A SARS-CoV-2 antigen rapid diagnostic test for resource limited settings

Area of Science:

• Medical Diagnostics
• Virology
• Biotechnology

Background:

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causes COVID-19, posing a significant global health challenge.
• Current diagnostic methods like RT-qPCR require extensive infrastructure, limiting accessibility in many regions.
• There is a critical need for affordable, rapid diagnostic tools to manage the pandemic and support economic recovery.

Purpose of the Study:

• To develop and evaluate an inexpensive lateral flow antigen test for the rapid detection of SARS-CoV-2.
• To provide an accessible diagnostic solution for active SARS-CoV-2 infections, particularly in resource-limited settings.

Main Methods:

• Development of a lateral flow assay for chromatographic detection of SARS-CoV-2 antigens.
• Testing the assay using anterior nares swab samples from patients.
• Performance evaluation against a validated RT-qPCR test, determining sensitivity, specificity, and limit of detection.

Main Results:

• The developed lateral flow test identifies SARS-CoV-2 antigens in 15 minutes.
• The test requires no specialized equipment or laboratory infrastructure.
• Achieved a limit of detection of 2.0 × 10^2 TCID50/mL, with 87.5% sensitivity and 100% specificity.

Conclusions:

• The inexpensive lateral flow antigen test offers a rapid and accessible method for diagnosing active SARS-CoV-2 infections.
• This diagnostic tool can significantly aid local, regional, and national strategies for pandemic control and economic reopening.
• The test's ease of use and minimal infrastructure requirements make it suitable for widespread deployment, especially in developing countries.