Histone Autoantibodies, 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 drug-induced lupus
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Histone Autoantibodies, S
Autoantibodies to Histones
Drug induced LE
Drug induced lupus
Drug induced LE
Drug induced lupus
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
Histones are the most basic protein components of chromatin and their structures are highly conserved in different species. Five classes of histones called H1, H2, H2b, H3, and H4 have been described and are characterized by their molecular weights, ranging from 11 to 23 kilodalton (kD), and their content of the basic amino acids lysine and arginine.
Histone autoantibodies may react with any of the 5 classes of histones.(1,2) Autoantibodies to total histones are elicited by unknown mechanisms in patients treated with certain drugs, particularly procainamide, hydralazine, quinidine, alpha methyldopa, penicillamine, and isoniazid. Those patients may have signs and symptoms that resemble systemic lupus erythematosus (SLE). This disorder is identified as drug-induced lupus. Testing for autoantibodies to total histones is useful for evaluating patients suspected of having drug-induced lupus. Such patients will usually have a positive test for histone autoantibodies and a negative test for autoantibodies to double stranded DNA (dsDNA). Patients with SLE have positive tests for both types of autoantibodies.
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.
<1.0 Units (negative)
1.0-1.5 Units (borderline)
>1.5 Units (positive)
Units are arbitrarily based on positive control serum.
Reference values apply to all ages.
A positive result for histone autoantibodies with a negative result for autoantibodies to double-stranded DNA (anti-ds-DNA) is consistent with drug-induced lupus.
A positive result for histone autoantibodies with a positive result for anti-dsDNA autoantibodies is consistent with systemic lupus erythematosus.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Positive tests for histone autoantibodies occur in some patients exposed to the above mentioned drugs who do not have signs or symptoms of lupus.
Testing for histone autoantibodies is not necessary to establish the diagnosis of systemic lupus erythematosus (SLE).
Test results are not useful for determining prognosis in patients with SLE or drug-induced lupus.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Borchers AT, Keen CL, Gershwin ME: Drug-induced lupus. Ann NY Acad Sci 2007;1108:166-182
2. S Vasoo. Drug-induced lupus: An update. Lupus 2006;15:757-761
Method Description Describes how the test is performed and provides a method-specific reference
Purified histones are 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. After washing, an anti-human IgG conjugated to horseradish peroxidase is added. After incubation and washing, tetramethylbenzidine (TMB) substrate is added to enable visualization of antibodies. The enzyme reaction is stopped and color development measured at 450 nm in a microtiter plate spectrophotometer. (Package insert: QUANTA Lite. Histone ELISA 708520, INOVA Diagnostics, Inc.)
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; 3:00 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|
|HIS||Histone Autoantibodies, S||43231-0|