Performance of the Flash10 COVID-19 point-of-care molecular test

Abstract

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.

Fig. 1

Workflow of the Flash10 POCT for SARS-CoV-2 detection.

Fig. 2

Regression analysis and Bland-Altman analysis of the cycle threshold (Ct) values of the ORF1ab, N and internal control (IC) gene between Flash10 POCT and RT-PCR tests.

Fig. 3

Boxplot of turn-around-time (TAT) between the Flash10 POCT and RT-PCR groups. The Y-axis is plotted on a log2 scale to better illustrate the fold changes in TAT. Each box represents the interquartile range (IQR), with the median indicated by central line. The whiskers extend to 1.5 times the IQR. The median TAT for the Flash10 POCT was significantly shorter at 1.05 h (IQR 0.75–1.17 h) compared to 16.15 h (IQR 6.91–23.90 h) for RT-PCR tests (Wilcoxon signed rank test, p < 0.0001).