A CLIA test kit for the quantitative determination of 25 OH Vitamin D (25-OH VD) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
| Product Name: |
25 OH Vitamin D (25-OH VD) Test Kit (CLIA), Concentration Of 25 OH Vitamin D ,Competition Method |
| Principle: |
Competition Method |
| Pack: |
40T |
| Format: |
Strip |
| Storage Temperature: |
2-8℃ |
| Cat No.: |
CI-VD |
| Specimen: |
WB/S/P |
| Shelf Life: |
2 Years |
| Certificate: |
CE |
| Cut-Off: |
5-100 Ng/mL |
【INTENDED USE】
The 25 OH Vitamin D (25-OH VD) Test Kit (CLIA) is intended for quantitative determine of the concentration of 25 OH vitamin D (25-OH VD) in human serum, plasma and whole blood, as an aid to evaluate vitamin D deficiency in clinical practice.
【SUMMARY】
Vitamin D is a steroid hormone precursor, which is mainly produced by the skin after exposure to light. There are two main forms: vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). Unlike vitamin D3, the human body cannot synthesize vitamin D2 and can only obtain it from fortified foods or food supplements. In the human body, vitamin D itself has no biological activity. Vitamin-binding protein combines with vitamin D3 and vitamin D2 and transports them to the liver and kidneys.
After being hydroxylated twice, it produces 1, 25-hydroxy vitamin D with biological activity.1 25-OH VD is the main storage form of vitamin D in the human body and the total vitamin D can be determined by testing it in the blood.
The half-life of circulating vitamin D (25-OH) is 2 to 3 weeks,under normal circumstances. Most of the 25-hydroxyvitamin D detected in the serum is 25-vitamin D3. The vitamin D2 test value is usually very low or undetectable. Only patients taking vitamin D2 supplements, 25- Vitamin D2 can reach the detection level.
Vitamin D is the main element for maintaining bone health, lack of vitamin D in childhood will lead to decreased availability of food calcium, muscle weakness and severe skeletal deformities, that is, rickets.
For adults, vitamin D deficiency can cause osteomalacia and increase the risk of falls. Especially for middle-aged and elderly people, vitamin D deficiency leads to secondary hyperparathyroidism and elevated PTH levels, bone turnover increases, bone mass decreases and fracture risk increases.
【PRINCIPLE】
This product adopts the competition method. In the first step, incubate the sample with the pretreatment solution to release 25-OH VD from the vitamin D binding protein. The second step is to mix the processed sample with magnetic particles coated with 25-OH VD antibody. After incubation, the 25-OH VD in the sample binds to the antibody on the magnetic particles and is fixed on the magnetic particles. In the third step, add 25-OH VD labeled with alkaline phosphatase and incubate.
Finally, magnetic separation and cleaning are performed to remove free enzyme-labeled 25-OH VD. Add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of 25-OH VD in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of 25-OH VD in the sample.
【REAGENTS】
The reagent strip includes 25-OH VD antibody coated with magnetic particles, alkaline phosphatase labeled 25-OH VD, wash buffer, substrate solution and pretreatment solution.
【STORAGE AND STABILITY】
1. Unopened test kits should be stored at 2-8 °C. When stored and handled as required, all unopened reagents are stable through the expiration date printed on the label.
2. Do not freeze. Do not turn the reagent strips over.
3. Store the test kit upright. Do not expose reagents to strong light during storage. Care should be taken to protect the components of the test from contamination.
4. Remaining reagents in the kit should be stored at 2-8°C immediately.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment,
containers or reagents can lead to false results.
6. Calibrator and Control Materials:
Unopened: Stable until the expiration date when stored at 2-8 °C.
Opened:
Undissolved: Stable for 1 week at 2-8 °C, avoid deliquescence
Dissolved: Stable for 3 days at 2-8 °C.
【PERFORMANCE CHARACTERISTICS】
1. Method comparison
lt was compared with commercial CLIA test kit, 50 specimens were tested and the correlation coefficient (R2 ) is 0.9678.
2. Accuracy The test deviation is≤±10%.
3. Assay Range and Detection Limit
Assay Range: 5-100 ng/mL
Minimum Detection Limit: 5 ng/mL
4. Linearity range
5-100 ng/ml, R≥0.990
5. Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 specimens containing 13 ng/mL, 45 ng/mLl of 25-OH VD. C.V. is ≤8%. Inter-lot precision Between-run precision has been determined by using 10 replicates for each of three lots using 2 specimens containing 13 ng/mL, 45 ng/mL of 25-OH VD. C.V. is ≤15%.
6. Interfering Substances
The following potentially interfering substances were added to 16.75 ng/mL and 59.74 ng/mL of 25-OH VD specimens.
Triglyceride: 10 mg/mL Bilirubin: 0.2 mg/mL
Biotin: 100 ng/mL Hemoglobin 5 mg/mL
None of the substances at the concentration tested interfered in the assay.
