J Infect Chemother. 2019 Sep 23. pii: S1341-321X(19)30264-8. doi: 10.1016/j.jiac.2019.08.015. [Epub ahead of print] Clinical evaluation of ID NOW influenza A & B 2, a rapid influenza virus detection kit using isothermal nucleic acid amplification technology - A comparison with currently available tests.

Mitamura K1, Shimizu H2, Yamazaki M3, Ichikawa M4, Abe T5, Yasumi Y6, Ichikawa Y7, Shibata T8, Yoshihara M9, Shiozaki K10, Baba S11, Kudo Y12, Tokushima M13, Konomi Y14, Kawakami C15.
Author information

1 Eiju General Hospital, Taito-ku, Tokyo 110-8645, Japan. Electronic address: mitamura@eijuhp.com. 2 Kawasaki City Institute for Public Health, Kawasaki, Kanagawa 210-0834, Japan. 3 Zama Children's Clinic, Zama, Kanagawa 252-0023, Japan. 4 Ichikawa Children's Clinic, Isehara, Kanagawa 259-1133, Japan. 5 Abe Children's Clinic, Yokohama, Kanagawa, 223-0051, Japan. 6 Yasumi Hospital, Morioka, Iwate 028-4125, Japan. 7 Ichikawa Clinic, Fukushima-shi, Fukushima 960-0112, Japan. 8 Futaba Children's Clinic, Ushiku, Ibaraki 300-1207, Japan. 9 Junseikai Yoshihara Clinic, Takasaki, Gunma 370-3524, Japan. 10 Shiozaki Clinic, Wakayama, Wakayama 640-8482, Japan. 11 Wakaayukai Baba Clinic, Nagaokakyou, Kyoto 617-0814, Japan. 12 Kudo Clinic, Kakogawa, Hyogo 675-0018, Japan. 13 Maebashi Kita Hospital, Maebashi, Gunma 371-0054, Japan. 14 Jinjikai Takahashi Clinic, Bando, Ibaraki 306-0631, Japan. 15 Yokohama City Institute of Public Health, Yokohama, Kanagawa 236-0051, Japan.


In this study, we evaluated the performance of ID NOW Influenza A & B 2 (ID NOW 2), a rapid molecular point-of-care test for influenza within 13 min, in comparison with currently available tests. A total of 254 nasopharyngeal swabs (NPS) and 271 nasopharyngeal aspirates (NPA) collected from 373 children and 152 adults with influenza-like illness were tested using ID NOW 2, viral culture, rapid antigen detection test, and loop-mediated isothermal amplification test to evaluate the sensitivity and specificity compared with real-time reverse transcription polymerase chain reaction as the reference method. The sensitivities of ID NOW 2 for influenza A were 95.9% and 95.7% in NPS and NPA, respectively, and for influenza B were 100% and 98.7% in NPS and NPA, respectively. The specificity was 100% for both influenza A and influenza B in NPS and NPA. Sensitivity of each test method reflected the difference of analytical sensitivity among the tests, and ID NOW 2 was not affected by time after illness onset and patient age. In conclusion, ID NOW 2 demonstrated a high sensitivity and specificity that is useful for diagnosis of influenza in the clinical setting and infection control.
Copyright ? 2019 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.


ID NOW influenza A & B 2; Influenza; Isothermal nucleic acid amplification; Point-of-care testing; Rapid antigen detection test

PMID: 31558351 DOI: 10.1016/j.jiac.2019.08.015