Rapid, Onsite COVID-19 Detection
調査の概要
詳細な説明
Virtually all COVID-19 RNA assays require centralized laboratories. Samples collected in locations including public testing sites, workplaces, nursing homes, and residential housing are transported to centralized laboratories for testing, leading to lengthy delays in results reporting. The window of maximal contagiousness is thought to be only a few days, so these delays create the risk of excess transmission. Current testing methods are painful, which encourages testing hesitancy. Rapid, onsite detection of SARS-CoV-2 RNA from non-invasive saliva could overcome these issues and provide a pathway to high-throughput detection of people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a testing program require real-world prototyping.
The investigators have developed a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour. This assay is not diagnostic for SARS-CoV-2; instead, it specifically identifies saliva samples that have high amounts of viral RNA that are correlated with live virus shedding. Many samples that would be identified as SARS-CoV-2 by diagnostic qRT-PCR would be negative with this saliva assay. Conversely, detection of RNA in saliva is a potential finding of clinical significance, so participants with that result will be contacted by a medical professional to discuss potential follow-up with their own health care provider, including a possible independent diagnostic testing.
Because the assay requires no specialized equipment, it can be performed at the site of sample collection using a portable laboratory that fits in the backseat of a car. The prototype testing will take place in a variety of settings that may include parking lots, workplaces, nursing homes and residential housing. Participants will be asked to consent to provide a saliva sample that will be tested for SARS-CoV-2 RNA levels consistent with live virus shedding. The consent document will explicitly state that this is not a diagnostic test for SARS-CoV-2 but that a potential finding of clinical significance should be discussed with a medical professional. Participants can opt-out of receiving any results at the time of consent and can provide samples for the sole purpose of contributing to community surveillance and assay development. Paper consent forms will be reviewed and signed and held by team members in a secure location (locked box at the collection site) until taken back to the AIDS Vaccine Research Laboratory for storage. Participants will then spit into a coded vessel (e.g., cup or tube). Samples should be at least 1ml (~¼ teaspoon) and will be assayed for the presence of SARS-CoV-2 RNA using the aforementioned detection assay; the presence of high concentrations of SARS-CoV-2 RNA is indicated by a colorimetric change from pink to yellow/orange.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Wisconsin
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Madison、Wisconsin、アメリカ、53711
- University of Wisconsin
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Willing to provide informed consent
- Willing to provide informed consent and spit into a vessel
- Individuals at least 5 years of age and have a parent or legal guardian present to consent if under 18 years
- Adult participants must have decision-making capacity to provide consent on their own behalf.
- Participants must be able to speak English
Exclusion Criteria:
- Under 18 years of age with no parent or legal guardian present or under the age of 5 yrs
- Participants must not have visual or hearing impairments, or low literacy, that would prevent them from reading the consent form and interacting with a member of the research team to ask questions and receive responses during the consent process
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Rapid Onsite COVID-29 Testing
Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.
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saliva assay test for high concentrations of SARS-CoV-2
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Samples Tested
時間枠:15 minutes
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samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.
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15 minutes
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Safety: Number of Participants Who Tested Positive for COVID-19
時間枠:up to 2 months
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Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.
This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.
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up to 2 months
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協力者と研究者
捜査官
- 主任研究者:David O'Connor, PhD、University of Wisconsin, Madison
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2020-0855
- A536300 (その他の識別子:UW Madison)
- SMPH/PATHOL-LAB MED/ANAT PATH (その他の識別子:UW Madison)
- 5P51OD011106-59 (米国 NIH グラント/契約)
- Protocol Version 8/30/2020 (その他の識別子:UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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Massachusetts General Hospital募集
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Sheba Medical Centerわからない
Rapid Onsite COVID-19 Detectionの臨床試験
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Abbott Rapid Dx完了COVID-19(新型コロナウイルス感染症) | インフルエンザA | インフルエンザB型アメリカ
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Abbott Rapid Dx完了COVID-19(新型コロナウイルス感染症) | インフルエンザA | インフルエンザB型アメリカ
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National Institute of Medical Sciences and Nutrition...完了
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Raphael SerreauAssistance Publique - Hôpitaux de Paris; University Hospital, Paris; François Rabelais University完了
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University of PennsylvaniaPublic Health Management Corporation完了
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Abbott Rapid Dx完了COVID-19(新型コロナウイルス感染症) | インフルエンザA | インフルエンザB型アメリカ
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Kanuni Sultan Suleyman Training and Research HospitalAyşegül Bestel; İbrahim Polat; Merve Aldıkaçtıoğlu Talmaç完了