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FLC LFD Controls

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 Serum, a rapid lateral flow test (immunochromatographic assay) for the quantitative 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.

FLC LFD Controls Contents

The FLC Controls are lyophilised samples containing known levels of free kappa and lambda light chains. The control samples are synthesised through the addition of human FLC to human sera. Sera should be treated as potentially hazardous material and appropriate handling and disposal methods established, including users wearing suitable protective equipment.

FLC LFD Control 1
Lyophilised high kappa and normal lambda FLC sample (1ml presented as freeze-dried material)

FLC LFD Control 2
Lyophilised high lambda and normal kappa FLC sample (1ml presented as freeze-dried material)

Also included are instructions for use (IFU) and a Certificate of Analysis Datasheet.

Once reconstituted the samples will produce numerical values that upon interpretation will be classified as:

FLC LFD Control 1

High kappa, normal lambda. Abnormal κ/λ ratio (above ratio range)

FLC LFD Control 2

High lambda, normal kappa. Abnormal κ/λ ratio (below ratio range)

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 LFD Controls and how to incorporate them into the Seralite®– FLC Serum user protocol please contact a member of our team on +44 (0) 1904 406080 or [email protected].