Rapid Molecular Test

100%

Specificity

100%

sensitivity

No

Extraction steps

< 90 mins

result time

700

tests per 8hr shift

Overview

 

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. 

 

benefit to clinical laboratories

references

  1. Atila Biosystems – IFU  
  2. WHO FIND Evaluation Update – Link
  3. Publication: Pinsky, et al. (2020) Journal of Clinical Virology – Link

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