| |
FDA Approval Received |
Specimen Type |
CLIA Category* |
Sensitivity**
(95% CI) |
Specificity**
(95% CI) |
Manufacturer |
Approved for HIV-2 Detection? |
List Price Per Device^ |
External Controls |
| OraQuick ADVANCE Rapid HIV-1/2 Antibody Test |
Nov 2002 |
Oral fluid |
Waived |
99.3%
(98.4-99.7) |
99.8%
(99.6-99.9) |
OraSure Technologies, Inc.
www.orasure.com |
Yes |
$17.50 |
Sold Separately
($25 each) |
| Whole Blood (finger stick or venipuncture) |
Waived |
99.6%
(98.5-99.9) |
100%
(99.7-100) |
| Plasma
|
Moderate Complexity |
99.6%
(98.9-99.8) |
99.9%
(99.6-99.9) |
| Uni-Gold Recombigen HIV |
Dec 2003 |
Whole blood
(fingerstick or venipuncture) |
Waived |
100%
(99.5-100) |
99.7%
(99.0-100) |
Trinity Biotech
www.unigoldhiv.com |
No |
$15.75
$8.00 ▪ |
Sold Separately
($26.25 each) |
| Serum & Plasma |
Moderate Complexity |
100%
(99.5-100) |
99.8%
(99.3-100) |
| Reveal G-3 Rapid HIV-1 Antibody Test |
Apr 2003 |
Serum |
Moderate Complexity |
99.8%
(99.2-100) |
99.1%
(98.8-99.4) |
MedMira, Inc.
www.medmira.com |
No |
$14.00 |
Included |
| Plasma |
Moderate Complexity |
99.8%
(99.0-100) |
98.6%
(98.4-98.8) |
| MultiSpot HIV-1/HIV-2 Rapid Test
|
Nov 2004 |
Serum |
Moderate Complexity |
100%
(99.94-100) |
99.93
(99.79-100) |
BioRad Laboratories
www.biorad.com |
Yes –differentiates HIV-1 from HIV-2 |
$25.00 |
Included |
| Plasma |
Moderate Complexity |
100%
(99.94-100) | 99.91
(99.77-100) |
| Clearview HIV 1/2 STAT-PAK |
May 2006 |
Whole Blood
(finger stick or venipuncture) |
Waived |
99.7%
(98.9-100) |
99.9%
(99.6-100) |
Inverness Medical Professional Diagnostics
www.invernessmedicalpd.com |
Yes |
$17.50
$8.00▪
|
Sold Separately
($50/set) |
|
Serum & Plasma |
Non-waived | 99.7%
(98.9-100)
| 99.9%
(99.6-100)
|
| Clearview COMPLETE HIV 1/2 |
May 2006 |
Whole Blood
(finger stick or venipuncture) |
Waived |
99.7%
(98.9-100) |
99.9%
(99.6-100) |
Inverness Medical Professional Diagnostics
www.invernessmedicalpd.com |
Yes |
$18.50
$9.00▪ |
Sold Separately
($50/set) |
| Serum & Plasma |
Non-waived | 99.7%
(98.9-100)
| 99.9%
(99.6-100)
|
