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

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.

Inclusion Criteria:

1. 12 years of age or older

2. Confirmed HIV infection, HIV-1 or HIV-2 according to medical history (this inclusion
will be waived for healthy non-HIV infected individuals who may need to be enrolled
in order to fill the high end of the CD4+ T-cell measurement range of the Pima CD4
Test.

3. Subject agrees to complete all aspects of the study

Exclusion Criteria:

1. Subject has already participated in this study at a previous date

2. Subject is enrolled in a study to evaluate a new drug

3. Patient unable or unwilling to provide informed consent

4. Vulnerable populations as deemed inappropriate for study by site principal
investigator.