GENECUBE HQ SARS-CoV-2 和 GENECUBE FLU A/B 的分析性能前瞻性评估
A Prospective Evaluation of the Analytical Performance of GENECUBE HQ SARS-CoV-2 and GENECUBE FLU A/B.
机构信息
Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan.
Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan.
出版信息
Mol Diagn Ther. 2021 Jul;25(4):495-504. doi: 10.1007/s40291-021-00535-5. Epub 2021 May 18.
BACKGROUND
Molecular tests are the mainstay of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, their accessibility can be limited by the long examination time and inability to evaluate multiple samples at once.
OBJECTIVE
This study evaluated the analytical performance of the newly developed rapid molecular assays GENECUBE HQ SARS-CoV-2 and GENECUBE FLU A/B.
METHOD
This prospective study was conducted between 14 December 2020 and 9 January 2021 at a polymerase chain reaction (PCR) center. Samples were collected from the nasopharynx with flocked swabs. Molecular tests were performed with the GENECUBE system and reference reverse transcription (RT)-PCR, and the results of the two assays were compared.
RESULT
Among 1065 samples, 81 (7.6%) were positive for SARS-CoV-2 on the reference RT-PCR. Three showed discordance between GENECUBE HQ SARS-CoV-2 and the reference RT-PCR; the total, positive, and negative samples of concordance for the two assays were 99.7%, 100%, and 99.7%, respectively. All discordant cases were positive with GENECUBE HQ SARS-CoV-2 and negative with the reference RT-PCR. SARS-CoV-2 was detected in all three samples using another molecular assay for SARS-CoV-2. For GENECUBE FLU A/B, the total, positive, and negative samples of concordance for the two assays were 99.5%, 100%, and 99.1%.
CONCLUSION
The GENECUBE HQ SARS-CoV-2 and GENECUBE FLU A/B demonstrated sufficient analytical performance to detect SARS-CoV-2 and influenza virus A/B.
背景
分子检测是检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的主要手段。然而，由于检测时间长且无法同时评估多个样本，其可及性可能受到限制。
目的
本研究评估了新开发的快速分子检测试剂盒 GENECUBE HQ SARS-CoV-2 和 GENECUBE FLU A/B 的分析性能。
方法
本前瞻性研究于 2020 年 12 月 14 日至 2021 年 1 月 9 日在聚合酶链反应（PCR）中心进行。使用植绒拭子从鼻咽部采集样本。使用 GENECUBE 系统和参考逆转录（RT）-PCR 进行分子检测，并比较两种检测方法的结果。
结果
在 1065 份样本中，81 份（7.6%）在参考 RT-PCR 上检测到 SARS-CoV-2 阳性。GENECUBE HQ SARS-CoV-2 与参考 RT-PCR 之间有 3 个结果不一致；两种检测方法的总符合率、阳性符合率和阴性符合率分别为 99.7%、100%和 99.7%。两种检测方法均为阳性的所有不一致病例，参考 RT-PCR 均为阴性。使用另一种 SARS-CoV-2 分子检测方法在这 3 个样本中均检测到 SARS-CoV-2。对于 GENECUBE FLU A/B，两种检测方法的总符合率、阳性符合率和阴性符合率分别为 99.5%、100%和 99.1%。
结论
GENECUBE HQ SARS-CoV-2 和 GENECUBE FLU A/B 表现出足够的分析性能，可用于检测 SARS-CoV-2 和流感病毒 A/B。
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