Freelite®
   

Freelite® Serum Free Light Chain Assays

Freelite® is a major breakthrough for the detection and monitoring of Multiple Myeloma (MM) and other B-cell dyscrasia. Freelite assays were developed by Binding Site to measure free lambda and free kappa immunoglobulin light chains. Our expertise in the manufacture of antibodies has enabled us to provide a quantifiable, highly specific, automatable free light chain assay for serum.

Significant clinical evidence indicates the benefit of Freelite® serum free light chain assays in initial screening for monoclonal gammopathies.  Other benefits include the identification of AL amyloidosis and Nonsecretory MM patients missed by conventional electrophoretic methods, use as a prognostic indicator for progression in myeloma, for risk stratification of MGUS patients, and rapid evaluation of treatment efficacy

Freelite® is a sensitive, specific marker of kappa and lambda free light chains (FLC) in serum and provides quantitative measurement of:

  • Free kappa in serum
  • Free lambda in serum
  • The serum free kappa/free lambda ratio (κ/λ)

The serum free light chain ratio is a strong indicator of monoclonality and is valuable for distinguishing monoclonal from polyclonal diseases.

 

In 2009 the International Myeloma Working Group published guidelines recommending the measurement of serum free light chain concentrations as an aid in the diagnosis, prognosis and monitoring of multiple myeloma patients.
The advice was based upon results obtained in extensive clinical trials using the polyclonal Freelite® assays.1

Freelite® nephelometric and turbidimetric assays can be run on most major immunology and clinical chemistry analysers. In the USA Freelite assays are available from all the major reference laboratories and most Myeloma centres.


Ordering information for Freelite® assays 

Description
Pack
Code
Freelite® Kappa Latex SPAPLUS kit
Range 4-180 mg/L (@1/10)
Range 40-1800 mg/L (1/100)
Sensitivity 0.4 mg/L
100 test
LK016.S
Freelite® Lambda Latex SPAPLUS kit
Range 4.5 - 165 mg/L (@1/10)
Range 45 - 1650 mg/L (@1/100)
Sensitivity 0.6 mg/L
100 test
LK018.S

Further assays are available on the Binding Site SPAplus

Description
Pack
Code
Roche cobas® 6000
Freelite® Kappa Kit

Range: 3.7 - 56.2 mg/L
Sensitivity: 0.8 mg/L @1/1
100 test
LK016.CB
Roche cobas® 6000
Freelite® Lambda Kit

Range: 5.6 - 74.8 mg/L
Sensitivity: 0.7 mg/L @1/1
100 test
LK018.CB
Roche cobas® 6000
Freelite® Kappa Bulk Kit
1000 test LK016.10CB
Roche cobas® 6000
Freelite® Lambda Bulk Kit
1000 test LK018.10CB

 

Description Pack Code
Roche COBAS Integra® 400/400 Plus/800
Freelite® Kappa Kit
Range: 2.9 - 127 mg/L
Sensitivity: 0.6 mg/L (1/2)
100 test
LK016.RI
Roche COBAS Integra® 400/400 Plus/800
Freelite® Lambda Kit

Range: 5.2 - 139 mg/L
Sensitivity: 1.3 mg/L (1/2)
100 test
LK018.RI

  

Description
Pack
Code
Roche Hitachi 911/912/917/P module
Freelite® Kappa Kit
Range: 3.70 - 56.2 mg/L
Sensitivity: 0.8 mg/L @1/1
2 x 50 test
LK016.H
Roche Hitachi 911/912/917/P module
Freelite® Lambda Kit
Range: 5.6 - 74.8 mg/L
Sensitivity: 0.7 mg/L @1/1
2 x 50 test
LK018.H
Roche Hitachi 911/912/917/P module
Freelite® Kappa Bulk Kit
20 x 50 test
LK016.10H
Roche Hitachi 911/912/917/P module
Freelite® Lambda Bulk Kit
20 x 50 test
LK018.10H

cobas® and Integra® are registered trademarks of F. Hoffman-La Roche Ltd, Basel, Switzerland.

Description
Pack
Code
Siemens BN™II
Freelite® Kappa Kit
Range: 5.94 - 190 mg/L
Sensitivity: 0.3 mg/L @ 1/5
2 x 50 test
LK016.T
Siemens BN™II
Freelite® Lambda Kit

Range: 5.0 - 160 mg/L
Sensitivity: 0.3 mg/L @ 1/5
2 x 50 test
LK018.T
Siemens BN™II
Freelite® Kappa Bulk Kit
20 x 50 test
LK016.10T
Siemens BN™II
Freelite® Lambda Bulk Kit
20 x 50 test
LK018.10T
Siemens BN ProSpec®
Freelite® Kappa Kit

Range: 5.94 - 190 mg/L
Sensitivity: 0.3 mg/L @ 1/5
2 x 50 test
LK016.P
Siemens BN ProSpec®
Freelite® Lambda Kit

Range: 5.0 - 160 mg/L
Sensitivity: 0.3 mg/L @ 1/5
2 x 50 test
LK018.P

Description
Pack
Code
Siemens ADVIA® 1650/1800/2400
Freelite® Kappa Kit

Range: 3.74 – 56.2 mg/L
Sensitivity: 0.8 mg/L @ 1/1
2 x 50 test
LK016.B
Siemens ADVIA® 1650/1800/2400
Freelite® Lambda Kit

Range: 5.6 – 74.8 mg/L
Sensitivity: 0.7 mg/L @ 1/1
2 x 50 test
LK018.B

ADVIA® and ProSpec® are registered trademarks of Siemens Healthcare Diagnostics Inc.
BNTMII is a trademark of Siemens Healthcare Diagnostics Inc.
 

Description
Pack
Code
Beckman Coulter IMMAGE®
Freelite® Kappa Kit
Range: 6.0 - 180 mg/L
Sensitivity: 3.0 mg/L @ 1/5
2 x 50 test
LK016.IM
Beckman Coulter IMMAGE®
Freelite® Lambda Kit

Range: 4.8 - 162 mg/L
Sensitivity: 2.4 mg/L @ 1/5
2 x 50 test
LK018.IM

Description
Pack
Code
Beckman Coulter
AU400/640/2700/5400
Freelite® Kappa Kit

Range: 6.0 - 150 mg/L
Sensitivity: 3.0 mg/L @ 1/5
2 x 50 test
LK016.AU
Beckman Coulter
AU400/640/2700/5400
Freelite® Lambda Kit

Range: 6.0 - 150 mg/L
Sensitivity: 3.0 mg/L @ 1/5
2 x 50 test
LK018.AU

IMMAGE® and AU are registered trademarks of Beckman Instruments Inc..

Freelite® Panel Sample Set

A panel of 20 samples is available for the assessment of Freelite® reagents. Diagnosis, SPE and IFE results for each sample are supplied.

Description
Pack
Code
Freelite® Panel Set*
20 samples
1
BP228

Storage and Stability - This product should be stored at 2-8°C where it will remain stable until the given expiry date.

 

 Freelite® Linearity Serum

This serum is available for the assessment of linearity across the calibration curve.

Description
Pack
Code
Freelite® Linearity Serum*
7mL
BP231

Storage and Stability - This product should be stored at 2-8°C where it will remain stable until the given expiry date. Any dilutions prepared from this product should be used within 4 hours.


* For Research Use only
 

 

Each comprehensive kit provides components required to perform 100 free kappa or 100 free lambda assays. Liquid stable reagents are provided as 2 x 50 tests or 1 x 100 tests, as indicated. Bulk kits contain reagents for 1000 tests.

• Calibrators
• Controls (1 x high and 1 x low)
• Liquid latex reagent

The liquid latex, calibrator and controls can be stored for up to 3 months at 2-8ºC after opening.

Kits are FDA cleared for in vitro diagnostic use to aid in the diagnosis and monitoring of Multiple Myeloma, Lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, Light Chain Deposition Disease and connective tissue diseases such as Systemic Lupus Erythematosus.

Freelite® is CE marked for many European countries, please contact us for the latest information.
 

  1. Dispenzieri A, et al. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia 2009; 23:215-224