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OraSure Technologies OraQuick™ Advance™ Rapid HIV-1/2 Antibody Test
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- The OraQuick™ ADVANCE™ Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes.
- Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens.
- CLIA-waived for oral fluid, fingerstick and venipuncture whole blood and offers the ability to test in non-traditional testing environments, such as outreach programs and mobile testing clinics.
- CLIA Moderately Complex for plasma samples.
- The OraQuick™ ADVANCE™ is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer solution.
- Each component is sealed in separate compartments of a single pouch to form the test.
- 25 Test count packaging includes: (25) Divided Pouches with Test Device and 1 mL Vial Developer Solution, (5) Reusable Test Stands, (25) Specimen Collection Loops, (25) Information Pamphlets, Package Insert, Customer Letter.
- 100 Test count packaging includes: (100) Divided pouches with (1) test device, (1) absorbent pack, (1) 1 mL developer solution vial; (10) reusable test stands, (100) specimen collection loops, (100) subject information pamphlets, (1) package insert, (1) customer letter.
- Store unused tests at 2 to 27°C (36-80°F).
- If stored refrigerated, ensure that the divided pouch is brought to operating temperature (15-37°C, 59-99°F) before opening.
Specifications
Certifications/Compliance
ISO 13485 Certified. FDA approved under PMA BP010047. Inspected to 21 CFR 820 and MDSAP certification.
Content And Storage
2°C to 27°C
Description
Detects HIV-1 and HIV-2. It is developed with synthetic peptides that represent the envelope region.
CE Marker
Yes
Detectable Analytes
HIV-1/2
Disposable
Single-use
Quantity
25 Tests
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