男性淋菌性尿道炎診断のための尿沈渣中淋菌迅速抗原検出法の評価

Evaluation of a rapid antigen detection test for Neisseria gonorrhoeae in urine sediment for diagnosis of gonococcal urethritis in males.

抄録

男性淋菌感染症の診断のため，尿道炎患者の尿検体を用いて，イムノクロマト法による淋菌迅速抗原検出法（NOW Gonorrhea Test）を評価した．尿道スワブ培養を受けた男性患者58例のうち、34例（58.6％）に淋菌感染が認められた。標準培養の結果と比較したNOWテストの感度と特異度は，それぞれ94.1％（32/34例）と95.8％（23/24例）であった．NOW陽性およびNOW陰性の予測値は，それぞれ96.9％（32/33）および92.0％（23/25）であった．淋菌懸濁液を抗原とした本測定法の検出限界は5×10(4)cfu/mlであった。標準培養法とは対照的に，検体中の淋菌抗原は室温または4℃で45時間保存しても検出可能であった．本法の迅速性と簡便性を考慮すると，NOW法は淋菌性尿道炎の有用かつ信頼性の高い診断スクリーニング手段である可能性が示唆された．

We evaluated a rapid antigen detection method with an immunochromatographic assay for Neisseria gonorrhoeae (NOW Gonorrhea Test) by using urine samples from patients with urethritis to diagnose gonococcal infection in males. Among 58 male patients who underwent urethral swab culture, 34 cases (58.6%) were found to have N. gonorrhoeae infection. The sensitivity and specificity of the NOW Test compared with the results of standard culture were 94.1% (32/34) and 95.8% (23/24), respectively. The predictive values of positive NOW and negative NOW were 96.9% (32/33) and 92.0% (23/25), respectively. The detection limit of this assay was determined as 5 x 10(4) cfu/ml using N. gonorrhoeae suspension as an antigen. In contrast to standard cultures, gonococcal antigens in specimens were still detectable by this method up to 45 h of storage at either room temperature or 4 degrees C. Considering the rapidity and ease of this method, our results suggest that the NOW method might be a useful and reliable diagnostic screening tool for gonococcal urethritis.