Transferrin detection kit for Colon Cancer Screening
1. INTEDED USE
This kit is suitable for in vitro qualitative detection of transferrin (Tf) in human fecal samples for the auxiliary diagnosis of gastrointestinal bleeding. This kit only provides test results for transferrin (Tf) levels, and the obtained results should be analyzed in combination with other clinical information.
2. PRODUCT SPECIFICATION
| Model No. | TF |
| 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 |
|
MAIN KIT COMPONENTS * Test device * Sample collection tube * Disposable pipette * Instructions for Use |
PACKING * 25 test /kit * Aluminum foil bag labeling * shrink wrap
|
3.TEST METHOD
4.RESULT EVALUATION AND EXPLANATION
 |
Positive: Two red bands appear, one at the control area (C) and the other at the test area (T), and the red band at the test area (T) is the same with or darker than the control area (C). Positive result indicates: Content of transferrin in the sample is higher than 40 ng/m |
 |
Negative:A single red band appears at the control area (C) and no other band at test area. No red band appears in test area (T). Negative result indicates: Content of transferrin in the sample is lower than 40 ng/mL |
 |
Invalid: Control line C fails to display. Invalid result indicates possible causes are incorrect operation process or deterioration and damage of reagents. The invalid result should be retested, and retest should be performed in strict accordance with the instruction for operation. If the problem persists, stop use the product of the batch immediately and contact local suppliers. |
5.CLINICAL PERFORMANCE
Clinical evaluation performance of the product is assessed by collecting 298 clinical samples. The listedcorresponding kit of colloidal gold method is used as the reference reagent The WIZ BIOTECH reagent test will be compared with the control reagent:
| Baysen Result of TF |
Test result of Reference reagent | Positive coincidence rate: 99.45% (95%C.I. 96.94%~99.90%) Negative coincidence rate: 99.15% (95%C.I.95.32%~99.85%) Total coincidence rate: 99.33% (95%C.I.97.59%~99.82%) |
||
| Positive | Negative | Total | ||
| Positive | 180 | 1 | 181 | |
| Negative | 1 | 116 | 117 | |
| Total | 181 | 117 | 298 | |
6. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
