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

HIV Clinical Trial

— MBIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530672
• Other study ID #: HS647
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: October 27, 2014
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2900
• Est. completion date: September 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV
• Syphilis

Intervention

Device:
• MBIO POC combined HIV syphilis test ( SnapEsi)
Venipuncture for routine ANC screening plus additional for device validation purposes.

Locations

Country	Name	City	State
Kenya	Kisumu District Hospital	Kisumu	Nyanza
Kenya	New Nyanza Provincial General Hospital	Kisumu	Nyanza

Sponsors (3)

Lead Sponsor	Collaborator
PATH	Kenya Medical Research Institute, Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device sensitivity/specificity	Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests	same-day	No
Secondary	Percent agreement with clinical diagnosis	Percent agreement with HIV & syphilis rapid tests completed at clinic	same-day	No