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Dual Kappa and Lambda free light chain (FLC) Controls

FLC LFD Controls are designed to be used within the quality control procedure for Seralite®– FLC Urine, a rapid lateral flow test (immunochromatographic assay) for the qualitative measurement of kappa (κ) and lambda (λ) immunoglobulin free light chains (FLCs) in serum.

Free light chains are an important diagnostic biomarker for identifying and monitoring B-cell Dyscrasias, including multiple myeloma.

Good laboratory practice recommends the use of quality controls within the testing procedure for clinical samples. The inclusion of these controls prior to performing the immunochromatographic assay will ensure the performance of the test devices and the subsequent quantification by the ADxLR5® Reader System.

FLC Urine LFD Controls Contents

The FLC Controls are lyophilised samples containing known levels of free kappa and lambda light chains. The elevated control sample is produced through the addition of human FLCs to a biological matrix. Handle control samples as if they were potentially infective material with appropriate handling and disposal methods established, including users wearing suitable protective equipment.

FLC LFD Control 1
Lyophilised Kappa Not Elevated and Lambda Not Elevated FLC sample (1ml presented as freeze-dried material)

FLC LFD Control 2
Lyophilised Lambda Elevated and Kappa Elevated FLC sample (1ml presented as freeze-dried material)

Also included are instructions for use (IFU).

Once reconstituted the samples will produce qualitative results that upon interpretation will be classified as:

FLC LFD Control 1

Kappa and Lambda both not elevated.

FLC LFD Control 2

Kappa and Lambda both Elevated.

The FLC LFD Controls are for in vitro use only and should only be used by laboratory diagnosticians and healthcare professionals.

If you have any questions about the FLC Urine LFD Controls and how to incorporate them into the Seralite®– FLC Urine user protocol please contact a member of our team on +44 (0) 1904 406080 or info@abingdonhealth.com.