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
- Simplest protocol: Not requiring RNA extraction.
- Fast turnaround time ~1 hour from dry swab to final result.
- Highly accurate: 100% specificity and 100% sensitivity, equivalent to RT-PCR methods3
- 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.
- Validated Real-time PCR system with FAM/HEX fluorescence channels: Biorad CFX96 Real-Time System, Roche LightCycler® 480 Instrument II, Atila PowerGene 9600 Plus Real-Time PCR System, and Applied BiosystemsTM 7500 Real-Time PCR Systems