Patient Preparation

No special patient preparation is required.

Collect

Blood should be collected by venipuncture.

Tube type:

   One 6.0 mL PST (Green) tube (preferred) or

   One 6.0 mL SST (Gold) tube 
      
   Volume Requirement:

   Optimum: 0.5 mL

   Minimum: 0.3 mL

   Also acceptable red top tube.

Specimen Preparation

Serum: The red or gold stopper tube should be allowed to clot before centifuging. Specimens should be centrifuged at minimum 2500 RPM for minimum 5 minutes. Serum should be separated from the cells promptly to an appropriately labeled tube, unless using SST tube.

Plasma: Mix anticoagulant with specimen adequately. Specimens should be centrifuged at minimum 2500 RPM for minimum 5 minutes. Remove plasma promptly from cells to an appropriately labeled tube, unless using PST tube.

Unacceptable Conditions


Avoid assaying grossly lipemic or hemolyzed samples.
Only one thaw cycle is recommended.  3 thaw cycles is allowed.

Stability (from collection to initiation)

Centrifuge and remove serum or plasma from the cells with 2 hours of collection.

 

Storage:

Plasma: Room temperature for 8 hours

Refrigerator temperature for up to 7 days

Freezer temperature at -20 C or colder for up to 1 year
 

Serum: Room temperature for 8 hours

Refrigerator temperature for 7 days

Freezer temperature at -20 C or colder for up to 1 year



 

Performed

Chemistry.
Daily, routine and STAT.

Remarks

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25‐hydroxyvitamin D [25(OH) vitamin D, 25-OH vitamin D2 AND 25-OH vitamin D3, together] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency.

Vitamin D is a lipid‐soluble steroid hormone that is produced in the skin through the action of sunlight or is obtained from dietary sources.1
The role of vitamin D in maintaining homeostasis of calcium and phosphorus is well established.2 Chronic severe vitamin D deficiency in infants and children causes bone deformation commonly known as rickets, while in adults, proximal muscle weakness, bone pain and osteomalacia may develop.3,4 Less severe vitamin D inadequacy may lead to secondary hyperparathyroidism, increased bone turnover, and progressive bone loss, increasing the risk of osteoporosis.4,5 The presence of the vitamin D receptor in other tissues and organs suggests that vitamin D may also be important in non‐skeletal biological processes.2,6
Vitamin D exists in two primary forms, vitamin D3 (cholecalciferol) and vitamin D2 (ergocalciferol). Vitamin D3 is produced from the conversion of 7‐dehydrocholesterol in the epidermis and dermis in humans upon exposure to sunlight, and can be found in oil‐rich fish (e.g. salmon, mackerel, and herring), egg yolks, and from foods supplemented with vitamin D.7 Vitamin D2 is found in certain plants and mushrooms.
Prescription or over‐the‐counter dietary supplements are also a major source of vitamin D for many people.2,7  Factors such as latitude, time of the day, aging, increased skin pigmentation, ethnic origin, application of sunscreen and season of the year can dramatically affect the production of vitamin D3 in the skin and thus the levels of vitamin D in the blood.2,7
Vitamin D originating from the skin or the diet is biologically inactive. It enters the circulation bound to vitamin D binding protein (DBP), and is transported to the liver to undergo a hydroxylation to produce 25(OH) vitamin D.1 25(OH) vitamin D also circulates as a complex with DBP. It is further metabolized in the kidneys by the enzyme 25‐hydroxy vitamin D‐1α‐hydroxylase to its biologically active form, 1,25‐dihydroxyvitamin D.8 1,25‐dihydroxyvitamin D circulates at levels 1000 times lower than 25(OH) vitamin D and its renal production is tightly regulated by plasma parathyroid hormone levels and serum calcium and phosphorus levels.7,8 Serum 25(OH) vitamin D is the major circulating metabolite of vitamin D in the body and reflects vitamin D inputs from cutaneous synthesis and dietary intake. For this reason, serum concentration of 25(OH) vitamin D is considered the standard clinical measure of vitamin D status.7 Because serum 25(OH) vitamin D will be a mixture of the D2 and D3 forms, both the vitamin D2 and vitamin D3 forms of vitamin D must be measured to accurately assess total 25(OH) vitamin D levels.


The Access 25(OH) Vitamin D Total assay is a two‐step competitive binding immunoenzymatic assay. In the initial incubation, sample is added to a reaction vessel with a DBP releasing agent and paramagnetic particles coated with sheep monoclonal anti‐25(OH) vitamin D antibody. 25(OH) vitamin D is released from DBP and binds to the immobilized monoclonal anti‐25(OH) vitamin D on the solid phase. Subsequently, a 25(OH) vitamin D analogue‐alkaline phosphatase conjugate is added which competes for binding to the immobilized monoclonal anti‐25(OH) vitamin D. After a second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi‐Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of 25(OH) vitamin D in the sample. The amount of analyte in the sample is determined from a stored, multi‐point calibration curve.
 

Performed

Chemistry.
Daily, routine and STAT.

Methodology

Instrument: Beckman Coulter DxI 800

Reported

Results same day

Synonyms

  • VITD

Reference Interval

Vitamin D:                   <30 ng/mL             Deficient
                                    30-80 ng/mL         Adequate
                                    80-120 ng/mL        Elevated
                                    >120 ng/mL           Possible toxicity**
**Vitamin D results that are >120 ng/mL recommend Vit D25, D2, and D3 by MSMS.


 

CPT Codes

82306
**CPT code is subject to limited coverage policies for many payers and may require an ABN or Patient Consent for Non-Covered Laboratory Services when ordering. BCBSNE recommends prior authorization.

BCBSNE Policy
Cigna Policy
Medicare Policy
UHC Policy
 

Test Build Information

OrderCode OrderName ResultCode ResultName Result Units LOINC CPT
VITD VTIAMIN D 25OH TOTAL VITD VTIAMIN D 25OH TOTAL ng/mL 35365-6 82306

Additional Information

For additional information or questions, contact RPSInterfaceSupport@unmc.edu
Collection

Patient Preparation

No special patient preparation is required.

Collect

Blood should be collected by venipuncture.

Tube type:

   One 6.0 mL PST (Green) tube (preferred) or

   One 6.0 mL SST (Gold) tube 
      
   Volume Requirement:

   Optimum: 0.5 mL

   Minimum: 0.3 mL

   Also acceptable red top tube.

Specimen Preparation

Serum: The red or gold stopper tube should be allowed to clot before centifuging. Specimens should be centrifuged at minimum 2500 RPM for minimum 5 minutes. Serum should be separated from the cells promptly to an appropriately labeled tube, unless using SST tube.

Plasma: Mix anticoagulant with specimen adequately. Specimens should be centrifuged at minimum 2500 RPM for minimum 5 minutes. Remove plasma promptly from cells to an appropriately labeled tube, unless using PST tube.

Unacceptable Conditions


Avoid assaying grossly lipemic or hemolyzed samples.
Only one thaw cycle is recommended.  3 thaw cycles is allowed.

Stability (from collection to initiation)

Centrifuge and remove serum or plasma from the cells with 2 hours of collection.

 

Storage:

Plasma: Room temperature for 8 hours

Refrigerator temperature for up to 7 days

Freezer temperature at -20 C or colder for up to 1 year
 

Serum: Room temperature for 8 hours

Refrigerator temperature for 7 days

Freezer temperature at -20 C or colder for up to 1 year



 

Performed

Chemistry.
Daily, routine and STAT.

Remarks

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25‐hydroxyvitamin D [25(OH) vitamin D, 25-OH vitamin D2 AND 25-OH vitamin D3, together] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency.

Vitamin D is a lipid‐soluble steroid hormone that is produced in the skin through the action of sunlight or is obtained from dietary sources.1
The role of vitamin D in maintaining homeostasis of calcium and phosphorus is well established.2 Chronic severe vitamin D deficiency in infants and children causes bone deformation commonly known as rickets, while in adults, proximal muscle weakness, bone pain and osteomalacia may develop.3,4 Less severe vitamin D inadequacy may lead to secondary hyperparathyroidism, increased bone turnover, and progressive bone loss, increasing the risk of osteoporosis.4,5 The presence of the vitamin D receptor in other tissues and organs suggests that vitamin D may also be important in non‐skeletal biological processes.2,6
Vitamin D exists in two primary forms, vitamin D3 (cholecalciferol) and vitamin D2 (ergocalciferol). Vitamin D3 is produced from the conversion of 7‐dehydrocholesterol in the epidermis and dermis in humans upon exposure to sunlight, and can be found in oil‐rich fish (e.g. salmon, mackerel, and herring), egg yolks, and from foods supplemented with vitamin D.7 Vitamin D2 is found in certain plants and mushrooms.
Prescription or over‐the‐counter dietary supplements are also a major source of vitamin D for many people.2,7  Factors such as latitude, time of the day, aging, increased skin pigmentation, ethnic origin, application of sunscreen and season of the year can dramatically affect the production of vitamin D3 in the skin and thus the levels of vitamin D in the blood.2,7
Vitamin D originating from the skin or the diet is biologically inactive. It enters the circulation bound to vitamin D binding protein (DBP), and is transported to the liver to undergo a hydroxylation to produce 25(OH) vitamin D.1 25(OH) vitamin D also circulates as a complex with DBP. It is further metabolized in the kidneys by the enzyme 25‐hydroxy vitamin D‐1α‐hydroxylase to its biologically active form, 1,25‐dihydroxyvitamin D.8 1,25‐dihydroxyvitamin D circulates at levels 1000 times lower than 25(OH) vitamin D and its renal production is tightly regulated by plasma parathyroid hormone levels and serum calcium and phosphorus levels.7,8 Serum 25(OH) vitamin D is the major circulating metabolite of vitamin D in the body and reflects vitamin D inputs from cutaneous synthesis and dietary intake. For this reason, serum concentration of 25(OH) vitamin D is considered the standard clinical measure of vitamin D status.7 Because serum 25(OH) vitamin D will be a mixture of the D2 and D3 forms, both the vitamin D2 and vitamin D3 forms of vitamin D must be measured to accurately assess total 25(OH) vitamin D levels.


The Access 25(OH) Vitamin D Total assay is a two‐step competitive binding immunoenzymatic assay. In the initial incubation, sample is added to a reaction vessel with a DBP releasing agent and paramagnetic particles coated with sheep monoclonal anti‐25(OH) vitamin D antibody. 25(OH) vitamin D is released from DBP and binds to the immobilized monoclonal anti‐25(OH) vitamin D on the solid phase. Subsequently, a 25(OH) vitamin D analogue‐alkaline phosphatase conjugate is added which competes for binding to the immobilized monoclonal anti‐25(OH) vitamin D. After a second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi‐Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of 25(OH) vitamin D in the sample. The amount of analyte in the sample is determined from a stored, multi‐point calibration curve.
 
Ordering

Performed

Chemistry.
Daily, routine and STAT.

Methodology

Instrument: Beckman Coulter DxI 800

Reported

Results same day

Synonyms

  • VITD
Result Interpretation

Reference Interval

Vitamin D:                   <30 ng/mL             Deficient
                                    30-80 ng/mL         Adequate
                                    80-120 ng/mL        Elevated
                                    >120 ng/mL           Possible toxicity**
**Vitamin D results that are >120 ng/mL recommend Vit D25, D2, and D3 by MSMS.


 
Administrative

CPT Codes

82306
**CPT code is subject to limited coverage policies for many payers and may require an ABN or Patient Consent for Non-Covered Laboratory Services when ordering. BCBSNE recommends prior authorization.

BCBSNE Policy
Cigna Policy
Medicare Policy
UHC Policy
 
RPS Interface Information

Test Build Information

OrderCode OrderName ResultCode ResultName Result Units LOINC CPT
VITD VTIAMIN D 25OH TOTAL VITD VTIAMIN D 25OH TOTAL ng/mL 35365-6 82306

Additional Information

For additional information or questions, contact RPSInterfaceSupport@unmc.edu

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