Detection is the first step in prevention
The OraQuick ADVANCE® Rapid HIV- 1/2 Antibody Test (25 tests) detects antibodies to HIV-1 and HIV-2
in 20 minutes.
(FDA PMA#: BP010047)
- Rapid: Provides results in 20 minutes, enabling patients to learn their status in a single visit and allows HIV positive patients to be connected to care immediately.
- Flexible: Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens. Ideal for both clinical and non-clinical settings
- Accurate: Greater than 99% agreement with confirmatory Western blot.1
- Simple: Offers the ability to test in non-traditional testing environments, such as outreach programs and mobile testing clinics for oral fluid, fingerstick and venipuncture whole blood.
- Patient-Preferred2: Offers patients accurate HIV testing without the need for blood or needles. Pain-free testing with oral fluid means more people get screened, more HIV positive patients are connected to care and fewer people are exposed.
Testing with an OraSure® HIV-1 Oral Specimen Collection Device is a safe, easy, and reliable way to test for HIV-1 antibodies. Testing with the OraSure® HIV-1 Oral Specimen Collection Device requires no blood or needles and has been shown to be more than 99% accurate.
Fair Balance Statement: The accuracy of the OraSure® HIV-1 oral specimen test is lower than that of blood. It has been demonstrated to range from 97.7% in high risk subjects to 99.6% in low risk populations. Please refer to the Product Insert for details.
Flexible Specimens for Clinical and Non-Clinical Settings
Simple Test Procedure*
*CLIA-Waived for Oral Fluid, Fingerstick and Venipuncture Whole Blood. Moderately Complex for Serum.
Oral Fluid (CLIA-Waived)
Patient preferred.1 Ideal for outreach programs and paraprofessionals.
1. Collect sample
Swab between the teeth and upper and lower gum once.
2. Insert the device into the buffer
3. Read between 20 and 40 minutes
Non-reactive
Line in the C Zone
|
Preliminary Positive
Line in the C and T Zones
|
Please note the test must be used in conjunction
with CDC guidelines for HIV testing and the communication and confirmation of reactive test results.
Fingerstick Whole Blood
(CLIA-Waived)
1. Collect sample
1b. Mix sample in buffer
2. Insert the device into the buffer
3. Read between 20 and 40 minutes
Non-reactive
Line in the C Zone
|
Preliminary Positive
Line in the C and T Zones
|
Settings Used:
- Prisons & Jails
- Hospital: Labs, Emergency Department, Occupational Health, Labor & Delivery
- Substance Abuse Treatment Centers
- Community Based Organizations
- Health Departments
- Dentists
- Internal Medicine, OB/GYN, Family Pratice, Infectiuous Disease
CLIA WAIVED/FDA 510K
CPT CODE: 86703-92
AVERAGE REIMBURSEMENT: 19.17 (Indicates National Average)