tetano
Editor, Senior Moderator
J Infect Chemother
. 2026 Sep 25:103085.
doi: 10.1016/j.jiac.2026.103085. Online ahead of print.
Yuki Sato 1 , Shinya Nirasawa 1 , Yoshihiro Fujiya 2 , Satoshi Takahashi 3
Affiliations
Background: Rapid nucleic acid amplification tests (rapid NAATs) may facilitate timely influenza diagnosis. This study evaluated the agreement of the GeneSoC® FluA/B Detection Kit (GeneSoC Flu), a rapid NAAT for detecting influenza A and B viruses.
Methods: A preselected panel of 180 nasopharyngeal swab specimens initially classified by prior clinical testing as FluA positive (n = 60), FluB positive (n = 70), or negative (n = 50) was evaluated. The same purified RNA extract from each specimen was tested using GeneSoC Flu, a National Institute of Infectious Diseases (NIID)-based real-time reverse transcription polymerase chain reaction (RT-PCR) method, and the TRexGene SARS-CoV-2&FluA/B Detection Kit.
Results: For detection of either influenza A or B virus, the overall percent agreement, positive percent agreement, and negative percent agreement of GeneSoC Flu were 99.4%, 99.2%, and 100.0%, respectively, relative to both the NIID-based method and TRexGene. Only two specimens yielded discordant initial results, and both had very low RNA copy numbers estimated from the NIID-based RT-PCR calibration curve. In addition, the cycle threshold (Ct) values obtained with GeneSoC Flu and TRexGene were strongly inversely correlated with estimated RNA levels (Spearman's ρ, -0.97 to -0.93; p < 0.01).
Conclusions: GeneSoC Flu showed high agreement with the comparator NAATs using shared purified RNA extracts. Prospective evaluation of the complete sample-to-result workflow is required to establish its real-world diagnostic performance and turnaround time.
Keywords: GeneSoC; influenza virus; microfluidic chip; nucleic acid amplification test; rapid molecular assay.
. 2026 Sep 25:103085.
doi: 10.1016/j.jiac.2026.103085. Online ahead of print.
Comparative evaluation of the GeneSoC FluA/B Detection Kit for influenza A and B virus detection using archived nasopharyngeal specimens
Yuki Sato 1 , Shinya Nirasawa 1 , Yoshihiro Fujiya 2 , Satoshi Takahashi 3
Affiliations
- PMID: 42790702
- DOI: 10.1016/j.jiac.2026.103085
Abstract
Background: Rapid nucleic acid amplification tests (rapid NAATs) may facilitate timely influenza diagnosis. This study evaluated the agreement of the GeneSoC® FluA/B Detection Kit (GeneSoC Flu), a rapid NAAT for detecting influenza A and B viruses.
Methods: A preselected panel of 180 nasopharyngeal swab specimens initially classified by prior clinical testing as FluA positive (n = 60), FluB positive (n = 70), or negative (n = 50) was evaluated. The same purified RNA extract from each specimen was tested using GeneSoC Flu, a National Institute of Infectious Diseases (NIID)-based real-time reverse transcription polymerase chain reaction (RT-PCR) method, and the TRexGene SARS-CoV-2&FluA/B Detection Kit.
Results: For detection of either influenza A or B virus, the overall percent agreement, positive percent agreement, and negative percent agreement of GeneSoC Flu were 99.4%, 99.2%, and 100.0%, respectively, relative to both the NIID-based method and TRexGene. Only two specimens yielded discordant initial results, and both had very low RNA copy numbers estimated from the NIID-based RT-PCR calibration curve. In addition, the cycle threshold (Ct) values obtained with GeneSoC Flu and TRexGene were strongly inversely correlated with estimated RNA levels (Spearman's ρ, -0.97 to -0.93; p < 0.01).
Conclusions: GeneSoC Flu showed high agreement with the comparator NAATs using shared purified RNA extracts. Prospective evaluation of the complete sample-to-result workflow is required to establish its real-world diagnostic performance and turnaround time.
Keywords: GeneSoC; influenza virus; microfluidic chip; nucleic acid amplification test; rapid molecular assay.