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.
For information see Vitamin B12 Deficiency Evaluation.
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
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.
For information see Vitamin B12 Deficiency Evaluation.
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. Fasting: 8 hours, required
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.
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL serum
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
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. The minimum volume is sufficient for one attempt at testing.
Serum: 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.
For information see Vitamin B12 Deficiency Evaluation.
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(20):1441-1448. doi:10.1056/NEJM199711133372007
2. Klee GG. Cobalamin and folate evaluation: measurement of methylmalonic acid and homocysteine vs vitamin B(12) and folate. Clin Chem. 2000;46(8 Pt 2):1277-1283
3. Ward PC. Modern approaches to the investigation of vitamin B12 deficiency. Clin Lab Med. 2002;22(2);435-445. doi:10.1016/s0272-2712(01)00003-8
4. Stabler SP, Allen RH. Vitamin B12 deficiency as a worldwide problem. Annu 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
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, 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 in the reaction vessel, 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
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, Sunday
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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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.
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 |