~0,03mg hhb / g stool. The test is capable of qualitative testing hhb at a concentration of 0,05 g / ml 500 g / ml or 0,03-60 mg / g stool. The Colon olyps revention Test is specific to human hemoglobin. ositive and negative specimens containing the following potentially interfering substances were tested with no effect on test result: Substance Concentration Comments Chicken HB 500 g / ml ASS ork HB 500 g / ml ASS Beef HB 000 g / ml ASS Goat HB 500 g / ml ASS Horse HB 500 g / ml ASS Rabbit HB 500 g / ml ASS Horseradish eroxidase 000 g / ml ASS o interference from common stools has been observed. Correlation Study For the purpose of this study the immunochromatographic Colon olyps revention Test was compared to a extremely widely used test for fecal occult blood, namely HAEMOCCULT, that is based on the guaiac method and to a reference method, namely COLOOSCOY. 5 patients completed all 3 test procedures and the following results were obtained: Colon olyps revention Test Haemoccult Colonoscopy Sum 5 Sum 5 Sum 5

5 + - Total Colonoscopy + Colon olyps revention Test Haemoccult Colonoscopy - Colon olyps revention Test Haemoccult Sum 5 SESITIVITY The sensitivity is the estimate of the percent of true positives for the Colon olyps revention Test, that is, the percent of the positive reference results which are positive by the Colon olyps revention Test. Therefore the relative sensitivity of Colon olyps revention Test when compared to the reference method (colonoscopy) is calculated as follows: 59/94 * 00 = 63%. The sensitivity of Haemoccult in this test is 7/94 * 00 = 8,7 %. One has to note here, that colonoscopy is only able to find bleeding sources in the colon area, but not at all more anterior regions. This can be seen as reason for virtually false positive results of Colon olyps revention Test. Additionally due to this fact sensitivity is actually not an allowed attribute for comparison. But generally, for screening tests high sensitivity is desired. SECIFICITY The specificity is the percent of true negatives for the Colon olyps revention Test test, that is, the percent of the negative reference results which are negative by the Colon olyps revention Test. The specificity of Colon olyps revention Test when compared to the reference method (colonoscopy) is calculated as follows: 47/57 * 00 = 94% The specificity of Haemoccult in this test is 53/57 * 00 = 97 %

6 Real Time Stability Test Results for Colon olyps revention Test, stored at 5 C 8 C Tested over 8 months Real Time Stability (Months) Type Sample Rep- licate egative Control 0,05 g hhb / ml Real Time Stability (Months) Type Sample Rep- licate egative Control 0,05 g hhb / ml Real Time Stability (Months) Type Sample Rep- licate egative Control 0,05 g hhb / ml REFERECES:. Kutter, D., Kremer, A., Aspesberro, F., and Gallego, F., Deparment des Sciences, Centre Universitaire de Luxembourg, Z.med.Lab.diagn. 3, 3/4 (99) L O T L O T L O T 3