An all-in-one point-of-care testing device for multiplexed detection of respiratory infections

• Published in: Biosensors & bioelectronics 2022-10, Vol.213, p.114454-114454, Article 114454
• Main Authors: Teixeira, William, Pallás-Tamarit, Yeray, Juste-Dolz, Augusto, Sena-Torralba, Amadeo, Gozalbo-Rovira, Roberto, Rodríguez-Díaz, Jesús, Navarro, David, Carrascosa, Javier, Gimenez-Romero, David, Maquieira, Ángel, Morais, Sergi
• Format: Article
• Language: English
• Subjects: Adenovirus; Antigens, Viral - analysis; Biosensing Techniques; COVID-19; COVID-19 - diagnosis; Humans; Immunoassay; Influenza; Influenza, Human - diagnosis; Microfluidics; Pandemics; Point-of-Care Systems; Point-of-Care Testing; Respiratory syncytial virus; Respiratory Tract Infections - diagnosis; SARS-CoV-2; Sensitivity and Specificity
• ISSN: 0956-5663; 1873-4235
• DOI: 10.1016/j.bios.2022.114454

The impact of the COVID-19 pandemic has reinforced the need for rapid, cost-effective, and reliable point-of-care testing (POCT) devices for massive population screening. The co-circulation of SARS-CoV-2 with several seasonal respiratory viruses highlights the need for multiplexed biosensing approaches. Herein, we present a fast and robust all-in-one POCT device for parallel viral antigen and serological analysis. The biosensing approach consists of a functionalized polycarbonate disc-shaped surface with microfluidic structures, where specific bioreagents are immobilized in microarray format, and a portable optoelectronic analyzer. The biosensor quantifies the concentration of viral antigens and specific immunoglobulins G and M for SARS-CoV-2, influenza A/B, adenovirus, and respiratory syncytial virus, using 30 μL of a sample. The semi-automated analysis of 6 samples is performed in 30 min. Validation studies performed with 135 serum samples and 147 nasopharyngeal specimens reveal high diagnostic sensitivity (98–100%) and specificity (84–98%), achieving an excellent agreement (κ = 0.937) with commercial immunoassays, which complies with the World Health Organization criteria for POC COVID-19 diagnostic tests. The versatility of the POCT device paves the way for the detection of other pathogens and analytes in the incoming post-pandemic world, integrating specific bioreagents against different variants of concerns and interests.