Field evaluation of GeneXpert(®) (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia.
Field evaluation of GeneXpert(®) (Cepheid) HCV performance for RNA quantification in a genotype 1 and 6 predominant patient population in Cambodia.
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DOI：
10.1111/jvh.13002
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发表时间：
2019-01
影响因子：
2.5
通讯作者：
Loarec A
中科院分区：
文献类型：
--
作者：
Iwamoto M;Calzia A;Dublineau A;Rouet F;Nouhin J;Yann S;Pin S;Sun C;Sann K;Dimanche C;Lastrucci C;Coulborn RM;Maman D;Dousset JP;Loarec A
GeneXpert®（Cepheid）是唯一一个经过世卫组织资格预审的丙型肝炎病毒（HCV）核酸扩增检测平台，适用于资源有限的情况下的床旁使用。然而，由于缺乏基因型6（GT 6）HCV的证据，其应用受到限制。我们在柬埔寨主要感染GT 6的患者人群中评估了其现场性能。2017年8月至9月期间，我们使用GeneXpert®检测了来自Preah Kossamak医院无国界医生HCV诊所知情同意患者的血浆样本的HCV病毒载量（VL），并将其结果与使用Institut Pasteur du Cambodge的COBAS ® AmpliPrep/Cobas® TaqMan® HCV Quantitative Test v2.0（Roche）获得的结果进行了比较。在769例患者中，77%的血清阳性患者（n = 454/590）具有使用罗氏可检测和可定量的VL，43%（n = 195/454）为GT 6。GeneXpert®对罗氏的敏感性和特异性分别为100%（95% CI 99.2，100.0）和98.5%（95% CI 94.8，99.8）。Roche可定量的454份样本的平均VL差异为−0.01（95% CI −0.05，0.02）log 10 IU/mL，GT 6（n = 195）为−0.07（95% CI −0.12，−0.02）log 10 IU/mL。所有GT的一致性限（LOA）为−0.76至0.73 log 10 IU/mL，GT 6为−0.76至0.62 log 10 IU/mL。29个GeneXpert®结果超出LOA。GeneXpert®的错误频率和中位周转时间（达特）分别为1%和0天（使用罗氏为4天）。我们证明了GeneXpert® HCV检测试剂盒在真实的世界、资源有限的临床环境中对GT 6 HCV患者具有良好的灵敏度、特异性、定量一致性和达特。
GeneXpert® (Cepheid) is the only WHO prequalified platform for hepatitis C virus (HCV) nucleic acid amplification testing that is suitable for point‐of‐care use in resource‐limited contexts. However, its application is constrained by the lack of evidence on genotype 6 (GT6) HCV. We evaluated its field performance among a patient population in Cambodia predominantly infected with GT6. Between August and September 2017, we tested plasma samples obtained from consenting patients at Médecins Sans Frontières’ HCV clinic at Preah Kossamak Hospital for HCV viral load (VL) using GeneXpert® and compared its results to those obtained using COBAS ® AmpliPrep/Cobas® TaqMan® HCV Quantitative Test, v2.0 (Roche) at the Institut Pasteur du Cambodge. Among 769 patients, 77% of the seropositive patients (n = 454/590) had detectable and quantifiable VL using Roche and 43% (n = 195/454) were GT6. The sensitivity and specificity of GeneXpert® against Roche were 100% (95% CI 99.2, 100.0) and 98.5% (95% CI 94.8, 99.8). The mean VL difference was −0.01 (95% CI −0.05, 0.02) log10 IU/mL for 454 samples quantifiable on Roche and −0.07 (95% CI −0.12, −0.02) log10 IU/mL for GT6 (n = 195). The limit of agreement (LOA) was −0.76 to 0.73 log10 IU/mL for all GTs and −0.76 to 0.62 log10 IU/mL for GT6. Twenty‐nine GeneXpert® results were outside the LOA. Frequency of error and the median turnaround time (TAT) for GeneXpert® were 1% and 0 days (4 days using Roche). We demonstrated that the GeneXpert® HCV assay has good sensitivity, specificity, quantitative agreement, and TAT in a real‐world, resource‐limited clinical setting among GT6 HCV patients.
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影响因子：
9.4
作者：
McHugh, M. P.;Wu, A. H. B.;Templeton, K. E.
通讯作者：
Templeton, K. E.
影响因子：
4.3
作者：
Petruzziello A;Marigliano S;Loquercio G;Cozzolino A;Cacciapuoti C
通讯作者：
Cacciapuoti C
DOI：
10.3390/v7092857
发表时间：
2015-09-16
期刊：
Viruses
影响因子：
--
作者：
Cuypers L;Li G;Libin P;Piampongsant S;Vandamme AM;Theys K
通讯作者：
Theys K
用于评估 Bland-Altman 方法两种测量方法之间一致性的样本量
影响因子：
1.2
作者：
Lu, Meng-Jie;Zhong, Wei-Hua;Ji, Mu-Huo
通讯作者：
Ji, Mu-Huo
影响因子：
25.7
作者：
Halfon, P;Khiri, H;Cartouzou, G
通讯作者：
Cartouzou, G