Intended Use

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The AQ-TOP™ COVID-19 Rapid Detection Kit is a PNA mediated Real-Time Loop-Mediated Isothermal Amplification (RT-LAMP) based in-vitro diagnostic product intended for detection of the novel coronavirus SARS-CoV-2 RNA in the sputum, bronchoalveolar lavage, upper and lower respiratory tract.

 

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It is a first of its kind and one of the only test that is FDA-EUA approved that uses both PNA and RT-LAMP!

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• PNA-focused tests allow for less prep work which increases speed and fewer chances of contamination.

• PNA mimics DNA does not go the DNA polymerase, instead of reports signals by hybridization and selective binding.

• It is Temperature and Chemically stable

• It has been acknowledged in the academic field to be a strong potential of diagnostics with Rt-PCR and better test than the TaqMan probe.

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RT- LAMP (Real-Time Loop-Mediated Isothermal Amplification)

• Does not require thermal cycling, performed at a constant temperature between 60 and 65 °C.

• Creates a 1 step nucleic process before running the reaction. 

 

Key Highlights

 

• Run time: negative results in 30 minutes, Positive results in 15 minutes per 94 samples

• Target Region: ORF1aB, N-Gene,  RNase-P

• Specificity/ Sensitivity: 100%

• Accuracy: 99.999%    

• False-positive rate: <0.1%

• LOD: 1 cp/µL

• Storage Temperature -10 to -30 °C

• stable for up to 1 year from the manufactured date

• 100 tests per box

• Compatible with CFX 96, ABI 7500, ABI 7500 Fast

• Integration and Procedure are seamless.