Uncut sheet for Heparin Binding Protein HBP FIA test kit
1. INTEDED USE
This kit is applicable to in vitro detection of heparin binding protein (HBP) in human whole blood/plasma sample, and it can be used for auxiliary disease diagnosis, such as respiratory and circulatory failure, severe sepsis, urinary tract infection in children, bacterial skin infection and acute bacterial meningitis. This kit only provides heparin binding protein test results, 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. | HBP Uncut sheet |
| Methodology | fluorescence immunochromatographic assay |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15 mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 5 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
|
3.TEST METHOD
| 1 | Open the aluminum foil bag package of reagent and take out the test device. |
| 2 | Horizontally insert the test device into the slot of immune analyzer. |
| 3 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface. |
| 4 | lick “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument and select sample type. Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step. |
| 5 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit
label. |
| 6 | Start to add sample in case of consistent information:
Step 1: slowly pipette 80 µL plasma/whole blood sample at once, and pay attention not to pipette bubbles; |
| 7 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 8 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 9 | Ⅰ-2: Result calculation and display After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration






