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. 2025 Jun;44(6):1405-1416.
doi: 10.1007/s10096-025-05104-w. Epub 2025 Mar 28.

Development of a point-of-care test for the simultaneous detection of respiratory syncytial virus and IL-33 as a disease biomarker in children

Felipe A Cancino #  1   2 , Daniela Moreno-Tapia #  1   2 , Mariana Ríos  1   2 , Yaneisi Vázquez  1   2 , Ana María Contreras  3 , Marcela Ferrés  3 , Dona Benadof  4 , Ana María Guzmán  5 , Francisca Valdivieso  6 , Mauricio Farfán  6 , Eduardo Espejo  7 , Angélica Domínguez  8 , Pablo J Bertrand  9 , Valentina Gutiérrez  10   11 , Hernán F Peñaloza  1   2   12 , Pablo A González  1   2 , Alexis M Kalergis  1   2   13 , Susan M Bueno  14   15
Affiliations

Development of a point-of-care test for the simultaneous detection of respiratory syncytial virus and IL-33 as a disease biomarker in children

Felipe A Cancino et al. Eur J Clin Microbiol Infect Dis. 2025 Jun.

Abstract

Purpose: The human respiratory syncytial virus (hRSV) is a leading cause of acute respiratory disease in children under 5 years of age. hRSV infection is associated with significant morbidity and mortality and represents a substantial economic burden for public health systems worldwide. Early and accurate diagnosis is critical for effective patient management, but current diagnostic tools, such as RT-qPCR, require specialized equipment and personnel. Further, currently available methods do not provide information regarding the prognosis of the disease caused by hRSV. Given this scenario, we aimed at generating and pre-validating a new rapid diagnosis test based on an immunochromatographic strip (ICS) to be used as a point-of-care (POC) test capable of simultaneously detecting the phosphoprotein P of hRSV (P-hRSV) and a biomarker of disease severity, interleukin-33 (IL-33) in nasal swabs.

Methods: Monoclonal antibodies against P-hRSV and IL-33 were produced and incorporated into an ICS. The 20-min rapid diagnostic test was evaluated and validated with recombinant proteins, virus-infected cells, viral dilutions, and hRSV-positive and negative clinical samples. Sensitivity and specificity were assessed.

Results: The ICS detected 103 pg of P-hRSV and as low as 187 PFUs of hRSV. Regarding recombinant IL-33, the ICS detected as low as 780 pg. The test strip exhibited high specificity, distinguishing hRSV from other respiratory viruses, including influenza and human metapneumovirus. Additionally, IL-33 was detected in some non-RSV infections.

Conclusions: The data obtained supports the feasibility of a combined rapid test detecting simultaneously hRSV and IL-33, which can be useful as a POC test for screening severe cases of hRSV in primary care settings and emergency rooms.

Keywords: HRSV; Immunochromatographic strip (ICS) immunochromatography; Interleukin 33 (IL-33); Nasopharyngeal swab; Over-the-counter (OTC); Point-of-care (POC); Rapid diagnosis test; Respiratory tract infection.

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Conflict of interest statement

Declarations. Ethical statement: Research ethics approval was granted by the Ethics Committee of the Pontificia Universidad Católica de Chile, Hospital Luis Calvo Mackenna and Sótero del Río Hospital. All samples were provided anonymously by the hospital laboratories. All methods were carried out following relevant guidelines and regulations. Competing interests: Patent applications have been filled by Pontificia Universidad Católica de Chile to protect the monoclonal antibodies and the immunochromatographic device.

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