Diagnostics

Rapid Qualitative Screening Test | Inverness Medical Innovations, Inc.

Inverness Medical Innovations, Inc.

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For professionals to provide rapid screening and detection of HIV 1 and HIV 2. The Clearview STAT-PAK can be used in either a waived or non-waived laboratory. The Clearview COMPLETE uses a patented “barrel” technology designed to maximize ease of use and exposure to infectious agents. Both tests are FDA-approved for use with fingerstick whole blood, venous whole blood, serum or plasma for the detection of HIV-1 and HIV-2 antibodies. The proprietary barrel format of Clearview COMPLETE has been designed to provide distinctive customer benefits relating to convenience, safety and performance.

Clearview HIV 1/2 STAT-PAK is a rapid qualitative screening test for the detection of antibodies to HIV-1 and HIV-2 in human whole blood, serum and plasma.

CLIA Waived, simple two-step procedure for whole blood.

Clearly different

Clearview's innovative technology provides highly accurate detection of HIV-1 and HIV-2.

Fast: two easy steps with a reactive result in as little as 15 minutes

Easy: CLIA-waived, easy-to-use test requires no training

Reliable: built-in control ensures accuracy

Flexible: use with multiple specimen types - whole blood (fingerstick or venipuncture), serum or plasma

Clearly better

Clearview HIV 1/2 STAT PAK provides answers for immediate and necessary treatment.

Supports early screening and diagnosis of human immunodeficiency virus

Detection and proper treatment may prevent transmission to an unborn child, as well as to sexual partners

Early diagnosis and treatment can lead to a prolonged survival rate

24 month shelf life provides flexibility to the laboratory

Reliable results - 99.7% sensitive, 99.9% specific

About HIV

Human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) remain leading causes of illness and death in the United States. However, at the end of 2003, of the approximately 1.0--1.2 million persons estimated to be living with HIV in the United States, an estimated one quarter (252,000--312,000 persons) were unaware of their infection and therefore unable to benefit from clinical care to reduce morbidity and mortality. A number of these persons are likely to have transmitted HIV unknowingly. 1

Treatment has improved survival rates dramatically, especially since the introduction of highly active antiretroviral therapy (HAART) in 1995. However, progress in effecting earlier diagnosis has been insufficient. The good news is that the new CDC guidelines have removed much of the barriers to screening and now encourages testing all persons 13-64 years of age in the United States.

New HIV Screening Guidelines

In September 2006, the CDC announced revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. The new guidelines highlight:

Screening for all patients aged 13-64 years regardless of risk

Patients are notified that testing will be performed unless they decline (opt-out screening)

Testing process is streamlined to lower the barriers of pre-test counseling and documented written consent

High risk populations such as IV drug users and their sex partners and men who have sex with men should be tested annually

This represents a substantial change from earlier recommendations:

Offer HIV testing routinely to all patients only in health-care settings with high HIV prevalence

Conduct targeted screening on the basis of risk behaviors for patients in low-prevalence settings

Require informed, written consent prior to testing

Pre-test counseling

Product Overview

The Clearview HIV 1/2 STAT-PAK is a rapid in vitro qualitative immunoassay for the detection of antibodies to HIV1 and HIV 2 in human whole blood, serum and plasma.

With its simple, two-step procedure, Clearview HIV 1/2 STAT-PAK is quick and easy to use, delivering clear, dependable results in just 15 minutes. Plus, Clearview HIV 1/2 STAT-PAK is waived for whole blood and requires a very small sample amount, making it easier to run and manage in a busy laboratory environment.

Clearview HIV-1/2 STAT-PAK will help healthcare workers diagnose individual infection, prevent mother-to-child transmission, and monitor HIV prevalence.

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Rapid Qualitative Screening Test | Inverness Medical Innovations, Inc.

Inverness Medical Innovations, Inc.

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