A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test

Официальное название

A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings

Обзор

To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.

Подробное описание

A prospective study 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 healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on TruPlex Tests. Subsequently, EDTA whole blood and SST whole blood samples will be further processed to obtain plasma and serum, respectively, for testing on the TruPlex. Additional venous whole blood samples will be collected and sent to the National Serology Reference Laboratory (NSRL) 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.

Вмешательства

• Устройство TruPlex HIV/HepB/Syphilis Rapid Test
  A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status.

Первичные конечные точки

• Performance Evaluation [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Usability Evaluation [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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 is 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Австралия · 1 центр

• St Vincent's Hospital (Melbourne), Dept. of Gastroenterology — Melbourne

Идентификаторы

NCT: NCT07569913 · CLS-021B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗