Description

The iAMP COVID-19 Detection Kit is a real-time reverse transcription isothermal amplification test. The test is based on a proprietary isothermal amplification technology termed OMEGA amplification (Patent: WO 2017/205510 A1; publication: The Journal of Molecular Diagnostics, Vol.22, No 3, 419-428, 2020). OMEGA primer sets are designed to specifically detect RNA and later cDNA from the N and ORF-1ab genes of the SARS-CoV-2 virus in nasal, nasopharyngeal and/or oropharyngeal swabs from patients with signs and symptoms of infection who are suspected of COVID-19.

The iAMP COVID-19 assay’s key differentiator from current rRT-PCR COVID-19 assays is its ability to detect SARS-CoV-2 RNA directly from samples without prior RNA extraction process. Swab specimens are inserted directly into our 1X iAMP COVID-19 Sample Buffer Mix with a 15 min incubation at room temperature and can be directly used for OMEGA isothermal amplification and signal detection. Sample to result takes about 1 hour.

Special Features:
• Simplest protocol: Not requiring RNA extraction.
• Fast turnaround time ~1 hour from dry swab to final result.
• High throughput: up to 94 samples per instrument run.
• Great Analytical Sensitivity: ~2000 copies of viral RNA per swab.
• Flexibility: any number of samples from 1 to 94 per round.

Technical Specs:
Sample Types: Nasal Swabs, nasopharyngeal swabs and/or oropharyngeal swabs collected dry with the Atila Sample Collection Device .
Reaction Volume: 25 µl
Reaction Time Per Sample: ~60min including sample processing
Sensitivity: 60 copies per reaction
Instruments: Compatible with Atila Power-Gene 9600 Plus, Bio-Rad CFX96, ABI7500, and other commonly used RT-qPCR instruments with FAM and HEX fluorescent channels.