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Abbott DETERMINE™ HIV-1/2 AG/AB Combo

$564.45

Product Overview

The first FDA approved rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. It enables health care providers to diagnose HIV infection earlier allowing individuals to seek medical care sooner.

Description

Features
  • CLIA-waived for fingerstick whole blood
  • It’s the first antigen/antibody rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen on a single test strip.
  • Built-in quality controls to let you know the test is working.
  • Test in three simple steps with clear results in just 20 minutes.
  • Test using whole blood, serum or plasma samples.
  • Proved 99.9% overall clinical sensitivity for all sample types.
Kit Contents
  • Determine HIV-1/2 Ag/Ab Combo Test Cards (20 tests/kit)
  • Desiccant Package
  • Chase Buffer (2.5 mL)
  • Disposable Capillary Tubes
  • Disposable Workstations
  • Subject Information Notices
  • Determine HIV-1/2 Ag/Ab Combo Package Insert
  • Quick Reference Card
  • Customer Letter
  • Package insert
  • 40 disposable pipettes
  • 4 vials (one HIV-1 Reactive Control, one HIV-2 Reactive Control, one HIV-1 p24 Antigen Control, and one Nonreactive Control)
Clinical Performance Measures
  • 99.9% sensitivity
  • 99.8% specificity

Note: This product is only available for purchase with the submission of a valid CLIA accreditation. This test should only be performed by medical professionals. Per FDA guidelines, this product is non-returnable and non-refundable.

Additional information

Weight 1 lbs
Dimensions 9 × 5 × 3 in

Attachments & Documentation

Determine HIV-12 AgAb Combo Fingerstick Procedure Guide

Determine HIV-12 AgAb Combo HIV-1 Control and HIV-2 Control SDS

Determine HIV-12 AgAb Combo IQCP Support Document

Determine HIV-12 AgAb Combo Package Insert

DEE675~1

Determine HIV-12 AgAb Combo Performance Sheet

Determine HIV-12 AgAb Combo Product Sheet

Determine HIV-12 AgAb Combo Product Specification Sheet

Determine HIV-12 AgAb Combo Reporting Results Letter

Determine HIV-12 AgAb Combo Subject Information Notice

Determine HIV-12 AgAb Combo Test Device SDS Performance of Determine Combo – S Masciotra JCV

Determine HIV 12 AgAb Combo Quick Reference Guide

Determine HIV-12 AgAb Combo Chase Buffer SDS

Determine HIV-12 AgAb Combo Control Package Insert

DEDCBD~1

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.

Abbott DETERMINE™ HIV-1/2 AG/AB Combo

$564.45

Product Overview

The first FDA approved rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. It enables health care providers to diagnose HIV infection earlier allowing individuals to seek medical care sooner.

Description

Features
  • CLIA-waived for fingerstick whole blood
  • It’s the first antigen/antibody rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen on a single test strip.
  • Built-in quality controls to let you know the test is working.
  • Test in three simple steps with clear results in just 20 minutes.
  • Test using whole blood, serum or plasma samples.
  • Proved 99.9% overall clinical sensitivity for all sample types.
Kit Contents
  • Determine HIV-1/2 Ag/Ab Combo Test Cards (20 tests/kit)
  • Desiccant Package
  • Chase Buffer (2.5 mL)
  • Disposable Capillary Tubes
  • Disposable Workstations
  • Subject Information Notices
  • Determine HIV-1/2 Ag/Ab Combo Package Insert
  • Quick Reference Card
  • Customer Letter
  • Package insert
  • 40 disposable pipettes
  • 4 vials (one HIV-1 Reactive Control, one HIV-2 Reactive Control, one HIV-1 p24 Antigen Control, and one Nonreactive Control)
Clinical Performance Measures
  • 99.9% sensitivity
  • 99.8% specificity

Note: This product is only available for purchase with the submission of a valid CLIA accreditation. This test should only be performed by medical professionals. Per FDA guidelines, this product is non-returnable and non-refundable.

Additional information

Weight 1 lbs
Dimensions 9 × 5 × 3 in

Attachments & Documentation

Determine HIV-12 AgAb Combo Fingerstick Procedure Guide

Determine HIV-12 AgAb Combo HIV-1 Control and HIV-2 Control SDS

Determine HIV-12 AgAb Combo IQCP Support Document

Determine HIV-12 AgAb Combo Package Insert

DEE675~1

Determine HIV-12 AgAb Combo Performance Sheet

Determine HIV-12 AgAb Combo Product Sheet

Determine HIV-12 AgAb Combo Product Specification Sheet

Determine HIV-12 AgAb Combo Reporting Results Letter

Determine HIV-12 AgAb Combo Subject Information Notice

Determine HIV-12 AgAb Combo Test Device SDS Performance of Determine Combo – S Masciotra JCV

Determine HIV 12 AgAb Combo Quick Reference Guide

Determine HIV-12 AgAb Combo Chase Buffer SDS

Determine HIV-12 AgAb Combo Control Package Insert

DEDCBD~1

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.