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要約 目的:アデノウイルス(AdV)結膜炎の診断にはイムノクロマト(IC)法キットが広く使用されているが,結膜擦過を必要とする。今回,結膜擦過を行わずに採取可能な結膜滲出液を含む涙液(以下,涙液)を用いるAdV IC法キットを従来法と比較検討した。
対象および方法:2016年7〜11月に福岡大学病院眼科およびみぎた眼科を受診したAdV結膜炎が疑われる93眼に2種類の迅速診断キットで検査を行った。対照キットとして結膜ぬぐい液を用いた従来のIC法キットを用いた。評価キットは,ろ紙を結膜に付着させて採取した涙液を検体とし,銀増幅IC法による専用の自動測定機器で測定された。AdV DNAの検出はreal-time PCR法で行い,遺伝子配列により型別判定を行った。
結果:全93眼のうちAdV54型が55眼,3型および19/64型がそれぞれ2眼検出された。対照キットおよび評価キットのそれぞれのPCR法に対する感度は89.8%,98.3%であり,特異度はいずれも100%であった。2種のIC法のPCR法陽性例における感度の差には有意差があった(p<0.01)。
結論:涙液を検体とした評価キットは結膜擦過が不要で,患者への負担が少なかった。専用機器で増感を行い,対照キットに比較して感度が高かった。評価キットは客観的で有用であると考えられた。
Abstract Purpose:Immunochromatography(IC)kit is widely used for the diagnosis of adenoviral conjunctivitis, but this needs conjunctival scraping for material collection. In this study, we evaluated a novel adenovirus(AdV)detection kit that used tears including conjunctival exudate without conjunctival scraping in comparison with a conventional IC kit.
Materials and Methods:Two kinds of rapid diagnosis kits were used on 93 cases who visited Fukuoka University Hospital Eye Center or Migita Eye Clinic between July 2017 and November 2017 and who were suspected for adenoviral conjunctivitis. The first kit(control kit)was a conventional IC kit for conjunctival scrapings. The other kit(test kit)was also an IC kit, but a physician pressed a filter paper strip on the conjunctiva to collect tear containing conjunctival exudate sample. The result was automatically obtained by specific reader which was based on silver amplification method in 15 minutes. Detection of AdV was carried out by real-time polymerase chain reaction method and its typing was done by direct sequencing.
Results:Adenovirus type 54 was detected in 55 eyes, and type 3 and type 19/64 was detected in 2 eyes, respectively. Sensitivity of control kit and test kit was 89.8% and 98.3%, respectively. Specificity of both kit was 100%. Significant difference was observed in the sensitivities of the two IC kits against PCR positivity(p<0.01).
Conclusions:Test kit using tears containing conjunctival exudate had less discomfort on patients in specimen collection. It also had higher sensitivity with a dedicated reader than that of the conventional IC kit. It was considered that the test kit was highly objective and useful.
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