A Single Reference Interval for Interpreting Serum Free Light Chains across Patients with Varying Renal Function.
BACKGROUND: Serum free light chain (sFLC) assays are interpreted using a sFLC-ratio-based reference interval (manufacturer's interval) that was defined using a cohort of healthy patients. However, renal impairment elevates the sFLC-ratio, leading to a high false positive rate when using the manufact...
| Publicado en: | Clinical Chemistry Vol. 69; no. 6; pp. 595 - 606 |
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| Autores principales: | , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
Oxford University Press / USA
Jun2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=164125329&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 164125329 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00099147 10CS jtl: Clinical Chemistry issn: 00099147 maglogo: N pubinfo: dt: Jun2023 vid: 69 iid: 6 pid: 622 pub: Oxford University Press / USA artinfo: ui: 164125329 10.1093/clinchem/hvad043 164125329 ppf: 595 ppct: 11 formats: fmt: @attributes: type: P tig: atl: A Single Reference Interval for Interpreting Serum Free Light Chains across Patients with Varying Renal Function. aug: au: Azimi, Vahid Slade, Michael Fiala, Mark Fortier, Julie M. Stockerl-Goldstein, Keith Frater, John L. Brestoff, Jonathan R. Jackups, Ronald Zaydman, Mark A. affil: Department of Pathology and Immunology, Washington University in St. Louis, School of Medicine, St. Louis, MO, United States sug: ab: BACKGROUND: Serum free light chain (sFLC) assays are interpreted using a sFLC-ratio-based reference interval (manufacturer's interval) that was defined using a cohort of healthy patients. However, renal impairment elevates the sFLC-ratio, leading to a high false positive rate when using the manufacturer's interval. Prior studies have developed renal-specific reference intervals; however, this approach has not been widely adopted due to practical limitations. Thus, there remains a critical need for a renally robust sFLC interpretation method. METHODS: Retrospective data mining was used to define patient cohorts that reflect the spectrum of renal function seen in clinical practice. Two new reference intervals, one based on the sFLC-ratio and one based on a novel principal component analysis (PCA)-based metric, were developed for the FREELITE assay (Binding Site) on the Roche Cobas c501 instrument (Roche). RESULTS: Compared to the manufacturer's reference interval, both new methods exhibited significantly lower false positive rates and greater robustness to renal function while maintaining equivalent sensitivity for monoclonal gammopathy (MG) diagnosis. While not significantly different, the point estimate for sensitivity was highest for the PCA-based approach. CONCLUSION: Renally robust sFLC interpretation using a single reference interval is possible given a reference cohort that reflects the variation in renal function observed in practice. Further studies are needed to achieve sufficient power and determine if the novel PCA-based metric offers superior sensitivity for MG diagnosis. These new methods offer the practical advantages of not requiring an estimated glomerular filtration rate result or multiple reference intervals, thereby lowering practical barriers to implementation. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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