Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test

Study Overview
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Brief Summary
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This is a diagnostic validation study for a combined Syphilis/HIV test made by MBio Diagnostics, Inc (MBio, Boulder, CO, USA). Although the MBio Syphilis/HIV diagnostic platform is designed for use at point of care (POC), it is made to provide similar performance as reference standards. Diagnosing HIV and syphilis accurately with a single POC test will save time for clinic health workers and technicians, reduce loss-to follow-up caused by lengthy delays for lab-based tests, and save costs by eliminating the need for multiple tests. For this study, the sensitivity and specificity of the MBio HIV/Syphilis Serology System point-of-care diagnostic test will be determined using reference tests performed under controlled laboratory conditions. For this, clients receiving routine care in the ANCs at the New Nyanza Provincial General Hospital (NNPGH) and Kisumu District Hospital (KDH) will be consented to provide blood for the proposed study. Study volunteers will receive HIV and syphilis rapid tests provided as part of routine care, and will donate an additional blood for evaluating the MBio test against the reference tests in a laboratory setting. This study is an investigational prototype, not for product registration. The results from this study will be used to inform product development of a second iteration of the MBio device design. At the time that the device is ready to be registered, it will undergo another field evaluation at which time it will be submitted to the appropriate regulatory body. Because the MBIO device is an HIV test, the device would be submitted to National AIDS & STI Control Program (NASCOP), which is the appropriate regulatory body for HIV tests in Kenya.

Official Title
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Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test

Conditions
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HIV, Syphilis

Intervention / Treatment
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* Device: MBIO POC combined HIV syphilis test ( SnapEsi)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Attending her first routine ANC visit and willing to undergo tests for HIV/syphilis Able and willing to legally consent for enrollment Able to demonstrate-comprehension of study details as they are explained in the consent process by passing all the test questions of understanding. The subject is only allowed two attempts at passing the test of understanding. Exclusion Criteria: Unwilling to provide written informed consent. Unable to legally consent (minor without guardian) Opt out of HIV or syphilis test Previously diagnosed with autoimmune disorder (lupus, Lyme disease), as determined by client recollection or clinical record.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANC clients<br> | Device: MBIO POC combined HIV syphilis test ( SnapEsi)<br>* Venipuncture for routine ANC screening plus additional for device validation purposes.<br>* Other names: SnapEsi-beta HIV-1/Syphilis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device sensitivity/specificity | Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests | same-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent agreement with clinical diagnosis | Percent agreement with HIV & syphilis rapid tests completed at clinic | same-day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Syphilis, Combination, POC, point-of-care, MBIO