| Classification: | Biological Diagnostics |
|---|---|
| Type: | Urine Analyzer |
| Certification: | CE, FDA, ISO13485 |
| Group: | Middle-aged and Old |
| Medical Device Regulatory Type: | Type 3 |
| Medical Devices Ad. Approval No.: | Sxzz-20152401060 |
| Samples: |
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| Customization: |
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Suppliers with verified business licenses
Audited Supplier 1. Function: It is intended to be used for the qualitative detection of antibodies/Antigen to H.Pylori to aid in the diagnosis of H.Pylori infection.
2. Formats: Strip, Cassette.
3. Specifications: strip(3.0mm,3.5mm,4mm,5mm), cassette(3.0mm, 4.0mm).
4. Specimens: Whole Blood/Serum/Plasma/ Feces.
5. Design: DAG or according to the customers' requirements.
6. Accuracy: >99%.
7. Shelf life: 2 years at 2-30°C.
8. The kits can be made according to the customers' artwork or design.
9. Inner packing: one piece of test, one pipette and one desiccant.
2.Product details
| Product | Cat No. | Format | Specimen | Read Time |
| H.Pylori Ab Rapid Test | HP-AG-F11 | Strip | Serum/Plasma | 10-20 min |
| HP-AG-F23 | Cassette | Serum/Plasma | 10-20 min | |
| HP-AB-W11 | Strip | Whole Blood/Serum/Plasma | 10-20 min | |
| HP-AB-W23 | Cassette | Whole Blood/Serum/Plasma | 10-20 min |
3.Procedure
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Use clean, dry containers for specimen collection. Best results will be obtained if the assay is performed within 6 hours after 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) Replace 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 collection tube vigorously to mix the specimen and the extraction 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) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of solution into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the membrane.
3) Wait for the colored band(s) to appear. The result should be read at 10minutes. Do not interpret the result after 20 minutes.
Note: If the specimen does not migrate due to the presence of particles, centrifuge the extracted specimens contained in the extraction buffer vial. Collect 100 μL of supernatant, dispense into the specimen well (S) of a new test device and start again, following the instructions described above.
4.More other products
HCG,LH,FSH,HIV,HBSAG,HCV,HBV, HEV,SYPLILIS,TB,HP,NGH,Chlamydia,Malaria,PSA,MORE rapid diagnostic products supplied
CEA,FOB,Dengue,Troponin I, Toxoplasma, Drug of Abuse test,saliva alcohol test and so on.
♦ Detailed Images
♦ Certifications
FAQ
Q1: What's the method u use to do the test?
A: Colloidal Gold Method.
Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.
Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest u the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.
Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.
Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.
Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice
Suppliers with verified business licenses
Audited Supplier 
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