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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy of California, San Diego, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In Vitro Diagnostic Device

Device

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

Primary outcomes

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).

Time frame: 20 minutes

Secondary outcomes

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.

Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

Chembio Diagnostic Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Dec 16, 2009
Registry last updated: Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed