Vitamin D Test Cassette
REF FI-VD-302
English
Concentrations
Clinical Reference
＜10 ng/mL
Deficient
10-30 ng/mL
Insufficient
＞30 ng/mL
Sufficient
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instructions for use
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European Community
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instructions for use
(Serum/Plasma)
Package Insert
A Fluorescence Immunoassay test for quantitative detection of total Vitamin D (D2+D3) in
human serum or plasma with the use of Fluorescence Immunoassay Analyzer.
For professional in vitro diagnostic use only.
【
INTENDED USE】
Vitamin D Test Cassette (Serum/Plasma) is intended for in vitro quantitative determination of
total Vitamin D in serum or plasma. Measurement of total Vitamin D (D2+D3) is used as an aid
to assessment of Vitamin D levels.
SUMMARY】
【
Vitamin D refers to a group of fat-soluble secosteroids responsible for increasing intestinal
absorption of calcium, iron, magnesium, phosphate, and zinc. In humans, the most important
compounds in this group are vitamin D3 and vitamin D21. Vitamin D3 is naturally produced in
the human skin through the exposure to ultraviolet light and Vitamin D2 is mainly obtained
from foods. Vitamin D is transported to the liver where it is metabolized to 25-hydroxy Vitamin
D. In medicine, a 25-hydroxy Vitamin D blood test is used to determine Vitamin D
concentration in the body. The blood concentration of 25-hydroxy Vitamin D (including D2 and
D3) is considered the best indicator of Vitamin D status.
Vitamin D deficiency is now recognized as a global epidemic.2 Virtually every cell in our body
has Receptors for Vitamin D, meaning that they all require “Sufficient” Level of Vitamin D for
adequate functioning. The health risks associated with Vitamin D deficiency are far more
severe than previously thought. Vitamin deficiency has been linked to various serious
diseases: Osteoporosis, Osteomalacia, Multiple Sclerosis, Cardiovascular Diseases,
Pregnancy Complications, Diabetes, Depression, Strokes, Autoimmune Diseases, Flu,
Different Cancers, Infectious Diseases, Alzheimer, Obesity and Higher Mortality etc.
Therefore, now detecting (25-OH) Vitamin D level is considered as “Medically Necessary
Screening Test”, and maintaining sufficient levels not just to improve bone health, but to
improve overall health and well-being.4
【PRINCIPLE】
The Vitamin D Test Cassette (Serum/Plasma) detects Vitamin D based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad.
Vitamin D in the sample will compete with the VD-BSA antigen coated on the membrane. The
less Vitamin D in the sample, the more fluorescent microspheres conjugated with anti-VD
antibodies can be captured by the VD-BSA antigen coated on the membrane (Test line). The
concentration of Vitamin D in the sample is inversely related to the intensity of the fluorescent
signal captured on the T line. According to the fluorescence intensity of the test and the
standard curve, the concentration of Vitamin D in the sample can be calculated by the
Fluorescence Immunoassay Analyzer to show Vitamin D concentration in the sample.
【
REAGENTS】
The test includes VD antibody coated particles and VD-BSA antigen coated on the
membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.
3. This test contains products of animal origin. Certified knowledge of the origin and/or
sanitary state of the animals does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore recommended that these products be treated as
potentially infectious, and handled observing usual safety precautions (e.g., do not ingest
or inhale).
4. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
5. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions
against microbiological hazards throughout the procedure and follow standard procedures
for proper disposal of specimens. Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are assayed.
6. Do not interchange or mix reagents from different lots.
7. Humi dity and temperature can adversely affect results.
8. Used testing materials should be discarded in accordance with local regulations.
9. Read the entire procedure carefully prior to any testing.
10. The Vitamin D Test Cassette should only be used with the Fluorescence Immunoassay
Analyzer by professionals.
【
STORAGE AND STABILITY】
1. The test should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the test from contamination.
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.
【SPECIMEN COLLECTION AND PREPARATION】
Specimen Collection
Collect the specimens according to standard procedures.
EDTA K2, Citrate sodium and Potassium Oxalate can be used as the anticoagulant for
collecting the plasma specimens.
A clean tube without anticoagulants can be used to collect serum specimens.
Specimen Storage and Shipping
Serum and plasma specimens may be stored at 2-8 °C for up to 7 days, and -20 °C for long
components. Low results may also be obtained due to instability or degradation of Vitamin
D antigen with time and temperature.
5. Other factors interfering with the test and causing erroneous results include
technical/procedural errors, degradation of the test components as well as presence of
interfering substances in the test samples.
6. The Vitamin D Test Cassette (Serum/Plasma) will only indicate the presence of Vitamin D
in the specimen and should not be used as the sole criteria for diagnosis.
7. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician
after all clinical and laboratory findings have been evaluated.
【
EXPECTED RESULTS】
term. Frozen specimens should be thawed and mixed before testing. Specimens should not
be frozen and thawed repeatedly.
If specimens are to be shipped, these should be packed in compliance with local regulations
covering the transportation of etiological agents.
Preparation
Before performing the test, please balance the sample to room temperature (15-30 °C).
Frozen specimens must be completely thawed and mixed well prior to testing.
【
MATERIALS】
Materials Provided
• Test Cassettes • Specimen Collection Tubes With Buffer
• ID Card • Package Insert
Materials Required But Not Provided
• Timer • Centrifuge • Fluorescence Immunoassay Analyzer
• Pipettes • Specimen Collection Containers
【
DIRECTIONS FOR USE】
3
Refer to Fluorescence Immunoassay Analyzer User Manual for the complete instructions on
use of the analyzer. The test should be conducted at room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30 °C)
prior to testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample
type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it within 1 hour. Best results
will be obtained if the assay is performed immediately after opening the foil pouch.
4. Place the test on a flat and clean surface.
Pipette 25μL of serum or plasma into the buffer tube; mix the specimen and the buffer
well. Then leave the mixture reaction for 2-5 minutes.
5. After 2-5 minutes, pipette 75μL of diluted specimen into the sample well of test cassette.
Start the timer at the same time.
6. Test results should be interpreted at 15 minutes with the use of Fluorescence
Immunoassay Analyzer.
Caution: There are different test modes of the Fluorescence Immunoassay Analyzer. The
difference between them is incubation of the test cassette is outside or inside the analyzer.
Choose test mode accordingly and confirm sample type. Consult the user manual of the
analyzer for detailed operation information.
Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to use and
become familiar with the processes and quality control procedures.
【
INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The test result of Vitamin D is calculated by Analyzer and reported as the numerical value with
unit ng/mL and results with Def/Insuf/Suf (shorted from Deficient/Insufficient/Sufficient). The
detection range of Vitamin D Test Cassette is 5-100 ng/mL.
QUALITY CONTROL】
【
Each Vitamin D Test Cassette contains internal control that satisfies routine quality control
requirements. This internal control is performed each time a sample is tested. This control
indicates that the test cassette was tested and read properly by Fluorescence Immunoassay
Analyzer. An invalid result from the internal control causes an “N/A” message on Fluorescence
Immunoassay Analyzer and indicates that the test should be repeated. Insufficient specimen
volume or incorrect procedural techniques are the most likely reasons for control failure.
Review the procedure and repeat the test with a new test. If the problem persists, discontinue
using the test kit immediately and contact your local distributor.
【
LIMITATIONS】
1. The Vitamin D Test Cassette (Serum/Plasma) should be used only with the Fluorescence
Immunoassay Analyzer.
Each laboratory should determine the applicability of the reference range through experiments,
and establish its own reference value range if necessary to ensure that it can correctly reflect
the situation of a particular population.
【PERFORMANCE CHARACTERISTICS】
1. Method comparison
For 98 specimens, the test results of Vitamin D Test Cassettes were consistent with a
commercial CLIA test kits, and correlation coefficient (R2) is 0.956.
2. Accuracy
The test deviation is ≤ ±15%.
3. Assay Range
Assay Range is 5-100 ng/mL.
4. Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 different concentrations
Vitamin D control, C.V. is ≤ 15%.
Inter-lot precision
Between-run precision has been determined by using 10 replicates for each of three lots using
2 different concentrations Vitamin D control, C.V. is ≤15%.
【BIBLIOGRAPHY】
1. Holick MF (March 2006). "High prevalence of vitamin D inadequacy and implications for
health". Mayo Clinic Proceedings. 81 (3): 353–73.
2. Eriksen EF, Glerup H (2002). "Vitamin D deficiency and aging: implications for general
health and osteoporosis". Biogerontology. 3 (1-2): 73–7.
3. Grant WB, Holick MF (June 2005). "Benefits and requirements of vitamin D for optimal
health: a review". Alternative Medicine Review.10 (2): 94–111.
4. Moyad MA. Vitamin D: a rapid review. DermatolNurs. 2009, 21:25-30
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Distributed in Italy by PM2 Services Srl, Corso Mazzini 38- Largo Marchi, 36071 Arzignano (VI)
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Number: F145106200
Revision Date:2022-09-14
2. The test should preferably be performed with freshly collected samples. For stored
specimens, please refer to specimen storage.
3. The Vitamin D Test Cassette (Serum/Plasma) is for professional in vitro diagnostic use,
and should only be used for the quantitative detection of Vitamin D.
4. The test may yield low results due to Vitamin D epitopes being covered by some unknown
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