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Development and Evaluation of a Smartphone App-Based Rapid 25-Hydroxy Vitamin D Test
SoYeong Han1, Seung Hyun Kim2, MyungJin Kim1
1BioFront, HangGang Xi Tower, 401, Yangcheon-ro, Gangseo-Gu, Seoul-si 07258, Republic of Korea.
Diagnostics (Basel, Switzerland)
|November 27, 2025
Summary
A new smartphone-based lateral flow immunoassay (LFA) provides semi-quantitative 25-hydroxyvitamin D [25(OH)D] measurements. This accessible system offers accurate vitamin D evaluation for point-of-care testing.
Area of Science:
- Biomedical Engineering
- Analytical Chemistry
- Point-of-Care Diagnostics
Background:
- Vitamin D deficiency is a global health concern requiring accessible monitoring.
- Current methods for measuring 25-hydroxyvitamin D [25(OH)D] can be complex and not suitable for widespread point-of-care use.
- Developing user-friendly, accurate diagnostic tools is crucial for public health initiatives.
Purpose of the Study:
- To develop and validate a smartphone-integrated lateral flow immunoassay (LFA) for semi-quantitative 25-hydroxyvitamin D [25(OH)D] measurement.
- To establish a reliable and accessible vitamin D evaluation system for point-of-care (POCT) settings.
- To incorporate automated image analysis for enhanced diagnostic capabilities.
Main Methods:
- Construction of a smartphone-based sandwich-type LFA for semi-quantitative 25(OH)D analysis.
- Integration of an automated image acquisition, calibration, and classification module within a smartphone application.
- Comprehensive evaluation of analysis performance, reproducibility, and sample type equivalence.
Main Results:
- The developed LFA demonstrated a detection range of 5-100 ng/mL with minimal interference and cross-reactivity.
- An image processing algorithm accurately classified samples into deficiency (<20 ng/mL), insufficiency (20-30 ng/mL), and sufficiency (>30 ng/mL) categories.
- High reproducibility (r=0.99) was observed across platforms, with excellent agreement (97.0% category consensus, κ=0.951) compared to a standard analyzer and 100% classification agreement for serum vs. capillary samples.
Conclusions:
- The smartphone-integrated LFA platform enables rapid, accurate, and semi-quantitative 25(OH)D detection from various specimen types.
- Combining LFA with computational imaging analysis overcomes limitations of traditional immunoassays for small molecules.
- This system holds significant potential for field diagnosis, decentralized testing, and large-scale vitamin D screening.
