Negative Results of Nucleic Acid Amplification Test for SARS-CoV-2 in Clinical Practice May Vary among Six Molecular Assays in COVID-19 Patients

Ayano Motohashi; Kei Yamamoto; Kazuhisa Mezaki; Ataru Moriya; Masami Kurokawa; Hitoshi Oki; Honami Ando; Erina Isaka; Ayaka Usami; Satoshi Ide; Keiji Nakamura; Takahito Nakamoto; Hidetoshi Nomoto; Norio Ohmagari

doi:10.7883/yoken.JJID.2021.416

This article has now been updated. Please use the final version.

Negative Results of Nucleic Acid Amplification Test for SARS-CoV-2 in Clinical Practice May Vary among Six Molecular Assays in COVID-19 Patients

Ayano Motohashi, Kei Yamamoto, Kazuhisa Mezaki, Ataru Moriya, Masami Kurokawa, Hitoshi Oki, Honami Ando, Erina Isaka, Ayaka Usami, Satoshi Ide, Keiji Nakamura, Takahito Nakamoto, Hidetoshi Nomoto, Norio Ohmagari

Author information

Ayano Motohashi
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Kei Yamamoto
Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan
Kazuhisa Mezaki
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Ataru Moriya
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Masami Kurokawa
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Hitoshi Oki
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Honami Ando
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Erina Isaka
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Ayaka Usami
Clinical Laboratory Department, National Center for Global Health and Medicine, Japan
Satoshi Ide
Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan
Keiji Nakamura
Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan
Takahito Nakamoto
Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan
Hidetoshi Nomoto
Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan
Norio Ohmagari
Disease Control and Prevention Center, National Center for Global Health and Medicine, Japan

Keywords: COVID-19, SARS-CoV-2, molecular diagnostics, quantitative reverse-transcription polymerase chain reaction

JOURNAL FREE ACCESS Advance online publication

Article ID: JJID.2021.416

DOI https://doi.org/10.7883/yoken.JJID.2021.416

The final version of this article is now available: Vol. 75 (2022), No. 3 pp. 309-313

Details

Abstract

Several commercial nucleic acid amplification tests (NAAT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed. We used six kits available in Japan in 13 NAAT-positive specimens with crossing point values >36 and 7 NAAT-negative specimens from patients with coronavirus disease (COVID-19); their results were compared. Specimens positive in ≥2 assays were considered true positive and examined for concordance with specimen results. The SARS-CoV-2 Detection Kit -Multi- (Toyobo M) (Toyobo, Osaka, Japan) using extracted RNA had the highest concordance (κ 1.00). This was followed by the cobas® SARS-CoV-2 (Cobas) (Roche, Basel, Switzerland) (κ 0.79). There was a weak correlation between number of negative results for each kit and days between onset and testing (Spearman rank correlation: ρ= 0.44; p<0.05). We believe that the variations in results among kits for specimens with low viral loads should not be problematic when these kits are used for screening infectious patients because these variations are more likely to be observed in specimens tested many days after onset (i.e., those that have lost their infectivity). However, for suspected late-stage COVID-19 with a low viral load, it may be better to use a test such as Toyobo M or Cobas.

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