7K61-25

en
B12
ARCHITECT 7K61-35 7K61
B12 G6-0569 / R10
B7K610
Read Highlighted Changes: Revised November 2015.

Package insert instructions must be carefully followed. Reliability of 1. Sample and Pre-Treatment Reagent 1, Pre-Treatment Reagent 2,
assay results cannot be guaranteed if there are any deviations from and Pre-Treatment Reagent 3 are combined.
the instructions in this package insert. 2. An aliquot of the pre-treated sample is aspirated and transferred
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NAME into a new Reaction Vessel (RV). The pre-treated sample, assay
diluent, and intrinsic factor coated paramagnetic microparticles
ARCHITECT B12
are combined. The B12 present in the sample binds to the
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INTENDED USE intrinsic factor coated microparticles.
The ARCHITECT B12 assay is a Chemiluminescent Microparticle 3. After washing, B12 acridinium-labeled conjugate is added to
Intrinsic Factor assay for the quantitative determination of vitamin create a reaction mixture.
B12 in human serum and plasma on the ARCHITECT iSystem. 4. Following another wash cycle, Pre-Trigger and Trigger Solutions
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SUMMARY AND EXPLANATION OF THE TEST are added to the reaction mixture.
5. The resulting chemiluminescent reaction is measured as relative
Vitamin B12 (B12), a member of the corrin family, is a cofactor for
the conversion of methylmalonyl Coenzyme-A (CoA) to succinoyl light units (RLUs). There is an inverse relationship between the
CoA. In addition, B12 is a cofactor in the synthesis of methionine amount of B12 in the sample and the RLUs detected by the
from homocysteine, is implicated in the formation of myelin, and, ARCHITECT iSystem optics.
along with folate, is required for DNA synthesis.1, 2 For additional information on system and assay technology, refer to
B12 is absorbed from food after binding to a protein called intrinsic the ARCHITECT System Operations Manual, Section 3.
factor which is produced by the stomach. Causes of vitamin B12 ll
REAGENTS
deficiency can be divided into three classes: nutritional deficiency,
Kit Contents
malabsorption syndromes, and other gastrointestinal causes. B12
deficiency can cause megaloblastic anemia (MA), nerve damage ARCHITECT B12 7K61
and degeneration of the spinal cord. Lack of B12, even mild NOTE: Some kit sizes are not available in all countries or for use on
deficiencies, damages the myelin sheath that surrounds and protects all ARCHITECT iSystems. Please contact your local distributor.
nerves, which may lead to peripheral neuropathy. The nerve damage 7K61-25 7K61-35
caused by a lack of B12 may become permanently debilitating, if
the underlying condition is not treated. People with intrinsic factor 100 500
defects who do not get treatment eventually develop a MA called
1 x 6.6 mL 1 x 27.0 mL
pernicious anemia (PA).2
The relationship between B12 levels and MA is not always clear in 1 x 5.9 mL 1 x 26.3 mL
that some patients with MA will have normal B12 levels; conversely, 1 x 10.0 mL 1 x 51.0 mL
many individuals with B12 deficiency are not afflicted with MA.
1 x 27.0 mL 1 x 50.4 mL
Despite these complications, however, in the presence of MA (e.g.,
elevated mean corpuscular volume (MCV)) there is usually serum 1 x 3.2 mL 1 x 13.4 mL
B12 or folate deficiency.2, 3 1 x 3.3 mL 1 x 13.8 mL
The true prevalence of B12 deficiency in the general population is
unknown but increases with age. In one study,4 fifteen percent of Intrinsic Factor (porcine) coated Microparticles
adults older than 65 years old had laboratory evidence of vitamin in borate buffer with protein (bovine) stabilizers. Minimum
B12 deficiency. Concentration: 0.1% solids. Preservative: antimicrobial agents.
A serum B12 level below the normal expected range may indicate B12 acridinium-labeled Conjugate in MES buffer.
that tissue B12 levels are becoming depleted. However, a B12 level Minimum concentration: 0.7 ng/mL. Preservative: ProClin.
in the low normal range does not ensure that B12 levels are healthy
B12 Assay Diluent containing borate buffer with
and symptomatic patients should be further evaluated with tests for
EDTA. Preservative: antimicrobial agents.
holotranscobalamin,5 homocysteine and methylmalonic acid.6, 7
There are a number of conditions that are associated with low serum B12 Pre-Treatment Reagent 1 containing
B12 levels, including iron deficiency, normal near-term pregnancy, 1.0 N sodium hydroxide with 0.005% potassium cyanide.
vegetarianism, partial gastrectomy/ileal damage, celiac disease, use B12 Pre-Treatment Reagent 2 containing
of oral contraception, parasitic competition, pancreatic deficiency, alpha monothioglycerol and EDTA.
treated epilepsy, and advancing age.2, 8-11 Disorders associated with
elevated serum B12 levels include renal failure, liver disease, and B12 Pre-Treatment Reagent 3 containing
myeloproliferative diseases.8, 12 cobinamide dicyanide in borate buffer with protein (avian)
stabilizers. Preservative: sodium azide.
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BIOLOGICAL PRINCIPLES OF THE PROCEDURE
The ARCHITECT B12 assay is a two-step assay with an automated
sample pretreatment, for determining the presence of B12 in human
serum and plasma using CMIA technology with flexible assay
protocols, referred to as Chemiflex.

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Other Reagents The following warnings and precautions apply to:
1 x 100 mL ARCHITECT Multi-Assay
Manual Diluent, 7D82-50, containing phosphate buffered saline
solution. Preservative: antimicrobial agent.
ARCHITECT Pre-Trigger Solution containing
1.32% (w/v) hydrogen peroxide. WARNING: Contains monothioglycerol.
ARCHITECT Trigger Solution containing 0.35 N H315 Causes skin irritation.
sodium hydroxide. H319 Causes serious eye irritation.
ARCHITECT Wash Buffer containing phosphate Prevention
buffered saline solution. Preservatives: antimicrobial agents. P264 Wash hands thoroughly after handling.
P280 Wear protective gloves / protective
Warnings and Precautions clothing / eye protection.
• Response
• For In Vitro Diagnostic Use P305+P351+P338 IF IN EYES: Rinse cautiously with water
Safety Precautions for several minutes. Remove contact
lenses, if present and easy to do.
CAUTION: This product requires the handling of human specimens.
Continue rinsing.
It is recommended that all human-sourced materials be considered
P337+P313 If eye irritation persists: Get medical
potentially infectious and handled in accordance with the OSHA
advice / attention.
Standard on Bloodborne Pathogens. Biosafety Level 2 or other
appropriate biosafety practices should be used for materials that P302+P352 IF ON SKIN: Wash with plenty of water.
contain or are suspected of containing infectious agents.13-16 P332+P313 If skin irritation occurs: Get medical
advice / attention.
The following warnings and precautions apply to: / P362+P364 Take off contaminated clothing and wash
it before reuse.
The following warnings and precautions apply to:

DANGER: Contains sodium borate.

H360 May damage fertility or the unborn child.
Prevention
DANGER: Contains sodium hydroxide.
P201 Obtain special instructions before use.
H314 Causes severe skin burns and eye
P280 Wear protective gloves / protective
damage.
clothing / eye protection.
H290 May be corrosive to metals.
Response
Prevention
P308+P313 IF exposed or concerned: Get medical
P234 Keep only in original container.
advice / attention.
P260 Do not breathe mist / vapors / spray.
Disposal
P264 Wash hands thoroughly after handling.
P501 Dispose of contents / container in
accordance with local regulations. P280 Wear protective gloves / protective
clothing / eye protection.
The following warnings and precautions apply to: Response
P301+P330+P331 IF SWALLOWED: Rinse mouth. Do NOT
induce vomiting.
P305+P351+P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact
DANGER: Contains sodium borate and sodium azide. lenses, if present and easy to do.
H360 May damage fertility or the unborn child. Continue rinsing.
EUH032 Contact with acids liberates very toxic gas. P303+P361+P353 IF ON SKIN (or hair): Take off immediately
all contaminated clothing. Rinse skin with
Prevention
water / shower.
P201 Obtain special instructions before use.
P310 Immediately call a POISON CENTER or
P280 Wear protective gloves / protective
doctor / physician.
clothing / eye protection.
P390 Absorb spillage to prevent material
Response
damage.
P308+P313 IF exposed or concerned: Get medical
Disposal
advice / attention.
P501 Dispose of contents / container in
Disposal
accordance with local regulations.
P501 Dispose of contents / container in
accordance with local regulations.

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The following warnings and precautions apply to: Storage Maximum Additional Storage
Temperature Storage Time Instructions
On board System 30 days Discard after 30 days.
temperature For information on tracking
onboard time, refer to
WARNING: Contains methylisothiazolones. the ARCHITECT System
H317 May cause an allergic skin reaction. Operations Manual,
Prevention Section 5.
P261 Avoid breathing mist / vapors / spray. * Reagents may be stored on or off the ARCHITECT iSystem. If
P272 Contaminated work clothing should not be reagents are removed from the system, store them at 2-8°C (with
allowed out of the workplace. septums and replacement caps) in an upright position. For reagents
P280 Wear protective gloves / protective stored off the system, it is recommended that they be stored in
clothing / eye protection. their original trays and boxes to ensure they remain upright. If the
Response microparticle bottle does not remain upright (with a septum
P302+P352 IF ON SKIN: Wash with plenty of water. installed) while in refrigerated storage off the system, the reagent
P333+P313 If skin irritation or rash occurs: Get kit must be discarded. For information on unloading reagents, refer
medical advice / attention. to the ARCHITECT System Operations Manual, Section 5.
P362+P364 Take off contaminated clothing and wash Indications of Reagent Deterioration
it before reuse. When a control value is out of the specified range, it may indicate
Disposal deterioration of the reagents or errors in technique. Associated test
P501 Dispose of contents / container in results are invalid, and samples must be retested. Assay recalibration
accordance with local regulations. may be necessary. For troubleshooting information, refer to the
ARCHITECT System Operations Manual, Section 10.
Safety Data Sheets are available at www.abbottdiagnostics.com or
contact your local representative. ll
INSTRUMENT PROCEDURE
For a detailed discussion of safety precautions during system The ARCHITECT B12 assay file must be installed on the ARCHITECT
operation, refer to the ARCHITECT System Operations Manual, iSystem from an ARCHITECT iSystem Assay CD-ROM prior to
Section 8. performing the assay.
Reagent Handling For detailed information on assay file installation and viewing
• Do not use reagent kits beyond the expiration date. and editing assay parameters, refer to the ARCHITECT System
Operations Manual, Section 2.
• Do not pool reagents within a kit or between kits.
For information on printing assay parameters, refer to the
• Before loading the reagent kit on the system for the first time, the
ARCHITECT System Operations Manual, Section 5.
microparticle bottle requires mixing to resuspend microparticles
that may have settled during shipment. For microparticle mixing For a detailed description of system procedures, refer to the
instructions, refer to the PROCEDURE, Assay Procedure section ARCHITECT System Operations Manual.
of this package insert. Alternate Result Units
• Septums MUST be used to prevent reagent evaporation and Edit assay parameter "Result concentration units" to select an
contamination and to ensure reagent integrity. Reliability of alternate unit.
assay results cannot be guaranteed if septums are not used Conversion formula:
according to the instructions in this package insert. (Concentration in Default result unit) x (Conversion factor) =
• Prolonged exposure of B12 Pre-Treatment Reagent 1 to air (Concentration in Alternate result unit)
may compromise performance. Default result unit Conversion factor Alternate result unit
• To avoid contamination, wear clean gloves when placing a pg/mL 0.7378 pmol/L
septum on an uncapped reagent bottle.
• Once a septum has been placed on an open reagent bottle, do ll
SPECIMEN COLLECTION AND PREPARATION
not invert the bottle as this will result in reagent leakage and FOR ANALYSIS
may compromise assay results.
Specimen Types
• Over time, residual liquids may dry on the septum surface. These
Verified specimen types to be used with this assay:
are typically dried salts and have no effect on assay efficacy.
For a detailed discussion of handling precautions during system Glass Plastic
operation, refer to the ARCHITECT System Operations Manual, Serum Serum
Section 7. Serum separator tubes
Reagent Storage Lithium heparin plasma separator
When stored and handled as directed, reagents are stable until the Sodium heparin
expiration date. Dipotassium EDTA
Storage Maximum Additional Storage • Other specimen collection tube types have not been tested with
Temperature Storage Time Instructions this assay.
Unopened/ 2-8°C Until May be used immediately • Performance has not been established for the use of body fluids
Opened* expiration after removal from 2-8°C other than human serum and plasma.
date storage. • The instrument does not provide the capability to verify specimen
Store in upright position. type. It is the responsibility of the operator to verify that the
correct specimen types are used in the assay.

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Specimen Conditions • ARCHITECT Wash Buffer
• Do not use specimens with the following conditions: • ARCHITECT Reaction Vessels
• heat-inactivated • ARCHITECT Sample Cups
• pooled • ARCHITECT Septum
• hemolyzed • ARCHITECT Replacement Caps
• obvious microbial contamination • Pipettes or pipette tips (optional) to deliver the volumes specified
• For accurate results, serum and plasma specimens should be on the patient or control order screen.
free of fibrin, red blood cells, and other particulate matter. Serum For information on materials required for maintenance procedures,
specimens from patients receiving anticoagulant or thrombolytic refer to the ARCHITECT System Operations Manual, Section 9.
therapy may contain fibrin due to incomplete clot formation. Assay Procedure
• To prevent cross contamination, use of disposable pipettes or • Before loading the reagent kit on the system for the first
pipette tips is recommended. time, the microparticle bottle requires mixing to resuspend
Preparation for Analysis microparticles that may have settled during shipment. After the
• Follow the tube manufacturer’s processing instructions for first time the microparticles have been loaded, no further mixing
collection tubes. Gravity separation is not sufficient for specimen is required.
preparation. • Invert the microparticle bottle 30 times.
• Mix thawed specimens thoroughly by low speed vortexing or by • Visually inspect the bottle to ensure microparticles are
inverting 10 times. Visually inspect the specimens. If layering or resuspended. If microparticles are still adhered to the bottle,
stratification is observed, continue mixing until specimens are continue to invert the bottle until the microparticles have
visibly homogeneous. been completely resuspended.
• To ensure consistency in results, specimens must be transferred • If the microparticles do not resuspend, DO NOT USE.
to a centrifuge tube and centrifuged at > 10,000 RCF (Relative Contact your local Abbott representative.
Centrifugal Force) for 10 minutes before testing if • Once the microparticles have been resuspended, place a
• they contain fibrin, red blood cells, or other particulate septum on the bottle. For instructions about placing septums
matter or on bottles, refer to the Reagent Handling section of this
• they were frozen and thawed. package insert.
• Transfer clarified specimen to a sample cup or secondary tube • Load the reagent kit on the ARCHITECT iSystem.
for testing. For centrifuged specimens with a lipid layer, transfer • Verify that all necessary reagents are present.
only the clarified specimen and not the lipemic material. • Ensure that septums are present on all reagent bottles.
• Inspect all specimens for bubbles. Remove bubbles with an • Order calibration, if necessary.
applicator stick before analysis. Use a new applicator stick for • For information on ordering calibrations, refer to the
each specimen to prevent cross contamination. ARCHITECT System Operations Manual, Section 6.
Specimen Storage • Order tests.
Specimen Type Storage Temperature Maximum Storage Time • For information on ordering patient specimens, calibrators
Serum/Plasma Room temperature ≤ 3 days and controls and for general operating procedures, refer to
the ARCHITECT System Operations Manual, Section 5.
2-8°C ≤ 7 days
• Minimum sample cup volume is calculated by the system
Specimens may be stored on or off the clot, red blood cells, or and printed on the Orderlist report. To minimize the effects of
separator gel. evaporation, verify adequate sample cup volume is present prior
If testing will be delayed more than 3 days for specimens stored to running the test.
at room temperature or more than 7 days for specimens stored at Maximum number of replicates sampled from the same sample
2-8°C, remove serum or plasma from the clot, red blood cells, or cup: 10
separator gel and store at -20°C or colder. • Priority:
Avoid more than 3 freeze/thaw cycles. Sample volume for first test: 87 μL
Specimen Shipping Sample volume for each additional test from same sample
• Package and label specimens in compliance with applicable cup: 37 μL
state, federal, and international regulations covering the transport • ≤ 3 hours on board:
of clinical specimens and infectious substances. Sample volume for first test: 150 μL
• Do not exceed the storage limitations listed above. Sample volume for each additional test from same sample
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PROCEDURE cup: 37 μL
• > 3 hours on board: Replace with a fresh sample (patient
Materials Provided specimens, controls, and calibrators).
7K61 ARCHITECT B12 Reagent Kit • If using primary or aliquot tubes, use the sample gauge to
Materials Required but not Provided ensure sufficient patient specimen is present.
• ARCHITECT B12 Assay file obtained from the ARCHITECT • Prepare ARCHITECT B12 Calibrators and Controls.
iSystem e-Assay CD-ROM found on www.abbottdiagnostics.com. • Mix calibrator(s) and controls by gentle inversion before use.
• 7K61-01 ARCHITECT B12 Calibrators • Hold bottles vertically and dispense recommended volumes
• 7K61-10 ARCHITECT B12 Controls into each respective sample cup.
• 7D82-50 ARCHITECT Multi-Assay Manual Diluent • Recommended volumes:
• ARCHITECT Pre-Trigger Solution for each calibrator: 3 drops
• ARCHITECT Trigger Solution for each control: 3 drops

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• Load samples. ll
RESULTS
• For information on loading samples, refer to the ARCHITECT
Calculation
System Operations Manual, Section 5.
The ARCHITECT B12 assay utilizes a 4 Parameter Logistic Curve fit
• Press RUN.
data reduction method (4PLC, Y-weighted) to generate a calibration
• For optimal performance, it is important to perform routine curve.
maintenance as described in the ARCHITECT System Operations
For information on alternate result units, refer to the INSTRUMENT
Manual, Section 9. Perform maintenance more frequently when
PROCEDURE, Alternate Result Units section of this package insert.
required by laboratory procedures.
Flags
Specimen Dilution Procedures
Some results may contain information in the Flags field. For a
Specimens with a B12 value exceeding 2000 pg/mL (1476 pmol/L)
description of the flags that may appear in this field, refer to the
are flagged with the code “>2000” when working in pg/mL (“>1476”
ARCHITECT System Operations Manual, Section 5.
when working in pmol/L) and may be diluted using either the
Automated Dilution Protocol or the Manual Dilution Procedure. ll
LIMITATIONS OF THE PROCEDURE
Automated Dilution Protocol • Results should be used in conjunction with other data; e.g.,
The system performs a 1:3 dilution of the specimen and symptoms, results of other tests, and clinical impressions.
automatically calculates the concentration of the specimen before • The diagnosis of B12 deficiency cannot be solely based on
dilution and reports the result. serum or plasma B12 levels. Further testing for folic acid, intrinsic
Manual Dilution Procedure factor blocking antibodies, holotranscobalamin,5 homocysteine,
and/or methylmalonic acid is suggested for symptomatic patients
Suggested dilution: 1:4
with hematological or neurological abnormalities.6, 7
Suggested dilution for specimens that generate repeated (2 or more)
• If the B12 results are inconsistent with clinical evidence,
“3350 Unable to process test-aspiration error for (Sample Pipettor) at
additional testing is recommended to confirm the result.
(RV 24)” errors: 1:2
• Hemolysis has been demonstrated to exhibit negative
1. For a 1:4 dilution, add 100 μL of the patient specimen to 300 μL
interference in this B12 assay. Hemolyzed specimens should not
of ARCHITECT Multi-Assay Manual Diluent.
be analyzed.
2. For a 1:2 dilution, add 100 μL of the patient specimen to 100 μL
• Specimens containing above normal protein concentrations
of ARCHITECT Multi-Assay Manual Diluent.
may generate repeated (2 or more) “3350 Unable to process
3. The operator must enter the dilution factor in the Patient or test-aspiration error for (Sample Pipettor) at (RV 24)” errors and
Control order screen. The system will use this dilution factor to should be quantified using the Automated Dilution Protocol or
automatically calculate the concentration of the sample before Manual Dilution Procedure (1:2).
dilution and report the result. The result should be > 83 pg/mL
• Heterophilic antibodies and rheumatoid factor (RF) in human
(61 pmol/L) before the dilution factor is applied.
serum can react with reagent immunoglobulins, interfering with
For detailed information on ordering dilutions, refer to the ARCHITECT in vitro immunoassays. Patients routinely exposed to animals or
System Operations Manual, Section 5. to animal serum products can be prone to this interference and
Calibration anomalous values may be observed. Additional information may
• Test Calibrators A-F in duplicate. The calibrators should be be required for diagnosis.17
priority loaded. • The assay is designed to test human serum and plasma.
A single sample of each control level must be tested to evaluate Specimens tested in other matrices may not give accurate
the assay calibration. Ensure that assay control values are within results.
the ranges specified in the respective control package insert. • Refer to the SPECIMEN COLLECTION AND PREPARATION
• Calibration Range: 0-2000 pg/mL (0-1476 pmol/L). FOR ANALYSIS section of this package insert for specimen
• Once an ARCHITECT B12 calibration is accepted and stored, all limitations.
subsequent samples may be tested without further calibration ll
EXPECTED VALUES
unless:
B12 Normals
• A reagent kit with a new lot number is used or
It is recommended that each laboratory establish its own range,
• Controls are out of range.
which may be unique to the population it serves depending upon
• For detailed information on how to perform an assay calibration, geographical, patient, dietary, or environmental factors.
refer to the ARCHITECT System Operations Manual, Section 6.
A study was performed based on guidance from Clinical and
Quality Control Procedures Laboratory Standards Institute (CLSI) document C28-A2.18 Serum
The recommended control requirement for the ARCHITECT B12 specimens from 143 individuals with normal mean corpuscular
assay is that a single replicate of each control level be tested once volume, homocysteine, and folate results were assayed for B12 using
every 24 hours each day of use. If the quality control procedures in the ARCHITECT B12 assay. The B12 concentration range for this
your laboratory require more frequent use of controls to verify test population was 141 to > 1218 pg/mL (104 to > 899 pmol/L) with a
results, follow your laboratory-specific procedures. mean of 407 pg/mL (300 pmol/L). The central 95% of the sample
Control values must be within the ranges specified in the control population is defined below:
package insert. If a control result is out of its specified range, any Expected Range 187-883 pg/mL (138-652 pmol/L)
test results generated since the last acceptable control results must
be evaluated to determine if sample results may have been adversely B12 Indeterminates
affected. Adversely affected test results are invalid, and these Levels above 300 or 400 pg/mL (221 or 295 pmol/L) are rarely
samples must be retested. For troubleshooting information, refer to associated with B12 deficiency induced hematological or
the ARCHITECT System Operations Manual, Section 10. neurological disease, respectively. Further testing is suggested for
Verification of Assay Claims symptomatic patients with B12 levels between 100 and 300 pg/mL
For protocols to verify package insert claims, refer to the ARCHITECT (74 and 221 pmol/L) (hematological abnormalities), and between 100
System Operations Manual, Appendix B. and 400 pg/mL (74 and 295 pmol/L) (neurological abnormalities).6, 7
The ARCHITECT B12 assay belongs to method group 1.

5
ll
SPECIFIC PERFORMANCE CHARACTERISTICS Accuracy by Correlation
Assay results obtained in individual laboratories may vary from the A study was conducted based on guidance from CLSI document
data presented in the following studies. EP9-A2.21 Three hundred and twenty nine serum specimens were
tested for the determination of B12 using the ARCHITECT B12 assay
Precision
and a commercially available diagnostic kit. The specimen testings
The ARCHITECT B12 assay is designed to have a Total CV of ≤ 11%
are shown in the following table*.
for concentrations in the range of the low, medium, and high controls.
Abbott ARCHITECT B12 vs AxSYM B12
A 20-day precision study was performed for the ARCHITECT B12
Number of Correlation
assay based on guidance from the CLSI document EP5-A2.19 Testing
Method Specimens Intercept Slope Coefficient
was conducted at Abbott Laboratories using three ARCHITECT
Least Squares Linear 329 -2.05 1.01 0.99
B12 assay reagent lots, two calibrator lots, one control lot, and two Regression
instruments. Four levels of controls and panels were assayed in Passing-Bablok Linear 329 21.96 0.95 0.99
replicates of three at two separate times of day for 20 different days. Regression22
The data are summarized in the following table.
In this evaluation, serum specimens tested ranged from 113 to
Within Laboratory
Within Run Precision (Total) 2769 pg/mL (83 to 2043 pmol/L) by the ARCHITECT B12 assay,
Instrument Sample n Mean (pg/mL) SD %CV SD %CV and from 93.5 to 2655.8 pg/mL (69.1 to 1959.5 pmol/L) by the
1 Serum 360 262 12.6 4.8 16.3 6.2 comparator assay.
Panel * Representative data, results in individual labs may vary from these
Low 354 246 13.8 5.6 16.7 6.8 data.
Control
Medium 355 424 14.3 3.4 16.8 4.0
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BIBLIOGRAPHY
Control 1. Lee DS, Griffiths BW. Human serum vitamin B12 assay methods - a
review. Clin Biochem 1985;18:261-266.
High 359 890 36.0 4.0 38.9 4.4 2. Chanarin I. Megaloblastic anaemia, cobalamin, and folate. J Clin
Control Pathol 1987;40:978-984.
2 Serum 357 248 11.6 4.7 13.3 5.4 3. Beuerlein FJ. Testing strategies for anemias. Lab Mgmnt 1988;
Panel Dec:23-29.
Low 356 241 10.4 4.3 12.9 5.4 4. Pennypacker LC, Allen RH, Kelly JP et al. High Prevalence of
Control Cobalamin Deficiency in Elderly Outpatients. J Am Geriatr Soc
Medium 352 408 13.3 3.3 15.5 3.8 1992;40:1197-1204.
Control 5. Obeid R, Herrmann W. Holotranscobalamin in laboratory diagnosis
High 355 885 23.9 2.7 29.7 3.4 of cobalamin deficiency compared to total cobalamin and
Control methylmalonic acid. Clin Chem Lab Med 2007; 45(12):1746-1750.
6. Klee GG. Cobalamin and folate evaluation: measurement of
Accuracy by WHO methylmalonic acid and homocysteine vs vitamin B12 and folate. Clin
Chem 2000;46:1277-1283.
A study was conducted to evaluate the accuracy of the ARCHITECT
7. Snow CF. Laboratory Diagnosis of Vitamin B12 and Folate
B12 assay using the B12 World Health Organization International Deficiency: A Guide for the Primary Care Physician. Arch Intern Med.
Standard 03/178. The assay demonstrated a -3.6% difference from 1999; 159:1289-1298.
the target value of 480 pg/mL (354 pmol/L). 8. Beck WS. Biological and medical aspects of vitamin B12. In:
Sensitivity Dolphin D, ed. B12 Volume 2, Biochemistry and Medicine. New York:
Wiley‑Interscience, 1982:1-30.
Sensitivity is defined as the Limit of Blank (LoB), Limit of Detection 9. Carethers M. Diagnosing Vitamin B12 Deficiency, A Common
(LoD), and Limit of Quantitation (LoQ) for the ARCHITECT B12 Geriatric Disorder. Geriatrics 1988; 43(3):89-112.
assay. The assay is designed to have an LoQ of ≤ 150 pg/mL 10. Herbert V. Five Possible Causes of All Nutrient Deficiency: Illustrated
(≤ 111 pmol/L). A study conducted based on guidance from CLSI by Deficiencies of Vitamin B12 and Folic Acid. Am J Clin Nutr 1973;
document EP17-A20 produced an LoB of 83 pg/mL (61 pmol/L), an 26:77-86.
LoD of 125 pg/mL (92 pmol/L) and LoQ of 125 pg/ mL (92 pmol/L). 11. Dahele A, Ghosh S. Vitamin B12 Deficiency in Untreated Celiac
Disease. Am J Gastroenterol. 2001; 96:745-750.
Specificity 12. Pratt JJ, Woldring MG. Radioassay of Vitamin B12 and Other
The ARCHITECT B12 assay is designed to have an interference Corrinoids. Methods Enzymol 1982; 84:369-406.
(difference) less than the LoD of the assay with cobinamide, a 13. US Department of Labor, Occupational Safety and Health
B12 analogue. The specificity of the ARCHITECT B12 assay was Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
14. US Department of Health and Human Services. Biosafety in
determined by studying the cross reactivity with cobinamide. A Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
human serum specimen at approximately 230 pg/mL (168 pmol/L) US Government Printing Office; December 2009.
was supplemented with cobinamide at 9000 pg/mL and the resulting 15. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
interference was 4 pg/mL (3 pmol/L). Geneva: World Health Organization; 2004.
16. Clinical and Laboratory Standards Institute (CLSI). Protection
Interference of Laboratory Workers From Occupationally Acquired Infections;
At the concentrations listed below, bilirubin (conjugated and Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
unconjugated), total protein, and triglycerides showed less than PA: CLSI; 2014.
10% interference in the ARCHITECT B12 assay for low samples 17. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all
(concentration range: 150 pg/mL to 250 pg/mL (111 pmol/L to immunoassays. Clin Chem 1988;34(1):27-33.
184 pmol/L)) and higher samples (concentration range: > 500 pg/mL 18. National Committee for Clinical Laboratory Standards (NCCLS).
(> 369 pmol/L)): How to Define and Determine Reference Intervals in the Clinical
Laboratory; Approved Guideline—Second Edition. NCCLS Document
Bilirubin < 25.1 mg/dL C28-A2. Wayne, PA: NCCLS; 2000.
Total Protein < 12 g/dL 19. National Committee for Clinical Laboratory Standards (NCCLS).
Triglycerides < 3325 mg/dL Evaluation of Precision Performance of Quantitative Measurement
Methods; Approved Guideline—Second Edition. NCCLS Document
Hemolyzed specimens should not be analyzed; refer to the EP5-A2. Wayne, PA: NCCLS; 2004.
LIMITATIONS OF THE PROCEDURE section of this package insert.

6
20. National Committee for Clinical Laboratory Standards (NCCLS). ARCHITECT, AxSYM and Chemiflex are trademarks of Abbott
Protocols for Determination of Limits of Detection and Limits of Laboratories in various jurisdictions.
Quantitation; Approved Guideline. NCCLS Document EP17-A. Wayne,
ProClin is property of its respective owner.
PA: NCCLS; 2004.
21. National Committee for Clinical Laboratory Standards (NCCLS).
Abbott Ireland
Method Comparison and Bias Estimation Using Patient Samples; Diagnostics Division
Approved Guideline—Second Edition. NCCLS Document EP9-A2. Lisnamuck, Longford
Wayne, PA: NCCLS; 2002. Co. Longford
22. Passing H, Bablok W. A new biometrical procedure for testing the Ireland
equality of measurements from two different analytical methods. +353-43-3331000
Application of linear regression procedures for method comparison
studies in clinical chemistry, Part I. J Clin Chem Clin Biochem
1983;21(11):709–720. Customer Service: Contact your local representative
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Sufficient for

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Assay Diluent
Conjugate
Contains Sodium Azide. Contact
with acids liberates very toxic
gas.
Control Number
Danger: Reproductive Hazard
In Vitro Diagnostic Medical
Device
Lot Number
Microparticles
Multi-Assay Manual Diluent
Pre-Trigger Solution
Pre-Treatment Reagent 1
Pre-Treatment Reagent 2
Pre-Treatment Reagent 3
Product of Ireland
Reaction Vessels
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Replacement Caps
Sample Cups
Septum
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Trigger Solution
Warning: May cause an allergic
reaction.
Warning: Severe Irritant
Wash Buffer