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Xpert® HIV-1 Qual

Xpert® HIV-1 Qual

Xpert® HIV-1 Qual

Product catalog summary
Introduction
The document discusses the Xpert® HIV-1 Qual, an in vitro diagnostic medical device designed for early detection of HIV-1 infection. It emphasizes the importance of early diagnosis for better patient care and reducing viral transmission.

The Need
The World Health Organization estimates 35 million people live with HIV/AIDS globally. Early detection is crucial as acute HIV infections, characterized by high viremia levels, occur before a detectable immune response. A sensitive qualitative test is needed for early detection, especially in high-risk populations.

The Solution
Xpert HIV-1 Qual offers on-demand molecular testing for early HIV diagnosis using GeneXpert technology. It provides a total nucleic acid-based test for RNA and proviral DNA in a single cartridge. Key features include:
  • Ease of Use: Requires only 100 μl of whole blood or 1 dried blood spot, with a simple workflow and no need for PCR room settings.
  • Speed: 92-minute runtime with less than 1 minute of hands-on time.
  • Flexibility: Capable of providing up to 394 results per 8-hour shift, with 24/7 availability and fixed cost per result.
The test can detect HIV infection before seroconversion, aiding in early diagnosis and management.

Performance
The limit of detection (LOD) for the test is 278 cp/mL for whole blood samples and 668 cp/mL for dried blood spot samples. Clinical performance was evaluated in Africa, showing high positive and negative predictive agreements compared to a CE-marked comparator assay.

Impact
Xpert HIV-1 Qual detects HIV-1 on average nine days earlier than antibody tests and five days earlier than antigen p24 tests. This rapid detection supports better clinical decisions and quicker entry into care for high-risk patients, potentially reducing morbidity and mortality.

Conclusion
Xpert® HIV-1 Qual provides a reliable, fast, and easy-to-use solution for early HIV detection, significantly impacting patient care and community health.
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Catalog excerpts

Xpert® HIV-1 Qual-1

The Power of Early Knowledge. Xpert® HIV-1 Qual Faster intervention for better patient care. In Vitro Diagnostic Medical Device C€ m A better way.

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Xpert® HIV-1 Qual-2

Xpert® HIV-1 Qual is so sensitive it can detect HIV infection before seroconversion. This technology enables us, for the first time, to diagnosis primary HIV infection in persons with high risk at the point-of-care, which will likely lead to lasting benefits in management of HIV infection and in reducing HIV transmission. The GeneXpert® System is fast, easy to use, and is well adapted to our growing needs." .. Michael Meulbroek Chair of BCN Checkpoint, Barcelona, Spain (community-based detection centre for HIV and other STIs) THE SOLUTION The World Health Organization estimates that 35 million...

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Xpert® HIV-1 Qual-3

© THE IMPACT • Greater Sensitivity: Detect HIV infections up to 7-10 days before seroconversion • Improve Patient Care: Same day results support better clinical decisions • Increase Efficiency: Rapid results enable quicker entry into care and treatment for high risk patients • Strengthen Communities: Quick decisions can help reduce morbidity or mortality Get Answers Earlier Xpert® HIV-1 Qual detected HIV-1 on average nine days1 earlier than a panel of HIV-1 antibody tests and five days1 earlier than a panel of HIV-1 antigen p24 tests.1 * PERFORMANCE The limit of detection (LOD) of the HIV-1 Qual...

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Xpert® HIV-1 Qual-4

Total hands-on time: <1 minute System Throughput* 8-hr shift Transfer 750 μL of sample reagent and 100 μL of whole blood into the cartridge * Operational throughput per 8-hr shift based on HIV-1 Qual testing, internal analysis. Scan, load cartridge and start test Xpert® HIV-1 Qual provides same day detection of HIV-1 nucleic acid in individuals at risk for HIV-1 infection.* CATALOG INFORMATION * Not intended for donor blood screening. References: 1. 2. 3. 4. 5. 6. WHO. HIV/AIDS Fact sheet N°360. Updated Nov 2014. Aids.gov. Aids Signs and Symptoms. Accessed May 2015. https://www.aids.gov/hiv-aids-basics/hiv-aids-101/signs-and-symptoms/...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.