NCT00951795

Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Clinical Evaluation of the Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Abbott RDx Cardiometabolic · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

Detailed description

Blood samples will be collected from HIV infected adolescents and adult men and women presenting to a physician's office or outpatient clinic. Capillary whole blood samples will be obtained by fingerstick in duplicate from all Subjects in the study for immediate measurement of CD4+ T-cell count on the Pima CD4 Test by a trained healthcare professional. Venous whole blood samples from all Subjects in the study will also be collected and transported to the clinical laboratory of each study site for concurrent testing on the reference method by a trained laboratory professional. Venous samples from all Subjects in the study will also be measured on the Pima CD4 Test at the study site. Hematocrit will also be measured for all Subjects.

Conditions

• HIV Infection
• AIDS
• HIV Infections

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-08-04
• Last updated: 2015-07-21

Locations

3 sites across 1 country: United States