
For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
INTENDED USE
Diagnostic Kit for Fecal Occult Blood (Fluorescence Immunochromatographic Assay) is suitable for the quantitative detection of hemoglobin in human feces by fluorescence immunochromatographic assay, it acts as gastrointestinal bleeding auxiliary diagnosis reagent clinical diagnosis. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.
SUMMARY
The slight bleeding of digestive tract disease give rise to FOB, so the detection of FOB has important value for gastrointestinal bleeding disease auxiliary diagnosis, it is the available approach for screening digestive tract diseases.
PRINCIPLE OF THE PROCEDURE
The strip has anti-FOB coating antibody on test region, which is fastened to membrane chromatography in advance. Lable pad is coated by fluorescence-labeled anti-FOB antibody in advance. When testing a positive sample, the FOB in the sample can be mixed with a fluorescence-labeled anti-FOB antibody, and form an immune mixture. As the mixture is allowed to migrate along the test strip, the FOB conjugate complex is captured by anti-FOB coating antibody on the membrane and forms complex. The fluorescence intensity is positively correlated with the FOB content. The FOB in the sample can be detected by fluorescence immunoassay analyzer.
REAGENTS AND MATERIALS SUPPLIED
25T package components:
Test card individually foil pouched with a desiccant 25T
Sample diluents 25T
Package insert 1
MATERIALS REQUIRED BUT NOT PROVIDED
Sample collection container, timer
SAMPLE COLLECTION AND STORAGE
1. Use a disposable clean container to collect fresh feces sample, and tested immediately. If cannot be tested immediately, please stored at 2-8°C for 3 days or below -15°C for 6 months.
2. Take out the sampling stick, inserted into the faeces sample,repeat the action 3 times,take the different parts of the faeces sample each time, then put the sampling stick back, screw tight and shake well, Or using the sampling stick picked about 50mg faeces sample, and put in a faeces sample tube containing sample dilution, and screw tightly.
3. Use disposable pipette sampling take the feces sample from the diarrhea patient, then add 3 drops (about 100µL) to the fecal sampling tube and shake well.
Notes:
1. Avoid freeze-thaw cycles.
2. Thaw samples to room temperature before use.
ASSAY PROCEDURE
Please read the instrument operation manual and package insert before testing.
1. Lay aside all reagents and samples to room temperature.
2. Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.
3. Scan the identification code to confirm the test item.
4. Take out the test card from the foil bag.
5. Insert the test card into the card slot, scan the QR code, and determine the test item.
6. Remove the cap from the sample tube and discard the first two drops diluted sample, add 3 drops (about 100uL) no bubble diluted sample vertically and slowly into the sample well of the card with the provided dispute.
7. Click the"standard test"button, after 15 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.