Evaluation of the Diagnostic Performance of a SARS-CoV-2 and Influenza A/B Combo Rapid Antigen Test in Respiratory Samples

Abstract

This study aimed to evaluate the performance characteristics of a rapid antigen test developed to detect SARS-CoV-2 (COVID-19), influenza A virus (IAV), and influenza B virus (IBV) (flu) compared with those of the real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. One hundred SARS-CoV-2, one hundred IAV, and twenty-four IBV patients whose diagnoses were confirmed by clinical and laboratory methods were included in the patient group. Seventy-six patients, who were negative for all respiratory tract viruses, were included as the control group. The Panbio™ COVID-19/Flu A&B Rapid Panel test kit was used in the assays. The sensitivity values of the kit were 97.5%, 97.9%, and 33.33% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load below 20 Ct values. The sensitivity values of the kit were 16.7%, 36.5%, and 11.11% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load above 20 Ct. The kit’s specificity was 100%. In conclusion, this kit demonstrated high sensitivity to SARS-CoV-2 and IAV for viral loads below 20 Ct values, but the sensitivity values were not compatible with PCR positivity for lower viral loads over 20 Ct values. Rapid antigen tests may be preferred as a routine screening tool in communal environments, especially in symptomatic individuals, when diagnosing SARS-CoV-2, IAV, and IBV with high caution.

Development of a rapid, sensitive detection method for SARS‐CoV‐2 and influenza virus based on recombinase polymerase amplification combined with CRISPR‐Cas12a assay

“…In addition, lateral flow immunoassay is one of the most economical and simple methods, but the sensitivity of performance is not optimal as nucleic acidbased tests in practical use. 48 Each method can be applied in specific scenarios according to its characteristics (Table S2).…”

“…However, some are considered time‐consuming as qPCR and ELISA; and some have to be performed by specially trained personnel with sophisticated lab equipment in labs as qPCR and CLIA. In addition, lateral flow immunoassay is one of the most economical and simple methods, but the sensitivity of performance is not optimal as nucleic acid‐based tests in practical use 48 . Each method can be applied in specific scenarios according to its characteristics (Table ).…”

The convergent evolution of influenza A virus: Implications, therapeutic strategies and what we need to know

“…Various rapid antigen detection kits are commercially available for detecting the presence of the influenza antigen, usually the nucleoprotein protein, in fresh nasopharyngeal samples or throat swabs, with a broad range of specificity and sensitivity ranging from as low as 58% and 52%, respectively, depending on the brands, site of collection and pathogenesis ( Takeuchi et al., 2022 ; Chartrand et al., 2010 ; Dinc et al., 2023 ). In addition, the emergence of SARS-CoV-2 and influenza A/B co-detection rapid test kit allows users to identify and distinguish the causative agent for the infection, which is often challenging due to the similar clinical symptoms ( Takeuchi et al., 2022 ).…”

Simultaneous detection of influenza A, B and respiratory syncytial virus in wastewater samples by one-step multiplex RT-ddPCR assay

“…Nowadays, various diagnostic tests are used to detect respiratory pathogens, including molecular tests and antigen detection tests [ 3 ]. Antigen tests can rapidly detect respiratory viral antigens [ 4 – 7 ], but with varying diagnostic accuracy between tests and moderate sensitivity compared to molecular tests [ 8 ]. Quantitative reverse transcription polymerase chain reaction (RT-qPCR) tests are widely used for the detection and quantification of pathogenic viruses in clinical [ 9 , 10 ] or highly complex samples, such as wastewater samples [ 11 – 14 ].…”