Multicenter evaluation of the performance characteristics of the Bayer VERSANT HCV RNA 3.0 assay (bDNA)
Multicenter evaluation of the performance characteristics of the Bayer VERSANT HCV RNA 3.0 assay (bDNA)
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DOI：
10.1128/jcm.42.2.563-569.2004
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发表时间：
2004-02-01
影响因子：
9.4
通讯作者：
Terrault, NA
中科院分区：
文献类型：
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作者：
Elbeik, T;Surtihadi, J;Terrault, NA
在这项多中心评估中，Versant丙型肝炎病毒RNA 3.0检测(BDNA)(纽约塔里敦的拜耳诊断公司)在样本采集基质(血清、EDTA、ACD-A)和丙型肝炎病毒(丙型肝炎病毒)1~6型之间具有良好的重复性、线性和分析灵敏度。变异系数(CV)在615~7,690,000(7.69×106)IU/ml范围内变化，总变异系数(CV)在615~6.8×106 IU/ml范围内线性关系良好。通过对999份无偿献血者标本的检测，确定了98.8%的分析特异性。用1a、1b、2a、2b、2c、3a、4a、5a和6a的代表性克隆和患者标本的RNA转录本评估丙型肝炎病毒的基因型，结果表明，作为检测标准的基因型1与非1型之间的最大差异在1.5倍以内。对潜在干扰的内源性物质和外源性物质和条件的检测发现，除了浓度大于或等于20毫克/分的未结合胆红素和浓度大于或等于9克/分的蛋白质外，对丙型肝炎病毒阳性或阴性标本没有干扰。对29名未接受丙型肝炎病毒治疗的临床稳定个体的生物变异性进行了评估，他们在8周的时间里每周接受一次测试。总(生物加化验)变异性的综合估计为0.15对数，0标准差(CV，36.1%)，倍数变化为2.6。因此，在临床稳定的个体中，观察到的任何两个连续的丙型肝炎病毒RNA检测之间的倍数变化预计在95%的时间内小于2.6倍(相当于0.41log(10)IU/ml)。
In this multicenter evaluation, the VERSANT HCV RNA 3.0 Assay (bDNA) (Bayer Diagnostics, Tarrytown, N.Y.) was shown to have excellent reproducibility, linearity, and analytical sensitivity across specimen collection matrices (serum, EDTA, ACD-A), and hepatitis C virus (HCV) genotypes 1 to 6. The VERSANT HCV bDNA Assay has a reportable range of 615 to 7,690,000 (7.69 x 106) IU/ml. The total coefficient of variation (CV) ranged from 32.4% at 615 IU/ml to 17% at 6.8 X 106 IU/ml. The assay was linear across the reportable range. Analytical specificity of 98.8% was determined by testing 999 specimens from volunteer blood donors. Evaluation of HCV genotypes using RNA transcripts of representative clones of la, 1b, 2a, 2b, 2c, 3a, 4a, 5a, and 6a and patient specimens showed that the largest difference between genotype 1, upon which the assay is standardized, and non-1 genotypes was within 1.5-fold. Testing of potentially interfering endogenous substances and exogenous substances and conditions found no interference in HCV-positive or HCV-negative specimens except for unconjugated bilirubin at concentrations of greater than or equal to20 mg/dI and protein at concentrations of greater than or equal to9 g/dI. Biological variability was estimated from 29 clinically stable individuals not on HCV therapy who were tested weekly over an 8-week period. The combined estimate of total (biologic plus assay) variability was 0.15 log,0 standard deviation (CV, 36.1%), a fold change of 2.6. Thus, the observed fold change between any two consecutive HCV RNA measures is expected to be less than 2.6-fold (equivalent to 0.41 log(10) IU/ml) 95% of the time in clinically stable individuals.