The FOB Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of human hemoglobin in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.
The FOB Rapid Test Device (Feces) has been designed to detect human hemoglobin through visual interpretation of color development in the internal strip. The membrane was immobilized with antihuman hemoglobin antibodies on the test region. During the test, the specimen is allowed to react with colored anti-human hemoglobin antibodies colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough human hemoglobin in specimens, a colored band
will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
| Specimen |
fecal |
| Width |
3.0mm and 4.0mm |
| Packaging |
100strips/box, 25 cassettes/box |
| Place of origin |
China |
Certificate: ISO 13485
Raw materials is imported from US, quality is high
Customized OEM packaging is available
TEST PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Use the specimen collection container for specimen collection.
2) Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
3) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4) Shake the specimen dilution tube vigorously to mix the specimen and buffer.
2. Testing
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2) Unscrew the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of solution (approximately 150μl) into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.
Innovation Biotech(Beijing) Co., Ltd. is a biotechnology company specializing in research, development and manufacturing of advanced medical in-vitro diagnostic (IVD) rapid test kits, medical and laboratory disposal products. We provide one step medical diagnostic rapid test kit, Product include Fertility Tests, Infectious diseases, Tumor markers, DOA drug of abuse test, Drug test cup, Urinalysis reagent strip, ELISA kit, Digital alcohol tester, urine analyzer, et.
OEM packaging is available, drug of abuse test, troponin I test, alcohol screening saliva test strips, urine strips, elisa kits.
Our focus is to expand our markets internationally by forming strategic alliances and entering into partnerships with distributors worldwide. We have established an international reputation for excellence in the manufacturing of quality medical and laboratory products. In addition, we have obtained approval licenses ISO13485, FSC certificate, and most of our products get CE mark Our objective is the utmost satisfaction of our clients all around the world by supplying our quality and economical products
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My mobile/WhatsApp/WeChat : 0086 13356149018
Telephone: 0086-010-68867437
