Blood Heparin Binding Protein 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.
2. PRODUCT SPECIFICATION
| Model No. | HBP |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | whole blood/plasma sample |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS: *Test device *solution *Instructions for Use |
Packing: *25 test /kit *Aluminum foil bag labeling *shrink wrap |
3.TEST METHOD
| 1 |
Open the aluminum foil bag package of reagent, and take out the test device;
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| 2 |
Horizontally insert the test device into the slot of immune analyzer;
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| 3 |
On home page of operation interface of immune analyzer, click “Standard” to enter test interface;
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| 4 |
Click “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;
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| 6 | slowly pipette 80 µL plasma/whole blood sample at once, and pay attention not to pipette bubbles; pipette sample to sample diluent, and thoroughly mix sample with sample diluent; |
| 7 | pipette 80µL thoroughly mixed solution into well of test device, and pay attention no to pipette bubbles during sampling. |
| 8 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 9 |
Immune analyzer will automatically complete test and analysis when test time is reached.
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| 10 |
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. |
4.Product Performance
Clinical performance of this product’s assessed through collection of 195 cases of clinical samples. Corresponding marketed kit of dry-type immunofluorescence quantitative assay’s used as reference reagent, detection results have been compared and their comparability has been studied through linear regression, and correlation coefficients of the two assays are y=1.024X-0.925 and R=0.9880 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
