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Epic Code LAB1230025 Cutaneous Direct Immunofluorescence Assay, Varies

Important Note

MUST be submitted in Michel's media, available in the lab.

 

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).

Additional Codes

Mayo Code: CIB

Reporting Name

Cutaneous Direct IFA, Biopsy
Laboratory Test Directory Note:

Test name reported in SH EPIC is: "Cutaneous Immunofluorescence, Biopsy"

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Clinical Information

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.

Useful For

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.

Specimen Type

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


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.


Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred) 30 days
  Frozen  120 days
  Refrigerated  30 days

Reject Due To

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

Day(s) Performed

Monday through Friday

Reference Values

An interpretive report will be provided.

Interpretation

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

Cautions

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

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

Method Name

Direct Immunofluorescence Assay (IFA)

Method Description

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)

Report Available

2 to 3 days

Test Classification

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

Per biopsy site:

88346

88350 x 5

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CIB Cutaneous Direct IFA, Biopsy In Process

 

Result ID Test Result Name Result LOINC Value
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