Note: This product is for in vitro diagnostic use, following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval. This test has not been reviewed by the FDA and results from testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19)
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. -