期刊
EUROPEAN JOURNAL OF NEUROLOGY
卷 23, 期 4, 页码 713-721出版社
WILEY
DOI: 10.1111/ene.12924
关键词
cerebrospinal fluid; formula; immunoglobulins; intrathecal synthesis
资金
- Bayer Schering
- Biogen
- Merck Serono
- Novartis
- Bayer Healthcare
- Biogen Idec
- Genzyme-Sanofi
- Merck
- Novartis Pharma
- Teva-Ratiopharm
- Betaferon
- Bayer Schering Pharma
- Avonex
- Rebif
- Copaxone
- Teva Pharmaceuticals
- Tysabri
Background and purposeIntrathecal immunoglobulin (Ig) synthesis occurs in various chronic inflammatory neurological diseases. Different formulae have been developed for quantitative determination of Ig synthesis within the cerebrospinal fluid (CSF) compartment. The hyperbolic formula of Reiber is frequently used which, however, returns a considerable number of false positive results in empirical observations. MethodsA computerized database of more than 19 000 paired CSF and serum samples was screened for patients presumed negative for local Ig synthesis and a new formula characterizing this collective was calculated. The validity of this formula was confirmed by several validation steps. ResultsA cohort of 1173 patients with normal CSF findings was used for quantile regression. The 97.5th quantile of the formula Qlim(IgX)=axQalbb was considered as the cut-off curve for intrathecal Ig synthesis using different constants a and b for IgG, IgA and IgM. Compared to the Reiber formula, a lower level of false positive results was produced especially for IgM and IgA which was confirmed in a separate clinically well defined validation cohort. In 77 patients with discrepant findings between Reiber and our formula no specific diagnoses were found confirming the low diagnostic value of borderline Ig synthesis. ConclusionsA new approximation formula was developed for determination of intrathecal Ig synthesis which produces fewer false positive results without reducing diagnostic sensitivity.
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