ViraLite: An Ultracompact HIV Viral Load Self-Testing System with Internal Quality Control

Area of Science:

• Biomedical Engineering
• Infectious Diseases
• Point-of-Care Diagnostics

Background:

• Effective antiretroviral therapy (ART) manages HIV, but requires consistent viral load (VL) monitoring.
• Limited access to frequent VL testing hinders optimal patient self-management.
• There is a critical need for accessible, user-friendly VL testing solutions.

Purpose of the Study:

• To develop ViraLite, a compact, accessible, and battery-powered system for HIV viral load monitoring.
• To enable frequent VL monitoring and empower self-management for people living with HIV (PLHIV).

Main Methods:

• Development of a probe-based RT-LAMP assay for multiplexed HIV VL detection and quantification.
• Integration of an internal RNase P control for enhanced result reliability.
• Utilized a machine learning-powered real-time sensing system and smartphone-guided protocol for assay analysis.

Main Results:

• ViraLite achieved 93.3% sensitivity and 100% specificity in analyzing archived samples when using the RNase P control.
• The RNase P control improved sensitivity from 66.66% to 93.33% by identifying 17 previously inconclusive samples.
• Survey results showed over 86% of PLHIV valued ViraLite's convenience and privacy, though 61% expressed concerns about accuracy.

Conclusions:

• ViraLite offers an accurate, user-friendly solution for HIV viral load self-management.
• The system integrates compact hardware, a reliable assay, and smartphone guidance for frequent monitoring.
• Addressing accuracy concerns is crucial for widespread adoption and improved HIV care.