Clinical evaluation of a developed paper-based Dengue NS1 rapid diagnostic test for febrile illness patients

Muhammad Hatta Prabowo; Supawat Chatchen; Patsamon Rijiravanich; Pana Klamkam; Thanit Chalermwatanachai; Kriengsak Limkittikul; Werasak Surareungchai

doi:10.1016/j.ijid.2021.05.007

Clinical evaluation of a developed paper-based Dengue NS1 rapid diagnostic test for febrile illness patients

Int J Infect Dis. 2021 Jun:107:271-277. doi: 10.1016/j.ijid.2021.05.007. Epub 2021 May 12.

Authors

Muhammad Hatta Prabowo¹, Supawat Chatchen², Patsamon Rijiravanich³, Pana Klamkam⁴, Thanit Chalermwatanachai⁴, Kriengsak Limkittikul², Werasak Surareungchai⁵

Affiliations

¹ School of Bioresources and Technology, King Mongkut's University of Technology Thonburi, Bang Khun Thian, Bangkok 10150, Thailand; Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Universitas Islam Indonesia, Sleman, Yogyakarta, 55584, Indonesia.
² Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Ratchathewi, Bangkok, 10400, Thailand.
³ Bioscience and System Biology Research Team, National Center for Genetic Engineering and Biotechnology, National Sciences and Technology Development Agency at King Mongkut's University of Technology Thonburi, Bang Khun Thian, Bangkok 10150, Thailand. Electronic address: patsamon.rij@biotec.or.th.
⁴ Department of Otolaryngology, Phramongkutklao Hospital and College of Medicine, Ratchathewi, Bangkok 10400, Thailand.
⁵ School of Bioresources and Technology, King Mongkut's University of Technology Thonburi, Bang Khun Thian, Bangkok 10150, Thailand. Electronic address: werasak.sur@kmutt.ac.th.

PMID: 33991681
DOI: 10.1016/j.ijid.2021.05.007

Abstract

Objectives: This study aimed to evaluate a microfluidic paper-based analytical device (DEN-NS1-PAD) based on a rapid NS1 antigen test for diagnosing dengue at the point of care.

Methods: 219 serum samples from suspected dengue cases were tested with the developed DEN-NS1-PAD and commercial RDT by SD BIOLINE. The results were compared with the nested-PCR results.

Results: The limit of detection of DEN-NS1-PAD was 0.78 ng mL^-1. It showed 88.89% sensitivity, 86.67% specificity, and a substantial agreement correlation (κ = 0.7522) compared with nested-PCR. In contrast, SD BIOLINE for NS1 (SD-NS1) detection showed 87.88% sensitivity, 90.00% specificity, and had a substantial agreement correlation with nested-PCR (κ = 0.7788).

Conclusions: DEN-NS1-PAD is a valuable tool for diagnosing DENV infections, especially for diagnosed patients with early acute phase samples with high viral load. DEN-NS1-PAD has better sensitivity than SD-NS1 but less specificity.

Keywords: Agreement; Dengue; Evaluation; Febrile cases; NS1.

MeSH terms

Antigens, Viral / analysis*
Antigens, Viral / immunology
Dengue Virus / immunology*
Fever / diagnosis*
Fever / virology*
Humans
Male
Middle Aged
Paper*
Point-of-Care Testing*
Time Factors

Substances

Antigens, Viral