全自動遺伝子検査装置GENECUBE を用いたSARS-CoV-2及びインフルエンザウイルスに対する迅速遺伝子検査について、臨床試験結果が受理されMolecular Diagnosis & Therapy誌で公開されました。
https://link.springer.com/article/10.1007/s40291-021-00535-5
試験方法：前向き観察研究（臨床性能試験）
実施場所：つくば（地域PCRセンター）
実施期間：2020年12月-2021年1月
対象人数：1065検体（鼻咽頭, 内陽性81検体）
比較法：RT-PCR (感染研法）
結果：SARS-CoV-2 全体一致率99.7%, 陽性一致率100%, 陰性一致率99.7%（乖離検体3検体は他の遺伝子検査法で陽性が確認）
インフルエンザウイルス 全体一致率99.5%, 陽性一致率100%, 陰性一致率99.1%
制限事項：本研究ではSARS-COV-2に対する唾液検体の検討結果は示されていない。
A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B
2021
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
https://link.springer.com/article/10.1007/s40291-021-00535-5
試験方法：前向き観察研究（臨床性能試験）
実施場所：つくば（地域PCRセンター）
実施期間：2020年12月-2021年1月
対象人数：1065検体（鼻咽頭, 内陽性81検体）
比較法：RT-PCR (感染研法）
結果：SARS-CoV-2 全体一致率99.7%, 陽性一致率100%, 陰性一致率99.7%（乖離検体3検体は他の遺伝子検査法で陽性が確認）
インフルエンザウイルス 全体一致率99.5%, 陽性一致率100%, 陰性一致率99.1%
制限事項：本研究ではSARS-COV-2に対する唾液検体の検討結果は示されていない。
A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B
2021
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
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