Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test

Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01032902

Enrollment

2808

Registered

2009-12-16

Start date

2010-01-31

Completion date

2012-04-30

Last updated

2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Human immunodeficiency virus, Rapid Test, HIV, HIV Seronegativity

Brief summary

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.

Interventions

DEVICEIn Vitro Diagnostic Device

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Must be at least 2 years of age (no upper age limit). * Must be willing and able to receive post-test counseling, if applicable. * Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable). * Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion criteria

* Am in a life threatening condition at the time of enrollment * Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.). * Have participated or are participating in a clinical trial for an HIV vaccine. * Have previously participated in this clinical trial.

Design outcomes

Primary

Measure	Time frame
The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).	20 minutes

Secondary

Measure	Time frame
The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.	20 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026