A multi-country field validation of the FluChip-8G Insight Assay

• Published in: Journal of virological methods Vol. 289; p. 114029
• Main Authors: Velasco, John Mark, Shrestha, Sanjaya, Valderama, Maria Theresa, Shrestha, Jasmin, Shrestha, Binob, Diones, Paula Corazon, Leonardia, Susie, Poolpanichupatam, Yongyuth, Hussem, Kittinun, Chua, Domingo, Navarro, Fatima Claire, Develos, Maribel, Macareo, Louis, Ellison, Damon, Fernandez, Stefan, Klungthong, Chonticha
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.03.2021
• Subjects: FluChip-8G; Influenza; Sensitivity; Specificity; Sensitivity; Specificity; FluChip-8G; Influenza
• ISSN: 0166-0934; 1879-0984
• DOI: 10.1016/j.jviromet.2020.114029

•This is a multi-country field validation of the FluChip-8G Insight, an assay which detects & characterizes seasonal & non-seasonal influenza.•Sensitivity and specificity for influenza A + B was 86 % and 100%, respectively. PPV was 100% (95% CI 99–100) and NPV was 73% (95% CI 68–78).•Sensitivity across all influenza subtypes was 100% for specimens with <20 and 20–25 Ct values, respectively.•As Ct values increased, sensitivity across all influenza subtypes decreased significantly(p < 0.001) for specimens with Ct values ≥32.•The assay showed good precision & reproducibility with robust identification of influenza with Ct values < 32 and in the absence of co-infection It is critical to rapidly detect novel and non-seasonal influenza strains. Currently available assays have limited sensitivity in detecting novel influenza subtypes. We performed a multi-country field validation of the FluChip-8G Insight, an assay able to detect and characterize influenza A/B viruses and non-seasonal influenza viruses. We evaluated the performance of the FluChip-8G Insight on nasal and throat swab clinical samples from Thailand, Philippines and Nepal. Influenza PCR positive and negative samples tested using the US CDC Human Influenza Dx Panel reference standard were selected for testing using the FluChip-8G Influenza Insight. A total of 909 specimens were included in the analysis. The overall sensitivity and specificity of the FluChip-8G Insight to detect combined influenza A+B was 86 % and 100%, respectively. PPV and NPV were estimated at 100 % (95 % CI 99–100) and 73 % (95 % CI 68–78), respectively. Sensitivity across all influenza subtypes was 100% for specimens with <20 and 20–25 Ct values, respectively, but as Ct values increased, sensitivity across all influenza subtypes decreased significantly (p < 0.001) for specimens with Ct values ≥32. The FluChip-8G Insight showed good precision and reproducibility among all 3 sites with robust identification of both influenza A and B targets with Ct values <32 and in the absence of co-infection. Positioning this platform in countries considered as hotspots for the emergence of novel/zoonotic influenza strains can increase the lead time in detecting and containing novel influenza strains with pandemic potential.