Serum / Plasma Plasma Vitamin D Rapid Test Cassette Fluorescence Immunoassay Test D2 D3

Vitamin D Test Cassette (Serum/Plasma), Fluorescence Immunoassay Test,Vitamin D (D2+D3)

A Fluorescence Immunoassay 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 D2^. 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. 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^.

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 include VD antibody coated particles and VD-BSA antigen coated on the membrane.

PRECAUTIONS

• For professional in vitro diagnostic use only.
• 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.
• 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).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• 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.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded in accordance with local regulations.
• Read the entire procedure carefully prior to any testing.
• The Vitamin D Test Cassette should only be used with the Fluorescence Immunoassay Analyzer by approved medical professionals.

DIRECTIONS FOR USE

Refer to Fluorescence Immunoassay Analyzer Operation 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.

• Turn on the Analyzer power.
• Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample type according to needs.
• Pipette 25μl of serum or plasma into the VD Dilution Buffer; mix the specimen and the buffer well. Then leave the mixture reaction for 2-5 minutes.
• After 2-5 minutes, pipette 75μl of diluted specimen into the sample well. Start the timer at the same time.
• 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 5-100ng/mL.

QUALITY CONTROL

Each Vitamin D Test Cassette contains internal control that satisfies routing quality control requirements. This internal control is performed each time a sample is tested. This control indicates that the test device was inserted and read properly by Fluorescence Immunoassay Analyzer. An invalid result from the internal control causes an error message on Fluorescence Immunoassay Analyzer indicating that the test should be repeated.

Order Information

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.