Diagnostic Accuracy and Analytical Sensitivity of IDEIA Norovirus Assay for Routine Screening of Human Norovirus
Diagnostic Accuracy and Analytical Sensitivity of IDEIA Norovirus Assay for Routine Screening of Human Norovirus
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DOI：
10.1128/jcm.00654-10
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发表时间：
2010-08-01
影响因子：
9.4
通讯作者：
Vinje, Jan
中科院分区：
文献类型：
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作者：
Costantini, Veronica;Grenz, LaDonna;Vinje, Jan
诺如病毒（Noroviruses，NoV）是引起流行性和散发性急性胃肠炎的主要病原。早期发现NoV对控制疾病的传播至关重要。在本研究中，我们在前瞻性和回顾性研究设计中评价了IDEIA诺如病毒检测试剂盒（酶免疫测定法[EIA]）的诊断准确性、分析灵敏度和分析反应性。共557个前瞻性收集的粪便样本和一组97个存档的粪便样本，包括21个不同的GI和GII基因型，进行了常规逆转录PCR（RT-PCR）/双向测序，实时RT-PCR和电子显微镜检查。EIA的敏感性和特异性分别为57.6%和91.9%。从暴发的粪便样品中检测NoV的灵敏度从检测3个样品时的44.1%提高到检测每次暴发5个样品时的76.9%。EIA能够检测来自7个GI和11个GII基因型的菌株。对于NoV GI和GII毒株，EIA的分析灵敏度分别为3.1 × 10（6）和1.6 × 10（7）病毒颗粒g（-1）粪便样品。大多数EIA阳性的GII样品的阈值循环（C（T））为25.6，这表明，虽然菌株来自GI基因型。8，GII。10、GII。16例未检出，EIA灵敏度低主要是病毒浓度低所致。总之，目前的EIA可用作诺如病毒暴发调查期间的快速筛查试验，当多个粪便样本可用时;然而，零星样本应通过分子方法进行检测。
Noroviruses (NoVs) are recognized as the leading cause of epidemic and sporadic acute gastroenteritis. Early detection of NoV is crucial to control the spread of the disease. In this study, we evaluated the diagnostic accuracy, analytical sensitivity, and analytical reactivity of the IDEIA Norovirus assay (an enzyme immunoassay [EIA]) in a prospective and retrospective study design. A total of 557 prospectively collected fecal samples and a panel of 97 archived fecal samples, including 21 different GI and GII genotypes, were tested by conventional reverse transcription-PCR (RT-PCR)/bidirectional sequencing, real-time RT-PCR, and electron microscopy. The sensitivity and specificity of the EIA were 57.6% and 91.9%, respectively. The sensitivity for detecting NoV in fecal samples from outbreaks improved from 44.1% when three samples were tested to 76.9% when five samples per outbreak were tested. The EIA was able to detect strains from 7 GI and 11 GII genotypes. The analytical sensitivity of the EIA was 3.1 x 10(6) and 1.6 x 10(7) virus particles g(-1) of fecal sample for NoV GI and GII strains, respectively. Most GII samples positive by EIA had a threshold cycle (C(T)) of 25.6, suggesting that, although strains from genotypes GI. 8, GII. 10, and GII. 16 were not detected, the low sensitivity of the EIA is primarily caused by low virus concentration. In conclusion, the current EIA may be of use as a rapid screening test during a norovirus outbreak investigation when multiple fecal samples are available; however, sporadic samples should be tested by molecular methods.