iAMP COVID-19 Detection Kit

iAMP COVID-19 Detection Kit

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.

Features

• Simplest protocol: Not requiring RNA extraction.
• High throughput: up to 94 samples per instrument run.
• Analytical Sensitivity: ~2000 copies of viral RNA per swab.
• Flexibility: any number of samples from 1 to 94 per round.
• Reaction Time Per Sample: ~60min including sample processing

Contents

• Primer Mix (COVIDPM) 540 µL X 1 tube
• Buffer Mix (COVIDBM) 540 µL X 1 tube
• Reaction Mix (COVIDRM) 1.3 mL X 1 tube
• Positive Control Template (COVIDPC) 300 µL X 1 tube
• Negative Control Template (COVIDNC) 300 µL X 1 tube
• Atila Sample Collection Device (iAMP-COVID19-SCD) 100 units

1. Synthetic fiber swabs with plastic shafts (100 individually packed swabs for the swab type as indicated)
2. Collection tubes (100 tubes for each kit)
3. 6X Atila COVID-19 Sample Buffer A (COVID-6XSBA, 1.25 mL X 5 tubes enclosed in the kit)
4. 30X Atila COVID-19 Sample Buffer B (COVID-30XSBB, 240 µL x 5 tubes enclosed in the kit).

• Instructions for use 1 booklet
  
  

* This product is For use under an Emergency Use Authorization (EUA) only in US