Clinical evaluation of cell-direct polymerase chain reaction-based nucleic acid lateral flow immunoassay for rapid detection of bacterial pathogens in clinically suspected sepsis: A multi-center study in Japan

Wataru Shibata; Kenichiro Uchida; Daiki Ozawa; Haruka Imai; Shiro Endo; Yuji Watanabe; Kosuke Kosai; Yasuhide Kawamoto; Hirotsugu Uehara; Norihiko Sugimoto; Hiroki Namikawa; Yasumitsu Mizobata; Kanemitsu Keiji; Hisakazu Yano; Mitsuo Kaku; Masafumi Seki; Katsunori Yanagihara; Hiroshi Kakeya

doi:10.1016/j.mimet.2022.106566

Clinical evaluation of cell-direct polymerase chain reaction-based nucleic acid lateral flow immunoassay for rapid detection of bacterial pathogens in clinically suspected sepsis: A multi-center study in Japan

J Microbiol Methods. 2022 Oct:201:106566. doi: 10.1016/j.mimet.2022.106566. Epub 2022 Sep 8.

Authors

Wataru Shibata¹, Kenichiro Uchida², Daiki Ozawa³, Haruka Imai⁴, Shiro Endo⁴, Yuji Watanabe⁵, Kosuke Kosai⁶, Yasuhide Kawamoto⁷, Hirotsugu Uehara⁸, Norihiko Sugimoto⁸, Hiroki Namikawa⁹, Yasumitsu Mizobata², Kanemitsu Keiji¹⁰, Hisakazu Yano¹¹, Mitsuo Kaku⁴, Masafumi Seki⁴, Katsunori Yanagihara⁶, Hiroshi Kakeya¹²

Affiliations

¹ Department of Infection Control Science, Osaka Metropolitan University, Graduate School of Medicine, Osaka, Japan.
² Department of Traumatology and Critical Care Medicine, Osaka Metropolitan University, Graduate School of Medicine, Osaka, Japan.
³ Department of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
⁴ Division of Infectious Disease and Infection Control, Tohoku Medical and Pharmaceutical University, Sendai, Miyagi, Japan.
⁵ Laboratory for Clinical Microbiology, Tohoku Medical and Pharmaceutical University, Sendai, Miyagi, Japan.
⁶ Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
⁷ Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.
⁸ Research and Development Center, Fuso Pharmaceutical Industries, Ltd., Osaka, Japan.
⁹ Department of Medical Education and General Practice, Osaka Metropolitan University, Graduate School of Medicine, Osaka, Japan.
¹⁰ Department of Infection Control, Fukushima Medical University, Fukushima, Japan.
¹¹ Department of Microbiology and Infectious Disease, Nara Medical University, Nara, Japan.
¹² Department of Infection Control Science, Osaka Metropolitan University, Graduate School of Medicine, Osaka, Japan. Electronic address: [email protected].

PMID: 36087825
DOI: 10.1016/j.mimet.2022.106566

Abstract

Blood culture, a method for identifying causative agents of bacterial sepsis, requires several days. The combination of cell-direct polymerase chain reaction and nucleic acid lateral flow immunoassay (cdPCR-NALFIA) is a simple and sensitive detection method for identifying pathogenic bacteria. Furthermore, this assay, when applied directly to blood samples yields results within 4.5 h, without requiring culture. This study was performed at five hospitals in Japan between 2013 and 2016. Blood samples from 73 patients with clinically suspected sepsis yielded 18 positive blood cultures, and the isolated bacterial species were detectable using cdPCR-NALFIA in nine samples. Thirteen samples were positive on cdPCR-NALFIA. In total, 17 samples confirmed to have bacterial species were detectable using cdPCR-NALFIA and/or blood culture with a true positive rate of 76.5% and 64.7%, respectively. The combination of blood culture and cdPCR-NALFIA could improve the rate of detection of bacterial sepsis.

Keywords: Bacteremia; Bloodstream infection; Cell-direct PCR; Rapid diagnostic test; sepsis.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Bacteria / genetics
Humans
Immunoassay / methods
Japan
Nucleic Acids*
Polymerase Chain Reaction / methods
Sensitivity and Specificity
Sepsis* / microbiology

Substances

Nucleic Acids