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

Sponsor

PATH (Other)

Overall Status

Completed

CT.gov ID

NCT01530672

Collaborator

Walter Reed Army Institute of Research (WRAIR) (U.S. Fed), Kenya Medical Research Institute (Other)

2,900

Enrollment

Locations

Arm

Duration (Months)

1450

Patients Per Site

72.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Syphilis	Device: MBIO POC combined HIV syphilis test ( SnapEsi)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2900 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ANC clients	Device: MBIO POC combined HIV syphilis test ( SnapEsi) Venipuncture for routine ANC screening plus additional for device validation purposes. Other Names: MBIO SnapEsi-beta HIV-1/Syphilis

Arm

Intervention/Treatment

Experimental: ANC clients

Device: MBIO POC combined HIV syphilis test ( SnapEsi)

Venipuncture for routine ANC screening plus additional for device validation purposes.

Other Names:

MBIO

SnapEsi-beta HIV-1/Syphilis

Outcome Measures

Primary Outcome Measures

Device sensitivity/specificity [same-day]
Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests

Secondary Outcome Measures

Percent agreement with clinical diagnosis [same-day]
Percent agreement with HIV & syphilis rapid tests completed at clinic

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.