Cellphone-Based Hand-Held Microplate Reader for Point-of-Care Testing of Enzyme-Linked Immunosorbent Assays

Area of Science:

• Biomedical Engineering
• Point-of-Care Diagnostics
• Medical Device Technology

Background:

• Standard enzyme-linked immunosorbent assays (ELISA) are crucial for disease screening but require expensive equipment, limiting their use in resource-limited settings.
• Existing diagnostic tools often necessitate large, costly readout instruments, hindering accessibility in field applications and low-resource environments.

Purpose of the Study:

• To develop a cost-effective, hand-held cellphone-based colorimetric microplate reader for high-throughput ELISA testing.
• To enable rapid and accessible disease screening at the point-of-care, overcoming limitations of traditional laboratory-based assays.

Main Methods:

• A 3D-printed opto-mechanical attachment was designed to hold and illuminate a 96-well microplate with an LED array.
• Optical fibers collected transmitted light, and captured images were processed via a custom mobile app using a machine learning algorithm.
• The platform was validated using FDA-approved ELISA tests for mumps IgG, measles IgG, and herpes simplex virus IgG (HSV-1 and HSV-2).

Main Results:

• The cellphone-based reader achieved high accuracy in diagnosing mumps IgG (99.6%), measles IgG (98.6%), HSV-1 IgG (99.4%), and HSV-2 IgG (99.4%).
• Diagnostic results were delivered within approximately 1 minute per 96-well plate.
• The system demonstrated successful performance in a clinical microbiology laboratory setting with over 1000 patient samples.

Conclusions:

• This cost-effective, hand-held platform facilitates high-throughput disease screening and vaccination campaign monitoring at the point-of-care.
• The device's portability and wireless connectivity support epidemiological studies and disease prevalence mapping in diverse settings.
• The technology democratizes advanced diagnostic capabilities for resource-poor and field environments.