07028121501V5.

Elecsys Vitamin B12 II

cobas e 402
07028121190 07028121501 300
cobas e 801

English a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )

For use in the USA only Test principle

Competition principle. Total duration of assay: 27 minutes.
System information
▪ 1st incubation: By incubating the sample (9 µL) with the vitamin B12
Short name ACN (application code number) pretreatment 1 and pretreatment 2, bound vitamin B12 is released.
B12 2 10088 ▪ 2nd incubation: By incubating the pretreated sample with the
ruthenium‑labeled intrinsic factor, a vitamin B12‑binding protein complex
Intended use is formed, the amount of which is dependent upon the analyte
Binding assay for the in vitro quantitative determination of vitamin B12 in concentration in the sample.
human serum and plasma. Measurements obtained by this device are used ▪ 3rd incubation: After addition of streptavidin-coated microparticles and
in the diagnosis and treatment of anemias of gastrointestinal malabsorption. vitamin B12 labeled with biotin, the still-vacant sites of the
The electrochemiluminescence immunoassay “ECLIA” is intended for use ruthenium‑labeled intrinsic factor become occupied, with formation of a
on cobas e immunoassay analyzers. ruthenium‑labeled intrinsic factor vitamin B12 biotin complex. The entire
complex becomes bound to the solid phase via interaction of biotin and
Summary streptavidin.
Vitamin B12, also referred to as cobalamin, is a complex organometallic ▪ The reaction mixture is aspirated into the measuring cell where the
compound in which a cobalt atom is situated within a corrin ring. It is a microparticles are magnetically captured onto the surface of the
water-soluble vitamin which is synthesized by microorganisms. It cannot be electrode. Unbound substances are then removed with ProCell II M.
synthesized in the human body and is seldom found in products of plant Application of a voltage to the electrode then induces chemiluminescent
origin. Main sources of vitamin B12 are meat, fish, eggs and dairy emission which is measured by a photomultiplier.
products.1 The uptake in the gastrointestinal tract depends on intrinsic
factor, which is synthesized by the gastric parietal cells, and on the “cubam ▪ Results are determined via a calibration curve which is instrument-
receptor” in the distal ileum. The most frequent cause of severe vitamin B12 specifically generated by 2‑point calibration and a master curve provided
deficiency is a lack of intrinsic factor due to autoimmune atrophic gastritis. via the cobas link.
The disease is historically called “pernicious anemia”, even though many Reagents - working solutions
patients present with mainly neurologic manifestations. Examples of other
causes for vitamin B12 deficiency are malabsorption due to gastrectomy, The cobas e pack (M, R1, R2) and the pretreatment reagents (PT1, PT2)
inflammatory bowel disease or dietary deficiency, e.g. in strict vegetarians are labeled as B12 2.
(vegans).2 PT1 Pretreatment reagent 1, 1 bottle, 7.3 mL:
Vitamin B12 is the cofactor for two enzymes, methionine synthase and Dithiothreitol 1.028 g/L; stabilizer, pH 5.5.
methylmalonyl CoA mutase.2,3 Methionine synthase, located in the
cytoplasm, requires vitamin B12 in the form of methylcobalamin and PT2 Pretreatment reagent 2, 1 bottle, 6.3 mL:
catalyzes the conversion of homocysteine to methionine, an essential Sodium hydroxide 40 g/L; sodium cyanide 2.205 g/L.
amino acid. During this step a methyl group is transferred from
methyltetrahydrofolate to the amino acid.3 This enzyme links the M Streptavidin-coated microparticles, 1 bottle, 12.4 mL:
methylation pathway through synthesis of the methyl donor S‑adenosyl Streptavidin-coated microparticles 0.72 mg/mL; preservative.
methionine and the pathway in which purine and pyrimidine are synthesized R1 Intrinsic factor~Ru(bpy) , 1 bottle, 18.8 mL:
via generation of tetrahydrofolate.3 In the form of
5’‑deoxyadenosylcobalamin, vitamin B12 is also required for the Ruthenium labeled recombinant porcine intrinsic factor 4 µg/L;
mitochondrial enzyme methylmalonyl CoA mutase, which converts cobinamide dicyanide 15 µg/L; stabilizer; human serum albumin;
methylmalonyl CoA to succinyl CoA. This is a step in the oxidation of phosphate buffer, pH 5.5; preservative.
odd‑chain fatty acids and catabolism of ketogenic amino acids.3 Thus,
vitamin B12 is important for DNA synthesis, regenerating methionine for R2 Vitamin B12~biotin, 1 bottle, 15.8 mL:
protein synthesis and methylation, as well as for the development and initial Biotinylated vitamin B12 25 µg/L; biotin 3 µg/L; phosphate buffer,
myelination of the central nervous system (CNS) and for the maintenance pH 7.0; preservative.
of normal CNS function.2,3
Precautions and warnings
Vitamin B12 deficiencies are common in wealthier countries principally
among the elderly and are most prevalent in poorer populations. In general For in vitro diagnostic use for health care professionals. Exercise the
the prevalence increases with age.4,5 normal precautions required for handling all laboratory reagents.
Vitamin B12 deficiency impacts red blood cell synthesis, resulting in Infectious or microbial waste:
megaloblastic anemia due to abnormal DNA synthesis.3 In addition it Warning: handle waste as potentially biohazardous material. Dispose of
impairs neurological function, in particular demyelination of nerves in part waste according to accepted laboratory instructions and procedures.
due to abnormal methylation, leading to peripheral neuropathy, dementia, Environmental hazards:
poor cognitive performance, and depression.3 Other effects of vitamin B12 Apply all relevant local disposal regulations to determine the safe disposal.
deficiency or depletion are increased risk of neural tube defects, Safety data sheet available for professional user on request.
osteoporosis, cerebrovascular and cardiovascular diseases.3 Early
diagnosis is essential, because of the latent nature of this disorder and the
risk of permanent neurological damage.3,5 This kit contains components classified as follows in accordance with the
Generally, the primary test performed to confirm the diagnosis of Regulation (EC) No. 1272/2008:
vitamin B12 deficiency is measurement of serum vitamin B12 level.2 Recent
publications suggest that in addition the following biomarkers should be
measured to improve the specificity of diagnosis: folate, methylmalonic acid
(MMA), homocysteine and holotranscobalamin.2,5,6,7
The Elecsys Vitamin B12 II assay employs a competitive test principle using
intrinsic factor specific for vitamin B12. Vitamin B12 in the sample competes Danger
with the added vitamin B12 labeled with biotin for the binding sites on the
ruthenium‑labeled intrinsic factor complexa). H290 May be corrosive to metals.

2023-12, V 5.0 English 1/5

07028121501V5.0

Elecsys Vitamin B12 II

H301 Toxic if swallowed. Criterion: Slope 0.9‑1.1 + intercept within ≤ ± 2x Limit of Blank + coefficient
of correlation ≥ 0.95.
H314 Causes severe skin burns and eye damage. Stable for 2 hours at 15‑25 °C, 48 hours at 2‑8 °C, 56 days at
‑20 °C (± 5 °C). Freeze only once.
H317 May cause an allergic skin reaction. Stability of serum obtained with separating tubes: 24 hours at 2-8 °C.
H412 Harmful to aquatic life with long lasting effects. The sample types listed were tested with a selection of sample collection
tubes that were commercially available at the time of testing, i.e. not all
Prevention: available tubes of all manufacturers were tested. Sample collection systems
from various manufacturers may contain differing materials which could
P261 Avoid breathing mist or vapours. affect the test results in some cases. When processing samples in primary
tubes (sample collection systems), follow the instructions of the tube
manufacturer.
P280 Wear protective gloves/ protective clothing/ eye protection/ Centrifuge samples containing precipitates before performing the assay.
face protection/ hearing protection. Do not use heat‑inactivated samples.
Response: Do not use samples and controls stabilized with azide.
Vitamin B12 determinations should be performed on serum or plasma
P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER/ samples from fasting patients.
+ P330 doctor. Rinse mouth.
Ensure the samples and calibrators are at 20‑25 °C prior to measurement.
P303 + P361 IF ON SKIN (or hair): Take off immediately all contaminated Due to possible evaporation effects, samples and calibrators on the
+ P353 clothing. Rinse skin with water. analyzers should be analyzed/measured within 2 hours.
Sample stability claims were established by experimental data by the
P304 + P340 IF INHALED: Remove person to fresh air and keep manufacturer or based on reference literature and only for the
+ P310 comfortable for breathing. temperatures/time frames as stated in the method sheet. It is the
responsibility of the individual laboratory to use all available references
Immediately call a POISON CENTER/ doctor. and/or its own studies to determine specific stability criteria for its
laboratory.
P305 + P351 IF IN EYES: Rinse cautiously with water for several
+ P338 minutes. Remove contact lenses, if present and easy to do. Materials provided
+ P310 Continue rinsing. Immediately call a POISON CENTER/ See “Reagents – working solutions” section for reagents.
doctor. Materials required (but not provided)
Product safety labeling follows EU GHS guidance. ▪ 07212780190, Vitamin B12 II CalSet, for 4 x 1.0 mL
Contact phone: 1-800-428-2336 ▪ 05618860160, PreciControl Varia, for 4 x 3.0 mL
All human material should be considered potentially infectious. All products ▪ 07299001190, Diluent Universal, 36 mL sample diluent
derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies ▪ General laboratory equipment
to HCV and HIV. The testing methods use assays that have been approved ▪ cobas e analyzer
by the FDA or that are in compliance with the legal rules applicable to Additional materials for cobas e 402 and cobas e 801 analyzers:
placing in vitro diagnostic medical devices for human use on the market in
the European Union. ▪ 06908799190, ProCell II M, 2 x 2 L system solution
However, as no testing method can rule out the potential risk of infection ▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
with absolute certainty, the material should be handled with the same level solution
of care as a patient specimen. In the event of exposure, the directives of the ▪ 07485409001, Reservoir Cup, 8 cups to supply ProCell II M and
responsible health authorities should be followed.8,9 CleanCell M
Avoid foam formation in all reagents and sample types (specimens,
calibrators and controls). ▪ 06908853190, PreClean II M, 2 x 2 L wash solution
▪ 05694302001, Assay Tip/Assay Cup tray, 6 magazines
Reagent handling x 6 magazine stacks x 105 assay tips and 105 assay cups, 3 wasteliners
The reagents in the kit have been assembled into a ready‑for‑use unit that
cannot be separated. ▪ 07485425001, Liquid Flow Cleaning Cup, 2 adaptor cups to supply
ISE Cleaning Solution/Elecsys SysClean for Liquid Flow Cleaning
All information required for correct operation is available via the cobas link. Detection Unit
Storage and stability ▪ 07485433001, PreWash Liquid Flow Cleaning Cup, 1 adaptor cup
Store at 2‑8 °C. to supply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow
Do not freeze. Cleaning PreWash Unit
Store the cobas e pack upright in order to ensure complete availability of ▪ 11298500160, ISE Cleaning Solution/Elecsys SysClean,
the microparticles during automatic mixing prior to use. 5 x 100 mL system cleaning solution
Assay
Stability:
For optimum performance of the assay follow the directions given in this
unopened at 2‑8 °C up to the stated expiration date document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions.
on the analyzers 16 weeks
Resuspension of the microparticles takes place automatically prior to use.
Specimen collection and preparation Place the cooled (stored at 2‑8 °C) cobas e pack on the reagent manager.
Only the specimens listed below were tested and found acceptable. Avoid foam formation. The system automatically regulates the temperature
Serum collected using standard sampling tubes or tubes containing of the reagents and the opening/closing of the cobas e pack.
separating gel. Calibration
Na‑heparin, Li‑heparin, K2‑EDTA and K3‑EDTA plasma. Traceability: This method has been standardized against the Elecsys
Li‑heparin plasma tubes containing separating gel can be used. Vitamin B12 assay ( 04745736).

2/5 2023-12, V 5.0 English

07028121501V5.0

Elecsys Vitamin B12 II

Accuracy to WHO Standard 03/178: A study was performed to evaluate the may be caused by, but not limited to, the following conditions:
accuracy of the Elecsys Vitamin B12 II assay using the Vitamin B12 World Lymphoma,14,15 bone marrow disorders such as multiple myeloma,
Health Organization International Standard 03/178.10 Two reagent lots were monoclonal gammopathy of undetermined significance (MGUS),
used on 16 instruments. The mean recovery of the target value of Waldenström macroglobulinemia, plasmocytoma,14,15,16,17,18,19,20
WHO IS 03/178 (480 pg/mL) was 102 %. Amyloidosis.20,21, Respective samples may lead to the formation of protein
The predefined master curve is adapted to the analyzer using the relevant gel in the assay cup, which may cause a run abort. The critical total protein
CalSet. concentration is dependent upon the individual sample composition.
Calibration frequency: Calibration must be performed once per reagent lot Pharmaceutical substances
using fresh reagent (i.e. not more than 24 hours since the cobas e pack In vitro tests were performed on 16 commonly used pharmaceuticals. No
was registered on the analyzer). interference with the assay was found.
Calibration interval may be extended based on acceptable verification of In rare cases, interference due to extremely high titers of antibodies to
calibration by the laboratory. analyte‑specific antibodies, streptavidin or ruthenium can occur. These
effects are minimized by suitable test design.
Renewed calibration is recommended as follows:
For diagnostic purposes, the results should always be assessed in
▪ after 12 weeks when using the same reagent lot conjunction with the patient’s medical history, clinical examination and other
▪ after 28 days when using the same cobas e pack on the analyzer findings.
▪ as required: e.g. quality control findings outside the defined limits Note: The presence of immunoglobulin-vitamin B12 complexes may cause
unexpectedly high values of vitamin B12.22,23
Quality control
Limits and ranges
For quality control, use PreciControl Varia.
Measuring range
In addition, other suitable control material can be used.
150‑2000 pg/mL or 111‑1476 pmol/L (defined by the Limit of Quantitation
Controls for the various concentration ranges should be run individually at and the maximum of the master curve). Values below the Limit of
least once every 24 hours when the test is in use, once per cobas e pack, Quantitation are reported as < 150 pg/mL or < 111 pmol/L. Values above
and following each calibration. the measuring range are reported as > 2000 pg/mL or > 1476 pmol/L (or up
The control intervals and limits should be adapted to each laboratory’s to 4000 pg/mL or 2952 pmol/L for 2‑fold diluted samples).
individual requirements. Values obtained should fall within the defined Lower limits of measurement
limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits. Limit of Blank, Limit of Detection and Limit of Quantitation
If necessary, repeat the measurement of the samples concerned. Limit of Blank = 50 pg/mL (36.9 pmol/L)
Follow the applicable government regulations and local guidelines for Limit of Detection = 100 pg/mL (73.8 pmol/L)
quality control. Limit of Quantitation = 150 pg/mL (111 pmol/L)
Calculation The Limit of Blank, Limit of Detection and Limit of Quantitation were
The analyzer automatically calculates the analyte concentration of each determined in accordance with the CLSI (Clinical and Laboratory Standards
sample (either in pmol/L or pg/mL). Institute) EP17‑A2 requirements.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of
Conversion factors: pmol/L x 1.36 = pg/mL analyte‑free samples over several independent series. The Limit of Blank
corresponds to the concentration below which analyte‑free samples are
pg/mL x 0.738 = pmol/L found with a probability of 95 %.
Limitations - interference The Limit of Detection is determined based on the Limit of Blank and the
The effect of the following endogenous substances and pharmaceutical standard deviation of low concentration samples. The Limit of Detection
compounds on assay performance was tested. Interferences were tested corresponds to the lowest analyte concentration which can be detected
up to the listed concentrations and no impact on results was observed. (value above the Limit of Blank with a probability of 95 %).
The Limit of Quantitation is the lowest analyte concentration that can be
Endogenous substances reproducibly measured with an intermediate precision CV of ≤ 20 %.
Compound Concentration tested It has been determined using low concentration vitamin B12 samples.
Bilirubin ≤ 1112 µmol/L or ≤ 65 mg/dL Dilution
Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL Samples with vitamin B12 concentrations above the measuring range can
be diluted with Diluent Universal. The recommended dilution is 1:2 (either
Intralipid ≤ 1500 mg/dL automatically by the analyzers or manually). The concentration of the
Biotin ≤ 205 nmol/L or ≤ 50 ng/mL diluted sample must be ≥ 1000 pg/mL or ≥ 738 pmol/L.
After manual dilution, multiply the result by the dilution factor.
Rheumatoid factors ≤ 1500 IU/mL
After dilution by the analyzers, the software automatically takes the dilution
IgG ≤ 2.8 g/dL into account when calculating the sample concentration.
IgA ≤ 1.6 g/dL Note: Sample-dependent non-linearity upon dilution is seen with samples
having analyte levels beyond the measuring range. As Diluent Universal
IgM ≤ 1 g/dL may contain low levels of endogenous vitamin B12, it is recommended that
Criterion: For concentrations ≤ 200 pg/mL the deviation is ≤ ± 20 pg/mL. linearity studies be performed using a known low analyte-containing serum
For concentrations > 200 pg/mL the deviation is ≤ 10 %. pool. Samples outside the measuring range can be diluted 1:2 with Diluent
Universal; the effect of endogenous vitamin B12 concentration is
Samples should not be taken from patients receiving therapy with high insignificant at these levels.
biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin
administration. Expected values
Because intrinsic factor is typically used as the binding protein in serum Because differences may exist with respect to population and dietary
vitamin B12 assays, anti-intrinsic factor antibodies (which are common in status, it is recommended that normal ranges be determined by each
pernicious anemia) can lead to elevated vitamin B12 measurement laboratory over a suitable period of time and in a statistically significant
values.2,11,12 The Elecsys Vitamin B12 II assay is designed to avoid number of assays before clinical significance is attached to the results of
interference due to anti-intrinsic factor antibodies.13 these tests.
Samples with extremely high total protein concentrations The values shown in the following table were performed on samples from
(hyperproteinemia) are not suitable for use in this assay. Hyperproteinemia an apparently healthy population, using the Elecsys Vitamin B12 II assay.

2023-12, V 5.0 English 3/5

07028121501V5.0

Elecsys Vitamin B12 II

The calculation is based on 120 sera (66 men, 54 women). The age range Analytical specificity
was between 22 and 79 years. Pregnant women were excluded. The The following cross-reactivities were found, tested with vitamin B12
reference population was selected according to normal homocysteine concentrations of 193 pg/mL and 1196 pg/mL.
values.
Cross-reactant Maximum Cross-reactivity
N Median Range (2.5th-97.5th percentile) concentration tested %
pg/mL pmol/L pg/mL pmol/L ng/mL
120 443 327 232-1245 171-919 Cobinamide dicyanide 210 -0.1
These values should only be used as guidelines. References
Each laboratory should investigate the transferability of the expected values 1 Thomas L. Clinical Laboratory Diagnostics: Use and Assessment of
to its own patient population and if necessary determine its own reference Clinical Laboratory Results; 1st Edition, Frankfurt/Main: TH-Books-
ranges. Verl.-Ges.,1998:424-431.
Specific performance data 2 Stabler SP. Vitamin B12 deficiency. N Engl J Med 2013;368:149-160.
Representative performance data on the analyzers are given below. 3 Allen LH. Vitamin B-12. Adv Nutr 2012;3(1):54-55. doi:
Results obtained in individual laboratories may differ. 10.3945/an.111.001370. Epub 2012 Jan 5.
Precision 4 Allen LH. How common is vitamin B-12 deficiency? Am J Clin Nutr
Precision was determined using Elecsys reagents, pooled human sera and 2009;89(2):693S-696S. Epub 2008 Dec 30.
controls in a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory 5 Chatthanawaree W. Biomarkers of cobalamin (vitamin B12) deficiency
Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). and its application. J Nutr Health Aging 2011 Mar;15(3):227-313.
The following results were obtained:
6 Yetley EA, Pfeiffer CM, Phinney KW, et al., Biomarkers of vitamin B-12
cobas e 402 and cobas e 801 analyzers status in NHANES: a roundtable summary. Am J Clin Nutr 2011
Jul;94(1):313S-321S.
Repeatability Intermediate
precision 7 Hvas AM, Nexo E. Diagnosis and treatment of vitamin B12 deficiency -
an update. Haematologica 2006;91(11):1506-1512.
Sample Mean SD CV SD CV
8 Occupational Safety and Health Standards: Bloodborne pathogens.
pg/mL pg/mL % pg/mL % (29 CFR Part 1910.1030). Fed. Register.
Human serum 1 131 9.45 7.2 10.6 8.1 9 Directive 2000/54/EC of the European Parliament and Council of
Human serum 2 168 8.50 5.1 9.74 5.8 18 September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
Human serum 3 206 7.92 3.9 9.28 4.5
10 Thorpe SJ, Heath A, Blackmore S, et al. International Standard for
Human serum 4 999 11.8 1.2 18.3 1.8 serum vitamin B12 and serum folate: international collaborative study to
evaluate a batch of lyophilised serum for B12 and folate content. Clin
Human serum 5 1984 22.4 1.1 47.4 2.4 Chem Lab Med 2007;45(3):380-386.
PreciControl Varia1 462 10.6 2.3 11.9 2.6 11 Yang DT, Cook RJ. Spurious elevations of vitamin B12 with pernicious
PreciControl Varia2 901 14.2 1.6 20.4 2.3 anemia. N Engl J Med 2012;366:1742-1743.
12 Carmel R, Agrawal YP. Failures of cobalamin assays in pernicious
cobas e 402 and cobas e 801 analyzers anemia. N Engl J Med 2012;367:385-386. [Erratum, N Engl J Med
2012;367:976.]
Repeatability Intermediate
precision 13 Schilling KA, Wiesgigl M. The Elecsys® Vitamin B12 assay is not
affected by anti-intrinsic factor antibodies. Clin Chem Lab Med 2013
Sample Mean SD CV SD CV Jun 29;51(11):e251-e252.
pmol/L pmol/L % pmol/L % 14 Wu AHB. Tietz clinical guide to laboratory tests, 4th ed. St. Louis,
Human serum 1 96.7 6.97 7.2 7.82 8.1 Saunders/Elsevier 2006:608-609, 916-917.
Human serum 2 124 6.27 5.1 7.19 5.8 15 Paricaud K, Moulis G, Combis MS, et al. Causes of protidemia above
100 g/L. Eur J Intern Med 2014;25:e123.
Human serum 3 152 5.84 3.9 6.85 4.5
16 Filippatos TD, Liamis G, Christopoulou F, et al. Ten common pitfalls in
Human serum 4 737 8.71 1.2 13.5 1.8 the evaluation of patients with hyponatremia. Eur J Intern Med
Human serum 5 1464 16.5 1.1 35.0 2.4 2016;29:22-25.
17 Mailankody S, Landgren O. Monoclonal gammopathy of undetermined
PreciControl Varia1 341 7.82 2.3 8.78 2.6 significance and Waldenström's macroglobulinemia. Best Pract Res
PreciControl Varia2 665 10.5 1.6 15.1 2.3 Clin Haematol 2016;29:187-193.
18 Morel P, Duhamel A, Gobbi P, et al. International prognostic scoring
Method comparison system for Waldenström macroglobulinemia. Blood
A comparison of the Elecsys Vitamin B12 II assay on the cobas e 801 2009;113:4163-4170.
analyzer (y) with the Elecsys Vitamin B12 II assay on the cobas e 601
analyzer (x) gave the following correlations (pg/mL): 19 Rajkumar SV. Multiple Myeloma. Curr Probl Cancer 2009;33:7-64.
Number of samples measured: 123 20 Gertz MA. Immunoglobulin light chain amyloidosis: 2016 update on
diagnosis, prognosis, and treatment. Am J Hematol 2016;91:947-956.
Passing/Bablok24 Linear regression 21 Wu AHB. Tietz clinical guide to laboratory tests, 4th ed. St. Louis,
y = 1.010x - 3.30 y = 1.047x - 22.4 Saunders/Elsevier 2006: 916-917, 925.
τ = 0.975 r = 0.998 22 Jeffery J, Millar H, MacKenzie P, et al. An IgG complexed form of
vitamin B12 is a common cause of elevated serum concentrations. Clin
The sample concentrations were between 162 and 1833 pg/mL (120 and Biochem 2010 Jan;43(1-2):82-88. doi:
1353 pmol/L). 10.1016/j.clinbiochem.2009.08.022. Epub 2009 Sep 8.

4/5 2023-12, V 5.0 English

07028121501V5.0

Elecsys Vitamin B12 II

23 Bowen RA, Drake SK, Vanjani R, et al. Markedly increased vitamin B12
concentrations attributable to IgG-IgM-vitamin B12 immune complexes.
Clin Chem 2006;52(11):2107-2114.
24 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
for method comparison studies in clinical chemistry, Part III.
J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
For further information, please refer to the appropriate user guide or
operator’s manual for the analyzer concerned, the respective application
sheets and the Method Sheets of all necessary components (if available in
your country).
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see
navifyportal.roche.com for definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume for reconstitution
GTIN Global Trade Item Number

Rx only For USA: Caution: Federal law restricts this device to

sale by or on the order of a physician.

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.
COBAS, NAVIFY, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
Fresenius Kabi AB.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2023, Roche Diagnostics

For USA: Rx only

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com
+800 5505 6606

Distribution in USA by:

Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336

2023-12, V 5.0 English 5/5