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Description

The OraSure OraQuick ADVANCE Rapid HIV Test Kit includes divided pouches (each containing a test device, an absorbent pack, and a developer solution vial), reusable test stands, specimen collection loops, subject information pamphlets, and a package insert with customer letter (Note: Find additional packaging configuration information below in the Package Quantities section).

Warranty: Until Use or Expiration (Two Year Shelf Life from the date of purchase).

Capable of detecting HIV-1 and HIV-2 antibodies in as little as 20 minutes, the OraSure OraQuick ADVANCE Rapid HIV Test Kit is 99% accurate with 99.9% specificity from "real world" data. Designed with the goal of stopping the spread of HIV one test at a time, this complete kit has the ability to batch test and is compatible with multiple specimen types such as oral fluid, fingerstick and venipuncture whole blood, and plasma. The high positive predictive value leads to minimal false positives. CLIA-waived.

Features

OraSure OraQuick ADVANCE Rapid HIV Test Kit Features

  • Detects HIV-1 and HIV-2 antibodies in as little as 20 minutes.
  • 99% accurate with 99.95% specificity from "real world" data.
  • Demonstrates third generation lab-accurate results including lgM antibody detection.
  • Has the ability to batch test.
  • Compatible with multiple specimen types including oral fluid, fingerstick and venipuncture whole blood, and plasma.
  • Proven performance with over 43 million tests worldwide.
  • High positive predictive value - minimal false positives.
  • CLIA-waived.
  • CPT Code: 86703.

Package Quantities

OraSure OraQuick ADVANCE Rapid HIV Test Kit Package Quantities

  • #1001-0079: Case of 25.
    • 25 divided pouches.
    • 5 reusable test stands.
    • 25 specimen collection loops.
    • 25 subject information pamphlets.
  • #1001-0078: Case of 100.
    • 100 divided pouches.
    • 10 reusable test stands.
    • 100 specimen collection loops.
    • 100 subject information pamphlets.

Frequently asked questions

How quickly do OraQuick ADVANCE tests provide results?

The OraSure OraQuick ADVANCE Rapid HIV Test Kit delivers results in as little as 20 minutes, enabling prompt action.

This CLIA-waived diagnostic tool offers high reliability for detecting antibodies to HIV-1 and HIV-2. Key performance metrics include:

  • Accuracy: 99% accurate
  • Specificity: 99.95% specificity, based on “real world” data

It utilizes third-generation technology that can detect lgM antibodies and is highly versatile, supporting multiple specimen types: oral fluid, fingerstick whole blood, venipuncture whole blood, and plasma.

Does the OraQuick ADVANCE have high accuracy?

Yes, the OraSure OraQuick ADVANCE Rapid HIV Test Kit is engineered for exceptional clinical performance, delivering highly reliable, lab-accurate results for detecting HIV-1 and HIV-2 antibodies.

Key performance metrics, derived from extensive “real world” data, include:

  • Accuracy: 99%
  • Specificity: 99.95%

This high reliability is further enhanced by its third-generation detection technology, which can detect IgM antibodies and provides a high positive predictive value, significantly minimizing false positives.

What specimen types are compatible with this rapid test?

The OraSure OraQuick ADVANCE Rapid HIV Test Kit is highly versatile and compatible with multiple specimen types, including:

  • Oral fluid
  • Fingerstick whole blood
  • Venipuncture whole blood
  • Plasma

This broad compatibility, combined with its CLIA-waived status, makes it suitable for various testing environments, providing accurate results in as little as 20 minutes.

Does this rapid test detect both HIV-1 and HIV-2?

Yes, the OraSure OraQuick ADVANCE Rapid HIV Test Kit is engineered for comprehensive screening, reliably detecting antibodies for both HIV-1 and HIV-2.

This CLIA-waived test delivers rapid and accurate results, supporting quick diagnostics:

  • Rapid Results: Provides results in as little as 20 minutes.
  • Dual Antibody Detection: Specifically identifies antibodies for both HIV-1 and HIV-2.
  • Third-Generation Technology: Utilizes advanced technology to detect IgM antibodies, ensuring lab-accurate results.
  • High Accuracy: Demonstrates 99% accuracy and 99.95% specificity, validated by extensive “real world” data.

This kit is a highly effective diagnostic tool due to its proven performance and advanced detection capabilities.

Is the OraQuick ADVANCE test CLIA-waived?

Yes, the OraSure OraQuick ADVANCE Rapid HIV Test Kit is CLIA-waived. This status allows for its use in waived testing environments, making it more accessible for rapid HIV-1 and HIV-2 detection.

Is the rapid test kit a complete diagnostic system?

Yes, the OraSure OraQuick ADVANCE Rapid HIV Test Kit is a complete, ready-to-use diagnostic system designed for professional settings. It provides rapid and accurate detection of HIV-1 and HIV-2 antibodies, with results available in as little as 20 minutes.

Each kit includes all the necessary materials to perform the tests:

  • Test Components: Divided pouches, each containing a test device, an absorbent pack, and a developer solution vial.
  • Support Tools: Reusable test stands for efficient batch testing.
  • Collection Supplies: Specimen collection loops.
  • Documentation: Subject information pamphlets, a package insert, and a customer letter.

Specific quantities of these items will correspond to the case size purchased (Case of 25 or Case of 100).

Does the OraQuick ADVANCE Rapid HIV Test Kit detect IgM antibodies?

Yes, the OraSure OraQuick ADVANCE Rapid HIV Test Kit is a third-generation test capable of detecting IgM antibodies, providing lab-accurate results for early HIV detection.

Where is the OraSure OraQuick ADVANCE Rapid HIV Test Kit manufactured?

The OraSure OraQuick ADVANCE Rapid HIV Test Kit is manufactured in the USA, ensuring high-quality production standards and compliance with regulatory requirements.

What is the shelf life of the OraQuick ADVANCE Rapid HIV Test Kit?

The OraQuick ADVANCE Rapid HIV Test Kit has a two-year shelf life from the date of purchase, and is warrantied until use or expiration.

Does this test have proven global performance?

Yes, the OraQuick ADVANCE Rapid HIV Test Kit has demonstrated proven performance with over 43 million tests conducted worldwide.