Colloidal Gold Calprotectin ∕ Fecal Occult Blood test kit
1. INTEDED USE
This kit is used for qualitative detection of calprotectin and hemoglobin 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 hemoglobin in stool sample, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | Cal/FOB |
| Methodology | Colloidal Gold |
| Sample Type | Faces |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
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MAIN KIT COMPONENTS * Test device * Sample collection tube * Disposable pipette * Instructions for Use |
PACKING * 20 test /kit * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 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). |
4.RESULT EVALUATION AND EXPLANATION
5.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 326 cases of clinical samples. Sample providers include patients with abnormal calprotectin index, patients with fecal occult blood and normal people. Marketed kit of colloidal gold methods used as reference reagent. The WIZ BIOTECH reagent test will be compared with the control reagent:
| Baysen Result of Cal |
Test result of Reference reagent | 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%) |
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| Positive | Negative | Total | ||
| Positive | 166 | 0 | 166 | |
| Negative | 1 | 159 | 160 | |
| Total | 167 | 159 | 326 | |
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Baysen Result of FOB |
Test result of Reference reagent | 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%) |
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| Positive | Negative | Total | ||
| Positive | 179 | 0 | 179 | |
| Negative | 1 | 146 | 147 | |
| Total | 180 | 146 | 326 | |
6. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
