Comparative analysis of antigen and molecular tests for the detection of Sars-CoV-2 and related variants: A study on 4266 samples.
Comparative analysis of antigen and molecular tests for the detection of Sars-CoV-2 and related variants: A study on 4266 samples.
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DOI：
10.1016/j.ijid.2021.04.048
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发表时间：
2021-07
期刊：
影响因子：
--
通讯作者：
Giardina E
中科院分区：
文献类型：
--
作者：
Caputo V;Bax C;Colantoni L;Peconi C;Termine A;Fabrizio C;Calvino G;Luzzi L;Panunzi GG;Fusco C;Strafella C;Cascella R;Battistini L;Caltagirone C;Salvia A;Sancesario G;Giardina E
本研究比较了Lumipulse G Sars-CoV-2 Ag试剂盒与TaqPath COVID-19 RT-PCR CE IVD试剂盒的性能。该研究对4266名鼻咽拭子进行了研究。对样本进行抗原RT-PCR检测，检测Sars-CoV-2及其相关变异。在R软件中进行统计分析。RT-PCR检测阳性503例，阴性3763例，其中H69-V70缺失携带者138例，抗原检测阳性538例，阴性3728例。经验au - roc和双正态au - roc分别为0.920和0.990，准确度为0.960，敏感性为0.866，特异性为0.973，阳性预测值和阴性预测值分别为0.810和0.980。我们发现病毒载量与抗原水平呈正相关（R2 = 0.81），发现高病毒载量（log10拷贝/mL > 5.4）完全一致。抗原水平> 222 pg/mL可作为鉴定阳性样本的可靠指标（p < 0.01）。对于变异携带者，抗原检测的准确性与其他阳性样本相同。分子和抗原检测应评估该地区的流行情况。在低流行率的情况下，抗原检测可作为一线筛查，及时识别病毒载量高的感染个体，以及Sars-CoV-2变体携带者。
The present study compared the performance of the Lumipulse G Sars-CoV-2 Ag kit with the TaqPath COVID-19 RT-PCR CE IVD kit. The study was conducted on 4266 naso-oropharyngeal swabs. Samples were subjected to antigen RT-PCR tests for the detection of Sars-CoV-2 and related variants. Statistical analyses were conducted in R software. We found 503 positives (including 138 H69-V70 deletion carriers) and 3763 negatives by RT-PCR, whereas 538 positives and 3728 negatives were obtained by antigen testing. We achieved empirical and binormal AU-ROCs of 0.920 and 0.990, accuracy of 0.960, sensitivity of 0.866, specificity of 0.973, positive and negative predictive values of 0.810 and 0.980. We obtained a positive correlation between viral loads and antigen levels (R2 = 0.81), finding a complete concordance for high viral loads (log10 copies/mL > 5.4). Antigen levels > 222 pg/mL were found to be reliable in assigning positive samples (p < 0.01). Concerning variant carriers, antigen test detected them with the same accuracy as other positive samples. Molecular and antigen tests should be evaluated regarding the prevalence of the area. In case of low prevalence, antigen testing can be employed as a first-line screening for the timely identification of affected individuals with high viral load, also if carriers of Sars-CoV-2 variants.
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DOI：
10.1016/j.ijid.2021.02.098
发表时间：
2021-04
期刊：
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
影响因子：
--
作者：
Gili A;Paggi R;Russo C;Cenci E;Pietrella D;Graziani A;Stracci F;Mencacci A
通讯作者：
Mencacci A
DOI：
10.3390/life10120351
发表时间：
2020-12-16
期刊：
Life (Basel, Switzerland)
影响因子：
--
作者：
Strafella C;Caputo V;Termine A;Barati S;Caltagirone C;Giardina E;Cascella R
通讯作者：
Cascella R
影响因子：
8.4
作者：
Hirotsu, Yosuke;Maejima, Makoto;Omata, Masao
通讯作者：
Omata, Masao
影响因子：
3.5
作者：
Strafella, Claudia;Caputo, Valerio;Cascella, Raffaella
通讯作者：
Cascella, Raffaella
DOI：
10.2807/1560-7917.es.2021.26.3.2100008
发表时间：
2021-01
期刊：
Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin
影响因子：
--
作者：
Bal A;Destras G;Gaymard A;Stefic K;Marlet J;Eymieux S;Regue H;Semanas Q;d'Aubarede C;Billaud G;Laurent F;Gonzalez C;Mekki Y;Valette M;Bouscambert M;Gaudy-Graffin C;Lina B;Morfin F;Josset L;COVID-Diagnosis HCL Study Group
通讯作者：
COVID-Diagnosis HCL Study Group