Clinical trial NCT01530672: Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
Official title: Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Syphilis
Keywords: HIV
Syphilis
Combination
POC
point-of-care
MBIO
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Institute of Research (WRAIR)
name: Kenya Medical Research Institute
First posted: 2012-02-10
Enrollment: 2900
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Device sensitivity/specificity
timeFrame: same-day
Secondary outcomes:
measure: Percent agreement with clinical diagnosis
timeFrame: same-day
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kisumu District Hospital
state: Nyanza
city: Kisumu
country: Kenya
facility: New Nyanza Provincial General Hospital
state: Nyanza
Study officials:
affiliation: PATH
name: Matthew Steele, Ph.D, M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed Project
name: John Waitumbi, Ph.D, D.V.M.
role: PRINCIPAL_INVESTIGATOR
affiliation: PATH
name: Kathleen Tietje, PhD
role: PRINCIPAL_INVESTIGATOR
References: