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

NCT01530672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2900

Last updated 2014-10-28

No results posted yet for this study

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

Interventions

DEVICE

MBIO POC combined HIV syphilis test ( SnapEsi)

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

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Kenya Medical Research Institute

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Matthew Steele, Ph.D, M.P.H. · PATH

  • John Waitumbi, Ph.D, D.V.M. · Walter Reed Project

  • Kathleen Tietje, PhD · PATH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2013-09-30

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530672 on ClinicalTrials.gov