A Novel Adaptive Platform for Rapid, Simple Flow-Based Antibody Detection Devices Predicts NAb Levels to SARS-CoV-2

Area of Science:

• Immunology
• Infectious Diseases
• Diagnostics

Background:

• COVID-19 poses a significant global health burden, necessitating reliable markers of immune protection.
• Neutralizing antibodies (NAbs) are crucial for vaccine development, antiviral therapies, and understanding immune response.
• Current methods for quantifying NAbs are often inaccessible, limiting personalized patient care and effective convalescent plasma donation.

Purpose of the Study:

• To evaluate a novel semi-quantitative lateral flow assay (sqLFA) for detecting functional neutralizing antibodies against SARS-CoV-2.
• To assess the diagnostic performance of the sqLFA compared to a gold-standard microneutralization assay.
• To establish a point-of-care platform for rapid assessment of NAb-based immune protection.

Main Methods:

• Application of a novel semi-quantitative method to an established antibody lateral flow assay (sqLFA).
• Testing the sqLFA using serum samples from individuals recovered from COVID-19.
• Comparison of sqLFA results with those from a standard microneutralization assay.

Main Results:

• The sqLFA demonstrated a strong positive correlation with the microneutralization assay.
• Achieved 80% specificity and 90% sensitivity at a microneutralization cutoff of 1:40.
• Indicated the assay's capability to detect functional NAbs in recovered individuals.

Conclusions:

• The sqLFA offers a promising new tool for point-of-care assessment of SARS-CoV-2 neutralizing antibody levels.
• This assay facilitates rapid readout of NAb-based immune protection.
• The sqLFA can support clinical decision-making regarding vaccination, therapy, and convalescent plasma donation.