Author(s)

Lei Zhang ¹, Feng Yang ², Junzhe Zhu ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Lei Zhang

ABSTRACT

This research undertakes an exhaustive clinical verification of the CITEST Dengue NS1 Rapid Test Cassette-an immunochromatographic device engineered for the qualitative identification of Dengue virus NS1 antigen in human whole blood, serum, and plasma samples; a commercially supplied Dengue Antigen Enzyme-Linked Immunosorbent Assay (ELISA) was employed as the gold standard reference method to assess the efficacy of the rapid diagnostic test, utilizing a total of 383 clinical specimens collected from both symptomatic and asymptomatic patients, and the rapid test exhibited a relative sensitivity of 95.8% (with a 95% confidence interval of 91.1% to 98.4%) and a relative specificity of 98.3% (95% CI: 95.8%–99.5%), which translated to an overall diagnostic precision of 97.4% (95% CI: 95.3%–98.7%), with consistent and high levels of concordance with the reference ELISA assay observed throughout the validation process; precision analyses revealed superior intra-assay and inter-assay reproducibility, with correct identification rates exceeding 99%, and furthermore, no cross-reactivity was found when the test was exposed to a panel of potentially interfering substances and antibodies, such as heterophile antibodies and rheumatoid factor, leading to the conclusion that the Dengue NS1 Rapid Test Cassette is a reliable, precise, and user-friendly point-of-care diagnostic tool, capable of facilitating the timely detection of dengue infections, which in turn supports prompt clinical intervention and effective public health responses in regions where dengue is endemic.

KEYWORDS

Dengue Virus; NS1 Antigen; Rapid Diagnostic Test; Point-of-Care Testing; Immunochromatographic Assay

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu. Performance Evaluation of Dengue NS1 Rapid Test Cassette (WB/S/P) via Clinical Validation. MEDS Clinical Medicine (2026). Vol. 7, No.1, 141-145. DOI: http://dx.doi.org/10.23977/medsc.2026.070114.

REFERENCES

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