Clinical evaluation of a gonorrhea immunochromatographic test using cervical swabs

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  • 子宮頸管部拭い検体を用いた淋菌迅速検査キットの臨床性能評価
  • シキュウ ケイカン ブ ヌグイケンタイ オ モチイタ リンキン ジンソク ケンサ キット ノ リンショウ セイノウ ヒョウカ

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Abstract

Gonorrhea is one of the most critical infectious diseases in Japan. We performed a clinical evaluation of the newly developed Neisseria gonorrhoeae antigen rapid test kit, RapidSP ≪Gonorrhoeae≫, which is based on an immunochromatographic method. The new kit, approved kit, and standard nucleic acid amplification test were used to examine 391 collected cervical specimens. The sensitivity, specificity, and accuracy of this new kit compared to the approved kit were 84.9%, 94.1%, and 92.8%, respectively. Compared to the standard nucleic acid amplification method, the sensitivity, specificity, and accuracy of the new kit were 67.7%, 99.3%, and 91.8%, respectively. The new kit can be used as a good diagnostic tool and first-hand choice for ruling in N. gonorrhoeae infection because its positive predictive value against the standard nucleic acid amplification method was 96.9%. These results suggest that the new kit can also be used for female patients who need a rapid diagnosis.

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  • 日本性感染症学会誌

    日本性感染症学会誌 33 (1), 37-44, 2023-03-20

    Japanese Society for Sexually Transmitted Infections

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