Kusnierz-Cabala Beata, Gernand Wojciech, Zabek-Adamska Anna, Tokarz Aleksandra, Naskalski Jerzy W
Department of Clinical Biochemistry, Collegium Medicum, Jagiellonian University, Krakow, Poland.
Clin Lab. 2008;54(9-10):341-6.
Serum concentration of high sensitive C-reactive protein (hsCRP) can predict the risk of chronic metabolic and cardiovascular diseases but it is unclear whether turbidimetric high sensitive assays of CRP are adequate.
Concentrations of serum CRP in 126 samples of serum were measured with high-sensitivity methods using nephelometry (BN II Nephelometer) and turbidimetry (Ortho Vitros FS 5.1).
For CRP concentrations measured by nephelometry and turbidimetry intra-assay CVs were 3.2 and 0.9% at mean CRP concentrations of 1.4 and 2.1 mg/l, inter-assay CVs for commercial controls were 3.1% and 3.6% at mean concentrations of 1.3 and 1.7 mg/l, and mean biases were 7.62% and 2.26%, respectively. Measurements were strongly, linearly correlated (r = 0.99; CRP vitros = 0.03 +1.03 CRP (BN II)). When disease risk was assessed by nephelometry and turbidimetry, results were similar. If the risk of disease was classified as moderate (1.0 < CRP < or = 3.0 mg/l) or high (CRP > 3.0 mg/l), the frequency of misclassified cases was only 2.3 and 2.1%, respectively. The classification agreement weighted kappa coefficient was 0.94 (95% C.I.: 0.89-0.98).
turbidimetric high sensitive CRP assays can properly classify CRP-related prediction of chronic metabolic diseases with special consideration on cardiovascular risk.
高敏C反应蛋白（hsCRP）的血清浓度可预测慢性代谢性疾病和心血管疾病的风险，但尚不清楚比浊法高敏CRP检测是否足够。
采用散射比浊法（BN II散射比浊仪）和比浊法（奥森多Vitros FS 5.1），用高灵敏度方法检测126份血清样本中的血清CRP浓度。
散射比浊法和比浊法检测CRP浓度时，批内变异系数在平均CRP浓度为1.4和2.1mg/L时分别为3.2%和0.9%，商业对照品的批间变异系数在平均浓度为1.3和1.7mg/L时分别为3.1%和3.6%，平均偏差分别为7.62%和2.26%。测量结果呈强线性相关（r = 0.99；Vitros法CRP = 0.03 + 1.03×BN II法CRP）。用散射比浊法和比浊法评估疾病风险时，结果相似。如果将疾病风险分类为中度（1.0 < CRP ≤ 3.0mg/L）或高度（CRP > 3.0mg/L），错误分类病例的频率分别仅为2.3%和2.1%。分类一致性加权kappa系数为0.94（95%置信区间：0.89 - 0.98）。
比浊法高敏CRP检测可对慢性代谢性疾病中与CRP相关的预测进行正确分类，尤其在考虑心血管风险方面。
