Navigation Links
First rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies now available
Date:10/29/2013

WALTHAM, Mass., Oct. 29, 2013 /PRNewswire/ -- Alere Inc. (NYSE: ALR), the world's leading provider of point-of-care rapid diagnostic and health information solutions, today announced the immediate U.S. availability of the Alere Determine™ HIV-1/2 Ag/Ab Combo test, the first U.S. Food and Drug Administration (FDA) approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.

"We're excited to announce the availability of the only fourth generation rapid test that can identify HIV infections in individuals earlier than ever before at the point of care by detecting the free HIV-1 p24 antigen," said Joe Medeiros, Director of Marketing, North America Virology Solutions at Alere. "The availability of the Alere Determine Combo test will contribute measurably to public health by helping HIV-positive individuals to become aware of their HIV status earlier, thereby potentially reducing HIV transmission. Earlier diagnosis can also allow effective treatment to be started without delay."    

The Alere Determine HIV-1/2 Ag/Ab Combo test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device. The test simultaneously detects free HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. The test can be used by trained professionals in healthcare settings to identify HIV-infected individuals.

Alere Determine HIV 1/2 Ag/Ab Combo is currently available to all health facilities and laboratories that are licensed to conduct tests of moderate complexity under the CLIA program.  Alere Determine HIV 1/2 Ag/Ab Combo test is currently undergoing CLIA-waiver studies to demonstrate its ease of use, safety and accuracy. In the fourth quarter of 2013, Alere anticipates submitting to the FDA its application to categorize Alere Determine HIV 1/2 Ag/Ab Combo as a CLIA-waived test, so it can be made widely available in physician offices and public health settings.

According to the Centers of Disease Control and Prevention (CDC), there are approximately 1.2 million Americans living with HIV, and an estimated 207,000 (18%) whose infections have not been diagnosed. In 2010, the CDC estimated that there were 47,500 newly infected people with the virus in the United States, indicating that HIV remains a serious health problem. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV.  

For more information, visit www.AlereHIV.com/US.  

About Alere

By developing new capabilities in near-patient diagnosis, monitoring and health information technology, Alere enables individuals to take charge of improving their health and quality of life at home. Alere's global leading products and services, as well as its new product development efforts, focus on infectious disease, cardiology, toxicology and diabetes. Alere is headquartered in Waltham, Massachusetts. For more information regarding Alere, please visit www.alere.com.   

 


'/>"/>
SOURCE Alere Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Techne Corporation Releases Unaudited First Quarter Fiscal Year 2014 Results
2. Array BioPharma To Report Financial Results For The First Quarter Of Fiscal 2014 On October 31, 2013
3. New Study Shows Promise For First Effective Medicine To Treat Cocaine Dependence
4. Philips and RealView Imaging conclude worlds first study to evaluate live 3D holographic imaging in interventional cardiology
5. Kinex Announces First Patient Dosed in Phase Ib Study of Oraxol, an Orally Dosed Paclitaxel
6. Perrigo Company To Release First Quarter Fiscal Year 2014 Results On October 31, 2013
7. Private Hospital Group in Spain Expands Radiotherapy Capabilities with Countrys First Elekta Versa HD System
8. Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2a Cellulite Study of Collegenase Clostridium Histolyticum
9. Avanir Pharmaceuticals Announces Enrollment of First Patient in Study of AVP-923 for the Treatment of Levodopa Induced Dyskinesia in Parkinsons Disease
10. Cardica To Announce Fiscal 2014 First Quarter Financial Results On Monday, November 4, 2013
11. First Prospective Cancer Monitoring Data Released - Indicating that Oncogene Mutation Signal in Urine Correlates with Response to Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... FRANCISCO , March 23, 2017  The ... interoperable system to identify and track prescription drugs as ... , in response to requirements from US FDA ... removal of potentially dangerous medicines. Blockchain ... with cryptographic identity chips and blockchain technology and recently ...
(Date:3/23/2017)... York , March 23, 2017 ... a consolidated vendor landscape with the top five ... market in 2015. These companies are Stryker Sustainability ... Hygia Health Services, Inc., and VANGUARD AG. Despite ... medical devices market is witnessing the prevalence of ...
(Date:3/23/2017)... CAMBRIDGE, Mass. , March 23, 2017 ... the enrollment of its first patient in a Phase ... an antibody-directed nanotherapeutic (ADN) that encapsulates a novel taxane ... suggest is overexpressed in 50-100% of many major tumor ... cancers. "The initiation of this study is ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... A recent report from the ... teacher preparation programs. The NCTQ report suggests, based on a review of GPA and ... improve teacher quality in the U.S. It argues that this higher bar should be ...
(Date:3/23/2017)... ... , ... The IoT (Internet of Things) is revolutionizing the way the world ... businesses and individual consumers alike. Laboratories can maximize their profit margin by increasing ... $4 trillion to $11 trillion dollars by the year 2025. McKinsey expects the IoT ...
(Date:3/23/2017)... ... March 23, 2017 , ... Benefits ... an innovative mobile app and centralized benefits dashboard solving one of the top ... from multiple locations. For the first time, employees can access up-to-date information and ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... businesses of the greater Fort Collins area, has unveiled a collaboration with nonprofit ... involvement program. Donations to this worthy cause may now be made at ...
(Date:3/23/2017)... ... March 23, 2017 , ... ChenMed, a privately owned ... of the strategic executive team expansion needed to further optimize growth and performance. ... team,” says Christopher Chen, MD, ChenMed Chief Executive Officer. “George Wheeler and ...
Breaking Medicine News(10 mins):