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

NCT01530672 | Completed

• 1 other identifier: HS647
• Study Type: interventional
• Target: 2,900
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Syphilis

Keywords

HIV; Syphilis; Combination; POC; point-of-care; MBIO

Outcome Measures

Primary Outcomes (1)

• Device sensitivity/specificity

  Sensitivity \& specificity of the MBIO device against HIV and syphilis reference tests

  same-day

Secondary Outcomes (1)

• Percent agreement with clinical diagnosis

  same-day

Study Arms (1)

ANC clients

EXPERIMENTAL

Device: MBIO POC combined HIV syphilis test ( SnapEsi)

Interventions

MBIO POC combined HIV syphilis test ( SnapEsi) DEVICE

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

Also known as: MBIO, SnapEsi-beta HIV-1/Syphilis

ANC clients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PATH: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Kenya Medical Research Institute: collaborator

Study Sites (2)

Kisumu District Hospital

Kisumu, Nyanza, Kenya

Location

New Nyanza Provincial General Hospital

Kisumu, Nyanza, Kenya

Location

Related Links

• Related Info

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 10, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

KE (2)