Multicenter evaluation of the performance characteristics of the NucliSens HIV-1 QT assay used for quantitation of human immunodeficiency virus type 1 RNA
Multicenter evaluation of the performance characteristics of the NucliSens HIV-1 QT assay used for quantitation of human immunodeficiency virus type 1 RNA
复制标题
DOI：
10.1128/jcm.41.1.164-173.2003
复制
发表时间：
2003-01-01
影响因子：
9.4
通讯作者：
Witt, DJ
中科院分区：
文献类型：
--
作者：
Ginocchio, CC;Kemper, M;Witt, DJ
在一项多中心试验中评估了NucliSens HIV-1 QT检测的分析性能，这是一种基于核酸序列扩增技术的高灵敏度检测。用502份人类免疫缺陷病毒1型（HIV-1）血清阴性志愿献血者血浆（EDTA）标本评估了检测的特异性。在任何供体标本中均未发现HIV-1 RNA。用高滴度特征明确的HIV-1 RNA原液（5.84 X 10(8)个RNA拷贝/ml）制备的板估计分析灵敏度和再现性。该方法的动态范围为10(6)~ 10(1)个HIV-1 RNA拷贝，检测下限为25拷贝/ml，检出率为95%，为176拷贝/ml。检测患者临床标本（n = 101）和市售或制备样品（n = 24）中HIV-1 RNA的灵敏度与NASBA HIV-1 RNA QT （NucliSens HIV-1 QT的早期版本）和美国食品和药物管理局批准的标准和超灵敏AMPLICOR HIV-1 MONITOR 1.0版本的检测方法进行比较。HIV-1 RNA的检测在5对数范围内可重复（平均标准差= 0.15对数）。NucliSens和标准AMPLICOR检测方法在57例临床标本中检测HTV-1 RNA(浓度为10（3)至10(5)拷贝/ml）的效果相同。NucliSens检测在较低浓度（小于或等于10(2)拷贝/ml）（44 / 44）下检测HIV-1 RNA比标准AMPLICOR检测（19 / 12）或NASBA检测（25 / 10）更敏感。与标准AMPLICOR试验（24例中有17例）相比，使用NucliSens试验（24例中有23例）观察到面板上HIV-1 RNA检测频率增加25%。该方法特异性强，具有良好的灵敏度和较宽的线性动态范围。
The analytical performance of the NucliSens HIV-1 QT assay, a highly sensitive test based on nucleic acid sequence-based amplification technology, was evaluated in a multicenter trial. Assay specificity was evaluated with 502 plasma (EDTA) specimens from human immunodeficiency virus type 1 (HIV-1)-seronegative volunteer donors. No HIV-1 RNA was reported in any of the donor specimens. Analytical sensitivity and reproducibility were estimated with panels prepared from a high-titer well-characterized HIV-1 RNA stock (5.84 X 10(8) RNA copies/ml). The assay's dynamic range was linear from 10(6) to 10(1) HIV-1 RNA copies, with a lower detectable limit of 25 copies/ml and a 95% detection rate of 176 copies/ml. Sensitivity of the assay to detect HIV-1 RNA in clinical specimens from patients (n = 101) and in commercially available or prepared panels (n = 24) was compared with NASBA HIV-1 RNA QT (an earlier version of NucliSens HIV-1 QT) and with the Food and Drug Administration-approved standard and ultrasensitive AMPLICOR HIV-1 MONITOR, version 1.0, assays. Detection of HIV-1 RNA was reproducible over a 5-log range (mean standard deviation = 0.15 log). The NucliSens and the standard AMPLICOR assays were equivalent in detection of HTV-1 RNA (concentration, 10(3) to 10(5) copies/ml) in 57 clinical specimens. The NucliSens assay was more sensitive in detecting HIV-1 RNA at lower concentrations (less than or equal to10(2) copies/ml) (44 of 44) than either the standard AMPLICOR test (12 of 19) or the NASBA assay (10 of 25). A 25% increase in HIV-1 RNA detection frequency with panels was observed with the NucliSens assay (23 of 24) compared with the standard AMPLICOR test (17 of 24). The new assay was highly specific and demonstrated good sensitivity with a broad linear dynamic range.