Colorectal Cancer screening calprotectin /Helicobacter Antigen Combo Test
Diagnostic Kit For Calprotectin/Fecal Occult Blood
Colloidal Gold
Production information
| Model Number | CAL+HP-AG | Packing | 25 Tests/ kit, 20kits/CTN |
| Name | Diagnostic Kit For Calprotectin/Helicobacter Antigen | Instrument classification | Class Ii |
| Features | High sensitivity, Easy opeation | Certificate | ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Test procedure
| 1 | Use sample collection tube to collect, mix well and dilute the sample. Use sampling stick to take about 30mg of stool. Then, transfer the stool to a sample collection tube containing sample diluent, tighten by rotating, and shake sufficiently. |
| 2 | If stool of patient with diarrhea is loose, use disposable pipette to draw the sample, add 3 drops (about 100μL) of sample-to sample collection tube, and shake the sample and sample diluent sufficiently. |
| 3 | Take the test device out of the aluminum foil bag, place it on a horizontal worktable flat, and make a proper mark. |
| 4 |
Discard the first two drops of diluted sample. Then, vertically, and slowly add 3 drops (about 100μL) of bubble-free diluted sample to the center of sample hole of the test device and start timing. |
| 5 | The result shall be read within 10-15 minutes. Test result obtained after 15 minutes is invalid (for detail about result see Interpretation of Test Results). |
Intend Use
This kit is used for qualitative detection of calprotectin and helicobacter antigen in human stool sample, and it’s suitable for auxiliary diagnosis of inflammatory bowel disease and gastrointestinal bleeding. This kit only provides detection results of calprotectin and helicobacter antigen in stool sample, and results obtained shall be used in combination with other clinical information for analysis.
Superiority
Testing time:15 mins
Storage:2-30℃/36-86℉
Methodology:Colloidal Gold
CFDA Certificate
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:
| WIZ result of Cal | Test result of reference reagents | Positive coincidence rate: 99.40% (95%C.I. 96.69%~99.89%) Negative coincidence rate: 100.00% (95%C.I. 97.64%~100.00%) Total coincidence rate: 99.69% (95%C.I. 98.28%~99.95%) |
||
| Positive | Negative | Total | ||
| Positive | 166 | 0 | 166 | |
| Negative | 1 | 159 | 160 | |
| Total | 167 | 159 | 326 | |
| WIZ Result of HP-AG | Test result of reference reagents | Positive coincidence rate: 99.44% (95%C.I. 96.92%~99.90%) Negative coincidence rate: 100.00% (95%C.I. 97.44%~100.00%) Total coincidence rate: 99.69% (95%C.I. 98.28%~99.95%) |
||
| Positive | Negative | Total | ||
| Negative | 179 | 0 | 179 | |
| Positive | 1 | 146 | 147 | |
| Total | 180 | 146 | 326 | |
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