25-hydroxy Vitamin D Determination Kit saline (PBS). 80ul/tube.

(25-OHVD Determination Kit)

25-OHVD antibody solution. The filling
（Fluoresncece Immunochromatographic Assay）
Buffer B level changes according to people’s
number.
PRODUCT NAME
QC(Freeze-dried The target value range:
Product Name: 25-hydroxy Vitamin D（Fluorescence
Immunochromatographic Assay） products. 2 Levels:（20±4）ng/mL,

Abbreviation: 25-OHVD Optional) （80±16）ng/mL

PACKAGE Have Calibration curve information of this

1 Tests/Box; 10 Tests/Box; 25 Tests/Box; 50 Tests/Box; 100
Tests/Box.
QC (Optional): 0.5mL×2; 1mL×2
INTENDED USE
For the quantitative detection of 25-hydroxy vitamin D in human
serum and plasma. They are for professional use only.
25-Hydroxy vitamin D promotes the absorption of calcium. That is, it
induces the synthesis of calpain in the small intestine. At the same
time, 1,25-dihydroxy D3 is delivered to the bone to promote calcium
concentration.
PRINCIPLE
Take the sample to the strip, the 25-OHVD in the sample is
combined with the antibody that coated with the fluorescent particles
and coated on the glass fiber to form a fluorescent particle-
antigen-antibody complex. The immune complex is further
chromatographed along the nitrocellulose membrane to the detection
zone (T), and combined with the pre-coated 25-OHVD-BSA
conjugate. The fluorescence intensity is inversely proportional to the
25-OHVD content in the sample. The anti-IgY fluorescent antibody
particles were chromatographed into the control region (C) and
bound to pre-coated chicken IgY.
STORAGE AND STABILITY
The strip is stable for 18months (while sealed in an aluminum foil
pouch) if stored at 2 - 30°C. Do not freeze. After the strip is opened,
the test should be performed in 1 hour. After resolving, the quality
control is stored at 2-8°C for 24 hours away from the light. The date
of manufacture is detailed in the label.
Name Composition
Consisting of a cartridge and a strip, the test
Magcard
batch reagents.
To describe basic information, usage
Manual
methods and precautions
Note: Components of different batches can’t be mixed.
The QC evaluation is different from batch to batch. The target value
of each batch is labeled.
The calibration curve can be traced back to the working calibrator
which has been compared with 25-OHVD determination kit on the
market and been evaluated.
APPLICABLE TEST SYSTEM
Suitable for all types Time-Resolved Immunofluorescence Analyzer
from Diagreat.
SAMPLE REQUIREMENTS
­ Clinical fresh non-hemolyzed serum and plasma samples.
­ After sampling, the sample should be tested within 24h at room
temperature. The sample should be stored for no more than 7
days in cold condition of 2-8°C and should be stored for no more
than one month in cryopreservation condition of -18°C.
­ The sample needs to be restored to room temperature before
testing. Cryopreserved samples need to be completely melted,
rewarmed, mixed evenly before use, avoid freezing and thawing
repeatedly.
TEST PROCEDURE
1. Please read this instruction manual, the instruction manual of
the dry fluorescence immunoassay analyzer and incubator
before use. Analyzer power adapter output is 12V, and incubator
power adapter output is 24V. Please do not mix the two adapters.
The cassette should be carried out under the room temperature
for a while before testing.

strip comprises a sample pad, a glass fiber, a 2. Reading card: Insert the magcard into the analyzer and click
“read card” on the machine. (only read one time for the same
nitrocellulose membrane (the detection zone
Strip item of the same batch) Then select the calibration curve for the
is coated with a 25-OHVD-BSA conjugate,
corresponding sample type.
and the quality control zone is coated with a
3. Sampling. Use a pipettor to add 20ul sample to 80ul buffer A(add
chicken IgY), absorbent paper, PVC board.
to a tube suitable for Diagreat’s incubator hole) , and then add
Buffer A Main component is phosphate buffered
Beijing Diagreat Biotechnologies Co., Ltd
 30ul buffer B to former compound for full mixing. Connect
power supply for Diagreat’s incubator. (Temperatures has been
set by Diagreat. Please do not adjust the temperature). The above
compound was put into the incubator tube location for 15
minutes incubation.
4. Add samples: Take out the strip from the bag and use a pipette to
take 80 ul of the step 3 sample and add it to the sample well of
the strip.
5. Test: After sample added, please insert the strip into Diagreat
incubator for 10 mins incubation. Please strictly control the time
for 10 mins. After incubation, please insert the strip into
Diagreat analyzer to read the result.(For D10 analyzer, click
“quick test”).
6. The dry fluorescence immunoassay analyzer measures and
analyzes the optical signal to quantify the concentration of the
substance to be tested.
REFERENCE INTERVAL
This product selected 200 healthy human serum in Beijing, using
95% confidence interval, and combined with reference to determine
the reference interval.
The sample reference interval is: 30-80 ng/mL. The above reference
interval is for reference only. Each laboratory should establish an
expected normal reference interval through experiments.
INTERPRETATION OF TEST RESULT
25-OHVD is normal at 30-80 ng/mL, <30 ng/mL is not
conducive to bone health, >150ng/mL may cause poisoning.
LIMITATIONS OF THE TEST
­ This kit is limited to in vitro diagnostics.
­ Diagnosis and treatment cannot rely solely on this test result.
Please consider both clinical history and other laboratory test
results.
PRODUCT PERFORMANCE
­ Appearance: The appearance of the reagent should be neat and
tidy, and the text symbol should be clearly marked. There is no
leakage. The test strip is intact. Freeze-dried products are
colorless or pale yellow after redissolution.
­ Analytical Sensitivity: 1ng/mL.
­ Linear range: 3-100ng/mL, and the correlation coefficient
R≥0.990.
­ Repeatability (Precision): Repeated testing (20 ± 4) ng / mL and
(80 ± 16) ng / mL samples, the result coefficient of variation
CV≤15%.
­ Inter batch difference: Testing (20 ±4) ng / mL and (80 ±16) ng /
mL samples, the relative difference R≤15%.
­ Accuracy: The recovery rate is 85% to 115%.
­ QC product evaluation effectiveness: test results of QC products
in test kit boxes are all within QC range.
­ Inter bottle difference of QC products: CV≤15%.
NOTES
­ This product is for in vitro diagnostic use only.
­ The operation steps cannot be omitted or simplified.
­ The reagent contains preservatives. It is strictly forbidden to
inhale or touch the skin. Once touched, immediately flush the
touched area with water.
­ This product should be stored at 2 °C - 8 °C. It should be used as
soon as possible after opening, to avoid being placed in the air
for too long to result in moisture. Expired products cannot be
used.
­ Disinfect or treat all samples and reagents with potential
pollution according to local regulations.
INDEX OF SYMBOLS
For technical assistance, please contact:
Diagreat’s Technical Services
Tel: (8610) 69502385
E-mail: info@diagreat.com
Beijing Diagreat Biotechnologies Co., Ltd
Floor 1-3, Building 19, No. 2 Yard, Huanke Middle Road, Tongzhou
District, Beijing, China.
Tel: (8610) 69502385
Fax: (8610) 69507615
www.diagreat.com
Revision No: 01
Date of last revision: 2021/6/2
Beijing Diagreat Biotechnologies Co., Ltd