Test Catalog

Test Id : IFBA

Intrinsic Factor Blocking Antibody, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Confirming the diagnosis of pernicious anemia

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Immunoenzymatic Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Intrinsic Factor Blocking Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti Intrinsic Factor

IF Blocking

Type 1 Intrinsic Factor Antibody

Intrinsic Factor Blocking Antibody

IFBA

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

For a comprehensive workup of patients with suspected pernicious anemia, order ACASM / Pernicious Anemia Cascade, Serum, which initiates testing with measurement of vitamin B12. Depending of the vitamin B12 concentration, testing for intrinsic factor blocking antibody, gastrin, and methylmalonic acid may be added.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation:

1. Patient should be fasting for 8 hours.

2. This test should not be performed on patients who have received a vitamin B12 injection or radiolabeled vitamin B12 injection within the previous 2 weeks.

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 14 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Confirming the diagnosis of pernicious anemia

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The cobalamins, also referred to as vitamin B12, are a group of closely related enzymatic cofactors involved in the conversion of methylmalonyl-coenzyme A to succinyl-coenzyme A and in the synthesis of methionine from homocysteine. Vitamin B12 deficiency can lead to megaloblastic anemia and neurological deficits. The latter may exist without, or precede, anemia. Adequate replacement therapy will generally improve or cure cobalamin deficiency. Unfortunately, many other conditions, which require different interventions, can mimic the symptoms and signs of vitamin B12 deficiency. Moreover, even when cobalamin deficiency has been established, clinical improvement may require different dosages or routes of vitamin B12 replacement, depending on the underlying cause. In particular, patients with pernicious anemia (PA), possibly the most common type of cobalamin deficiency in developed countries, require either massive doses of oral vitamin B12 or parenteral replacement therapy. This is due to patients with PA having gastric mucosal atrophy, most likely caused by a destructive autoimmune process. This results in diminished or absent gastric acid, pepsin, and intrinsic factor (IF) production. Gastric acid and pepsin are required for liberation of cobalamin from binding proteins, while IF binds the free vitamin B12, carries it to receptors on the ileal mucosa, and facilitates its absorption. Most PA patients have autoantibodies against gastric parietal cells or IF, with the latter being very specific but only present in approximately 50% of cases. By contrast, parietal cell antibodies are found in approximately 90% of PA patients, but are also found in a significant proportion of patients with other autoimmune diseases and in approximately 2.5% (4th decade of life) to approximately 10% (8th decade of life) of healthy individuals.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

The aim of the work-up of patients with suspected vitamin B12 deficiency is to first confirm the presence of deficiency and then to establish its most likely etiology.

 

Measurement of serum vitamin B12, either preceded or followed by serum methylmalonic acid measurement, is the first step in diagnosing pernicious anemia (PA). If these tests support deficiency, then intrinsic factor blocking antibody (IFBA) testing is indicated to confirm PA as the etiology. A positive IFBA test very strongly supports a diagnosis of PA. Since the diagnostic sensitivity of IFBA testing for PA is only around 50%, an indeterminate or negative IFBA test does not exclude the diagnosis of PA. In these patients, either PA or another etiology, such as malnutrition, may be present. Measurement of serum gastrin levels will help in these cases. In patients with PA, fasting serum gastrin is elevated to more than 200 pg/mL in an attempted compensatory response to the achlorhydria seen in this condition.

 

For a detailed overview of the optimal testing strategies in PA diagnosis, see ACASM / Pernicious Anemia Cascade, Serum and associated Vitamin B12 Deficiency Evaluation.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Patients who have received a vitamin B12 injection or radiolabeled vitamin B12 injection within the previous 2 weeks may have high serum vitamin B12 levels, which can interfere with this assay leading to falsely elevated results.

 

Some patients with other autoimmune diseases may have positive intrinsic factor blocking antibody (IFBA) assays without suffering from pernicious anemia (PA). This is reported particularly in patients with autoimmune thyroid disease or type I diabetes mellitus. In the validation of this assay, 24 individuals with these autoimmune endocrine diseases were tested and all were IFBA negative. However, 5 of 15 of patients with rheumatoid arthritis were IFBA positive during the validation of this assay. The literature suggests such individuals may, in fact, be at risk of later development of PA.

 

Since this is a competitive binding assay, the risk of heterophile antibody interference is low. During validation, 24 human antimouse antibody positive specimens and 25 specimens with other heterophile antibodies were tested and all were IFBA negative. However, if the clinical picture does not agree with the IFBA test result, the laboratory should be consulted for advice.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Toh BH, Van Driel IR, Gleeson PA: Pernicious anemia. N Engl J Med. 1997;337:1441-1448. doi: 10.1056/NEJM199711133372007

2. Klee GG: Cobalamin and folate evaluation: measurement of methylmalonic acid and homocysteine vs vitamin B12 and folate. Clin Chem. 2000;46:1277-1283

3. Ward PC: Modern approaches to the investigation of vitamin B12 deficiency. Clin Lab Med. 2002:22;435-445. doi: 10.1016/s0272-2712(01)00003-8

4. Stabler SP, Allen RH: Vitamin B12 deficiency as a worldwide problem. Ann Rev Nutr. 2004;24:299-326. doi: 10.1146/annurev.nutr.24.012003.132440

5. Roberts NB, Taylor A, Sodi R: Vitamins and trace elements. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:639-718

6. Bizzaro N, Antico A: Diagnosis and classification of pernicious anemia. Autoimmun Rev. 2014;13(4-5):565-568. doi: 10.1016/j.autrev.2014.01.042

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

The Access Intrinsic Factor (IF) Antibody assay is a competitive binding immunoenzymatic assay. The sample is added to a reaction vessel along with IF alkaline phosphatase conjugate and a protein blocking solution. IF antibody in the sample binds to the IF conjugate. After incubation in a reaction vessel, paramagnetic particles coated with a mouse monoclonal antibody, specific for the vitamin B12 binding site on IF, is added to the reaction. IF conjugate that has not been blocked by sample anti-IF binds to the monoclonal antibody on the solid phase. After an additional incubation, materials bound to the solid phase are held in a magnetic field, while unbound materials are washed away. Chemiluminescent substrate 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 IF antibody in the sample expressed in AU/mL (antibody units/mL). The amount of analyte in the sample is determined from a stored calibration.(Package insert: Access Intrinsic Factor Ab. Beckman Coulter, Inc; 06/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 day to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86340

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
IFBA Intrinsic Factor Blocking Ab, S 31444-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
IFBLA Intrinsic Factor Blocking Ab, S 31444-3
CMT31 Comment 48767-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

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Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports