The FOB Rapid Test is a rapid, lateral flow chromatographic immunoassay for the qualitative detection of fecal occult
in human fecal specimens. It is intended to be used by healthcare professionals as a screening test to aid in the detection of bleeding caused by a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.
Format |
Cassette
|
Specimen |
Feces
|
Package |
1 Test/Kit, 2 Tests/Kit, 5 Tests/Kit, 7 Tests/Kit, 10 Tests/Kit, 20 Tests/Kit, 25 Tests/Kit, 40 Tests/Kit
|
Shelf Life (in months) |
24 |
Accuracy |
Over 99% |
Read time |
|
Storage Temp. |
2-30° |
TEST PROCEDURES
1. Collect a random sample of feces in a clean, dry specimen collection container.
2. Label the specimen collection tube with the specimen's ID number. Unscrew the top of the specimen collection tube and then
randomly stab the specimen collection stick into the fecal specimen in at least five different sites. Do not scoop the fecal
specimen. Ensure that stool specimen is only in the grooves of the collection stick. Excess stool specimen may result in an invalid
test result.
3. Screw on the collection stick in the tube and tighten securely to close the specimen collection tube.
4. Shake the specimen collection tube vigorously so as to extract the hHb in the specimen.
After above steps, the specimen is ready for testing, transportation or storage.
Note: It is recommended to test the specimen immediately after extraction. If test is not performed immediately, the extracted specimen may be stored at room temperature (20-37°C) for up to 10 days or at 2-8°C for up to 21 days. For longer storage, the extracted specimen may be frozen at -20°C. Avoid multiple freeze-thaw cycles (maximum 3 times).
TEST PROCEDURES
1. Before testing, open the package and equilibrate the test device, specimens and/or controls to room temperature(15-30°C). Once the specimen is thawed, mix well prior to performing the test.
2. Take out the test device from sealed foil pouch and place on a dry, clean and level surface. Be sure to label the device with specimen's ID number.
3. Shake the specimen collection tube vigorously to ensure a homogenous liquid suspension.
4. Hold the specimen collection tube vertically. Unscrew the cap. Add 2 drops (approximately 70-90 µL) of the extracted specimen into the specimen well(S) of the test device. Do not overload samples. See illustrations below.
5. Start the timer immediately.
6. Wait for the colored line(s) to appear. Read test results at 5-10 minutes. Positive results may be visible in as short as 1 minute. Negative results must be confirmed at the end of the 10 minutes only. Do not interpret the result after 10 minutes.
MOQ:
The minimum order quantity is negotiable, welcome to contact us with your specific requirements, such as the slot/strip size, dimension, quantity, color, etc.
Our service:
OEM&ODM, customize cassette model and logo printing are available
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Times Medical is principally engaged in the manufacture and sale of medical devices and in vitro diagnostic reagents. It mainly involves medical equipments such as physical examination, diagnosis, reproduction, family medicine, gynecological examination, and medical analysis.
Diagnostics now covers 29 items such as early pregnancy, ovulation, infectious diseases, sexually transmitted diseases, AIDS, and gynecological diseases; family medicine covers blood pressure, blood sugar, blood lipid testing, Cooling Patch and Warm Patch; gynecological examinations include bacterial vaginitis testing equipment and supplies.