title: Evaluation of a novel immunochromatographic device for rapid and accurate clinical detection of Porphyromonas gingivalis in subgingival plaque.
abstract: An important goal for the improved diagnosis and management of infectious and inflammatory diseases, such as periodontitis, is the development of rapid and accurate technologies for the decentralized detection of bacterial pathogens. The aim of this prospective multicenter study was to evaluate the clinical use of a novel immunochromatographic device with monoclonal antibodies for the rapid point-of-care detection and semi-quantification of Porphyromonas gingivalis in subgingival plaque. Sixty-three patients with chronic periodontitis and 28 periodontally healthy volunteers were subjected to clinical and microbiological examinations. Subgingival plaque samples were analyzed for the presence of P. gingivalis using a novel immunochromatography based device DK13-PG-001, designed to detect the 40k-outer membrane protein of P. gingivalis, and compared with a PCR-Invader method. In the periodontitis group, a significant strong positive correlation in detection results was found between the test device score and the PCR-Invader method (Spearman rank correlation, r=0.737, p<0.0001). The sensitivity, specificity, and positive and negative predictive values of the test device were 96.2%, 91.8%, 90.4% and 96.7%, respectively. The detection threshold of the test device was determined to be approximately 10(4) (per two paper points). There were significant differences in the bacterial counts by the PCR-Invader method among groups with different ranges of device scores. With a cut-off value of ≥0.25 in device score, none of periodontally healthy volunteers were tested positive for the subgingival presence of P. gingivalis, whereas 76% (n=48) of periodontitis subjects were tested positive. There was a significant positive correlation between device scores for P. gingivalis and periodontal parameters including probing pocket depth and clinical attachment level (r=0.317 and 0.281, respectively, p<0.01). The results suggested that the DK13-PG-001 device kit can be effectively used for rapid, chair-side detection and semi-quantification of P. gingivalis in subgingival plaque.
  
  
  BACKGROUND
  UMIN Clinical Trials Registry (UMIN-CTR) UMIN000011943.
authors.affiliation: Department of Periodontology, Tokyo Dental College, 2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 101-0061, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Imamura
authors.affiliation: Department of Periodontology, Tokyo Dental College, 2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 101-0061, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Takayama
authors.affiliation: Department of Periodontology, Tokyo Dental College, 2-9-18 Misaki-cho, Chiyoda-ku, Tokyo 101-0061, Japan. Electronic address: atsaito@tdc.ac.jp.
authors.forename: A
authors.initials: A
authors.lastname: Saito
authors.affiliation: Department of Periodontology, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan.
authors.forename: E
authors.initials: E
authors.lastname: Inoue
authors.affiliation: Department of Periodontology, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Nakayama
authors.affiliation: Department of Periodontology, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba 271-8587, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ogata
authors.affiliation: Department of Periodontology, Tsurumi University, School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama 230-8501, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Shirakawa
authors.affiliation: Department of Periodontology, Tsurumi University, School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama 230-8501, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Nagano
authors.affiliation: Department of Periodontology, Tsurumi University, School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama 230-8501, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Gomi
authors.affiliation: Division of Periodontology, Department of Oral Biological Science, Niigata University Graduate School of Medical and Dental Sciences, 2-5274 Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Morozumi
authors.affiliation: Reagent R&D Department, Denka Seiken Co., Ltd., 1359-1, Kagamida, Kigoshi, Gosen-shi, Niigata 959-1695, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Akiishi
authors.affiliation: Showa Yakuhin Kako Co., Ltd, 4-12-15-19F Ginza, Chuo-ku, Tokyo 104-0061, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Division of Periodontology, Department of Oral Biological Science, Niigata University Graduate School of Medical and Dental Sciences, 2-5274 Gakkocho-dori, Chuo-ku, Niigata 951-8514, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Yoshie
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal; D001431:Bacteriological Techniques / Q000295:instrumentation* / Q000379:methods; D002846:Chromatography, Affinity / Q000295:instrumentation* / Q000379:methods; D003773:Dental Plaque / Q000382:microbiology*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010518:Periodontitis / Q000382:microbiology; D019095:Point-of-Care Systems; D016966:Porphyromonas gingivalis / Q000276:immunology / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D011446:Prospective Studies
chemical_list: D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal
keywords: Immunochromatography; Periodontitis; Periodontopathic bacteria; Porphyromonas gingivalis