Test Catalog

Test Id : CIB

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Cutaneous Direct Immunofluorescence Assay, Varies

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Overview

Test Catalog

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

Confirming a diagnosis of bullous pemphigoid, cicatricial pemphigoid, pemphigoid gestationis and other variants of pemphigoid, all types of pemphigus, including paraneoplastic pemphigus (paraneoplastic multiorgan syndrome), dermatitis herpetiformis, linear IgA bullous dermatosis, chronic bullous disease of childhood, epidermolysis bullosa acquisita, porphyria cutanea tarda, bullous eruption of lupus erythematosus, and atypical or mixed forms of bullous disease, systemic lupus erythematosus, cutaneous lupus erythematosus, or other variants, vasculitis, lichen planus, and other inflammatory diseases

 

This test is not useful for diagnosis of malignancies involving the skin.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Direct Immunofluorescence Assay (IFA)

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

Cutaneous Direct IFA, Biopsy

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

Anti-Epithelial Antibody

Anti-Skin Basement Membrane

Basement Membrane

Biopsy

Blistering Disease

Bullous Disease

Bullous Pemphigoid

Chronic Bullous Disease of Childhood

CI-B

Cicatricial Pemphigoid

Connective Tissue Disease

Dermatitis herpetiformis

Dermatoimmunopathology

Dermatopathology

Direct Immunofluorescence

Epidermal Cell Surface Antibody

Epidermal Fluorescence Antibody

Epidermolysis Bullosa Acquisita

Immunodermatology

Immunofluorescence Antibodies

Immunopathology

Intercellular Substance Antibody

Lichen Planus

Linear IgA Bullous Dermatosis

Lupus Erythematosus (LE)

Oral Ulcers

Paraneoplastic Pemphigus

Pemphigoid

Pemphigus

Porphyria Cutanea Tarda

Skin Basement Membrane Antibodies

Skin Biopsy

Urticaria

Vasculitis

Cutaneous Immunofluorescence

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

1. Date of collection and location of biopsy site are required: whether biopsy was obtained from sun-exposed verses unexposed skin, and whether it is from perilesional, involved, or uninvolved skin.

2. Pathology Report/Clinical Notes are required (include a brief history, pertinent laboratory results, suspected diagnosis, and reason for testing).

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

Two or more biopsies from same site and sent in 1 specimen vial will be processed as 1 specimen. Two or more biopsies from different sites require separate specimen vials, however, they can be ordered together. Test performed on each site will be billed accordingly.

 

Transport Medium Method

Supplies: Michel's Transport Media for Immunofluorescent Testing on Tissue (T321)

Specimen Type: Tissue

Sources: Skin or 1 of the following mucosae: oral (oropharyngeal), nasal, genital, esophageal, conjunctival, laryngeal, or epiglottis

Container/Tube: Transport medium (Michel's, also called Zeus media)

Specimen Volume: 2-8 mm punch specimen, intact or bisected; excisional biopsy specimen intact or bisected

Collection Instructions:

1. Collect biopsy of uninvolved or involved skin. Refer to Recommended Biopsy Site Selection Based on Disease State below.

2. Immediately place specimen into a labeled vial of transport medium and seal tightly.

 

Snap-Frozen Method

Specimen Type: Tissue

Sources: Skin or 1 of the following mucosae: oral (oropharyngeal), nasal, genital, esophageal, conjunctival, laryngeal, or epiglottis

Container/Tube: Plastic vial

Specimen Volume: 2-8 mm punch specimen, intact or bisected; excisional biopsy specimen, intact or bisected

Collection Instructions:

1. Collect biopsy of uninvolved or involved skin. Refer to Recommended Biopsy Site Selection Based on Disease State below.

2. Immediately place specimen into liquid nitrogen and allow to freeze thoroughly (do not allow specimen to desiccate). If liquid nitrogen is not available, specimen may be frozen by placing it on a small square of aluminum foil on a block of dry ice. Liquid nitrogen is preferred.

3. Immediately wrap specimen carefully in aluminum foil. At no time should the specimen be allowed to thaw.

4. Place the wrapped specimen into the prelabeled plastic vial and seal tightly. Ship frozen.

 

Recommended Biopsy Site Selection Based on Disease State

1. Pemphigus and pemphigoid groups (including linear IgA bullous dermatosis and chronic bullous disease of childhood): Biopsy erythematous perilesional skin or mucosa. Avoid erosions, ulcers, and bullae while obtaining tissue adjacent to active lesions. Label as perilesional skin.

2. Dermatitis herpetiformis: Biopsy normal-appearing skin, 0.5-1 cm away from lesion. Label as perilesional skin.

3. Lupus erythematosus: Involved areas of skin such as erythematous or active borders are preferred biopsy sites to confirm the diagnosis of lupus erythematosus, either discoid or systemic. Label as involved skin. Avoid ulcers, old lesions, and facial lesions, if possible. Uninvolved, nonexposed skin is the preferred site to detect a lupus band as may be found in systemic lupus erythematosus. Should unexposed skin be desired, buttock or medial thigh is suggested. Label as uninvolved, nonexposed skin.

4. Mixed connective tissue disease: Biopsy as for lupus erythematosus except when sclerodermoid features are present. For sclerodermoid features, biopsy inflamed area. Label as involved or uninvolved, exposed or nonexposed skin.

5. Vasculitis and urticaria: The erythematous or active border of a new lesion is preferred. Avoid old lesions and ulcers. Label as involved skin. If appropriate, skin lesion is not present, diagnosis may sometimes be made from uninvolved skin.

6. Porphyria cutanea tarda: Biopsy involved skin. Avoid old lesions and ulcers. Label as involved skin.

7. Lichen planus and lichenoid reactions: Biopsy involved skin. Avoid old lesions and ulcers. Label as involved skin.

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

See Specimen Required

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

Biopsy from lung, kidney, muscle, salivary gland, veins, synovial tissue, bronchial tissue, or bronchial lavage
Biopsy in formalin fixation
Frozen in alcohol
Trumps media
Glutaraldehyde 		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
Varies Ambient (preferred) 30 days
Frozen 120 days
Refrigerated 30 days

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

Confirming a diagnosis of bullous pemphigoid, cicatricial pemphigoid, pemphigoid gestationis and other variants of pemphigoid, all types of pemphigus, including paraneoplastic pemphigus (paraneoplastic multiorgan syndrome), dermatitis herpetiformis, linear IgA bullous dermatosis, chronic bullous disease of childhood, epidermolysis bullosa acquisita, porphyria cutanea tarda, bullous eruption of lupus erythematosus, and atypical or mixed forms of bullous disease, systemic lupus erythematosus, cutaneous lupus erythematosus, or other variants, vasculitis, lichen planus, and other inflammatory diseases

 

This test is not useful for diagnosis of malignancies involving the skin.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Skin or mucosal tissue from patients with autoimmune bullous diseases, connective tissue disease, vasculitis, lichen planus, and other inflammatory conditions often contains bound immunoglobulin, complement, or fibrinogen.

 

Biopsy specimens are examined for the presence of bound IgG, IgM, IgA, third component of complement (C3), fibrinogen, and IgG4.

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.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

A board-certified Dermatopathologist will review and interpret the test results in correlation with other clinical findings as provided.

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

This test is an adjunctive test to be interpreted in the context of clinical information, histologic studies, and serologic studies as clinically indicated.

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

1. Jain S, Basavaraj V, Vimala MG: Utility of Direct Immunofluorescence Studies in Subclassification of Autoimmune Sub-Epidermal Bullous Diseases: A 2-Year Study in a Tertiary Care Hospital. Turk Patoloji Derg. 2016;32(2):91-98. doi: 10.5146/tjpath.2015.01345

2. Diercks GF, Pas HH, Jonkman MF: Immunofluorescence of Autoimmune Bullous Diseases. Surg Pathol Clin. 2017 Jun;10(2):505-512. doi: 10.1016/j.path.2017.01.011

3. Kershenovich R, Hodak E, Mimouni D: Diagnosis and classification of pemphigus and bullous pemphigoid. Autoimmun Rev. 2014 Apr-May;13(4-5):477-481. doi: 10.1016/j.autrev.2014.01.011

4. Buschman KE, Seraly M, Thong HY, Deng JS, Draviam RP, Abernethy JL: A predominant IgG4 subclass may be responsible for false-negative direct immunofluorescence in bullous pemphigoid. J Cutan Pathol. 2002 May;29(5):282-286. doi: 10.1034/j.1600-0560.2002.290504.x

5. Lamb PM, Patton T, Deng JS: The predominance of IgG4 in prodromal bullous pemphigoid. Int J Dermatol. 2008 Feb;47(2):150-153. doi: 10.1111/j.1365-4632.2008.03361.x

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Frozen sections of biopsy specimens are brought to ambient temperature, air dried, washed with phosphate-buffered saline (PBS), and then layered with fluorescein isothiocyanate (FITC)-conjugated rabbit antihuman IgG, IgA, IgM, C3, fibrinogen, and IgG4. These slides are incubated in a moist chamber at ambient temperature. The sections are then washed with PBS, mounted in buffered glycerine, and viewed under a fluorescence microscope.(Mysorekar VV, Sumathy TK, Shyam Prasad AL: Role of direct immunofluorescence in dermatological disorders. Indian Dermatol Online J. 2015;6[3]:172-180. doi: 10.4103/2229-5178.156386)

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 through Friday

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 3 days

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

Stained slides:14 days; Remaining biopsy tissue: 30 days

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

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

Per biopsy site:

88346

88350 x 5

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
CIB Cutaneous Direct IFA, Biopsy In Process
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.
71145 Interpretation 66121-5
71146 Participated in the Interpretation No LOINC Needed
71147 Report electronically signed by 19139-5
71610 Addendum 35265-8
71855 Case Number 80398-1

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

Test Update Resources

Change Type Effective Date
Test Changes - Method 2021-07-20