Parietal Cell Antibodies, IgG, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluating patients suspected of having pernicious anemia or immune-mediated deficiency of vitamin B12 with or without megaloblastic anemia
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Parietal Cell Ab, IgG, S
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||21 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Pernicious anemia (PA) is characterized by atrophic body gastritis (ABG) and is the end state of a progressive disease known as autoimmune chronic atrophic gastritis.(1) In this disease, immune-mediated inflammation leads to destruction of gastric parietal cells with the resultant loss of intrinsic factor production and the inability to absorb dietary vitamin B12. Diagnosis of PA involves demonstrating the presence of a macrocytic anemia in the context of vitamin B12 deficiency, as well as documenting positive autoantibody serology, specifically anti-parietal cell antibody (PCA) and intrinsic factor antibody (IFA).(2) PCAs bind to the alpha- and beta-subunits of the membrane-bound H(+)/K(+)-ATPase. In contrast, IFAs bind directly to intrinsic factor, blocking its ability to bind vitamin B12.(1,2) Both PCAs and IFAs are useful diagnostic markers for PA. In a recently published study, PCAs were 81% sensitive and 90% specific for ABG, while IFAs were 27% sensitive and 100% specific. The study concluded that a combination of PCA and IFA testing was the optimal strategy for the evaluation of patients with suspected PA.(4)
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: < or =20.0 Units
Equivocal: 20.1-24.9 Units
Positive: > or =25.0 Units
Reference values apply to all ages.
A positive result indicates the presence of IgG antibodies to H(+)/K(+) ATPase and suggests the possibility of pernicious anemia (PA) or a related autoimmune disease.
A negative result indicates no detectable IgG antibodies to H(+)/K(+) ATPase; it does not rule out PA.
An equivocal result is indeterminate.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The presence of immune complexes or other immunoglobulin aggregates in the patient specimen may cause an increased non-specific binding and produce false-positive results in this assay.
A negative result does not rule out the presence of parietal cell antibodies; the concentration of antibody may be below the detection limit of the assay.
A positive result only indicates the presence of antibody to H(+)/K(+) ATPase and does not necessarily indicate the presence of autoimmune disease or other diseases.
The assay performance has not been established for pediatric patients.
Results of this assay should be used in conjunction with clinical findings and other serological tests.
The assay performance characteristics have not been established for matrices other than serum.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Toh BH, Van Driel IR, Gleeson PA: Pernicious anemia. N Eng J Med 1997;337(20):1441-1448
2. Lahner E, Annibale B: Pernicious anemia: new insights from a gastroenterological point of view. World J Gastroenterol 2009;15(41):5121-5128
3. Lahner E, Normal GL, Severi C, et al: Reassessment of intrinsic factor and parietal cell autoantibodies in atrophic gastritis with respect to cobalamin deficiency. Am J Gastroenterol 2009;104(8):2071-2079
4. Product Insert: QUANTA Lite GPA, INOVA Diagnostics, Inc., San Diego, CA
Method Description Describes how the test is performed and provides a method-specific reference
Purified H(+)/K(+) ATPase antigen, isolated from pig gastric mucosa, is bound to the wells of a polystyrene microwell plate under conditions that will preserve the antigen in its native state. Prediluted controls and diluted patient sera are added to separate wells, allowing any H(+)/K(+) ATPase antibodies present to bind to the immobilized antigen. Unbound sample is washed away and an enzyme-labeled antihuman IgG conjugate is added to each well. A second incubation allows the enzyme-labeled antihuman IgG to bind to any patient antibodies, which have become attached to the microwells. After washing away any unbound enzyme-labeled antihuman IgG, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops. The assay is evaluated spectrophotometrically by measuring and comparing the color intensity that develops in the patient wells with the color in the control wells. (Package insert: QUANTA Lite GPA, INOVA Diagnostics, Inc., December 2002, Revision 1)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday, Friday; 3 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|PCAB||Parietal Cell Ab, IgG, S||40960-7|