Total Vitamin D CLIA Test CE

The Total Vitamin D (Vit-D) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of Vitamin D in human serum or plasma (Lithium heparin or K2EDTA) using the ALTA CLIAlyzer.

Vitamin D is a fat-soluble steroid hormone that is ingested through diet and synthesized in the skin, liver and kidneys after exposure to sunlight. Two main forms of Vitamin D are found in the diet, Vitamin D3 (cholecalciferol) and Vitamin D2 (ergocalciferol). Vitamin D3, however, is more effective at regulating Vitamin D levels than Vitamin D2. Vitamin D plays an important role in the regulation of calcium and phosphorus in the human body. It has been shown to be important for maintenance of healthy bones and teeth, and for the support of immune, nervous, endocrine, and cardiovascular system health.

Vitamin D deficiency is a global health issue, and is one of the most common nutrient deficiencies. It is more prevalent in females than males, and varies according to ethnicity and eating habits. Vitamin D deficiency has been associated with rickets, osteomalacia, and osteoporosis, as well as fetal development, immune system function, neurological disorder such as multiple sclerosis, cancer, and many other pathologies.

Therefore, accurate measurement of Vitamin D levels in patients is very important for the diagnosis of Vitamin D deficiency and for the monitoring of deficient patients in order to achieve optimal levels.

  • Individual ready-to-use cartridges
  • Combines competitive immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 75 μL


Working range: 3.0-100 ng/mL

Detection Limits

Limit of Detection (LOD): 3.0 ng/mL


Intra-lot Precision

CV less than 10%

Inter-lot Precision

CV less than 12%


Linearity greater than 0.9900 within the interval from 3.0 and 100 ng/mL


Cross-reactivity was evaluated by spiking zero serum samples, with100 ng/mL cross-reactive compounds. The results of this study are shown as following table:

SubstanceCross Reaction rate
25-OH-Vitamin D298.9%
25-OH-Vitamin D399.5%
Vitamin D20.4%
Vitamin D30.9%
1,25-(OH)-Vitamin D20.0%
1,25-(OH)-Vitamin D30.0%
3-epi-25 OH-Vitamin D30.2%



No significant interference was detected up to the concentrations mentioned below:

Hemoglobin≤ 200 mg/dL
Bilirubin≤ 25 mg/dL
Triglyceride≤ 1000 mg/dL
Total protein≤ 6 g/dL

 HAMA Interference

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values.  Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.


Reagents and materials provided:

  1. 19-well Vit -D reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators Vit-D free goat serum at:
    1. 0 ng/mL
    2. 5 ng/mL
    3. 75 ng/mL
  3. Registration card
  4. Calibrator card
  5. Instructions for Use

Materials maybe required but not provided:

  1. Commercial controls

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL.
  2. For other specific materials and disposables, refer to CLIAlyzer user manual.
  3. CLIAlyzer instrument
  4. Powderless gloves
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