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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ana Subramanian
- Número de telefone: 16042046784
- E-mail: asubramanian@biolytical.com
Estude backup de contato
- Nome: Patrick Diaz
- Número de telefone: 16042046784
- E-mail: pdiaz@biolytical.com
Locais de estudo
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Gauteng
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Johannesburg, Gauteng, África do Sul, 2193
- Recrutamento
- Epicentre Health Research (Johannesburg)
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Contato:
- Cherie Cawood
- E-mail: cheriec@epicentre.org.za
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KwaZulu-Natal
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Durban, KwaZulu-Natal, África do Sul, 3650
- Recrutamento
- Epicentre Health Research
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Contato:
- Cherie Cawood
- Número de telefone: +27 31 880 2150
- E-mail: cheriec@epicentre.org.za
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Western Cape
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Cape Town, Western Cape, África do Sul, 7925
- Recrutamento
- Epicentre Health Research (Cape Town)
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Contato:
- Cherie Cawoood
- Número de telefone: +27 21 201 1658
- E-mail: cheriec@epicentre.org.za
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Triagem
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Performance Evaluation
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Usability Evaluation
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CLS-021A
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