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Abstract：
To validate kappa free light chain (KFLC) and lambda free light chain (LFLC) indices as a diagnostic biomarker in multiple sclerosis (MS).
We performed a multicenter study including 745 patients from 18 centers (219 controls and 526 clinically isolated syndrome (CIS)/MS patients) with a known oligoclonal IgG band (OCB) status. KFLC and LFLC were measured in paired cerebrospinal fluid (CSF) and serum samples. Gaussian mixture modeling was used to define a cut-off for KFLC and LFLC indexes.
The cut-off for the KFLC index was 6.6 (95% confidence interval (CI) = 5.2-138.1). The cut-off for the LFLC index was 6.9 (95% CI = 4.5-22.2). For CIS/MS patients, sensitivity of the KFLC index (0.88; 95% CI = 0.85-0.90) was higher than OCB (0.82; 95%CI = 0.79-0.85; p < 0.001), but specificity (0.83; 95% CI = 0.78-0.88) was lower (OCB = 0.92; 95% CI = 0.89-0.96; p < 0.001). Both sensitivity and specificity for the LFLC index were lower than OCB.
Compared with OCB, the KFLC index is more sensitive but less specific for diagnosing CIS/MS. Lacking an elevated KFLC index is more powerful for excluding MS compared with OCB but the latter is more important for ruling in a diagnosis of CIS/MS.
We performed a multicenter study including 745 patients from 18 centers (219 controls and 526 clinically isolated syndrome (CIS)/MS patients) with a known oligoclonal IgG band (OCB) status. KFLC and LFLC were measured in paired cerebrospinal fluid (CSF) and serum samples. Gaussian mixture modeling was used to define a cut-off for KFLC and LFLC indexes.
The cut-off for the KFLC index was 6.6 (95% confidence interval (CI) = 5.2-138.1). The cut-off for the LFLC index was 6.9 (95% CI = 4.5-22.2). For CIS/MS patients, sensitivity of the KFLC index (0.88; 95% CI = 0.85-0.90) was higher than OCB (0.82; 95%CI = 0.79-0.85; p < 0.001), but specificity (0.83; 95% CI = 0.78-0.88) was lower (OCB = 0.92; 95% CI = 0.89-0.96; p < 0.001). Both sensitivity and specificity for the LFLC index were lower than OCB.
Compared with OCB, the KFLC index is more sensitive but less specific for diagnosing CIS/MS. Lacking an elevated KFLC index is more powerful for excluding MS compared with OCB but the latter is more important for ruling in a diagnosis of CIS/MS.
摘要：
验证无κ轻链（KFLC）和无λ轻链（LFLC）指数作为多发性硬化症（MS）的诊断生物标志物。
我们进行了一项多中心研究，包括来自18个中心的745名患者（219名对照和526名临床孤立综合征（CIS）/MS患者），这些患者具有已知的寡克隆IgG带（OCB）状态。在配对的脑脊液(CSF)和血清样品中测量KFLC和LFLC。高斯混合建模用于定义KFLC和LFLC指数的截止值。
KFLC指数的截止值为6.6(95%置信区间(CI)=5.2-138.1)。LFLC指数的截止值为6.9(95%CI=4.5-22.2)。对于CIS/MS患者，KFLC指数(0.88;95%CI=0.85-0.90)的敏感性高于OCB(0.82;95CI=0.79-0.85;p<0.001),但特异性(0.83;95%CI=0.78-0.88)较低(OCB=0.92;95%CI=0.89-0.96;p<0.001)。LFLC指数的敏感性和特异性均低于OCB。
与OCB相比，KFLC指数对诊断CIS/MS更敏感，但特异性较低。与OCB相比，缺乏升高的KFLC指数对于排除MS更有效，但后者对于诊断CIS/MS更为重要。
我们进行了一项多中心研究，包括来自18个中心的745名患者（219名对照和526名临床孤立综合征（CIS）/MS患者），这些患者具有已知的寡克隆IgG带（OCB）状态。在配对的脑脊液(CSF)和血清样品中测量KFLC和LFLC。高斯混合建模用于定义KFLC和LFLC指数的截止值。
KFLC指数的截止值为6.6(95%置信区间(CI)=5.2-138.1)。LFLC指数的截止值为6.9(95%CI=4.5-22.2)。对于CIS/MS患者，KFLC指数(0.88;95%CI=0.85-0.90)的敏感性高于OCB(0.82;95CI=0.79-0.85;p<0.001),但特异性(0.83;95%CI=0.78-0.88)较低(OCB=0.92;95%CI=0.89-0.96;p<0.001)。LFLC指数的敏感性和特异性均低于OCB。
与OCB相比，KFLC指数对诊断CIS/MS更敏感，但特异性较低。与OCB相比，缺乏升高的KFLC指数对于排除MS更有效，但后者对于诊断CIS/MS更为重要。
