tetano
Editor, Senior Moderator
Sci Rep
. 2024 Oct 27;14(1):25622.
doi: 10.1038/s41598-024-77837-1. Performance of the Flash10 COVID-19 point-of-care molecular test
Runqing Li[SUP] 1 2 [/SUP], Xiuying Zhao[SUP] 3 [/SUP], Kai Jiang[SUP] 3 [/SUP], Jie Tang[SUP] 3 [/SUP], Song Yang[SUP] 3 [/SUP], Jing Hu[SUP] 3 [/SUP], Xuzhu Ma[SUP] 4 [/SUP]
Affiliations
After the COVID-19 pandemic, fever clinics urgently require rapid nucleic acid tests to enhance their capacity for timely pathogen detection. This study evaluated the analytical performance and clinical utility of the Flash10 SARS-CoV-2 point-of-care test (Flash10 POCT) for detecting SARS-CoV-2 in patients with fever in the adult fever clinic in Beijing Tsinghua Changgung Hospital from August 1 to August 30, 2023. The analytical performance and clinical utility of the Flash10 POCT for detecting SARS-CoV-2 were assessed in 125 patients with fever syndrome in the adult fever clinic. The Flash10 POCT demonstrated an analytical precision of 3.1% for the Ct values of the ORF1ab gene and 2.9% for the Ct values of the N gene in SARS-CoV-2 nucleic acid testing. Furthermore, the Flash10 POCT demonstrated a lower limit of detection (LoD) of 100 copies/mL, with no detected aerosol contamination leakage. Of the 125 patients (median age 61.9 years, 52% male and 48% female), both the Flash10 POCT and RT-PCR tests yielded positive results for 100 patients and negative results for 25 patients (Fisher's exact test, p < 0.0001). The median turn-around-time for the Flash10 POCT was significantly shorter, at 1.05 h, compared to 16.15 h required for RT-PCR tests (Wilcoxon signed rank test, p < 0.0001). The Flash10 POCT showed high analytical performance, achieving a 100% detection rate for SARS-CoV-2 compared to RT-PCR tests, while also exhibiting a significantly shorter turn-around-time. Implementing the Flash10 POCT had the potential to expedite the care of adults presenting with fever.
Keywords: COVID-19; SARS-CoV-2; diagnostic; point-of-care testing.
. 2024 Oct 27;14(1):25622.
doi: 10.1038/s41598-024-77837-1. Performance of the Flash10 COVID-19 point-of-care molecular test
Runqing Li[SUP] 1 2 [/SUP], Xiuying Zhao[SUP] 3 [/SUP], Kai Jiang[SUP] 3 [/SUP], Jie Tang[SUP] 3 [/SUP], Song Yang[SUP] 3 [/SUP], Jing Hu[SUP] 3 [/SUP], Xuzhu Ma[SUP] 4 [/SUP]
Affiliations
- PMID: 39465327
- DOI: 10.1038/s41598-024-77837-1
After the COVID-19 pandemic, fever clinics urgently require rapid nucleic acid tests to enhance their capacity for timely pathogen detection. This study evaluated the analytical performance and clinical utility of the Flash10 SARS-CoV-2 point-of-care test (Flash10 POCT) for detecting SARS-CoV-2 in patients with fever in the adult fever clinic in Beijing Tsinghua Changgung Hospital from August 1 to August 30, 2023. The analytical performance and clinical utility of the Flash10 POCT for detecting SARS-CoV-2 were assessed in 125 patients with fever syndrome in the adult fever clinic. The Flash10 POCT demonstrated an analytical precision of 3.1% for the Ct values of the ORF1ab gene and 2.9% for the Ct values of the N gene in SARS-CoV-2 nucleic acid testing. Furthermore, the Flash10 POCT demonstrated a lower limit of detection (LoD) of 100 copies/mL, with no detected aerosol contamination leakage. Of the 125 patients (median age 61.9 years, 52% male and 48% female), both the Flash10 POCT and RT-PCR tests yielded positive results for 100 patients and negative results for 25 patients (Fisher's exact test, p < 0.0001). The median turn-around-time for the Flash10 POCT was significantly shorter, at 1.05 h, compared to 16.15 h required for RT-PCR tests (Wilcoxon signed rank test, p < 0.0001). The Flash10 POCT showed high analytical performance, achieving a 100% detection rate for SARS-CoV-2 compared to RT-PCR tests, while also exhibiting a significantly shorter turn-around-time. Implementing the Flash10 POCT had the potential to expedite the care of adults presenting with fever.
Keywords: COVID-19; SARS-CoV-2; diagnostic; point-of-care testing.