RT-LAMP for COVID-19 testing

The COVID-19 pandemic is undertested

Rapid and accurate diagnosis of COVID-19 infection is a cornerstone for controling the ongoing pandemic. New diagnostic technologies with minimal hardware requirement, rapid turnaround time, and reliable performance are incresingly needed. For further reading see "The explosion of new coronavirus tests that could help to end the pandemic (Nature | Vol 583 | 23 July 2020)", where the CEO of KARAHCO, Dr. Nabil Karah, stressed out the need for novel tests to diagnose the coronavirus in countries with low resources and war-torn areas.

Project Goal

Our goal is to introduce new technology for molecular diagnosis of infectious diseases. The proposed μPAD-RT-LAMP COVID-19 chip aims to enable equity access to molecular testing of COVID-19 at the national, by reaching remote communities in the rural regions of Norway, and global levels, by reaching overlooked people in low- and middle-income countries, and those confined to protracted humanitarian crises. The first milestone of our project is to produce a prototype and penetrate to the COVID-19 diagnostics market

Analytical Performance

The analytical performance, diagnostic accuracy, and cost-effectiveness of our μPAD-RT-LAMP COVID-19 chip will be examined and compared to those of the traditional machine-dependent method (namely, reverse transcription real time polymerase chain reaction, RT-qPCR). The limit of detection (LOD) of both assays will be investigated using a dilution series of stock controls. The analytical specificity of μPAD-RT-LAMP will be determined by testing a set of negative controls related to other commonly encountered viral and bacterial respiratory pathogens

Clinical Application

Selected healthcare facilities will be supported with the necessary equipment and technical supervisory (step-to-step protocols, guidance notes and instruction videos). Appropriate biosafety measures and waste management practices will be underlined and strictly followed. Potential application of μPAD-RT-LAMP for clinical diagnosis and surveillance of COVID-19 as a complementary method to RT-PCR, will be evaluated. Ease of use will be assessed by surveying the operators for feedback on each step of the analytical procedure. Clinical samples will be systematically collected as part of the routine surveillance activities conducted by our local partners. Samples will be selected for COVID-19 testing according to the “Laboratory Testing Guidance for COVID-19” and the “Laboratory Testing Strategy Recommendations for COVID-19 in Suspected Human Cases” published by the World Health Organization in March 2020.