Here's the testing results done in China as reported by 3D med on their 3DMed 2019-nCoVRT-qPCR detection ket. Maybe someone with clinical testing background can weigh in.
282 clinical specimens had been collected using oropharyngeal swabs from the persons under investigation in China and extracted RNA in a third party clinical laboratory. All 282 extracted RNA samples were sent to 3DMed facility and tested with 3DMed 2019- nCoV RT-qPCR Detection Kit by 3DMed R&D personnel. Respiratory specimens for 119 of the 282 PUI subjects tested negative and 163 out of 282 PUI subjects tested positive by 3DMed 2019-nCoV RT-qPCR Detection Kit.
¦ The performance of 3DMed 2019-nCoV RT-qPCR Detection Kit was estimated against a comparator’s assay which is a EUA product in China. The negative agreement is 70.8% and positive percentage agreement is 100%. All the specimens with different detectable results will be further investigated by genetic sequencing. The sequencing results are pending at the Pre-EUA submission period of time.
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