COVID-19 iAMP PCR Test Kits for Research and CLIA Labs Only, 100 Reagent Tests

COVID-19 iAMP PCR Test Kits for Research and CLIA Labs Only, 100 Reagent Tests

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10 units
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The FDA EUA-approved iAMP COVID-19 Detection Kit is approved for sale to CLIA Laboratories only.

The iAMP COVID-19 Detection Kit is a real-time fluorescent isothermal assay on raw samples without RNA extraction.

  • For use by CLIA certified labs only.
  • The only thing required to successfully run this test is PCR equipment.
  • Tests are FDA Approved for use with Bio-Rad CFX96 only. Other equipment requires validation prior to using these tests.
  • includes extraction kit, complete kit, 100 tests

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: test 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: ~60 min 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.

FDA EUA Approved Documents: IFU, Fact Sheet For Patients, Fact Sheet For Providers.

Cat. No. Description Size
iAMP-COVID19-100 iAMP COVID-19 Detection Kit 100 tests

* This product is For use under an Emergency Use Authorization (EUA) only in US
Related Information Recent News – Atila Biosystems Gets FDA Emergency Use Authorization for SARS-CoV-2 Test… Read More.

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