Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test (MBIO)
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ClinicalTrials.gov Identifier: NCT01530672 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : October 28, 2014
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Condition or disease | Intervention/treatment | Phase |
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HIV Syphilis | Device: MBIO POC combined HIV syphilis test ( SnapEsi) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2900 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Evaluation of the MBio Combined Syphilis/HIV Point-of-Care Diagnostic Test |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: ANC clients |
Device: MBIO POC combined HIV syphilis test ( SnapEsi)
Venipuncture for routine ANC screening plus additional for device validation purposes.
Other Names:
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- Device sensitivity/specificity [ Time Frame: same-day ]Sensitivity & specificity of the MBIO device against HIV and syphilis reference tests
- Percent agreement with clinical diagnosis [ Time Frame: same-day ]Percent agreement with HIV & syphilis rapid tests completed at clinic

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530672
Kenya | |
Kisumu District Hospital | |
Kisumu, Nyanza, Kenya | |
New Nyanza Provincial General Hospital | |
Kisumu, Nyanza, Kenya |
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 |
Responsible Party: | PATH |
ClinicalTrials.gov Identifier: | NCT01530672 |
Other Study ID Numbers: |
HS647 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | October 28, 2014 |
Last Verified: | October 2014 |
HIV Syphilis Combination |
POC point-of-care MBIO |
Syphilis Treponemal Infections Gram-Negative Bacterial Infections Bacterial Infections |
Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Sexually Transmitted Diseases Infection |