Updated on March 8, 2024

·

Created on August 31, 2021

LAMP on Disc COVID-19 Test

Upcoming Update

Loop-mediated isothermal amplification (LAMP) based COVID-19 test. Courtesy of WHO Compendium 2021

Tested By
  • Karolinska Institutet
Content Partners
Unknown

Author

Product Description

The loop-mediated isothermal amplification (LAMP) based COVID-19 test uses viral RNA from heat-inactivated nasopharyngeal swab samples in an integrated modular centrifugal microfluidic platform. This method can deliver 20 test results via smartphone within 30 minutes. One device can perform up to 600 tests per day. This product is currently a prototype.

This product was selected for inclusion in WHO’s 2021 Compendium of Innovative Health Technologies for Low‐Resource Settings.

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$500.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, NGOs

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

Patent

Consumables

Lamp mastermix reagent

Detection sensitivity

~94%

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

No

Number of Tests Performed

1

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Replaceable battery

Time required for procedure (minutes)

~30 minutes

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

Product Schematics

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; 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

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