Description
Orasure HIV Package Insert
Orasure Visual Reference Panel
Regulatory Status: CLIA Waived Home Test
Contents: 6 Individual Boxes each containing: (1) Divided Pouch with 1 Test device and 1mL of Developer Solution, (1) specimen collection loop, 1 information pamphlet, 1 package insert
Determinations: HIV-1 and HIV-2
Storage Requirements: 2° – 27° C (35°-80° F)
Processing Time: 20 Minutes
THE ORAQUICK ADVANCE® RAPID HIV-1/2 ANTIBODY TEST DETECTS ANTIBODIES TO HIV-1 AND HIV-2 IN 20 MINUTES.
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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.
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Flexible
Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens. Ideal for both clinical and non-clinical settings.
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Accurate
Greater than 99% agreement with confirmatory Western blot.1
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Simple
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. Walk-away procedure allows providers to batch tests, enabling more people to get tested, reducing indirect costs and improving turnaround time.
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Reliable
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.
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