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A Prospective Evaluation of the Analytical Performance of GENECUBE® HQ SARS-CoV-2 and GENECUBE® FLU A/B.
Kiyasu, Yoshihiko; Akashi, Yusaku; Sugiyama, Akio; Takeuchi, Yuto; Notake, Shigeyuki; Naito, Asami; Nakamura, Koji; Ishikawa, Hiroichi; Suzuki, Hiromichi.
  • Kiyasu Y; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan.
  • Akashi Y; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan. yusaku-akashi@umin.ac.jp.
  • Sugiyama A; Akashi Internal Medicine Clinic, 3-1-63 Asahigaoka, Kashiwara, Osaka, 582-0026, Japan. yusaku-akashi@umin.ac.jp.
  • Takeuchi Y; Diagnostic System Department, TOYOBO Co., Ltd, 2-2-8, Dojima Hama, Kita-ku, Osaka, 530-8230, Japan.
  • Notake S; Department of Infectious Diseases, University of Tsukuba Hospital, 2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan.
  • Naito A; Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan.
  • Nakamura K; Department of Clinical Laboratory, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan.
  • Ishikawa H; Tsukuba i-Laboratory LLP, 2-1-17, Amakubo, Tsukuba, Ibaraki, 305-0005, Japan.
  • Suzuki H; Department of Clinical Laboratory, Tsukuba Medical Center Hospital, 1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan.
Mol Diagn Ther ; 25(4): 495-504, 2021 07.
Article in English | MEDLINE | ID: covidwho-1231951
ABSTRACT

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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Real-Time Polymerase Chain Reaction / COVID-19 Nucleic Acid Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Mol Diagn Ther Journal subject: Molecular Biology / Pharmacology / Laboratory Techniques and procedures Year: 2021 Document Type: Article Affiliation country: S40291-021-00535-5

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Real-Time Polymerase Chain Reaction / COVID-19 Nucleic Acid Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Mol Diagn Ther Journal subject: Molecular Biology / Pharmacology / Laboratory Techniques and procedures Year: 2021 Document Type: Article Affiliation country: S40291-021-00535-5