Test Catalog

Test Id : HIS

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Histone Autoantibodies, Serum

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

Evaluating patients suspected of having drug-induced lupus


Test is not useful for determining prognosis in patients with systemic lupus erythematosus or drug-induced lupus

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.


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

Histone Autoantibodies, S

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

Autoantibodies to Histones

Drug induced LE

Drug induced lupus

Drug-induced LE

Drug-induced lupus


Specimen Type
Describes the specimen type validated for testing


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


Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

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

0.35 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus 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) 21 days
Frozen 21 days

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

Evaluating patients suspected of having drug-induced lupus


Test is not useful for determining prognosis in patients with systemic lupus erythematosus or drug-induced lupus

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.

Provides information to assist in interpretation of the test results

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.

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).

Clinical Reference
Recommendations for 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., San Diego, CA., Revision 19, 3/2015)

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, Wednesday, Friday; 3 p.m.

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 - 4 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


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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.


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
HIS Histone Autoantibodies, S 43231-0
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.
HIS Histone Autoantibodies, S 43231-0

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.

Excel | 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