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Test Code COL7 Anti-Collagen type VII, IgG Antibodies, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Secondary ID

616879

Useful For

Initial screening test in the diagnosis of epidermolysis bullosa acquisita and other immunobullous diseases mediated by collagen VII

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Anti-Collagen type VII, Serum

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  30 days
  Ambient  14 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Epidermolysis bullosa acquisita and certain other rare immunobullous diseases, including bullous lupus erythematosus, are caused by the development of IgG antibodies directed against collagen type VII, which lead to blisters and erosions that may heal with scarring. Circulating IgG autoantibodies against collagen type VII can be found in patient serum in these conditions.

Reference Values

Collagen type VII

<20 RU/mL (negative)

≥20 RU/mL (positive)

Interpretation

Antibodies to IgG collagen type VII have been shown to be present in patients with epidermolysis bullosa acquisita and certain other rare immunobullous diseases, including bullous lupus erythematosus

Cautions

The results obtained with collagen type VII enzyme-linked immunosorbent assay kit serve as an aid to diagnosis and should be interpreted in the patient’s clinical context.

 

Performance of the assay on other matrices besides serum has not been established.

Clinical Reference

1. Chen M, Chan LS, Cai X, O’Toole EA, Sample JC, Woodley DT: Development of an ELISA for rapid detection of anti-type VII collagen autoantibodies in epidermolysis bullosa acquisita. J Invest Dermatol. 1997 Jan;108(1): 68-72

2. Holtsche MM, van Beek N, Hashimoto T, et al: Diagnosis of epidermolysis bullosa acquisita: multicentre comparison of different assays for serum anti-type VII collagen reactivity. Acta Derm Venereol. 2021 Mar 23;101(3):adv00420

3. Schmidt T, Hoch M, Lofti Jad SS, et al: Serological diagnostics in the detection of IgG autoantibodies against human collagen VII in epidermolysis bullosa acquisita: a multicentre analysis. Br J Dermatol. 2017 Dec;117(6):1683-1692

4. Komorowski L, Muller R, Vorobyev A, et al: Sensitive and specific assays for routine serological diagnosis of epidermolysis bullosa acquisita. J Am Acad Dermatol. 2013 March;68(3):89-95

Method Description

This enzyme-linked immunosorbent assay (ELISA) method detects and measures serum levels of antibodies of certain pemphigoid diseases. Calibrators and patient sera are added to microwells coated with collagen type VII antigens, allowing antibodies to react with the immobilized antigens. After washing to remove any unbound serum proteins, horseradish peroxidase-conjugate IgG is added and incubated. Following another wash step, the peroxidase substrate is added and allowed to incubate for an additional period. A stop solution is then added to each well to cancel the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results. The amount of antigen-specific bound antibody is proportional to the color intensity.(Unpublished Mayo method)

Day(s) Performed

Varies

Report Available

1 to 5 days

Specimen Retention Time

30 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

83516

LOINC Code Information

Test ID Test Order Name Order LOINC Value
COL7 Anti-Collagen type VII, Serum In Process

 

Result ID Test Result Name Result LOINC Value
616879 COL7, S 94096-5