Accu-Tell Rapid Occult Blood Rapid FOB Test Strip

Specifications 1.CE mark.

2.Fecal Occult Blood (FOB) Rapid Test is intended as a aid in the diagnosis of lower gastrointestinal (g.i.) disord

RAPID FECAL OCCULT BLOOD TEST

Catalog No.	Product Name	Specimen	Note
ABT-FOB-A22	FOB Cassette	Fecal	CE
ABT-FOB-B22	FOB Strip	Fecal	CE

  INTENDED USE Accu-Tell® Fecal Occult Blood (FOB) Rapid Test is rapid, self performing, qualitative, two site sandwich immunoassays for the determination of human blood hemoglobin in fecal samples. This test is intended as an aid in the diagnosis of lower gastrointestinal (g.i.) disorders. The test is for professional use only.   PERFORMANCE CHARACTERISTICS
Sensitivity: A sample containing human hemoglobin at concentration equal to or higher than 100 ng/ml produces a positive result. In some cases sample containing human hemoglobin at concentrations less than 100ng/ml can also be tested as positive. Prozone effect: sample containing as high as 0.5mg/ml hemoglobin can still test positive. Specificity: The FOB Test Strip is specific for human hemoglobin and soes not show any cross-reaction with the hemoglobin from bovine, pig, rabbit, horse and sheep concentrations up to 0.5mg/ml. The FOB Test Strip also do not show any cross raction with billirubin, vitamin C and horse radish peroxidase.   SPECIMEN COLLECTION AND PREPARATION 1. Collect a random sample of feces in a clean dry container or receptacle. 2. Unscrew and remove the collection tube applicator stick. Be carefull not to spill or spatter solution from container. 3. Collect random sample by using the applicator stick. Take sample from various surfaces of the feces specimen. 4. Re-insert the applicator stick into the tube and screw the cap tightly. Be careful not to break the tip of the sample collection tube. 5. The specimen is now ready to be stored at 2-30°c, transported or tested. The specimen should be tested as soon as possible, but may be held up to 2 days prior to testing. The specimen should be transported and stored in an airtight container and it is recommended to store it at +2 °c -+8 °c until tested.     TEST PROCEDURE  Test procedure Test strip, patient's sample, and controls should be brought to room temperature (15-30 °c ) prior to testing. Do not open pouches until ready to perform the assay. 1. Remove the test strip from its pouch when ready to perform the test. 2. Shake the collection tube thotoughly to ensure proper mixing of the fecal sample with the extraction solution. 3. Using a piece of tissue paper, break the tip of the collection tube using a twisting motion. Discard the 1st drop of the solution. 4. Hold the collection tube vertically and vertically and dispense 8-10 drops of the solution into the sample cup. 5. Dip the area marked with max of the strip in the sample solution submerging only up to the MAX mark. If sample solution touches the reaction zone the strip is detective. 6. Observe for the release of the colloidal gold complex on the membrane and could take about 25 seconds to appear depending upon the sample. 7. Remove the strip and place horizontally on a flat surface. 8. Observe the result in 5 minutes. Strong positive results may be observed sooner. 9. Do not interpret the result(s) after 8 minutes after the addition of sample.   INTERPRETATION OF RESULTS Positive: Two pink-red colored bands appear. One in the control region (C) and one in the test region (T). When testing with strong positive samples, the intensity of the control band may be lighter than expected. Comparison of the line intensities is not reconnended. Negative: Only one pink-red colored band appears in the control region (C). No apparent faint pink to red colored band in the test region (T). Invalid: A total absence of pink colored bands in both regions is an indication of procedural error or that test reagents may have deteriorated. Repeat the test with a new test device.      ABOUT US we have exported our in vitro rapid diagnostic test and lab equipment to over 50 countries.   Our Aim: ——Let every family benefit from our convenient and reliable diagnostic products and services. ——Let our lab equipment be used in every laboratory of the world. Our Values on Quality: ——Delivers customer value in all in all projects, services and processes; ——Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made; ——Drives QMS results to the bottom line in terms of defect reduction and financial benefits; ——Allocates resources to achieve quality execution.   Our product have got ISO13485 & ISO9001 certification . If you need high quality product at competitive price, good after-sale service, good supply chain —— Please contact us without hesitation or visit our website at www.accubiotech.com.