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

chemagic Viral DNA/RNA 300 Kit

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).

Detection RateMean CT
NORF1abNORF1abNORF1abInternal control
Nasopharyngeal Swab27.2468.32395% (19/20)95% (19/20)38.5338.4433.81
40.87112.485100% (20/20)100% (20/20)38.5037.7932.72
Oropharyngeal Swab23.3807.14295% (19/20)95% (19/20)38.4438.7633.13
35.07010.713100% (20/20)100% (20/20)38.7438.1133.09

Similar PCR or sequencing-based workflows could be applied for other species with a 60 minute extraction protocol. With good fulfilment of reproducibility, repeatability, and linearity of extraction yield, performance with chemagic systems also showed no cross-contamination.

Kit Specifications

Product No.IVD-1033-S
Sample300 µl fresh/frozen plasma, stabilized saliva, transport media from naso- or oropharyngeal swabs (refer IFU for tested collection tubes)
Instrument(s)chemagic 360-D instrument/chemagic Prime instrument/chemagic MSM I instrument
Runtime60 min (various species), 18 min (SARS-CoV-2), 31 min (SARS-CoV-2) on chemagic 360 instrument
Elution volume100 µl
Required items not supplied in kitchemagic 360-D instrument (prod. no. 2024-0010) with chemagic 360 96 Rod Head Set (prod. no. CMG-370)
pipettes and pipette tips with aerosol barriers
chemagic Stand 96 (prod. no. CMG-301) (Optional)
isotonic saline solution, sterile (Optional)
Sarstedt tube (prod. no. 72.693 or 72.694)
chemagic consumables (tips, deep well plates and low well plates, prod. no. 4155-0010)
pipettes and pipette tips with aerosol barriers
chemagic Stand 96 (prod. no. CMG-301) (Optional)
DocumentsInstructions For Use (IFU) – EN
Instructions For Use (IFU) – IT
Instructions For Use (IFU) – ES
Instructions For Use (IFU) – FR

Instrument Protocols (ZIP file)

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Please note that product labelling (such as kit insert, product label, and kit box) may be different compared to the company branding. Please contact your local representative for further details.