Performance of the Flash10 COVID-19 point-of-care molecular test | Scientific Reports

Nov 03, 2024

Scientific Reports volume 14, Article number: 25622 (2024) Cite this article

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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.

Severe acute respiratory syndrome coronavirus (SARS-CoV-2) has sparked the coronavirus disease (COVID-19) pandemic, leading to the deaths of millions of patients1,2,3,4. A subset of COVID-19 patients, particularly the elderly, experience persistent symptoms for months following the resolution of their acute illness5,6. Nucleic acid amplification tests (NAATs) for SARS-CoV-2 are the most effective tools for detecting COVID-19. However, conventional laboratory-based reverse transcription polymerase chain reaction (RT-PCR) testing presents several challenges, including the need for samples transfer to central laboratory, its labor-intensive process and a prolonged analytical workflow (specimen preparation, extraction, detection and result analysis), which often results in delayed reporting beyond 4–6 h. These limitations of laboratory-based RT-PCR testing impede the goals of rapid case detection and early treatment7. In contrast, point-of-care testing (POCT) offers distinct advantages, including ease of use, rapid reporting of results, and the capacity to enable timely interventions in a time-effective manner8,9. Post the COVID-19 pandemic, fever clinics urgently require rapid nucleic acid tests to enhance their capacity for timely pathogen detection10.

The Coyote FlashDetect® Flash10 point-of-care test (Flash10 POCT) (Coyote Bioscience Co., Ltd.; Beijing, China) is a device designed for the rapid detection of SARS-CoV-2. To date, the majority of performance comparison studies on SARS-CoV-2 NAATs have relied on reference materials, and less frequent use of clinical specimens11,12. This study was undertaken to evaluate the analytical performance and clinical utility of the Flash10 POCT for detecting SARS-CoV-2 in patients in an adult fever clinic of a tertiary teaching hospital. The findings of this study may serve as a valuable reference for future NAAT POCT studies in clinical settings.

This study was conducted in accordance with the Declaration of Helsinki. It received ethical approval from the Ethics Committee of Beijing Tsinghua Changgung Hospital (approval number: 23412-2-01), and obtained informed consent from all participants.

The Flash10 POCT was a reverse transcription polymerase chain reaction (RT-PCR) molecular diagnostics platform. In this study, Flash10 POCT was designed for detecting SARS-CoV-2 nucleic acid. Simultaneous detection of the Open reading frame 1ab (ORF1ab) gene (FAM channel) and the nucleocapsid (N) gene (ROX channel) of SARS-CoV-2 was achieved, with human RNaseP serving as the internal control (IC) gene (HEX channel). The Flash10 POCT featured four random-access modules, enabling the simultaneous detection of 1–4 samples. The Flash10 POCT utilized 45 amplification cycles for detecting SARS-CoV-2. A sample was considered positive if it exhibited a clear exponential amplification phase and a cycle threshold (Ct) value of ≤ 42 for ORF 1ad gene and N gene.

The cartridges of the Flash10 POCT included negative controls and positive controls. For the negative control, the Ct values for the ORF1ab gene and N gene should indicate ‘undetected’ with no significant amplification curve. The Ct value for the IC gene should be ≤ 35, with a clear exponential amplification phase. For the positive control, the Ct values for the ORF1ab gene and N gene should be ≤ 35, exhibiting a clear exponential amplification phase. It has been confirmed that a single quality control test with positive and negative control materials was sufficient for each batch of reagents during every 10 h operational period of the Flash10 POCT.

The Flash10 POCT was a smart device that enabled a ‘sample in, result out’ process, utilizing fully sealed, all-in-one detection cartridges. These cartridges integrated sample loading, magnetic bead nucleic acid extraction, and PCR amplification. The cartridges were pre-loaded with lyophilized reagents, making them conveniently stored and transported at room temperature. Samples were collected from the patient’s nasopharynx using a swab, which could be directly loaded into the cartridge for subsequent detection. Alternatively, swab samples could be inserted into the collection tubes containing virus transfer medium (VTM) for temporary storage and then 300 µL of VTM containing the swabs could be transferred to the cartridge slot. The cartridge’s barcode was scanned and inserted into the Flash10 POCT instrument. The RNA isolation process consisted of four steps: sample lysis, nucleic acid binding to magnetic beads, washing away debris, and purified nucleic acid elution. The extracted nucleic acids were then transferred to lyophilized PCR reagents in the cartridges for PCR amplification. Final results (positive, negative, or invalid) and Ct values were available within approximately 25 min (3 min for nucleic acid extraction and 22 min for the amplification). This approach significantly simplified the clinical workflow, eliminating the need for biosafety cabinets and pipetting operations. The workflow was illustrated in Fig. 1.

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

This study was conducted in the laboratory department, an ISO 15,189 accredited laboratory, of Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University (Beijing, China) from August 1 to August 30, 2023. Prior to clinical implementation, the prospective analytical performance of the Flash10 POCT was evaluated, including accuracy, precision, the lower limit of detection (LoD), and system airtightness. All experimental procedures and process management conformed to the ISO 15,189 accreditation criteria.

Analytical precision was confirmed by repeated testing of the manufacturer’s standard materials at a concentration of 500 copies/mL, conducted 20 times over four consecutive days (with 5 tests performed each day). The accuracy of the Flash10 POCT was verified by assessing the qualitative recovery of a manufacturer’s standard material with a concentration of 100 copies/mL for SARS-CoV-2 in 20 technical replicates, as well as testing the virus transfer medium (VTM) blank in 20 technical replicates. The manufacturer’s standard materials were provided by BDS Biological Technology Co., Ltd. (Guangzhou, Guangdong, China). The LoD verification was evaluated using serial dilutions of the reference materials to achieve a concentration of 100 copies/mL for SARS-CoV-2, with subsequent analysis of the dilutions in multiple technical replicates7. The airtightness of the Flash10 POCT was evaluated by retesting SARS-CoV-2 in 12 swabs collected from the surface of the instruments and the cartridges after two rounds of positive amplification experiments.

Two duplicate nasopharyngeal swabs were collected from each of the 125 patients attending the adult fever clinic by trained nurses. One swab was processed on the Flash10 POCT device, located adjacent to the adult fever clinic (test group), while the other swab was sent to the central laboratory within the hospital for reverse transcription polymerase chain reaction (RT-PCR) testing (standard group). The RT-PCR tests were performed using a Sansure commercial kit (lot number: 20230510B; Sansure Biotech, Changsha, Hunan, China). The Sansure commercial nucleic acid extraction reagent was employed for the RNA extraction of SARS-CoV-2 from nasopharyngeal swabs using a magnetic bead extraction method. The Sansure RT-PCR utilized a fluorescence-probing real-time RT-PCR method to detect ORF1ab gene and N gene of SARS-CoV-2, with human RNaseP serving as the internal control (IC) gene. The LoD of the Sansure RT-PCR was 200 copies/mL. The Sansure RT-PCR assay comprised 45 amplification cycles, and a result was considered positive if it exhibited a clear exponential amplification phase in conjunction with a cycle threshold (Ct) value of ≤ 40 for ORF1ab gene and N gene. Viral load was assessed based on the Ct values obtained from the Sansure kit, and the enrolled samples were further classified into three groups according to the Ct values: high viral load (Ct < 25), moderate viral load (25 ≤ Ct ≤ 30) and low viral load (Ct > 30)13.

The turn-around-time (TAT) for both Flash10 POCT and RT-PCR tests was defined as the duration from specimen collection to result reporting, including the specimen transport time. The clinical performance of the Flash10 POCT was assessed by comparing the qualitative results, Ct values and the TAT of SARS-CoV-2 testing between the Flash10 POCT and RT-PCR methods.

Regression analysis and Bland-Altman analysis were employed to evaluate the Ct values of the ORF1ab gene, N genes, and IC genes obtained from the Flash10 POCT and RT-PCR tests. Fisher’s exact test chi-square p values and Cohen’s kappa analysis were employed to assess the statistical significance of the categorical results, specifically the positive and negative classifications based on the individual cut-off values for each test14. The clinical sensitivity and specificity, along with the positive and negative predictive values of the Flash10 POCT, were evaluated using the available clinical data. Since the TAT of two tests was not normally distributed, as determined by the Kolmogorov–Smirnov test, the data was presented as median and interquartile range (IQR). A paired Wilcoxon signed rank test was conducted using GraphPad Prism version 7 (GraphPad Software, San Diego California USA) to compare the TAT between the two groups. A two-tailed p-value of less than 0.05 was considered statistically significant.

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. The accuracy verification experiment confirmed that Flash10 POCT achieved perfect concordance with the expected outcomes. When testing the manufacturer’s standard materials, serving as positive samples with a concentration of 100 copies/mL, in 20 technical replicates, all 20 tests resulted in positive outcomes. Conversely, testing the virus transfer medium (VTM) blank, serving as negative samples, in 20 technical replicates, all 20 tests yielded negative results. The LoD verification experiment confirmed that the LoD of the Flash10 POCT achieved 100 copies/mL for SARS-CoV-2. The system’s airtightness experiment showed that 12 swabs taken from the surface of the instruments and the cartridges were all negative for SARS-CoV-2 after two rounds of positive amplification experiments, indicating the absence of aerosol contamination leakage from nucleic acid amplification products.

The prospective, real-world clinical study was carried out from August 1 to August 30, 2023, and involved a total of 125 patients presenting with fever symptoms (temperature > 37.2 ℃) at the adult fever clinic. Two duplicated nasopharyngeal swabs were collected from each patient by trained nurses, and paired SARS-CoV-2 testing was conducted using the Flash10 POCT and RT-PCR tests, respectively. The study enrolled patients with a wide age distribution, with 52.0% (65/125) being 60 years of age or older. The demographic and clinical characteristics of the 125 patients were presented in Table 1.

Among the 125 patients, 100 were found to be SARS-CoV-2 positive by both Flash10 POCT and RT-PCR tests, whereas the remaining 25 patients were negative by both methods. The results of the Flash10 POCT were 100.0% concordant with those of RT-PCR tests (kappa = 1.00, Z = 11.18, p < 0.0001). Based on the clinical data, the Flash10 POCT demonstrated perfect performance, achieving 100% clinical sensitivity, 100% specificity, 100% positive predictive value, and 100% negative predictive value in the detection of SARS-CoV-2.

Among the 100 SARS-CoV-2 positive patients, 25 were classified into the high viral load group (Ct < 25), 33 into the moderate viral load group (25 ≤ Ct ≤ 30) and 42 into the low viral load group (Ct > 30) based on the Ct values of the N gene from the Sansure RT-PCR tests. Regression analysis showed a high degree of correlation between the Ct values of the ORF1ab, N and IC genes obtained by the Flash10 POCT and RT-PCR tests across the three viral load groups (p < 0.0001). The regression equations were presented in the upper part of Fig. 2 (p < 0.0001). Bland-Altman consistency analysis demonstrated that the mean differences in Ct values between the Flash10 POCT and RT-PCR tests were 2.73, 4.48 and 4.80 higher for the ORF1ab, N and IC genes, respectively. Only 1.0% (1/100), 3.0% (3/100), and 2.0% (2/100) of the Ct values for the ORF1ab, N and IC gene amplification, respectively, fell outside the 95% limits of agreement (ORF1ab gene: − 0.05 to 5.51; N gene: − 1.83 to 7.13, IC gene: − 1.81 to 7.78) (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.

A total of 39.2% (49/125) of the SARS-CoV-2 results were obtained within one hour, and 100.0% (125/125) were reported within 4 h, when samples were processed immediately upon receipt using the Flash10 POCT. In contrast, laboratory-based RT-PCR tests were conducted in batches once a day, leading to only 1.6% (2/125) of the RT-PCR reports being issued within four hours time frame (Table 2).

Notably, the median TAT with 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, the differences were statistically significant as determined by the paired Wilcoxon signed rank test (n = 125 patients, Z = − 9.70, p < 0.0001) (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).

Rapid and sensitive detection of pathogens was crucial for interrupting the transmission of infectious diseases15,16,17,18,19,20. In the context of COVID-19, rapid and reliable SARS-CoV-2 nucleic acid amplification tests were urgently required to facilitate the prompt identification of COVID-19 patients in clinical settings, such as fever clinics and emergency surgeries21,22,23. This study evaluated the analytical and clinical performance of the Flash10 POCT in comparison with RT-PCR tests for detecting SARS-CoV-2 in patients with fever in the adult fever clinic. The Flash10 POCT showed 100.0% concordant with RT-PCR tests. In addition, the LoD of the Flash10 POCT was 100 copies/mL for SARS-CoV-2. This LoD was lower than that of other comparable POCT systems, such as the Coyote Flash20 system (with LoD of 400 copies/mL), the Sansure iPonatic system (200 copies/ml) and the Daangene AGS8830 system (200 copies/ml). This study showed that the Flash10 POCT had the capability to detect low levels of the virus early in infection, thereby aiding in the early diagnosis of COVID-19 patients.

The TAT, defined as the time interval from specimen collection to result reporting, including samples transportation time, was observed to be 1.05 h with the Flash10 POCT, which was significantly shorter than the 16.15 h with RT-PCR. Deploying Flash10 POCT testing solutions beyond centralized laboratories, particularly at primary or urgent care facilities, was a crucial step towards rapidly identifying COVID-19 cases. These devices could eliminate the need to transport samples to a clinical laboratory for analysis, thereby greatly reducing the waiting time for patients. Additionally, the Flash10 POCT was capable of providing respiratory multi-pathogen panels, including SARS-CoV-2, influenza A virus, and influenza B virus. Further research into respiratory multi-pathogen detection with Flash10 POCT was conducted (data not shown). The Flash10 POCT could provide a comprehensive time-effective solutions for detecting SARS-CoV-2, thereby offering rapid support for patient treatment management22,24,25.

Notably, no false positive or negative results were observed with the Flash10 POCT in this study. Treatment decisions were based on the Ct values of SARS-Cov-2, the age of the patients, and their clinical status. All 100 (100.0%) of COVID-19 patients were treated immediately upon receiving positive results from the Flash10 POCT, with 78 (78.0%) of these patients receiving Paxlovid™ oral treatment for COVID-19, and none of the patients died due to COVID-19. The Flash10 POCT tests effectively facilitate the management of COVID-19 patients. These results indicated significant potential for the integration of routine POCT SARS-CoV-2 diagnostics in resource-limited settings21.

The finding of this study may further inform strategies for pathogen testing capabilities in the context of other communicable diseases within the adult fever clinics. To prevent the transmission of respiratory infections within the hospital, fever clinics should possess the capability of nucleic acid POCT for common respiratory tract infection pathogens (such as SARS-CoV-2, influenza virus, respiratory syncytial virus, Mycoplasma pneumoniae, etc.), thereby enhancing their capacity for timely pathogen detection26. Integrating the Flash10 POCT into the construction program for laboratory testing capability had the potential to improve patient safety and alleviate the economic burden by expediting diagnosis, improving treatment outcomes with rapid viral clearance and accelerating the patients’ recovery.

It should be noted that there were some limitations in this study. Firstly, due to constraints on experimental resources, genotype analysis and sequencing analysis of the collected samples were not performed, thus the exact genotype of the virus were not provided. Data from the Chinese Center for Disease Control and Prevention (CDC) indicated that the omicron variant prevailing at the time in China, with initially the variants BA.5.2 and BF.7 circulated27, followed by XBB28. Despite the highly conserved regions for amplification in the ORF1ab gene and N gene, the clade of SARS-CoV-2 could potentially influence amplification efficiency. Secondly, the sample size of this study was relatively small and the study was conducted in a single center with geographical limitations. Further studies with larger sample sizes and multi-center approaches were necessary to draw more general conclusions.

In conclusion, the study validated that the Flash10 POCT exhibited high analytical performance, achieving a 100% detection rate for SARS-CoV-2 compared to RT-PCR tests, and exhibited a significantly shorter turn-around-time. Implementing the Flash10 POCT had the potential to expedite the care of patients within the adult fever clinics. The findings from this study could inform the development of POCT services beyond the scope of COVID-19 in clinical settings.

Data is provided within the manuscript. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Confidence interval

Coronavirus disease 2019

Cycle threshold

Internal control

Interquartile range

Lower limit of detection

Nucleic acid amplification test

Point-of-care testing

Reverse transcription polymerase chain reaction

Severe acute respiratory syndrome coronavirus 2

Standard deviation

Turn-around-time

Virus transfer medium

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The authors are grateful to the staff of the infectious disease department of Beijing Tsinghua Changgung Hospital for their efforts in this study.

the Education Reform Project of Tsinghua University (ZY01_02) and the Beijing High-level Public Health Technical Personnel Project (2023-03-03).

Laboratory Medicine Department of Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, No. 168 Litang Road, Changping District, Beijing, 102218, China

Runqing Li, Xiuying Zhao, Kai Jiang, Jie Tang, Song Yang & Jing Hu

Laboratory Medicine Department of Tiantongyuan North Community Healthcare Center, Beijing, China

Runqing Li

Infectious Disease Department of Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China

Xuzhu Ma

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Analyzed the data: J.T., S.Y. Wrote the paper: R.L. Study design: R.L., X.Z. Data collection: K.J., X.M. Data interpretation: J.H.

Correspondence to Runqing Li.

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Li, R., Zhao, X., Jiang, K. et al. Performance of the Flash10 COVID-19 point-of-care molecular test. Sci Rep 14, 25622 (2024). https://doi.org/10.1038/s41598-024-77837-1

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Received: 29 July 2024

Accepted: 25 October 2024

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DOI: https://doi.org/10.1038/s41598-024-77837-1

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