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OraQuick Advance® HIV-1/2 Antibody Sexual Health Test Kit #1001-0079

OraQuick Advance®

$612.49
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OraQuick Advance® HIV-1/2 Antibody Sexual Health Test Kit #1001-0079
  • 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
  • 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
    ic__sync_id:
    1
    ic__id:
    1238
    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