Test Catalog

Test Id : FLCS

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Immunoglobulin Free Light Chains, Serum

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Overview

Test Catalog

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

Monitoring serum from patients with monoclonal light chain diseases without a M-spike on protein electrophoresis

 

May be useful as a diagnostic test in patients in whom there is a suspicion of primary systemic amyloidosis, light chain deposition disease, or non-secretory myeloma

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
KFLCS Kappa Free Light Chain, S No Yes
LFLCS Lambda Free Light Chain, S No Yes
KLRS Kappa/Lambda FLC Ratio No Yes

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

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

Turbidimetry

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

Immunoglobulin Free Light Chains, S

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

Free Light Chains

Kappa

Kappa FLC

Kappa-Free Light Chain

Lambda

Lambda FLC

Lambda-Free Light Chain

Light Chains

Serum Free Light Chains

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

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: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen: 

-General Request (T239)

-Hematopathology/Cytogenetics Test Request (T726)

-Renal Diagnostics Test Request (T830)

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 OK
Gross lipemia Reject
Gross icterus OK

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

Monitoring serum from patients with monoclonal light chain diseases without a M-spike on protein electrophoresis

 

May be useful as a diagnostic test in patients in whom there is a suspicion of primary systemic amyloidosis, light chain deposition disease, or non-secretory myeloma

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

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

The monoclonal gammopathies are characterized by a clonal expansion of plasma cells that secrete a monoclonal immunoglobulin. The monoclonal immunoglobulin secreted by these cells serves as a marker of the clonal proliferation, and the quantitation of monoclonal protein can be used to monitor the disease course. The monoclonal gammopathies include multiple myeloma (MM), light chain MM (LCMM), Waldenstrom macroglobulinemia (WM), nonsecretory MM (NSMM), smoldering MM (SMM), monoclonal gammopathy of undetermined significance (MGUS), primary systemic amyloidosis (AL), and light chain deposition disease (LCDD). The monoclonal light chain diseases (LCMM, AL, LCDD, and NSMM) often do not have serum monoclonal proteins in high enough concentration to be detected and quantitated by serum protein electrophoresis.

 

An elevated ratio of kappa to lambda free light chains (FLC K/L) indicates a monoclonal kappa FLC, and an abnormally low FLC K/L indicates a monoclonal lambda FLC. The kappa and lambda FLC may both be elevated in the sera of patients with polyclonal hypergammaglobulinemia, but the FLC K/L is normal. If a patient has an abnormal serum FLC K/L ratio but has no serum monoclonal protein detected by immunofixation, a urine monoclonal protein study (eg, immunofixation) should be performed and the serum immunofixation should be repeated.

 

The FLC K/L ratio may be useful as a diagnostic test for patients in whom immunofixation for serum monoclonal light chains is negative and in whom there is a suspicion of primary systemic amyloidosis, light chain deposition disease, or non-secretory myeloma.

 

The quantitation of kappa or lambda immunoglobulin free light chains may be used to monitor disease activity in patients with monoclonal light chain diseases without a serum M-spike.

 

The following algorithms are available:

-Amyloidosis: Laboratory Approach to Diagnosis

-Multiple Myeloma: Laboratory Screening

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.

KAPPA-FREE LIGHT CHAIN

0.33-1.94 mg/dL

 

LAMBDA-FREE LIGHT CHAIN

0.57-2.63 mg/dL

 

KAPPA/LAMBDA FLC RATIO

0.26-1.65

Interpretation
Provides information to assist in interpretation of the test results

The specificity of this assay for detection of monoclonal light chains relies on the ratio of free kappa and lambda (K/L) light chains. Once an abnormal free light chain (FLC) K/L ratio has been demonstrated and a diagnosis has been made, the quantitation of the monoclonal light chain is useful for monitoring disease activity.

 

Changes in FLC quantitation reflect changes in the size of the monoclonal plasma cell population. Our experience to date is limited, but changes of more than 25% or trending of multiple specimens are needed to conclude biological significance.

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

Elevated kappa and lambda (K/L) free light chain (FLC) may occur due to polyclonal hypergammaglobulinemia or impaired renal clearance. A specific increase in FLC (eg, FLC K:L ratio) must be demonstrated for diagnostic purposes.

This assay has not been established for use with the pediatric population.   

Moderate-to-marked lipemia may interfere with the ability to perform testing.

Supportive Data

Studies at Mayo Clinic have shown that in some patients with urine monoclonal light chains and negative serum immunofixation (IF), the free light chain (FLC) assay can identify monoclonal FLC in the serum. These studies support the increased sensitivity of the nephelometric FLC assay. In a series of patients with primary systemic amyloid treated by stem cell transplantation, the quantitation and monitoring of FLC predicted organ response (eg, disease course).

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

1. Kaleta E, Kyle R, Clark R, Katzmann J: Analysis of patients with gamma-heavy chain disease by the heavy/light chain and free light chain assays. Clin Chem Lab Med. 2014 May;52(5):665-669. doi: 10.1515/cclm-2013-0714

2. Palladini G, Russo P, Bosoni T, et al: Identification of amyloidogenic light chains requires the combination of serum-free light chain assay with immunofixation of serum and urine. Clin Chem. 2009 Mar;55(3):499-504. doi: 10.1373/clinchem.2008.117143

3. Dispenzieri A, Kyle R, Merlini G, et al: International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia. 2009 Feb;23(2):215-224. doi: 10.1038/leu.2008.307

4. Drayson M, Tang LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR: Serum free light chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood. 2001 May 1;97(9):2900-2902

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

The determination of the soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibrations curve stored within the instrument.(Package inserts: Optilite Freelite Kappa Free Kit. The Binding Site Group, Ltd; 08/2018; Optilite Freelite Lambda Free Kit. The Binding Site Group, Ltd; 08/2018)

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.

Monday through Friday

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.

Same day/1 to 2 days

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

14 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

83521 x 2

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
FLCS Immunoglobulin Free Light Chains, S 104533-5
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.
LFLCS Lambda Free Light Chain, S 33944-0
KLRS Kappa/Lambda FLC Ratio 104546-7
KFLCS Kappa Free Light Chain, S 104544-2

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