Diagnostic kit for Antibody to Helicobacter Pylori
Diagnostic Kit For Antibody to Helicobacter Pylori
Colloidal Gold
Production information
| Model Number | HP-ab | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit For Antibody to Helicobacter | Instrument classification | Class I |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Test procedure
| 1 |
Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in sample marking.
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| 2 |
In case of serum and plasma sample, add 2 drops to the well, and then add 2 drops of sample diluent dropwise. In case of whole blood sample, add 3 drops to the well, and then add 2 drops of sample diluent dropwise.
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| 3 |
Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation)
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Intend Use
Diagnostic Kit for Calprotectin(cal) is is a colloidal gold immunochromatographic assay for the semiquantitative determination of cal from human faeces, which has important accessory diagnostic value for inflammatory bowel disease. This test is a screening reagent. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only. Meanwhile, this test is used for IVD, extra instruments are not needed.
Summary
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• Factory direct price
• Do not need extra machine for result reading
Result reading
The WIZ BIOTECH reagent test will be compared with the control reagent:
| Test result of wiz | Test result of reference reagents | Positive coincidence rate:99.03%(95%C.I.94.70%~99.83%) Negative coincidence rate:100%(95%C.I.97.99%~100%)
Total compliance rate: 99.68%(95%C.I.98.2%~99.94%) |
||
| Positive | Negative | Total | ||
| Positive | 122 | 0 | 122 | |
| Negative | 1 | 187 | 188 | |
| Total | 123 | 187 | 310 | |
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