Immunochromatography test for rapid diagnosis of Mycoplasma pneumoniae infection

Shigeru Onari; Takashige Okada; Takafumi Okada; Syuko Okano; Osamu Kakuta; Hirokazu Kutsuma; Masaaki Kobayashi; Yasuo Kondo; Naoya Sakaguchi; Takeshi Tajima; Masayoshi Nagao; Eiichi Nakayama; Ryo Niimi; Syuichi Nishimura; Yoshihito Higashidate; Toshiyuki Hikita; Hidenori Meguro; Toshihiko Mori; Yuko Yoto; Hiroyuki Tsutsumi

doi:10.1111/ped.13383

Immunochromatography test for rapid diagnosis of Mycoplasma pneumoniae infection

Pediatr Int. 2017 Oct;59(10):1123-1125. doi: 10.1111/ped.13383.

Authors

Shigeru Onari¹, Takashige Okada², Takafumi Okada³, Syuko Okano⁴, Osamu Kakuta⁵, Hirokazu Kutsuma⁶, Masaaki Kobayashi⁷, Yasuo Kondo⁸, Naoya Sakaguchi⁹, Takeshi Tajima¹⁰, Masayoshi Nagao¹¹, Eiichi Nakayama¹², Ryo Niimi¹³, Syuichi Nishimura¹⁴, Yoshihito Higashidate¹⁵, Toshiyuki Hikita¹⁶, Hidenori Meguro¹⁷, Toshihiko Mori¹⁸, Yuko Yoto¹⁹, Hiroyuki Tsutsumi¹⁹

Affiliations

¹ Department of Nakafukawa Pediatric Clinic, Hiroshima, Japan.
² Department of Okada Pediatric Clinic, Marugame, Japan.
³ Department of Pediatrics, Shikoku Medical Center for Children and Adults, Zentsuuji, Kagawa, Japan.
⁴ Okano Pediatric Clinic, Tokyo, Japan.
⁵ Kakuta Clinic, Kumagaya, Saitama, Japan.
⁶ Kid's Clinic Kamoi, Yokohama, Kanagawa, Japan.
⁷ Kobayashi Pediatric Clinic, Fujieda, Shizuoka, Japan.
⁸ Kondo Pediatric Clinic, Funabashi, Japan.
⁹ Naoya Pediatric Clinic, Tokyo, Japan.
¹⁰ Department of Pediatrics, Hakujikai Memorial Hospital, Tokyo, Japan.
¹¹ Department of Pediatrics, Hokkaido Medical Center, Sapporo, Hokkaido, Japan.
¹² Rêve Kids Clinic, Tokyo, Japan.
¹³ Kid's Clinic Kawaguchi Maekawa, Kawaguchi, Saitama, Japan.
¹⁴ Nishimura Clinic, Maizuru, Kyoto, Japan.
¹⁵ Department of Pediatrics, JCHO Sapporo Hokushin Hospital, Sapporo, Hokkaido, Japan.
¹⁶ Hikita Pediatric Clinic, Kiryu, Gunma, Japan.
¹⁷ Meguro Clinic, Ichikawa, Chiba, Japan.
¹⁸ Department of Pediatrics, NTT East Sapporo Hospital, Sapporo, Hokkaido, Japan.
¹⁹ Department of Pediatrics, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan.

PMID: 29081076
DOI: 10.1111/ped.13383

Abstract

The sensitivity and specificity of a new rapid Mycoplasma pneumoniae antigen immunochromatography (IC) test, DK-MP-001, were determined using particle agglutination (PA) antibody response and loop-mediated isothermal amplification (LAMP) gene detection as the gold standard. Of 165 patients, 59 were diagnosed with M. pneumoniae infection based on a ≥fourfold rise of serum PA antibody during the course of the illness. Of the first visit swabs, 60 were positive for M. pneumoniae on LAMP, and 49 were positive for M. pneumoniae antigen on IC test. Compared with PA antibody and LAMP, the sensitivity/specificity of the IC test were 81.4% (48/59) and 99.1% (105/106); and 81.7% (49/60) and 100% (105/105), respectively. IC test detected antigen in pharyngeal swabs more sensitively than in nasal swabs for the same subjects (P < 0.05). The IC test performs well enough to be used with pharyngeal swabs at the first examination.

Keywords: Mycoplasma pneumoniae; Mycoplasma pneumoniae pneumonia; immunochromatography; rapid diagnosis.

MeSH terms

Adolescent
Adult
Aged
Child
Child, Preschool
Chromatography, Affinity / methods*
Female
Humans
Infant
Male
Middle Aged
Pneumonia, Mycoplasma / diagnosis*
Retrospective Studies
Sensitivity and Specificity
Young Adult