Proven LAMP-DX SARS-COV2 virus (COVID19)  Detection.

This diagnostic has been clinically validated and Health Canada and FDA's independent review is pending.

RAPID
PROCESSING

ULTRA-
SENSITIVE

L.A.M.P
AMPLIFICATION

RNA
AMPLIFICATION

USES EXISTING
PCR LABS

EFFICIENT
SUPPLY CHAIN

Flexible Collection Methods with High Accuracy

LAMPDX utilizes loop mediated isothermal amplification (LAMP) which achieve highly accurate testing results from nose/throat swabs or saliva. It leverages existing laboratory equipment and non-PCR consumables for consistent high throughput.

Test Sample Accuracy

NASAL

99.9%

Nasopharyngeal

THROAT

99%

Oropharyngeal

SPUTUM

93%+

Swish Gargle & Spit

Pr ecision Data addressing repeatability of the COVID-19 Dx assay . Instrument-1 (CFX96-CT032971) Minutes to Positive Call DA Y 1 DA Y 2 DA Y 3 DA Y 4 DA Y 5 Negative control N/A N/A N/A N/A N/A Positive control 1 11.24 12.58 11.58 13.54 17.07 Positive control 2 10.63 10.35 11.35 12.43 12.43 Replicate 1 (~1000 copy/µL) 11.48 10.99 14.47 14.57 15.95 Replicate 2 (~1000 copy/µL) 11.54 9.65 13.86 13.86 15.83 Replicate 3 (~1000 copy/µL) 12.08 9.29 13.67 13.67 16.47 Replicate 4 (~1000 copy/µL) 12.28 10.37 12.88 12.88 16.89 Replicate 5 (~1000 copy/µL) 12.02 9.29 12.47 12.47 17.06 Instrument-2 (CFX96-CT027753) Minutes to Positive Call DA Y 1 DA Y 2 DA Y 3 DA Y 4 DA Y 5 Negative control N/A N/A N/A N/A N/A Positive control 1 11.61 13.33 14.61 12.25 13.08 Positive control 2 12.64 12.74 13.14 13.08 11.97 Replicate 1 (~1000 copy/µL) 12.27 10.49 14.21 15.76 17.93 Replicate 2 (~1000 copy/µL) 11.87 11.03 13.41 17,62 16.31 Replicate 3 (~1000 copy/µL) 12.83 10.14 12.20 14.73 15.82 Replicate 4 (~1000 copy/µL) 12.97 10.86 13.16 16.15 15.39 Replicate 5 (~1000 copy/µL) 13.13 10.84 13.88 14.75 17.31 Instrument-3 (CFX96-CT008619) Minutes to Positive Call DA Y 1 DA Y 2 DA Y 3 DA Y 4 DA Y 5 Negative control N/A N/A N/A N/A N/A Positive control 1 12.04 10.61 14.16 12.81 12.36 Positive control 2 11.38 9.31 13.65 11.43 12.14 Replicate 1 (~1000 copy/µL) 12.28 10.44 13.25 16.52 16.34 Replicate 2 (~1000 copy/µL) 12.36 10.01 12.37 15.13 16.73 Replicate 3 (~1000 copy/µL) 12.11 10.15 14.91 15.81 16.18 Replicate 4 (~1000 copy/µL) 12.17 9.43 13.40 18.66 14.71 Replicate 5 (~1000 copy/µL) 12.46 13.94 12.31 15.33 11.96
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Functional diagnostics at the limit of detection Sample data set displays repeated detection near the limit of detection 62.5 Copies/reaction Minutes for positive call 14.83 13.12 Replicate 3 14.45 Replicate 4 14.04 Replicate 5 15.79 Replicate 6 15.68 Replicate 7 15.13 Replicate 8 20.19 Replicate 9 15.66 Replicate 10 13.17 Replicate 11 15.11 Replicate 12 17.03 Replicate 13 15.57 Replicate 14 16.37 Replicate 15 22.03 Replicate 16 15.22 Replicate 17 13.9 Replicate 18 19.08 Replicate 19 15.02 Replicate 20 24.12