- Rapid antibody test for HIV-1 and HIV-2; results in 20 minutes.
- CLIA-waived for oral fluid and whole blood; CLIA-moderate for plasma.
- Oral-fluid option is pain-free and ideal for outreach and nonclinical settings.
- Greater than 99% agreement with confirmatory Western blot/standard methods.
- SKU:
- 773625
- Contents:
- (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
- QTY Per Sell:
- 25
- Number of Tests:
- 25 Tests
- Reading Type:
- Visual Read
- Sample Type:
- Whole Blood / Plasma / Saliva Sample
- Time to Result:
- 20 minutes
- CLIA Classification:
- CLIA-waived: oral fluid, fingerstick, venipuncture whole blood
- CLIA-moderate: plasma
- Storage Requirements:
- Store unopened at 2–27°C (36–80°F); do not freeze
- Regulatory / Certifications:
- FDA cleared / PMA listed (OraSure)
- ISO 13485; CE marked; WHO prequalified (select kits)
- Sensitivity & Specificity:
- Oral fluid sensitivity ~99.1%
- Oral fluid specificity ~100%
- Test Format & Method:
- Lateral flow, cassette format
- Single-use immunoassay
- Intended Use:
- Point-of-care qualitative detection of HIV-1/2 antibodies for screening
- Shelf Life / Dating:
- Shelf life per pouch; check outer packaging for expiration
- Manufacturer Link:
- Manufacturer: OraSure Technologies (product support and IFU available on orasure.com)
- Packaging Options:
- 25 tests/box (1001-0079)
- 100 tests/box (1001-0078)
- Clinical Notes:
- Use in multi-test algorithms as appropriate
- Reactive results require confirmatory testing
