RapiRead CUBE Rapid Test Reader

Product Quantity: 1 device

Manufacturer: Gentaur

Rapid immunochromatographic test based on the “sandwich” method for antigent detection. This rapid test is intended for quantitative detection of total 25-OH Vitamin D in samples from human whole blood.

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25 OH Vitamin D Rapid test

 

#GEN-1155-10      Rapi-D Test device (10 Tests/Box)

#GEN-1155-25      Rapi-D Test device (25 Tests/Box)

#GEN-1155-read  RapiRead CUBE Reader  

Rapid Whole Blood Vitamin D Test

 

 

A Rapid “Sandwich” Immunochromatographic Test for the Quantitative Detection of total 25-OH Vitamin D in human Whole Blood

For Research purposes only                              Read Instructions before use

 

 

INTENDED USE

GENTAUR’s 25 OH Vitamin D Rapid Test is a one step in vitro test based on immunochromatography. It is intended for quantitative determination of the total 25-hydraxy Vitamin D (25-OH Vitamin D) present in samples from human blood. This rapid test is excellent for obtaining preliminary diagnostic test result and for screening for Vitamin D deficiency. Analysis by liquid chromatography followed by a mass spectrometry (LC-MS/MS) or other quantitative immunoassays are recommended to further confirm the diagnostic test results.

 

 

 

SUMMARY AND EXPLANATION

Vitamin D is a hormone of steroid origin which is responsible for enhancing the calcium absorption by the intestines and the regulation of its homeostasis. There are two most common forms Vit. D: Vitamin D2 and Vitamin D3. Vitamin D3 is produced naturally in the skin by the exposure to ultraviolet light. The Vitamin D2 is mostly obtained through food intake. Vitamin D is metabolized to 25hydroxy Vitamin D the liver. A 25-hydroxy Vitamin D blood test is used by the medics to determine the concentration of Vitamin D in the patient’s 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 has now been recognised as an epidemic of global magnitude. Almost every cell in the human body has receptors for Vitamin D. This means that they all of them require a certain level of Vitamin D for maintaining their functions and viability. As more studies were done and more data accumulated, it became clear that the health risks associated with Vitamin D deficiency are much more severe than the ones previously suspected. Vitamin D deficiency is associated to a number of serious diseases such as Osteoporosis, Osteomalacia, Multiple Sclerosis, Cardiovascular Diseases, Pregnancy Complications, Diabetes, Depression, Strokes, Autoimmune Diseases, Flu, Different Cancers, Infectious Diseases, Alzheimer, Obesity and Higher Mortality, etc. Due to this nowadays the detection of (25-OH) Vitamin D levels is embraced by the medical community as “Medically Necessary Screening Test. Now it is well understood that maintaining sufficient levels of Vit. D isn’t just necessary for improvement of bone health, but is also essential for the overall health and well-being of the individuals.

 

Though multiple studies on Vitamin D deficiency have been performed and published by a number of health organizations, a common and accepted by all recommendation for the levels of Vit. D still remains to be established. Based on recent studies and literature the following table of ranges for the classification of Vitamin D is suggested:

 

25-OH Vitamin D Level Reference Range (ng/ml)
Deficient 0 – 10
Insufficient 10 – 30
Sufficient 30 – 100
Toxicity >100

 

TEST PRINCIPLE

25 OH Vitamin D Rapid Test utilizes the principle of immunochromatography. More specifically it is a unique two-site “sandwich” immunoassay on a membrane.  The test employs a pair of highly specific anti-25-OH Vitamin D monoclonal antibodies. One of them is conjugated with colloidal gold and the other is immobilized on the solid phase. This technology yields a highly selective, sensitive and specific method for Vitamin D detection.

 

As the test sample flows through the membrane assembly within the test device, the coloured anti-25-OH Vitamin D-colloidal gold conjugate complexes with 25-OH Vitamin D from the sample.  This complex moves further on the membrane by the capillary action to the test region (T) where it is immobilized by another anti-25-OH Vitamin D coated on the membrane, leading to formation of a pink / purple colored band, which confirms a positive test results. The intensity of coloured band in the test line region depends on the concentration of 25-OH Vitamin D. The higher the concentration of 25-OH Vitamin D in the sample is, the stronger is colouring of the band. As a procedural control there is a control line located within the test window. The coloured band has to appear always on the control line region (C) if the test device is stored in proper condition and the test is performed appropriately. If the control line is not present upon use the test must be discarded. If any issues occur, please, contact GENTAUR at [email protected]

 

MATERIALS PROVIDED

  1. 25 OH Vitamin D Rapid Test Kit (Two Sizes are available: 25 Tests/Box and 10 Tests/Box)
  2. Buffer for diluting the sample
  3. A 10ul capillary pipette (one such pipette is included inside each bag)
  4. Manual and instructions
  5. RapiRead CUBE Reader (*to be purchased separately)

 

MATERIALS REQUIRED BUT NOT PROVIDED

  1. Timer or clock
  2. Lancet
  3. Alcohol Swab

 

STORAGE AND STABILITY

The 25 OH Vitamin D Rapid Test Kit should be stored at 4ºC to 30ºC. The kit’s performance will remain unchanged until the expiration date which is labeled on the package. This item is sensitive to humidity therefore it has to be used immediately upon opening. A product which is not sealed properly must not be used for testing and has to be discarded.

 

PRECAUTIONS

  1. 25 OH Vitamin D Rapid Test is to be used only for in vitro
  2. If the product is expired, it should not be used.
  3. All samples for testing must be handled with caution as potentially infectious.
  4. The product is sensitive to humidity. The foil bag is not to be opened until the samples are ready to be tested immediately.

 

QUALITY CONTROL

Good Laboratory Practice recommends the daily use of control materials to validate the reliability of device. If control values do not fall within established range, assay results are invalid. Control materials which are not provided with this test kit are commercially available.

 

The 25 OH Vitamin D Rapid Test provides a built-in process control with a different antigen/antibody reaction at the control region (C). This control line should always appear regardless the presence of Vitamin D. If the control line does not appear, the test device should be discarded and the obtained result is invalid. The presence of this control band in the control region serve as 1) verification that sufficient volume is added, 2) that proper flow is obtained.

 

SPECIMEN COLLECTION AND PREPARATION

  1. Wash your hand thoroughly and dry completely.
  2. Rub and Wipe your ring or middle finger of non-dominant hand.
  3. Using safety lancet puncture the side of your finger.
  4. Collect 10 µl blood using Microsafe plastic capillary tube (See instructions below) and perform testing immediately

 

 

INSTRUCTIONS TO USE MICROSAFE CAPILLARY TUBE:

microsafe

 

 

 

 

 

 

 

 

 

 

 

PROCEDURE:

 

  1. Bring all materials and specimens to room temperature.
  2. Remove the test card from the sealed foil pouch and place it on a hard flat surface.
  3. Using Microsafe plastic capillary tube, apply 10 µl of whole blood in the center of the sample well (S).
  4. Apply immediately three drops of the Sample Buffer to the sample well (S).
  5. Read and record the results at 15 Minutes by RapiRead CUBE Reader.

 

Serum Protocol:

25 OH Vitamin D Rapid Test has been designed for finger-prick capillary blood. However, Serum sample can be used for testing. Apply 5µl of Serum in Sample well (S) using Micropipette (Not provided with the Kit) and follow the above steps.

 

 Important Note: Result after 15 minutes will not be accurate.