Evaluation of the Kaira COVID-19/Flu/RSV Detection Kit for detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus: A comparative study with the PowerChek SARS-CoV-2, influenza A&B, RSV Multiplex Real-time PCR Kit

• Published in: PloS one Vol. 17; no. 12; p. e0278530
• Main Authors: Kim, Tae Yeul, Bae, Go Eun, Kim, Ji-Youn, Kang, Minhee, Jang, Ja-Hyun, Huh, Hee Jae, Chung, Doo Ryeon, Lee, Nam Yong
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 14-12-2022
• Subjects: Animals; Assaying; Biology and life sciences; Comparative studies; Coronaviruses; COVID-19; COVID-19 - diagnosis; Evaluation; Health risks; Humans; Influenza; Influenza A; Influenza B; Influenza B virus - genetics; Influenza, Human - diagnosis; Medical tests; Medicine and Health Sciences; Methods; Multiplexing; Nasopharynx; Performance evaluation; Polymerase chain reaction; Public health; Real time; Real-Time Polymerase Chain Reaction; Respiratory diseases; Respiratory syncytial virus; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human - genetics; SARS-CoV-2 - genetics; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2; Spiders - genetics; Viral diseases; Viruses; South Korea; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0278530

Co-circulation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory viruses, such as influenza and respiratory syncytial virus (RSV), can be a severe threat to public health. The accurate detection and differentiation of these viruses are essential for clinical laboratories. Herein, we comparatively evaluated the performance of the Kaira COVID-19/Flu/RSV Detection Kit (Kaira; Optolane, Seongnam, Korea) for detection of SARS-CoV-2, influenza A and B, and RSV in nasopharyngeal swab (NPS) specimens with that of the PowerChek SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit (PowerChek; Kogene Biotech, Seoul, Korea).
A total of 250 archived NPS specimens collected for routine clinical testing were tested in parallel by the Kaira and PowerChek assays. RNA standards were serially diluted and tested by the Kaira assay to calculate the limit of detection (LOD).
The positive and negative percent agreements between the Kaira and PowerChek assays were as follows: 100% (49/49) and 100% (201/201) for SARS-CoV-2; 100% (50/50) and 99.0% (198/200) for influenza A; 100% (50/50) and 100% (200/200) for influenza B; and 100% (51/51) and 100% (199/199) for RSV, respectively. The LODs of the Kaira assay for SARS-CoV-2, influenza A and B, and RSV were 106.1, 717.1, 287.3, and 442.9 copies/mL, respectively.
The Kaira assay showed comparable performance to the PowerChek assay for detection of SARS-CoV-2, influenza A and B, and RSV in NPS specimens, indicating that the Kaira assay could be a useful diagnostic tool when these viruses are co-circulating.