Test Catalog

Test Id : K11CS

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Kelch-Like Protein 11 Antibody, Cell Binding Assay, Serum

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Overview

Test Catalog

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

Evaluating patients with paraneoplastic or autoimmune encephalitis (brainstem encephalitis or limbic encephalitis or cerebellar ataxia) using serum specimens

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
K11TS KLHL11 Ab IFA Titer, S No No

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

If the cell binding antibody result is reactive, then the immunofluorescence titer assay will be performed at an additional charge.

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

Cell-Binding Assay (CBA)

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

KLHL11 Ab CBA, S

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

KLHL11

Kelch-like protein 11

Kelch 11

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

If the cell binding antibody result is reactive, then the immunofluorescence titer assay will be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Serum

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

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

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

 

Forms

If not ordering electronically, complete, print, and send a Neurology Specialty Testing Client Test Request (T732) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus 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
Serum Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 72 hours

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

Evaluating patients with paraneoplastic or autoimmune encephalitis (brainstem encephalitis or limbic encephalitis or cerebellar ataxia) using serum specimens

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

If the cell binding antibody result is reactive, then the immunofluorescence titer assay will be performed at an additional charge.

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

Kelch-like protein 11 (KLHL11 or Kelch-like family member 11) IgG is a biomarker of paraneoplastic encephalitis, KLHL11 encephalitis is a unique paraneoplastic syndrome commonly associated with testicular germ cell tumors mainly seminoma. Ataxia, diplopia, dysarthria, and vertigo are common presenting features of the rhombencephalitis phenotype. Hearing loss and tinnitus may precede other neurological signs and symptoms by weeks to months. A subset of patients also has clinical and magnetic resonance imaging (MRI) presentations consistent with limbic encephalitis. Most patients with this syndrome have inflammatory spinal fluid profiles, especially elevated oligoclonal bands. MRI brain demonstrates T2 fluid attenuated inversion recovery (T2/FLAIR) abnormalities involving the brainstem or limbic system. The accompanying neurological disorder is usually severe. Clinical improvement following treatment of cancer or immunotherapy has been reported.

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

Evaluating patients with paraneoplastic or autoimmune encephalitis (brainstem encephalitis or limbic encephalitis or cerebellar ataxia) using serum specimens

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

A negative Kelch-like protein 11 (KLHL11) antibody test result does not exclude autoimmune neurological disease or cancer. 

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

1. Mandel-Brehm C, Dubey D, Kryzer TJ, et al: Kelch-like protein 11 antibodies in seminoma-associated paraneoplastic encephalitis. N Engl J Med. 2019;381:47-54

2. Dubey D, Wilson MR, Clarkson B, et al: Expanded clinical phenotype, oncological associations, and immunopathologic insights of paraneoplastic Kelch-like protein-11 encephalitis. JAMA Neurol. 2020 Aug 3;77(11):1-10

 

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

Cell Binding Assay:

Methodology for detecting Kelch-like protein 11 (KLHL11)-IgG uses a cell binding assay (CBA) with confirmation by tissue immunofluorescence (IFA). The CBA utilizes HEK293 cells that are stably transfected with DNA encoding the KLHL11 protein that has been tagged with green fluorescent protein (GFP). Since KLHL11 is localized to cytoplasmic vesicles when ectopically expressed, cells will be fixed and permeabilized prior to exposure to patient sample. Patients that are positive for KLHL11-IgG will have human IgG bound to the transfected cells. Binding will colocalize with the GFP-tagged KLHL11 protein in cytoplasmic vesicles. Patient IgG will be detected using a tetramethylrhodamine (TRITC)-conjugated anti-human secondary antibody. The negative samples will not bind to KLHL11-GFP in transfected cells. Performed in a 96 well plate format, the plates are scanned, and the images saved using the ImageXpress Micro Confocal High-Content Imaging System (Molecular Devices). Images will be scored positive or negative.(Unpublished Mayo method)

 

Indirect Immunofluorescence Assay:

Tissue IFA utilizes mouse composite slides including brain, kidney, and stomach tissue sections, which are commercially purchased. After tissue sections are fixed and permeabilized, patient sample is added to the well. After washing with phosphate buffer saline, bound human IgG is detected with a fluorescent conjugated secondary antibody targeting human IgG. Slides are read under a fluorescent microscope for the unique tissue-specific staining pattern characteristic of KLHL11-IgG.(Unpublished Mayo method)

 

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.

Varies

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.

3 to 5 days

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

28 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 account representative. 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 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
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.

0432U

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
K11CS KLHL11 Ab CBA, S 99072-1
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.
610581 KLHL11 Ab CBA, S 99072-1

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