Abstract：
UNASSIGNED: To develop a highly sensitive and rapid nucleic acid detection method for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
UNASSIGNED: We designed, developed, and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection. The precision of the liquid transfer and temperature control was tested. A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR). The entire process, from SARS-CoV-2 nucleic acid extraction to amplification, was evaluated.
UNASSIGNED: The precision of the syringe transfer volume was 19.2 ± 1.9 μL (set value was 20), 32.2 ± 1.6 (set value was 30), and 57.2 ± 3.5 (set value was 60). Temperature control in the amplification tube was measured at 60.0 ± 0.0 °C (set value was 60) and 95.1 ± 0.2 °C (set value was 95) respectively. SARS-Cov-2 nucleic acid extraction yield through the device was 7.10 × 10 6 copies/mL, while a commercial kit yielded 2.98 × 10 6 copies/mL. The mean time to complete the entire assay, from SARS-CoV-2 nucleic acid extraction to amplification detection, was 36 min and 45 s. The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL.
UNASSIGNED: The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test (POCT).
UNASSIGNED: We designed, developed, and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection. The precision of the liquid transfer and temperature control was tested. A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR). The entire process, from SARS-CoV-2 nucleic acid extraction to amplification, was evaluated.
UNASSIGNED: The precision of the syringe transfer volume was 19.2 ± 1.9 μL (set value was 20), 32.2 ± 1.6 (set value was 30), and 57.2 ± 3.5 (set value was 60). Temperature control in the amplification tube was measured at 60.0 ± 0.0 °C (set value was 60) and 95.1 ± 0.2 °C (set value was 95) respectively. SARS-Cov-2 nucleic acid extraction yield through the device was 7.10 × 10 6 copies/mL, while a commercial kit yielded 2.98 × 10 6 copies/mL. The mean time to complete the entire assay, from SARS-CoV-2 nucleic acid extraction to amplification detection, was 36 min and 45 s. The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL.
UNASSIGNED: The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test (POCT).
摘要：
■开发一种用于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的高灵敏度，快速的核酸检测方法。
■我们设计了，开发,并制造了用于SARS-CoV-2核酸提取和检测的集成一次性设备。测试了液体转移和温度控制的精度。使用实时荧光逆转录聚合酶链反应（RT-PCR）对我们的设备和用于SARS-Cov-2核酸提取的商业试剂盒进行了比较。整个过程,从SARS-CoV-2核酸提取到扩增,进行了评估。
■注射器转移体积的精度为19.2±1.9μL（设定值为20），32.2±1.6(设定值为30),57.2±3.5(设定值为60)。分别在60.0±0.0°C(设定值为60)和95.1±0.2°C(设定值为95)测量扩增管中的温度控制。通过该装置提取SARS-Cov-2核酸的产量为7.10×106拷贝/mL，而商业试剂盒产生2.98×106拷贝/mL。完成整个化验的平均时间,从SARS-CoV-2核酸提取到扩增检测,为36分钟和45秒。SARS-CoV-2核酸的检测极限为250拷贝/mL。
■集成的一次性装置可用于SARS-CoV-2点护理测试(POCT)。
■我们设计了，开发,并制造了用于SARS-CoV-2核酸提取和检测的集成一次性设备。测试了液体转移和温度控制的精度。使用实时荧光逆转录聚合酶链反应（RT-PCR）对我们的设备和用于SARS-Cov-2核酸提取的商业试剂盒进行了比较。整个过程,从SARS-CoV-2核酸提取到扩增,进行了评估。
■注射器转移体积的精度为19.2±1.9μL（设定值为20），32.2±1.6(设定值为30),57.2±3.5(设定值为60)。分别在60.0±0.0°C(设定值为60)和95.1±0.2°C(设定值为95)测量扩增管中的温度控制。通过该装置提取SARS-Cov-2核酸的产量为7.10×106拷贝/mL，而商业试剂盒产生2.98×106拷贝/mL。完成整个化验的平均时间,从SARS-CoV-2核酸提取到扩增检测,为36分钟和45秒。SARS-CoV-2核酸的检测极限为250拷贝/mL。
■集成的一次性装置可用于SARS-CoV-2点护理测试(POCT)。
