<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Sharon Dhillon</style></author><author><style face="normal" font="default" size="100%">Cindy Simoens</style></author><author><style face="normal" font="default" size="100%">Lize Cuypers</style></author><author><style face="normal" font="default" size="100%">Jannes Bode</style></author><author><style face="normal" font="default" size="100%">Bonde, Jesper</style></author><author><style face="normal" font="default" size="100%">Philippe Corbisier</style></author><author><style face="normal" font="default" size="100%">Clementina E Cocuzza</style></author><author><style face="normal" font="default" size="100%">Marc Van Ranst</style></author><author><style face="normal" font="default" size="100%">M. Arbyn</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Assessment of the clinical and analytical performance of the Aptima SARS-CoV-2 assay using the VALCOR protocol.</style></title><secondary-title><style face="normal" font="default" size="100%">Virol J</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Clinical Laboratory Techniques</style></keyword><keyword><style  face="normal" font="default" size="100%">COVID-19</style></keyword><keyword><style  face="normal" font="default" size="100%">COVID-19 Testing</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Molecular Diagnostic Techniques</style></keyword><keyword><style  face="normal" font="default" size="100%">Pandemics</style></keyword><keyword><style  face="normal" font="default" size="100%">SARS-CoV-2</style></keyword><keyword><style  face="normal" font="default" size="100%">Sensitivity and Specificity</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2023</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2023 Feb 24</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">20</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;&lt;b&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;BACKGROUND:&lt;/strong&gt;&lt;/b&gt;&lt;br&gt;
The COVID-19 pandemic highlighted the importance of diagnostic testing against curbing the spread of SARS-CoV-2. The urgent need and scale for diagnostic tools resulted in manufacturers of SARS-CoV-2 assays receiving emergency authorization that lacked robust analytical or clinical evaluation. As it is highly likely that testing for SARS-CoV-2 will continue to play a central role in public health, the performance characteristics of assays should be evaluated to ensure reliable diagnostic outcomes are achieved.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;METHODS:&lt;/strong&gt; &lt;/b&gt;&lt;br&gt;
VALCOR or &quot;VALidation of SARS-CORona Virus-2 assays&quot; is a study protocol designed to set up a framework for test validation of SARS-CoV-2 virus assays. Using clinical samples collated from VALCOR, the performance of&amp;nbsp;Aptima SARS-CoV-2 assay was assessed against a standard comparator assay. Diagnostic test parameters such as sensitivity, specificity and overall per cent agreement were calculated for the clinical performance of Aptima SARS-CoV-2 assay.&lt;/p&gt;

&lt;p&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;&lt;b&gt;RESULTS: &lt;/b&gt;&lt;/strong&gt;&lt;br&gt;
A total of 180 clinical samples were tested with an addition of 40 diluted clinical specimens to determine the limit of detection. When compared to the standard comparator assay Aptima had a sensitivity of 100.0% [95% CI 95.9-100.0] and specificity of 96.7% [95% CI 90.8-99.3]. The overall percent agreement was 98.3% with an excellent Cohen's coefficient of κ = 0.967 [95% CI 0.929-1.000]. For the limit of detection, Aptima was able to detect all of the diluted clinical samples.&lt;/p&gt;

&lt;p&gt;&lt;b&gt;&lt;strong style=&quot;color:#69aa41;&quot;&gt;CONCLUSION:&lt;/strong&gt; &lt;/b&gt;&lt;br&gt;
In conclusion. validation of Aptima SARS-CoV-2 assay using clinical samples collated through the VALCOR protocol showed excellent test performance. Additionally, Aptima demonstrated high analytical sensitivity by detecting all diluted clinical samples corresponding to a low limit of detection.&lt;/p&gt;
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