Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC
A Study to Evaluate the Clinical Performance, Usability and Readability of the iStatis COVID-19 Ag Rapid Test Performed With Anterior Nasal Swabs
調査の概要
状態
詳細な説明
Primary Objective: To evaluate the Clinical Performance of iStatis COVID-19 Antigen Test by untrained operators at Point of Care settings that meet requirements for CLIA waived tests.
Secondary Objective: To evaluate the performance of iStatis COVID-19 Antigen test around Limit of Detection Samples will be collected in CLIA Waived settings from approximately 200 subjects who present with or are referred for concerns about SARS-CoV-2. The goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects and N=30 confirmed Covid-19 negative subjects of comparable ages, genders, and races.
Individual participation only includes sample collection and 1 day visit for the purpose of study
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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Florida
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Fort Lauderdale、Florida、アメリカ、33308
- Therafirst Medical Center
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Maryland
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Elkridge、Maryland、アメリカ、21075
- Centennial Medical Group
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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:
- Participant is willing to sign verbal informed consent form
- Age 18 or older
- Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)
- Subjects with above mentioned symptom onset within the 7 days
- Participant is willing to provide two swabs - one anterior nasal swab sample for iStatis Test and another nasopharyngeal or nasal swab sample for comparator RT-PCR testing
Exclusion Criteria:
- Individuals who presented with 8 or greater days of COVID- 19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or postdefervescence and/or convalescence
- Any reason as identified by the Principal Investigator at the participating site that could disqualify the subject from participation. The reason for exclusion was documented
- Subject withdraw consent
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Anterior nasal swab sample tested on iStatis Covid-19 Antigen Testing diagnostic device
An anterior nasal swab was collected using the swab provided with the iStatis test kit and will be used for the iStatis Covid-19 Antigen Testing at the site.
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SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
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アクティブコンパレータ：Anterior nasal swab sample tested with RT-PCR
Another anterior nasal swab sample was collected to be tested with RT-PCR at the central research laboratory.
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The Labcorp COVID-19 RT-PCR or EURORealTime SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test
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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 |
|---|---|---|
|
Summary of the iStatis COVID-19 Ag test performance data compared to the comparator EUA RT-PCR test when all data from 4 POC/CLIA sites are combined.
時間枠：2 - 3 weeks
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The primary efficacy analyses will be analysis of relative positive percent agreement (PPA) and negative percent agreement (NPA) of the iStatis COVID-19 Antigen test results compared with the participant's RT-PCR results. The overall lower 95% confidence interval will be determined when: Positive Percent Agreement (PPA) = [TP / (TP + FN)] x 100, where
Negative Percent Agreement (NPA) = [TN / (TN + FP)] x100, where
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2 - 3 weeks
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協力者と研究者
スポンサー
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
- CLS-011
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?
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
米国で製造され、米国から輸出された製品。
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。