Test Kit Name (Approval Date) |
Specimen Type |
CLIA Category |
Sensitivity (95% CI) |
Specificity (95% CI) |
Manufacturer (Web Site) |
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test (Nov 2002) |
Oral fluid
Whole blood
Plasma |
Waived
Waived
Moderate complexity |
99.3% (98.4-99.7)
99.6% (98.5-99.9)
99.6% (98.9-99.8) |
99.8% (99.6-99.9)
100% (99.7-100)
99.9% (99.6-99.9) |
Orasure Technologies, Inc. (http://www.orasure.com/) |
Reveal Rapid HIV-1 Antibody Test (Apr 2003) |
Serum
Plasma |
Moderate complexity
Moderate complexity |
99.8% (99.2-100)
99.8% (99.0-100) |
99.1% (98.8-99.4)
98.6% (98.4-98.8) |
MedMira, Inc. (http://www. medmira.com) |
Uni-Gold Recombigen HIV-1 Test (Dec 2003) |
Whole blood
Serum and Plasma |
Waived
Moderate complexity |
100% (99.5-100)
100% (99.5-100) |
99.7% (99.0-100)
99.8% (99.3-100) |
Trinity BioTech, plc (http://www. trinitybiotech.com/EN/index.asp) |
MultiSpot HIV-1/HIV-2 Rapid Test (Nov 2004) |
Serum
Plasma |
Moderate complexity
Moderate complexity |
100% (99.94-100)
100% (99.94-100) |
99.93% (99.79-100)
99.91% (99.77-100) |
BioRad Laboratories (www.biorad.com) |
Clearview HIV 1/2 STAT-PAK (May 2006) |
Whole blood
Serum and plasma |
Waived
Nonwaived |
99.7% (98.9-100)
99.7% (98.9-100) |
99.9% (99.6-100)
99.9% (99.6-100) |
Inverness Medical Professional Diagnostics (www. invernessmedicalpd.com) |
Clearview COMPLETE HIV-1/-2 STAT-PAK (May 2006) |
Whole blood
Serum and plasma |
Waived
Nonwaived |
99.7% (98.9-100)
99.7% (98.9-100) |
99.9%(99.6-100)
99.9% (99.6-100) |
Inverness Medical Professional Diagnostics (www. invernessmedicalpd.com) |
Note: CLIA, Clinical Laboratory Improvement Amendments. |
Source: Ref. 6. |