IVD-1033-S chemagic™ Viral DNA/RNA 300 Kit H96

The chemagic™ Viral DNA/RNA 300 Kit H96 was used with the chemagic 360 instrument during the coronavirus pandemic to support efficient, high-throughput SARS-CoV-2 testing. The IVD-1033-S chemagic Viral DNA/RNA 300 Kit H96 is intended for DNA and RNA extraction on chemagic instruments from 300 μL fresh or frozen human plasma samples collected in EDTA or citrate blood tubes, stabilized saliva, and transport media from naso- or oropharyngeal swabs. 

The kit is suitable for diverse IVD downstream applications employing enzymatic amplification and detection of DNA and RNA (e.g., PCR, RT-PCR, NGS). 

On the chemagic 360-D instrument, the extraction protocol processes 96 samples in parallel in approximately 60 minutes. For SARS-CoV-2 RNA extraction, faster 18 min and 31 min protocols have been established and tested.

Together with the SARS-CoV-2 Real-time RT-PCR Assay, which was established in the FDA SARS-CoV-2 reference panel to have the market’s lowest limit of detection (LOD) for SARS-CoV-2 of 20 copies/ml, the following results were obtained on respective samples. Pooled negative samples spiked with inactivated SARS-CoV-2 virus at predicted LOD were extracted with the kit on the chemagic 360 instrument, then analyzed on the Applied Biosystems 7500 PCR system (other systems tested indicated in Instructions For Use Document).