Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker

Polycystic Ovary Syndrome (PCOS) is a multifactorial endocrine disorder with significant diagnostic challenges, especially in early stages. Current diagnostic methods are often complex, time-consuming, and dependent on laboratory-based infrastructure. This study presents the design and fabrication o...

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Main Authors: Aniket Nandi, Yash Kumar Gaur, Divyanshi Thakur, Ekta Daweshar, Kalicharan Sharma
Format: Article
Language:English
Published: Elsevier 2025-10-01
Series:Biosensors and Bioelectronics: X
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Online Access:http://www.sciencedirect.com/science/article/pii/S2590137025000998
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author Aniket Nandi
Yash Kumar Gaur
Divyanshi Thakur
Ekta Daweshar
Kalicharan Sharma
author_facet Aniket Nandi
Yash Kumar Gaur
Divyanshi Thakur
Ekta Daweshar
Kalicharan Sharma
author_sort Aniket Nandi
collection DOAJ
description Polycystic Ovary Syndrome (PCOS) is a multifactorial endocrine disorder with significant diagnostic challenges, especially in early stages. Current diagnostic methods are often complex, time-consuming, and dependent on laboratory-based infrastructure. This study presents the design and fabrication of a smartphone-assisted paper-based lateral flow assay (LFA) for the early detection of PCOS via the quantification of sex hormone-binding globulin (SHBG), a promising metabolic biomarker. Fluorescent nitrogen-doped carbon dots (CDs) were synthesized using a microwave-assisted method and conjugated with anti-SHBG antibodies via EDC/NHS chemistry. The LFA strips were constructed using Whatman filter paper, and hydrophobic barriers were drawn using permanent marker ink. A portable device equipped with a 365 nm UV LED and a smartphone camera enabled fluorescence detection. Recombinant SHBG antigen samples in phosphate-buffered saline (PBS) were tested across a concentration range of 80–4000 ng/mL. The system exhibited a strong linear response (R2 = 0.9677) between SHBG concentration and fluorescence intensity, with a calculated limit of detection (LOD) and limit of quantification (LOQ) of 2.68 ng/mL and 19.93 ng/mL, respectively. The analytical range of 80–4000 ng/mL corresponds to 0.8–42.1 nmol/L, covers the clinical diagnostic threshold of SHBG (<36 nmol/L). These results demonstrate the feasibility of a low-cost, point-of-care diagnostic tool for early PCOS screening. Further validation with clinical samples is necessary for real-world deployment.
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spelling doaj-art-dd577c126cbf4586b3b68221ea8968442025-08-20T04:01:02ZengElsevierBiosensors and Bioelectronics: X2590-13702025-10-012610067210.1016/j.biosx.2025.100672Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarkerAniket Nandi0Yash Kumar Gaur1Divyanshi Thakur2Ekta Daweshar3Kalicharan Sharma4Department of Pharmaceutical Chemistry and Analysis, ISF College of Pharmacy, Moga, Punjab, 142001, IndiaDepartment of Pharmaceutical Chemistry and Analysis, ISF College of Pharmacy, Moga, Punjab, 142001, IndiaDepartment of Pharmaceutical Chemistry and Analysis, ISF College of Pharmacy, Moga, Punjab, 142001, IndiaDepartment of Medical Devices, National Institute of Pharmaceutical Education and Research-Ahmedabad, Gandhinagar, 382355, Gujarat, IndiaDepartment of Pharmaceutical Chemistry and Analysis, ISF College of Pharmacy, Moga, Punjab, 142001, India; Corresponding author. Department of Pharmaceutical Chemistry, ISF College of Pharmacy, G.T Road, Ghal Kalan, Moga, Punjab, 142001, India.Polycystic Ovary Syndrome (PCOS) is a multifactorial endocrine disorder with significant diagnostic challenges, especially in early stages. Current diagnostic methods are often complex, time-consuming, and dependent on laboratory-based infrastructure. This study presents the design and fabrication of a smartphone-assisted paper-based lateral flow assay (LFA) for the early detection of PCOS via the quantification of sex hormone-binding globulin (SHBG), a promising metabolic biomarker. Fluorescent nitrogen-doped carbon dots (CDs) were synthesized using a microwave-assisted method and conjugated with anti-SHBG antibodies via EDC/NHS chemistry. The LFA strips were constructed using Whatman filter paper, and hydrophobic barriers were drawn using permanent marker ink. A portable device equipped with a 365 nm UV LED and a smartphone camera enabled fluorescence detection. Recombinant SHBG antigen samples in phosphate-buffered saline (PBS) were tested across a concentration range of 80–4000 ng/mL. The system exhibited a strong linear response (R2 = 0.9677) between SHBG concentration and fluorescence intensity, with a calculated limit of detection (LOD) and limit of quantification (LOQ) of 2.68 ng/mL and 19.93 ng/mL, respectively. The analytical range of 80–4000 ng/mL corresponds to 0.8–42.1 nmol/L, covers the clinical diagnostic threshold of SHBG (<36 nmol/L). These results demonstrate the feasibility of a low-cost, point-of-care diagnostic tool for early PCOS screening. Further validation with clinical samples is necessary for real-world deployment.http://www.sciencedirect.com/science/article/pii/S2590137025000998Polycystic ovary syndromeSex hormone-binding globulinDiagnosisLateral flow assayCarbon dot
spellingShingle Aniket Nandi
Yash Kumar Gaur
Divyanshi Thakur
Ekta Daweshar
Kalicharan Sharma
Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker
Biosensors and Bioelectronics: X
Polycystic ovary syndrome
Sex hormone-binding globulin
Diagnosis
Lateral flow assay
Carbon dot
title Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker
title_full Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker
title_fullStr Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker
title_full_unstemmed Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker
title_short Design and fabrication of smartphone based single paper lateral flow assay for early detection of PCOS biomarker
title_sort design and fabrication of smartphone based single paper lateral flow assay for early detection of pcos biomarker
topic Polycystic ovary syndrome
Sex hormone-binding globulin
Diagnosis
Lateral flow assay
Carbon dot
url http://www.sciencedirect.com/science/article/pii/S2590137025000998
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