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Epic Test Code KM55 Galactose Deficient IgA1 (KM55) Immunostain, Technical Component Only

Test Down Notes

Effective October 08, 2024:  This test is temporarily unavailable due to analytic issues.  The downtime is expected to be >30 days.  An alternate test option is not available.  See test notification here.


Ordering Guidance


This test includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.



Shipping Instructions


Attach the green "Attention Pathology" address label (T498) and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.



Specimen Required


Specimen Type: Tissue

Supplies: Immunostain Technical Only Envelope (T693)

Container/Tube: Immunostain Technical Only Envelope

Preferred:

-Formalin-fixed, paraffin-embedded tissue block

OR

-2 Unstained, positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick

Acceptable: None


Useful For

Identification of Galactose deficient IgA1 by KM55, useful in the diagnosis of IgA nephropathy

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IHTOI IHC Initial, Tech Only No No
IHTOA IHC Additional, Tech Only No No

Testing Algorithm

For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).

Method Name

Immunohistochemistry (IHC)

Reporting Name

KM55 IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time Special Container
TECHONLY Ambient (preferred)
  Refrigerated 

Reject Due To

Wet/frozen tissue 
Cytology smears 
Nonformalin fixed tissue 
Nonparaffin embedded tissue 
Noncharged slides 
ProbeOn slides 
Snowcoat slides 		 Reject 

Clinical Information

KM55 antibody has been shown to identify galactose deficient IgA1 (Gd-IgA1), useful in the diagnosis of IgA nephropathy.  Gd-IgA1 (KM55) is detected in the glomeruli of patients with IgA nephropathy and IgA vasculitis and may aid in distinguishing IgA nephropathy and IgA vasculitis from other glomerular diseases with IgA deposits detected by routine IgA staining.

Interpretation

This test does not include pathologist interpretation, only technical performance of the stain. If interpretation is required, order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.

 

The positive and negative controls are verified as showing appropriate immunoreactivity. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 855-516-8404.

 

Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Cautions

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

 

The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.

 

Best practices for storage of positively charged slides:

-Minimize time slides are stored after being unpackaged

-Limit exposure to high humidity and heat

-Minimize exposure to plastics

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Specimen Retention Time

Until staining is complete

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

88342-TC, Primary

88341-TC, If additional IHC

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.