AlHamad Tasneem, Younes Salma, El Chaar Dayana, Nizamuddin Parveen B, Al Mohannadi Eiman, Alghanim Asmaa, Younes Nadin, Al-Dewik Nader, Laiwattanapaisal Wanida, Ammaranond Palanee, Hawken Phillip, Abu-Raddad Laith J, Nasrallah Gheyath K
Biomedical Sciences Department, College of Health Sciences, Qatar University, Doha, Qatar.
Biomedical Research Center, Qatar University, Doha, Qatar.
PLoS One. 2025 Aug 4;20(8):e0329796. doi: 10.1371/journal.pone.0329796. eCollection 2025.
BACKGROUND/OBJECTIVES: Vitamin D deficiency is a significant global health concern, requiring accurate diagnosis. This study evaluates the performance of four chemiluminescent immunoassay (CLIA) platforms; Snibe, Roche, DiaSorin, and Architect for vitamin D measurement.
A total of 345 serum samples, selected to represent a broad range of vitamin D levels and diverse health conditions, including pregnancy, chronic kidney disease, and osteoporosis, were analyzed using four platforms. Diagnostic metrics, including sensitivity, specificity, and overall percent agreement (OPA), were calculated. Spearman's rank correlation and bias assessment were performed to evaluate inter-assay agreement.
Spearman's rank correlations were strong to very strong across the platforms, ranging from r = 0.924 to r = 0.969, reflecting high inter-assay concordance. Pairwise comparisons indicated that Snibe demonstrated high specificity (98-99%) and strong agreement with DiaSorin (κ = 0.91), while DiaSorin maintained a favorable balance between sensitivity (86-98%) and specificity (94-99%). Roche showed consistent diagnostic characteristics, with sensitivity ranging from 93-99% and specificity from 85-96%. Architect exhibited high sensitivity (97-99%) but relatively lower specificity (81-92%).
All platforms demonstrated robust diagnostic performance. Snibe showed notably high specificity, while DiaSorin offered balanced sensitivity and specificity. These findings underscore the relative strengths of each platform and support their use in clinical evaluation of vitamin D status.
背景/目的：维生素D缺乏是一个重大的全球健康问题，需要准确诊断。本研究评估了四种化学发光免疫分析（CLIA）平台（新波、罗氏、索灵和雅培）检测维生素D的性能。
共选取345份血清样本，这些样本代表了广泛的维生素D水平和不同的健康状况，包括妊娠、慢性肾脏病和骨质疏松症，使用四种平台进行分析。计算了诊断指标，包括敏感性、特异性和总体百分一致性（OPA）。进行了斯皮尔曼等级相关性分析和偏差评估，以评估不同检测方法之间的一致性。
各平台之间的斯皮尔曼等级相关性很强至非常强，范围从r = 0.924至r = 0.969，反映出不同检测方法之间具有高度一致性。两两比较表明，新波表现出高特异性（98 - 99%），且与索灵具有很强的一致性（κ = 0.91），而索灵在敏感性（86 - 98%）和特异性（94 - 99%）之间保持了良好的平衡。罗氏显示出一致的诊断特征，敏感性范围为93 - 99%，特异性范围为85 - 96%。雅培表现出高敏感性（97 - 99%）但相对较低的特异性（81 - 92%）。
所有平台都表现出强大的诊断性能。新波显示出特别高的特异性，而索灵提供了平衡的敏感性和特异性。这些发现强调了每个平台的相对优势，并支持它们在维生素D状态临床评估中的应用。
