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It adds PMDA's finding on pain and tearing, measured in the trial against the swab of the rapid antigen test.","title":"審査報告書 ｎｏｄｏｃａ（ノドカ）","url":"https://www.pmda.go.jp/medical_devices/2022/M20220516002/112714000_30400BZX00101_A100_4.pdf","date":"2022-02-15","written_by":"independent","quote":"検体採取にともなう痛みの度合いや涙流頻度がイムノクロマト法検査と比べ有意に低かったことから、本品の安全性に関して特段の懸念はないと判断した。"}],"replication":{"produced_by":["The camera photographed the back of the throat, and the software analyzed the image with 26 items of interview data such as temperature and symptoms.","The approved version was run on stored data from 659 patients of a trial at 11 sites in Japan, after Aillis changed the program and the camera."],"must_hold":["Patients are at least 6 years old and have influenza-like symptoms.","A doctor makes the diagnosis with other clinical findings, and the device does not replace the rapid antigen test.","Other infections that produce lymphoid follicles in the throat may need other tests."],"echoes":[]},"paired_incident":null,"headline":"*nodoca* throat photos met preset accuracy goals in Japan's review","metric":"76.0% sensitivity and 88.1% specificity","comparator":{"against":"Sensitivity and specificity goals set before the additional test (the published report withholds the goal values)","before":null,"after":"Sensitivity 76.0% (lower 95% confidence limit 70.7%) and specificity 88.1% (lower limit 85.5%) against PCR","basis":"measured","quote":"追加試験における主要有効性評価項目の評価結果は、表 18 に示すとおり感度 76.0%（下側 95%信頼区間：70.7%）、特異度 88.1%（下側 95%信頼区間：85.5%）であった。","url":"https://www.pmda.go.jp/medical_devices/2022/M20220516002/112714000_30400BZX00101_A100_4.pdf"},"later":null,"value":null,"developer_country":"Japan","deployer_country":"Japan","unrated_because":"The approved version was tested on stored trial data and guided no care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the Pharmaceuticals and Medical Devices Agency.","source":"https://www.pmda.go.jp/medical_devices/2022/M20220516002/112714000_30400BZX00101_A100_4.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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