Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool

Campbell, John P.; Heaney, Jennifer; Shemar, Meena; Baldwin, Dene; Griffin, Ann; Oldridge, Emma; Goodall, Margaret; Afzal, Zaheer; Plant, Tim; Cobbold, Mark; Jefferis, Roy; Jacobs, Joannes F M; Hand, C.W.; Drayson, Mark T.

doi:10.1515/cclm-2016-0194

Cited by 31 publications

(33 citation statements)

References 39 publications

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“…However, evaluation has been carried out with N Latex in patients with renal impairment (without myeloma) where, unlike Seralite® and Freelite®, an adapted κ:λ ratio renal reference range was found not to be required [20]. Good clinical concordance has been shown between the different sFLC methods previously [14, 15, 17]. However, it is essential to remember that assays cannot be used interchangeably as they quantitate sFLC levels in different ways, particularly monoclonal FLCs [14, 15, 20, 21].…”

Section: Discussionmentioning

confidence: 99%

Multiple myeloma can be accurately diagnosed in acute kidney injury patients using a rapid serum free light chain test

et al. 2017

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BackgroundAcute kidney injury (AKI) is common in patients with multiple myeloma (MM). Whether serum free light chain (sFLC) measurements can distinguish between myeloma and other causes of AKI requires confirmation to guide early treatment. A rapid and portable sFLC test (Seralite®) is newly available and could reduce delays in obtaining sFLC results and accelerate diagnosis in patients with unexplained AKI. This study evaluated the accuracy of Seralite® to identify MM as the cause of AKI.MethodsFLCs were retrospectively analysed in patients with AKI stage 3 as per KDIGO criteria (i.e. serum creatinine ≥354 μmol/L or those on dialysis treatment) (n = 99); 45/99 patients had a confirmed MM diagnosis.ResultsThe Seralite® κ:λ FLC ratio accurately diagnosed all MM patients in the presence of AKI: a range of 0.14–2.02 returned 100% sensitivity and specificity for identifying all non-myeloma related AKI patients. The sFLC difference (dFLC) also demonstrated high sensitivity (91%) and specificity (100%): an optimal cut-off of 399 mg/L distinguished between myeloma and non-myeloma AKI patients. We propose a pathway of patient screening and stratification in unexplained AKI for use of Seralite® in clinical practice, with a κ:λ ratio range of 0.14–2.02 and dFLC 400 mg/L as decision points.ConclusionsSeralite® accurately differentiates between AKI due to MM and AKI due to other causes in patients considered at risk of myeloma. This rapid test can sensitively screen for MM in patients with AKI and help inform early treatment intervention.

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Section: Discussionmentioning

confidence: 99%

Multiple myeloma can be accurately diagnosed in acute kidney injury patients using a rapid serum free light chain test

et al. 2017

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“…However, evaluation has been carried out with N Latex in patients with renal impairment (without myeloma) where, unlike Seralite® and Freelite®, an adapted κ:λ ratio renal reference range was found not to be required [20]. Good clinical concordance has been shown between the different sFLC methods previously [14,15,17]. However, it is essential to remember that assays cannot be used interchangeably as they quantitate sFLC levels in different ways, particularly monoclonal FLCs [14,15,20,21].…”

Section: Discussionmentioning

confidence: 99%

“…Good clinical concordance has been shown between the different sFLC methods previously [14,15,17]. However, it is essential to remember that assays cannot be used interchangeably as they quantitate sFLC levels in different ways, particularly monoclonal FLCs [14,15,20,21]. Users need to ensure consecutive samples from individual patients are compared using the same assay, taking into account the specific healthy and renal reference limits provided by the different tests.…”

Section: Discussionmentioning

confidence: 99%

“…All serum samples underwent analysis for FLCs using Seralite® -a portable lateral-flow test that utilises anti-FLC monoclonal antibodies (Abingdon Health Ltd., Oxford, UK) enabling simultaneous quantification of κ and λ FLC levels (described in full elsewhere) [14]. Healthy donor patient samples were also analysed for creatinine (Roche Hitachi Cobas C501).…”

Section: Serum Sample Analysesmentioning

confidence: 99%

“…Seralite® (Abingdon Health Ltd., UK) is a lateral-flow test that rapidly quantitates serum κ and λ FLC levels simultaneously in 10 min, which can be easily used as an urgent assay for small numbers of samples in routine hospital laboratories. Seralite® and associated FLC assays using the same anti-FLC reagents have already been shown to perform well in diagnosing and monitoring multiple myeloma in the absence of severe renal impairment [14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

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Multiple Myeloma Can Be Accurately Diagnosed in Acute Kidney Injury Patients Using a Rapid Serum Free Light Chain Test

Drayson

Heaney

Campbell

et al. 2017

Clinical Lymphoma Myeloma and Leukemia

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Background: Acute kidney injury (AKI) is common in patients with multiple myeloma (MM). Whether serum free light chain (sFLC) measurements can distinguish between myeloma and other causes of AKI requires confirmation to guide early treatment. A rapid and portable sFLC test (Seralite®) is newly available and could reduce delays in obtaining sFLC results and accelerate diagnosis in patients with unexplained AKI. This study evaluated the accuracy of Seralite® to identify MM as the cause of AKI. Method: sFLCs were retrospectively analysed in patients with AKI stage 3 as per KDIGO criteria (i.e. serum creatinine ≥354 μmol/L or those on dialysis treatment) (n = 99); 45/99 patients had a confirmed MM diagnosis. Results: The Seralite® κ:λ FLC ratio accurately diagnosed all MM patients in the presence of AKI: a range of 0.14-2.02 returned 100% sensitivity and specificity for identifying all non-myeloma related AKI patients. The sFLC difference (dFLC) also demonstrated high sensitivity (91%) and specificity (100%): an optimal cut-off of 399 mg/L distinguished between myeloma and non-myeloma AKI patients. We propose a pathway of patient screening and stratification in unexplained AKI for use of Seralite® in clinical practice, with a κ:λ ratio range of 0.14-2.02 and dFLC 400 mg/L as decision points. Conclusions: Seralite® accurately differentiates between AKI due to MM and AKI due to other causes in patients considered at risk of myeloma. This rapid test can sensitively screen for MM in patients with AKI and help inform early treatment intervention.

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Serum free light chain quantitative assays: Dilemma of a biomarker

Cigliana¹,

Gulli

Napodano

et al. 2017

Clinical Laboratory Analysis

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Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool

Abstract: Seralite® sensitively quantitates FLC and rapidly identifies clinical conditions where FLC are abnormal, including MM.

Cited by 31 publications

References 39 publications

Multiple myeloma can be accurately diagnosed in acute kidney injury patients using a rapid serum free light chain test

Multiple myeloma can be accurately diagnosed in acute kidney injury patients using a rapid serum free light chain test

Multiple Myeloma Can Be Accurately Diagnosed in Acute Kidney Injury Patients Using a Rapid Serum Free Light Chain Test

Serum free light chain quantitative assays: Dilemma of a biomarker

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