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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Kenya Medical Research Institute
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01530672
First received: January 23, 2012
Last updated: February 17, 2014
Last verified: February 2014

January 23, 2012
February 17, 2014
January 2012
December 2012   (final data collection date for primary outcome measure)
Device sensitivity/specificity [ Time Frame: same-day ] [ Designated as safety issue: No ]
Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests
Device sensitivity/specificity
Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests
Complete list of historical versions of study NCT01530672 on ClinicalTrials.gov Archive Site
Percent agreement with clinical diagnosis [ Time Frame: same-day ] [ Designated as safety issue: No ]
Percent agreement with HIV & syphilis rapid tests completed at clinic
Percent agreement with clinical diagnosis
Percent agreement with HIV & syphilis rapid tests completed at clinic
Not Provided
Not Provided
 
Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV
  • Syphilis
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
Experimental: ANC clients
Intervention: Device: MBIO POC combined HIV syphilis test ( SnapEsi)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2900
June 2014
December 2012   (final data collection date for primary outcome measure)

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.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01530672
HS647
No
PATH
PATH
  • Walter Reed Army Institute of Research (WRAIR)
  • Kenya Medical Research Institute
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
PATH
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP