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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Syphilis
• Intervention / Treatment: Device: MBIO POC combined HIV syphilis test ( SnapEsi)

• Study Type: Interventional
• Enrollment (Actual): 2900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Kisumu, Nyanza, Kenya
      • New Nyanza Provincial General Hospital
    • Kisumu, Nyanza, Kenya
      • Kisumu District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PATH
• Collaborators: Walter Reed Army Institute of Research (WRAIR); Kenya Medical Research Institute
• Investigators: Principal Investigator: Matthew Steele, Ph.D, M.P.H., PATH; Principal Investigator: John Waitumbi, Ph.D, D.V.M., Walter Reed Project; Principal Investigator: Kathleen Tietje, PhD, PATH

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (ESTIMATE): February 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: HIV; Combination; Syphilis; POC; point-of-care; MBIO
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Syphilis
• Other Study ID Numbers: HS647