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Test Code CIB Cutaneous Direct Immunofluorescence Assay, Varies

Reporting Name

Cutaneous Direct IFA, Biopsy

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.

Method Name

Direct Immunofluorescence Assay (IFA)


Necessary Information


All requisition and supporting information must be submitted in English.

 

Each of the following items is required:

1. All requisitions must be labeled with:

-Patient name, date of birth, and medical record number

-Name and phone number of the referring pathologist or ordering provider

-Anatomic site and collection date

2. A suspected diagnosis and reason for testing

See Specimen Required - Recommended Biopsy Site Selection Based on Disease State for how to label biopsy site specimens.



Specimen Required


Processed as 1 specimen: Two or more biopsies from same site and sent in 1 specimen vial.

Processed as 2 specimens: Two or more biopsies from different sites require separate specimen vials.

Note: These can be ordered together. Tests performed on each site will be billed accordingly.

 

Transport Medium Method

Specimen Type: Tissue

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

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

Container/Tube: Screw-capped container or vial containing transport medium (Michel's, also called Zeus media)

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

Collection Instructions:

1. Collect biopsy of skin or mucosa avoiding old lesions (including facial), ulcers, erosions, or bullae. 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.

 

Acceptable

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 skin or mucosa avoiding old lesions (including facial), ulcers, erosions, or bullae. 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: 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 Type

Varies

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

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.

Day(s) Performed

Monday through Friday

Report Available

2 to 5 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

Testing Algorithm

For information see Pathology Consultation Ordering Algorithm