Test Catalog

Test Id : FACT

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Filamentous-Actin (F-actin) Antibody, IgG, Serum

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Overview

Test Catalog

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

Evaluation of patients with hepatitis of unknown origin associated with hypergammaglobulinemia and/or abnormal liver enzymes

 

This test may also be useful for confirming positivity for smooth muscle antibodies.

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

F-Actin Ab, IgG, S

Specimen Type
Describes the specimen type validated for testing

Serum

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

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

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

0.4 mL

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Heat treated specimens Reject

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) 21 days
Frozen 21 days

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

Evaluation of patients with hepatitis of unknown origin associated with hypergammaglobulinemia and/or abnormal liver enzymes

 

This test may also be useful for confirming positivity for smooth muscle antibodies.

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

Autoimmune hepatitis (AIH) is a chronic disease resulting from immune-mediated liver injury with varied clinical manifestations.(1,2) The precise factors leading to disease initiation and perpetuation are unknown, but likely reflect a combination of genetic predisposition relating to defects in immunological control of autoreactivity, as well as environmental triggers, which precipitate a persistent breakdown in self-tolerance.(2) Initially, patients with AIH may be clinically asymptomatic and are usually identified only through an incidental finding of abnormal liver function tests.(1-4) At a more advanced stage, patients may manifest with symptoms such as jaundice, pruritus, or ascites, which are secondary to the more extensive liver damage. As implied by the name, AIH has many characteristics of an autoimmune disease, including female predominance, hypergammaglobulinemia, association with specific HLA alleles, responsiveness to immunosuppression, and the presence of autoantibodies.(1-3)

 

The clinical features of AIH are nonspecific and can be seen in variety of liver diseases (drug/alcohol-associated hepatitis, viral hepatitis, primary sclerosing cholangitis, etc), the diagnosis can be challenging. A set of diagnostic criteria for AIH has been published and includes the presence of various autoantibodies, elevated total IgG, evidence of hepatitis on liver histology, and absence of viral markers.(1,3,4) Based on the specific autoantibodies present, AIH can be placed into one of three categories.(4) The most prevalent is AIH type 1, linked to the presence of smooth muscle autoantibodies (SMA), antinuclear antibodies (ANA) and perinuclear anti-neutrophil cytoplasmic antibodies. SMA are generally identified by indirect immunofluorescence using a smooth muscle substrate. The antigen specificity of SMA in the context of AIH has been identified as filamentous-actin (F-actin).(3) The combination of autoantibody serology, specifically SMA and anti-F-actin antibodies with liver histology and thorough clinical evaluation are useful in the evaluation of patients with suspected autoimmune hepatitis. SMAs are detected in up to 85% of patients with AIH, either alone or in conjunction with ANA.(1,4,5) The SMA titer can also contribute to International Autoimmune Hepatitis Group diagnostic score in patients with a probable or definite diagnosis of AIH.(1,4,5) These antibodies have also been reported in 33% to 65% of cases of primary biliary cholangitis/AIH overlap syndrome,(6) the concomitant presence of SMA and antimitochondrial antibodies being highly suggestive in this setting.

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: <20.0 U

Weak Positive: 20.0-30.0 U

Positive: >30.0 U

Interpretation
Provides information to assist in interpretation of the test results

Positivity for anti-filamentous-actin (F-actin) antibodies may help support a diagnosis of autoimmune hepatitis (AIH) following exclusion of other causes of hepatitis.

 

A negative result for anti-F-actin antibodies does not exclude a diagnosis of AIH.

 

In a study conducted at Mayo Clinic, the F-actin enzyme-linked immunosorbent assay (ELISA) had a clinical sensitivity of 92.9% when using the manufacturer's recommended cutoff of 20.0 U. In addition, the F-actin ELISA had a clinical specificity of 76.7% when using the aforementioned cutoffs. See Supportive Data.

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

Serologic tests for autoantibodies, including anti-filamentous-actin (F-actin), should not be relied upon exclusively to determine the etiology or prognosis of patients with liver disease.

 

A negative result for anti-F-actin antibodies does not exclude a diagnosis of autoimmune hepatitis.

Supportive Data

In a study performed at Mayo Clinic, 173 serum samples submitted for clinical testing for anti-smooth muscle antibodies (anti-SMA), as performed by indirect immunofluorescence, were collected. These samples were subsequently tested using the anti-filamentous-actin (F-actin) antibody enzyme-linked immunosorbent assay (ELISA). By using the manufacturer's cut-offs for the 2 tests (negative at <20.0 units for the F-actin ELISA and <1:20 titer for the anti-SMA indirect immunofluorescence), the 2 tests had an overall concordance of 79.8%. In addition to the analytical concordance, patient histories were abstracted for diagnoses related to liver dysfunction. Of the 14 patients with autoimmune hepatitis, 13 were positive (> or =20.0 units) for F-actin antibodies by ELISA, which corresponded to a sensitivity of 92.9%. Of the remaining 159 patients who had a diagnosis of something other than autoimmune hepatitis, 122 were negative (<20.0 units), which corresponded to a specificity of 76.7%. In comparison, at a clinical specificity of 76.1%, which is similar to the ELISA, the anti-SMA indirect immunofluorescence method had a significantly lower clinical sensitivity of 78.6%. Positivity for either anti-F-actin antibodies or anti-SMA improved the diagnostic sensitivity to 92.9%, although the specificity decreased to 66.0%. This data indicates that the ELISA for F-actin antibodies may have improved diagnostic utility in comparison to the anti-SMA by indirect immunofluorescence, although a combination of these tests may be useful for some patients.

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

1. European Association for the Study of the Liver. EASL clinical practice guidelines: autoimmune hepatitis. J Hepatol. 2015;63(4):971-1004

2. Mieli-Vergani G, Vergani D, Czaja AJ, et al. Autoimmune hepatitis. Nat Rev Dis Primers. 2018;4:18017

3. Sebode M, Weiler-Normann C, Liwinski T, Schramm C. Autoantibodies in autoimmune liver disease-clinical and diagnostic relevance. Front Immunol. 2018;9:609

4. Terziroli Beretta-Piccoli B, Mieli-Vergani G, Vergani D. Autoimmune hepatitis: serum autoantibodies in clinical practice. Clin Rev Allergy Immunol. 2022;63(2):124-137

5. Bogdanos DP, Invernizzi P, Mackay IR, Vergani D. Autoimmune liver serology: current diagnostic and clinical challenges. World J Gastroenterol. 2008;14(21):3374-3387

6. Muratori P, Granito A, Pappas G, et al. The serological profile of the autoimmune hepatitis/primary biliary cirrhosis overlap syndrome. Am J Gastroenterol. 2009;104(6):1420-1425.

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

The method used to detect antibodies directed against filamentous-actin is enzyme-linked immunosorbent assay. Prediluted controls and diluted patient sera are added to separate wells, allowing any actin antibodies present to bind to the antigen. Unbound sample is washed away, and an enzyme labeled anti-human IgG is added to each well. A second incubation allows the enzyme labeled anti-human IgG to bind to any patient antibodies, which have become attached to the microwells, and any unbound conjugate is removed by another wash step. The bound conjugate is visualized with 3,3',5,5' tetramethylbenzidine (TMB) substrate, which gives a blue reaction product, the intensity of which is proportional to a concentration of autoantibody in the sample. Sulfuric acid is added to each well to stop the reaction. This produces a yellow endpoint color, which is read at 450 nm. Testing is performed on the DS2 instrument by Dynex.(Package insert: QUANTA Lite Actin IgG ELISA 708785. INOVA Diagnostics; Rev. 6, 11/2018)

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

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.

2 to 8 days

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

14 days

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

Rochester

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.

83516

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
FACT F-Actin Ab, IgG, S 44706-0
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.
FACT F-Actin Ab, IgG, S 44706-0

Test Setup Resources

Setup Files
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Excel | PHP Pdf | CMS Pdf

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