25-hydroxy vitamin D rapid test kit
1. INTEDED USE
This kit is intended for the in vitro quantitative detection of 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum/plasma samples to evaluate the level of Vitamin D. The kit only provides test result of 25-hydroxy Vitamin D.
2. PRODUCT SPECIFICATION
| Model No. | VD |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | serum/plasma/whole blood |
| 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;
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| 5 |
Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit
label;
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| 6 |
After information consistency is confirmed, start adding sample:
Step 1: Slowly draw 30µL of serum/plasma sample at a time. Be cautious not to draw bubbles.
Step 2: Add the drawn sample into A Solution (transparent centrifuge tube), draw and blow for 3-4 times (note:
the liquid in bottle cap shall be drawn into the bottle);
Step 3: Add all mixed solution in A solution (transparent centrifuge tube) into B tube (red centrifuge tube), stir evenly (note: ensure that the marker pad is immersed in liquid), and incubate at 37℃ for 8 minutes;
Step 4: Pipette 80µL of the liquid in step 3 into the sample hole of test device. Avoid drawing bubble during sampling.
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| 7 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit label; |
| 8 |
After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the
interface.
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| 9 |
Immune analyzer will automatically complete test and analysis when test time is reached.
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4.Product Performance
The clinical evaluation performance of this product was evaluated by collecting 196 clinical samples. The results of the tests were compared using the corresponding kits of the marketed electrochemiluminescence method as reference reagents, and their comparability was investigated by linear regression, and the correlation coefficients of the two tests were y = 1.019x and R = 0.9571, respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
