Performance of SARS-CoV-2 amplification assay with Abbott ID NOW

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  • OKADA Tomoki
    Department of Clinical Laboratory, Juntendo University Hospital
  • TSUCHIYA Koji
    Department of Clinical Laboratory, Juntendo University Hospital
  • TAKEMURA Hiroyuki
    Department of Clinical Laboratory, Juntendo University Hospital
  • WAKITA Mitsuru
    Department of Clinical Laboratory, Juntendo University Hospital
  • AI Tomohiko
    Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine
  • MISAWA Shigeki
    Department of Clinical Laboratory Technology, Juntendo University Faculty of Medical Science
  • TABE Yoko
    Department of Clinical Laboratory, Juntendo University Hospital Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine
  • MIIDA Takashi
    Department of Clinical Laboratory, Juntendo University Hospital Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine

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Other Title
  • 迅速SARS-CoV-2増幅アッセイAbbott ID NOWの性能評価
  • ジンソク SARS-CoV-2 ゾウフク アッセイ Abbott ID NOW ノ セイノウ ヒョウカ

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Abstract

<p>We examined the accuracy and clinical usefulness of a rapid SARS-CoV-2 test, “ID NOW COVID-19” (ID NOW), which uses the nicking enzyme amplification reaction (NEAR), an isothermal nucleic acid amplification method. A total of 673 patients who visited the emergency room at Juntendo University Hospital in Tokyo between February 1 and August 25, 2021 were enrolled. Both ID NOW and real-time reverse transcription PCR (PCR method) were performed using nasopharyngeal swab samples. The PCR method showed positive results in 36 and negative results in 637 patients, whereas ID NOW showed positive results in 35 and negative results in 638 patients. Of the 36 SARS-CoV-2-positive patients determined by the PCR method, 31 were also determined to be positive by ID NOW. Of the 637 SARS-CoV-2-negative patients determined by the PCR method, 633 were also determined to be negative by ID NOW, yielding an agreement rate of 98.7%. By using the PCR method as a reference, we found that the sensitivity of ID NOW was 86.1% and the specificity was 99.4%. The cause of the four false positives could not be identified. False positives can be minimized by repeated testing of patients with positive results, having a controlled environment, and having the test performed by authorized laboratory personnel. ID NOW provides optimal performance as a point-of-care test when the tests adhere to those measures.</p>

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