Access Active-B12 Assay

Greater confidence in vitamin B12 test results

The Access Active-B12 assay is the newest addition to an already comprehensive menu for anemia management. With the largest measuring range on the market, fastest time to first result and standardization to WHO International Standard (IS) 03/178, Access Active-B12 delivers confidence and flexibility over other methods of vitamin B12 testing.

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Benefits of the Access Active-B12 assay

Market-leading time to first result, the widest measuring range on the market and longer time between calibrations to bring efficiency to laboratory workflow
Standardization to WHO IS 03/178, providing accurate and harmonized results
Improved diagnostic accuracy for vitamin B12 deficiency, with fewer indeterminate results than serum vitamin B12 tests¹
Confidence in results with no interference from intrinsic factor antibodies

Vitamin B12 and its impact on patient health

Vitamin B12 deficiency can have a profound impact on a person's health. Among numerous consequences is megaloblastic anaemia and progressive neurologic disease of the central and peripheral nervous system.² Vitamin B12 (cobalamin) is an essential nutrient naturally found in meat, fish and dairy products and can only be obtained through dietary intake. B12 deficiency can be prevalent in individuals who consume no animal-sourced foods or vegetarians who eat too little egg or dairy products. The condition is also prevalent in the elderly, where conditions such as atrophic gastritis, pernicious anaemia, Crohn’s disease and immune system disorders can impact how the body absorbs vitamin B12.

Vitamin B12 in circulation exists in two forms: holotranscobalamin (holoTC) and holohaptocorrin (holoHC). Only holoTC transports vitamin B12 from its site of absorption in the ileum to tissues and cells throughout the body, while holoHC is considered inert or biologically unavailable. HoloTC is considered the bioactive form of B12 or Active-B12.² While traditional serum B12 testing measures the entirety of circulating B12, only the Active-B12 assay measures the critical form. Evidence suggests that when used as either a screening or resolving test, Active-B12 provides a more reliable and earlier indicator of B12 deficiency. It also ensures fewer indeterminate results, as well as greater sensitivity and specificity than total serum B12 or methylmalonic acid tests.^1,3

Expected Values

The Access Active-B12 assay results were obtained on 132 apparently healthy males (n=83) and females (n=49), who were not prescreened for the consumption of dietary supplements, including vitamin B12. The age range was 21 to 68 years. The median Active-B12 concentration for the group was established at 75.9 pmol/L with a 95% central reference interval from 32.2–152.6 pmol/L according to EP28-A3c. (See Table 1.)

Table 1. Access Active-B12 Assay Results

Population	General Population (males and females, aged 21–68)
Sample Size	132
Median (pmol/L)	75.9
95% Reference Interval (pmol/L)	32.2–152.6

Note: Each laboratory should establish its own reference intervals to ensure proper representation of specific populations.

Imprecision

Representative data for imprecision is provided for illustration only. Performance obtained in individual laboratories may vary. The Access Active-B12 assay exhibits total imprecision CV≤10% at concentrations of 3 pmol/L to 160 pmol/L.

One study, using four serum-based samples on an Access 2 immunoassay system, generated a total of 40 assays—two replicates per assay—over 20 days. There were two runs per day, which provided the following data, calculated based on CLSI EP5-A3 guidelines. (See Table 2.)

Table 2. Access Active-B12 Assay Imprecision Results

Sample Number	Mean (pmol/L)	Within Run (pmol/L)		Between Run (pmol/L)		Total (pmol/L)
Sample Number	Mean (pmol/L)	SD	CV	SD	CV	SD	CV
1	14.2	0.2	1.7	0.5	3.6	0.6	4.0
2	39.7	0.7	1.8	1.4	3.7	1.6	4.1
3	16.7	0.5	3.2	1.0	5.9	1.1	6.7
4	82.3	1.4	1.7	4.3	4.3	3.8	4.6

Characteristics

Sample Type/Size	Serum (gel and no gel) / 50uL
Reportable Measuring Range	LoD to 160 pmol/L
Limit of Detection (LoD)	3 pmol/L
Limit of Quantitation (LoQ)	3 pmol/L @ ≤10% CV.0 pg/mL (ng/L)
Imprecision	Total imprecision: ≤10% CV within the reportable measuring range
Open Pack Stability	35 days
Calibration Stability	49 days
Approximate Calibrator Levels	0.0, 6.0, 13.0, 26.0, 60 and 160 pmol/L
Approximate Control Levels	15 and 48 pmol/L
Time to First Result	Access 2 analyzer: 17 minutes DxI analyzers: 23 minutes

Current Beckman Coulter customers may download the Product Announcement (login required) and Information Bulletin (login required) for more information on Access Active-B12 assay performance and helpful tools for bringing Access Active-B12 to your laboratory.

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Happy and healthy older couple enjoying life without the worries of anemia

Article Anemia: Finding Causes, Supporting Treatment

Active-B12 assessment is one of many tools that can be used to help diagnose and treat anemia. Anemia is a common disease that leads to a significant burden on healthcare. Find out about the serious economic and quality-of-life impacts of anemia, as well as how a comprehensive suite of anemia screening and diagnostic tools can help your laboratory support patients experiencing or at risk for this condition.

Learn more

¹Valente E, et al, Clin Chem, 2011;57:6 856–863.

²Brady J, et al, Clin Chem, 2008: 54;3 567–573.

³Herrman W, Obeid RVakur Bor M, Nexo E. "Vitamin B12—cobalamin". In: Herrman W, Obeid R, eds. Vitamins in the prevention of human diseases. Berlin: De Gruyter, 2011:187–99.

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Access Active-B12 Assay

Benefits of the Access Active-B12 assay

Vitamin B12 and its impact on patient health

Expected Values

Population

Sample Size

Median (pmol/L)

95% Reference Interval (pmol/L)

Imprecision

Characteristics

Sample Type/Size

Reportable Measuring Range

Limit of Detection (LoD)

Limit of Quantitation (LoQ)

Imprecision

Open Pack Stability

Calibration Stability

Approximate Calibrator Levels

Approximate Control Levels

Time to First Result

Article Anemia: Finding Causes, Supporting Treatment

95% Reference Interval
(pmol/L)