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Atellica IM/ADVIA Centaur Active-B12 Assay

Early detection and diagnosis of anemia with reliable Active-B12 assays

The Active-B12 (AB12) assay from Siemens Healthineers measures holoTC in the blood—the only form of vitamin B12 that is taken up and used by cells of the body. The assay helps:

  • Identify anemia sooner by using a better indicator of vitamin B12 status.
  • Measure the biologically active form of vitamin B12, delivering confidence in patient results with improved sensitivity and specificity.
  • Minimize lot-to-lot variability with an active-B12 assay that uses kitted calibrators and is traceable to WHO International Standard for holotranscobalamin; NIBSC code 03/178.

Vitamin B12 (cobalamin) plays an important role in DNA synthesis and neurologic function. Deficiency can lead to a wide spectrum of hematologic and neuropsychiatric disorders that can often be reserved by early diagnosis and prompt treatment.1 Laboratory testing is used to detect a vitamin deficiency, determine its severity, establish it as the underlying cause of someone's symptoms, and monitor the effectiveness of treatment.5

The primary analysis of vitamin B12 deficiency is the measurement of serum cobalamin (vitamin B12).2 The commonly used tests measure total vitamin B12, which is found in blood bound to two carrier proteins:

  • Haptocorrin (HC)
  • Transcobalamin (TC)

When vitamin B12 is bound to transcobalamin it is referred to as holotranscobalamin (holoTC). HoloTC is also known as active-b12, as it contains the biologically available cobalamin and only holoTC promotes the uptake of cobalamin by all cells via specific receptors.

In comparison, approximately 80% of the circulating cobalamin that is carried by haptocorrin is considered metabolically inert because no cellular receptors exist (with the exception of receptors found in the liver).3

Atellica IM and ADVIA Centaur Active-B12 Assay Specifications

 

Atellica IM

ADVIA Centaur XP/XPT

ADVIA Centaur CP

Sample Type

Serum

Serum

Serum

Sample Volume

50µL

50 µL

50 µL

Assay Range

4.25-146.00 pmol/L

5.00 – 146.00 pmol/L

5.00 – 146.00 pmol/L

Detection Capability

LoB: 0.46 pmol/L
LoD: 0.83 pmol/L
LoQ: 4.25 pmol/L

LoB: 0.52 pmol/L
LoD: 1.19 pmol/L
LoQ: 5.00 pmol/L

LoB: 2.73 pmol/L
LoD: 2.99 pmol/L
LoQ: 5.00 pmol/L

Calibration Interval

Lot: 28 days
Pack: 28 days

44 days

30 days

Onboard Stability

28 days

44 days

38 days

Time to First Result

38 min

47 min

42 min

Vitamin B12 Deficiency overview

The most common causes of megaloblastic anemia are deficiency of either cobalamin (vitamin B12) or folate (vitamin B9).4 The body needs folate and vitamin B12 to produce enough healthy red blood cells. A diet lacking in these along with other key nutrients can cause decreased red blood cell production. Additionally, some people may consume enough vitamin B12, but their bodies are not able to process the vitamin. This can lead to vitamin deficiency anemia, also known as pernicious anemia.5

A deficiency in vitamin B12 can result in varying degrees of neuropathy or nerve damage. In severe cases, mental changes that range from confusion and irritability to dementia may occur.6

Pregnant women need increased folate for proper fetal development because of the added stress of rapidly growing fetal cells. Folate deficiency during pregnancy, especially in the early weeks when a woman might not know she is pregnant, may lead to premature birth and neural tube birth defects (NTDs) such as spina bifida.6

What are the signs and symptoms of vitamin B12 deficiency?7,8

Vitamin B12 deficiency-associated signs and symptoms may take years to manifest in adults. Infants and children will show signs of deficiency much sooner because they have not yet had time to store sufficient amounts. People with vitamin B12 deficiency may encounter symptoms such as:

  • Anemia
  • Fatigue
  • Weakness and lightheadedness
  • Shortness of breath
  • Loss of balance
  • Yellowed skin
  • Strange sensations, numbness, or tingling in the hands, legs, or feet

Who is likely to develop vitamin B12 deficiency?

  • The elderly
  • People with intestinal and/or digestive disorders
  • Heavy alcohol drinkers
  • Pregnant women
  • Vegetarians and vegans

References:

2

Yetley EA, Pfeiffer CM, Phinney KW, et al. Biomarkers of vitamin B-12 status in NHAVES: a roundtable summary. Am J Clin Nutr. 2011;94:313S-21S.

3

ADVIA Centaur AB12 Instructions for use. Siemens Healthineers. RPBL1160R5_EN Rev. E, 2019-11.

4

Anemia, Megaloblastic. National Organization for Rare Disorders. Available from: https://rarediseases.org/rare-diseases/anemia-megaloblastic/

6
WHO/UNICEF/UNU. Iron deficiency anemia: assessment, prevention, and control. World Health Organization Geneva. 2001; (WHO/NDH/01.3).
The products/features mentioned here are not commercially available in all countries. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for more details.