LAMP on Disc COVID-19 Test

Target Users (Target Impact Group)

Distributors / Implementing Organizations

None, as of 2020

Manufacturing/Building Method

Potential to be mass-produced in location. The Disc requires either injection molding of plastic or hot embossing or CNC drilling capabilities and the reagents for the LAMP assay can be mass-produced.

Intellectural Property Type

Open Source

Design Specifications

1. Collect swab sample into a transportation media; 2. Heat at 95 for 5 min to inactivate the sample (virus is now dead); 3. Take 1 microliter sample and add to LAMP mastermix (total volume = 10 uL) and pipette the solution into the microfluidics Disc channel and seal with a tape (Each disc can take 20 different samples); 4 Put the disc into the Hardware and push a button to start the isothermal reaction (programmed to stop after 30 min);6. Take a picture using smartphone (and analyse the image) Using state of the art microfluidics, we have developed a LAMP based COVID test. In addition to precise fluid control, at the heart of our innovation is a novel agarose bead-based sample processing strategy to (1) stop the reaction and (2) improve the signal response of reaction (approx. 30x signal enhancement), thus allowing either visual by naked eye or smartphone-based detection. 1 uL swab sample is added to LAMP mastermix --> heat at 65 for 30 min --> readout using any smartphone. The end-user takes swab sample,add to Lamp mastermix and and put into the channel, and push start button. After the reaction, the end-user uses a smart phone to take an image for analysis. Since the reaction is terminated automatically, the enduser do not need to make the image analysis directly  Uses rechargeable batteries 1 kg, 250 x  200 x 150 mm³

Replacement Components

Available separately

Lifecycle

5-10 years

Manufacturer Specified Performance Parameters

Reusable, cost-effective, and scalable

Vetted Performance Status

The method was first tested using extracted SARS-CoV-2 RNA for testing the assay specificity(specificity: 100% for SARS-CoV-2). Following, using clinical swab samples from Karolinska Hospital, the method was benchmarked against RT-qPCR (n =31), with proven sensitivity of 94% and specificity of 100%. Note, while the RT-qPCR was performed in centralised lab using standard procedure, our method takes heat-inactivated clinical sample and deliver results within 30 minutes; https://www.medrxiv.org/content/10.1101/2020.11.04.20225888v1.full.pdf 1) We are planning to perform two pilot studies at resource-limited settings over the coming 6 months (in Ethiopia and Nigeria).

Complementary Technical Systems

Requires replaceable batteries to function as well as a clean water supply.

Academic Research and References

Compliance with regulations

None as of 2020