クリニテストCOVID-19抗原迅速テスト(一般用)は、付随の滅菌綿棒で鼻腔ぬぐい液を採取するというシンプルなプロセスにより、その場で迅速に測定結果を得ることができる一般用抗原定性検査キットです。
※厚生労働省より一般用の体外診断用医薬品として承認を取得
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新型コロナウイルス抗原検査キット
簡単操作、15分で結果判定
クリニテストCOVID-19抗原迅速テスト
弊社「クリニテストCOVID-19抗原迅速テスト」は、販売終了いたしました。詳細はこちら
クリニテストCOVID-19抗原迅速テスト(一般用)は、付随の滅菌綿棒で鼻腔ぬぐい液を採取するというシンプルなプロセスにより、その場で迅速に測定結果を得ることができる一般用抗原定性検査キットです。
※厚生労働省より一般用の体外診断用医薬品として承認を取得
使用方法
大切な検査を1回で確実に判定するためにも、必ずお読みください。
※測定に先立ち、本品が冷蔵庫などで保管されていた場合には測定カセット及び緩衝液入り抽出チューブを15~30℃に戻してから使用ください。
Step1:準備
Step2:検体採取
Step3:前処理
Step4:検体抽出
Step5:滴下
Step6:結果確認
※20分以上経過した場合の結果は判定に使用しないでください
コントロールライン(C)と測定ライン(T)が2本とも現れた場合
お住まいの地域の自治体の最新の情報等も確認し、適切に医療機関の受診等をおこなってください。
コントロールライン(C)のみ現れた場合
偽陰性(過って陰性と判定されること) の可能性も考慮し、症状がある場合には陽性であった場合と同様に、適切に医療機関の受診等を行ってください。また、陰性であったとしても引き続き感染予防策を行ってください。
コントロールライン(C)が現れない場合
結果は無効と見なします。無効となった原因として、検体採取及び操作手順が適切でなかったこと、または測定カセットの期限切れにより劣化していることが考えられます。新しい測定カセットにて再測定を実施ください。
【判定に関する注意】
・ 測定ライン領域(T)に現れる色の強度は、検体中の検体濃度により変わることがあります。濃淡の差はあっても、測定ライン領域(T)に色が現れた場合、陽性と見なす必要があります。本品は定性測定であり、検体中の検体濃度を測定することはできません
・コントロールラインが現れない場合、検体量の不足、手順の誤り、測定カセットの期限切れが主な原因として考えられます
・本品は、新型コロナウイルス抗原の生存の有無にかかわらず検出可能です。本品の性能は新型コロナウイルス抗原の量で左右され、同一検体のウイルス培養結果と相関しない可能性があります
・測定手順から外れた場合、測定結果が悪影響を受けたり無効となったりする場合があります
・新型コロナウイルス抗原のテストが最小検出レベルを下回っている場合、又は検体採取が不適切な場合、結果が陰性となる可能性があります。そのため測定結果が陰性であっても、新型コロナウイルス抗原が検体に存在しないことを保証するものではありません
FAQs
体調が気になる場合等のセルフチェックとして使用ください。
陽性の場合には、適切に医療機関を受診してください。陰性の場合でも、偽陰性(過って陰性と判定されること)の可能性も考慮し、症状がある場合には医療機関を受診してください。症状がない場合であっても、引き続き、外出時のマスク着用、手指消毒等の基本的な感染対策を続けてください。
※お住まいの地域の自治体で医療機関の受診方法に関する案内が出ている場合は、その案内にしたがって適切に医療機関の受診等を行ってください。
※その他、濃厚接触者となった場合等における活用方法については、厚生労働省から発出された最新の情報を参照してください。
製造から24ヶ月保存可能です。使用期限はキットごとに記載がされていますので、期限切れのキットは使用しないでください。
測定カセットを袋から出したあとは1時間以内にご使用ください。もし1時間以内に使用できない場合は破棄してください。
直射日光を避け、室温もしくは冷蔵で保存してください(2~30℃)
本品が冷蔵庫などで保管されていた場合には測定カセット及び緩衝液入り抽出チューブを15~30℃に戻してから使用ください。
滅菌綿棒で検体を採取後、直ちに検査を行ってください。採取から1時間以上経過した検体は使用しないでください。すぐに測定できない場合、密閉可能の清潔なプラスチックチューブに入れて保管し、1時間以内に測定ください。
COVID-19 に感染している可能性があります。確定診断には臨床症状やPCR等、他の検査結果と合わせて医師による総合的な判断が必要ですので、お住まいの地域の発熱外来や各都道府県の指示に従ってください。
抽出液の中に稀に見られる浮遊物は、測定結果や安全面への影響がないため、通常通りにご使用いただけます。浮遊物は、プラスチック製の抽出チューブの成形工程で発生するプラスチック片が、チューブ内側に残留したものです。検証の結果、測定結果に影響を及ぼさないことが確認されております。
その他の質問はこちらからご覧ください
重要な基本的注意
本品は、薬剤師から説明を受け、「使用上の注意」をよく読んでお使いください。
検査結果が「陽性」の場合は適切に医療機関の受診等を行ってください。
検査結果が「陰性」であっても症状がある場合には、適切に医療機関の受診等を行ってください。
全般的な注意
廃棄に関する注意
本キットや検体採取に使用した綿棒などは家庭ごみとして各自治体の廃棄方法に従って廃棄してください。
使用後の綿棒等は感染性を有するおそれがありますので、廃棄時の取扱いには十分注意し、使用したキット(綿棒、チューブ等を含む)をごみ袋に入れて、しっかりしばって封をする、ごみが袋の外面に触れた場合や袋が破れている場合は二重にごみ袋に入れる等、散乱しないように気を付けてください。
販売名:クリニテストCOVID-19 抗原迅速テスト(一般用)
分類:第1類医薬品
包装単位:5回用、1回用
製造販売承認番号:30400EZX00062000
使用目的:鼻腔ぬぐい液中のSARS-CoV-2抗原の検出(SARS-CoV-2感染疑いの判定補助)
保管期間:2~30℃
有効期間:24か月(使用期限は外箱に記載)
キットの内容及び成分(反応系に関与する成分1テスト中)
金コロイド標識抗SARS-CoV-2マウスモノクローナル抗体 0.00023mg
抗SARS-CoV-2マウスモノクローナル抗体 0.0003mg
つながるを、止めない。
ここからは Siemens Healthineersの体外診断用医薬品、新型コロナウイルス抗原検査キットを使用もしくは使用予定の方に適正に使用いただくための情報提供ページです。