A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings
The objectives of this study are as follows:
To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings
To evaluate the usability of the TruPlex test through:
Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.
To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids).
To monitor test system reliability, including invalid rates.
調査の概要
詳細な説明
The study is designed to evaluate TruPlex Test when used by trained users.
Non-invasive samples (fingerstick, EDTA whole blood, EDTA-plasma, and SST-serum) will be collected and tested on TruPlex tests by on-site trained operators. Capillary (fingerstick) whole blood and EDTA whole blood samples will be collected by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on the TruPlex tests. Subsequently, the EDTA whole blood and SST whole blood samples will be further processed to obtain EDTA plasma and SST serum, respectively, for testing on the TruPlex. Blood samples will be collected and sent to the central laboratory for confirmatory testing (HIV, Syphilis and HBsAg) using approved on-the-market assays. Any remaining samples will be stored for further discrepancy testing or future research use.
A minimum of two TruPlex Test lots will be used for the study.
The following studies will also be performed:
Usability evaluation to assess user experience and success in label comprehension of the TruPlex test via a questionnaire.
Contrived result interpretation with a minimum of 15 intended users across a minimum of 3 clinical sites. Participants will be trained healthcare professionals that are paid employees of the study sites. Participants will have prior experience using rapid tests. Participants will evaluate a set of contrived tests to determine and document if intended users can successfully interpret various TruPlex Test results that include - strong positive, weak positive, negative, and a range of invalid results.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ana Subramanian
- 電話番号：16042046784
- メール：asubramanian@biolytical.com
研究連絡先のバックアップ
- 名前：Patrick Diaz
- 電話番号：16042046784
- メール：pdiaz@biolytical.com
研究場所
-
-
Gauteng
-
Johannesburg、Gauteng、南アフリカ、2193
- 募集
- Epicentre Health Research (Johannesburg)
-
コンタクト：
- Cherie Cawood
- メール：cheriec@epicentre.org.za
-
-
KwaZulu-Natal
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Durban、KwaZulu-Natal、南アフリカ、3650
- 募集
- Epicentre Health Research
-
コンタクト：
- Cherie Cawood
- 電話番号：+27 31 880 2150
- メール：cheriec@epicentre.org.za
-
-
Western Cape
-
Cape Town、Western Cape、南アフリカ、7925
- 募集
- Epicentre Health Research (Cape Town)
-
コンタクト：
- Cherie Cawoood
- 電話番号：+27 21 201 1658
- メール：cheriec@epicentre.org.za
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 18 years of age or older
- Subject is able to provide and willing to sign and date the Informed Consent Form
- Subject is able to complete the required testing on the allocated testing day.
- Subject able to speak/read/write English or a translator is available
Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons:
- At risk for any one of the target diseases
- Having signs or symptoms indicative of the target diseases
- Routine testing
- Note: Subjects who are pregnant and re-infected are eligible to participate
- Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART).
- Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study.
- Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results
Exclusion Criteria:
- Subject has a bleeding disorder
- Subject is currently undergoing Syphilis treatment
- Subject has received any experimental HIV vaccine
- Subject received HBV vaccine within the last 7 days
- Known HIV positive subjects and currently on ART for 12 months or longer
- Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.
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：ふるい分け
- 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：TruPlex HIV/HepB/Syphilis Rapid Test Performance
Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test.
|
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status
|
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 |
|---|---|---|
|
Performance Evaluation
時間枠：6 months
|
The diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined. Test invalid rate will be tabulated and reported. |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Usability Evaluation
時間枠：6 months
|
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing.
The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
|
6 months
|
|
Contrived result interpretation evaluation
時間枠：6 months
|
Trained operators will evaluate a panel of contrived (mock) TruPlexdevices.
These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results.
Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.
|
6 months
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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-021A
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
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