SLIDE: Saliva-Based SARS-CoV-2 Self-Testing with RT-LAMP in a Mobile Device

Area of Science:

• Molecular Biology
• Biotechnology
• Infectious Disease Diagnostics

Background:

• Current SARS-CoV-2 testing methods like nucleic acid amplification tests (NAATs) offer high accuracy but have long turnaround times.
• Rapid antigen tests provide quick results but have lower sensitivity, potentially leading to missed infections.
• There is a critical need for accessible, rapid, and accurate self-testing solutions for SARS-CoV-2.

Purpose of the Study:

• To develop and evaluate a fully integrated, self-administered nucleic acid testing device for SARS-CoV-2 using saliva samples.
• To achieve rapid turnaround time with high sensitivity and specificity comparable to gold-standard methods.

Main Methods:

• Development of an automated device integrating thermal lysis, sample dispensing, reverse transcription loop-mediated isothermal amplification (RT-LAMP), and real-time detection.
• Utilized self-collected saliva samples for non-invasive testing.
• Compared the device's limit of detection (LoD) and clinical performance against quantitative real-time polymerase chain reaction (qRT-PCR).

Main Results:

• The developed RT-LAMP device achieved a limit of detection of 5 copies/μL, comparable to qRT-PCR (6 copies/μL).
• The platform demonstrated a total turnaround time of less than 45 minutes from sample collection to result.
• Clinical validation showed good agreement between the self-testing platform and the gold-standard RT-PCR method.

Conclusions:

• The integrated RT-LAMP device enables accurate, rapid, and self-administered nucleic acid testing for SARS-CoV-2 using saliva.
• This platform offers a viable solution for at-home COVID-19 diagnostics, improving accessibility and speed.
• The technology holds promise for ongoing pandemic control and preparedness for future infectious disease outbreaks.