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Point-of-care test improves infant HIV diagnosis rate, treatment starts and retention in care


A study conducted in Mozambique, led by Ilesh Jani, Instituto Nacional de Saude, Maputo, Mozambique, concluded that using a point-of-care test to diagnose HIV in infants significantly improved retention in care, speeded up ART initiation and increased the proportion of infants who started treatment. The study, supported by UNITAID and UNICEF, used the point-of-care Alere q HIV-1/2 Detect test, recently prequalified by the World Health Organisation.

The results of the study, which randomised 16 health facilities to provide standard-of-care testing or to implement point-of-care testing, were significant.

Of the point-of-care results, 99.5% were provided to the infant’s caregiver, compared to 65% of the standard-of-care test results. Only 7.2% of the results of standard-of-care tests reached the caregiver within two months of testing, and only 47.2% within six months of testing. Results took a median of 125 days to reach caregivers after the sample was collected in the standard-of-care facilities.

UNITAID, the international drug and diagnostics purchase fund, is investing $63m in point-of-care early infant diagnosis and HIV viral load testing in nine countries in sub-Saharan Africa, with the aim of increasing the proportion of infants who are tested, retained in care and initiated on ART. UNITAID is working with the Elisabeth Glaser Pediatric AIDS Foundation to test at least 215,000 infants.

Read the full article here

Alere supports World AIDS Day and strategy to end AIDS epidemic


Alere supports World AIDS Day and strategy to end AIDS epidemic

The 1st of December marks a day of global awareness and support for those affected by HIV/AIDS.

Since 2010, improved access to testing and treatment has resulted in a 26% decline in AIDS relation deaths globally.1 To continue the momentum we need to create an AIDS-free world by 2030, UNAIDS recommends fast tracking innovations and investments that lead to life-saving care. That means a point of care movement that reaches everyone — no matter where they live or who they are.

To help end the AIDS epidemic by 2030, UNAIDS set 90-90-90 goals.1 They’re designed to address significant gaps and shortcomings in every aspect of the cascade of care.

Over the past decade, Alere has partnered with various organizations to improve diagnosis, enhance patient care, and scale up access to treatment.

Our portfolio of diagnostic products makes it possible to diagnose and monitor HIV infected patients. Leveraging the power of real-time data, clinicians and healthcare workers in the field can make therapeutic decisions that lead to improved health outcomes.

Learn more about the Alere HIV Cascade of Care.

Hands up for #HIVprevention is the theme of World AIDS Day 2016.

The UNAIDS campaign Hands Up for #HIVprevention explores how to address all the barriers that prevent adolescent girls and young women, at-risk populations, and people living with HIV from accessing and using these services.

This highly social, highly emotional campaign features the hopes, concerns, and encouragement of real people illustrating just how personal — and all encompassing— the HIV/AIDS epidemic is.

Join the conversation. Add your voice — and your hand — to this important campaign.

1. Joint United Nations Programme on HIV/AIDS. UNAIDS Global AIDS Update. 2016.

Frost & Sullivan Recognises Alere’s Wide Palette of HIV Diagnostics Products with Cutting-edge Technologies


Based on its recent analysis of the HIV diagnostics market, Frost & Sullivan recognises Alere with the 2015 African Frost & Sullivan Award for Product Line Strategy Leadership.

Alere has pioneered technologies for point-of-care testing products, enabling highly efficient workflows and quality test results. For instance, the Alere Pima™ Analyser is the world’s first device to provide absolute CD4 results at the point-of-care and helps providers initiate and improve the management of antiretroviral therapy. Other solutions include Alere Determine™ HIV-1/2, Alere™ HIV Combo, Alere SD HIV/Syphilis Duo and Alere™ q HIV-1/2 Detect.

2015 African Frost & Sullivan Award for Product Line Strategy Leadership

“In terms of affordability, Alere’s HIV screening products are the assays of choice in more than 30 African nations,” noted Saravanan Thangaraj, Frost & Sullivan Research Analyst. “The solutions are designed to improve early diagnosis and turnaround time, reduce loss-to-follow-up, and enhance treatment compliance and adherence. This results in the best health economic outcomes to countries that employ the technology.”

Krishna Srinivasan, Global President and Managing Partner Frost & Sullivan stated,

“Alere has done a remarkably good job of understanding customer needs in the HIV diagnostics market. Its diverse product range is uniquely positioned for sustained success because it addresses the core issues that customers care about – quality, functionality and reliability.”

Read the full press release here

Alere Partners with Desmond Tutu HIV Foundation to Reduce Impact of Disease on Vulnerable Youth


Tutu Teen Truck


On August 13 2015, Alere announced a grant of 2.5 million South African Rand to support the work of the Desmond Tutu HIV Foundation (DTHF), a Cape Town-based organization under the patronage of Archbishop Emeritus Desmond Tutu. The Foundation is a leader in HIV and TB research; community development and support are integral to its research endeavors. The grant will support the Foundation’s Tutu Teen Truck project and expand the reach of infectious, sexual and reproductive services for youth and adolescents from communities around Cape Town.

The Tutu Teen Truck is the second vehicle in the Tutu Tester mobile services fleet. It is a self-sufficient mobile healthcare unit equipped with two counseling rooms and a dispensing cubicle. The vehicle will be used to provide counseling and healthcare services to youth around Cape Town’s under-served communities. In addition to HIV, TB and STI screening, a wellness package known as HCT PLUS will include diabetes, hypertension, obesity, cervical, breast and testicular cancer screening. Comprehensive health advice will also be provided and referral to care and treatment when necessary.

“South Africa is estimated to have more people infected with HIV than any other county, and it has one of the highest incidences of tuberculosis worldwide,” said Archbishop Emeritus Desmond Tutu, Patron of the HIV Foundation.

“I commend Alere for responding to this challenge through their support for the Tutu Teen Truck project. The Tutu Teen Truck will be able to reach you in under-serviced areas, providing easy access to screening for a variety of infectious and chronic diseases and will move us closer to achieving the UNAIDS goal to eliminate HIV by 2030.”

The Alere grant will equip the vehicle with rapid point-of-care technology spanning the entire continuum of care for HIV, TB and STI testing and monitoring, as well as tests and screens for common chronic illnesses, reducing the stigma of testing. The grant will also cover costs of hiring a full team, led by a dedicated nurse practitioner, who will bring healthcare directly to communities.

Alere Receives CE Mark for Alere™ HIV Combo

POSTED February 23, 2015

Rapid 4th Generation HIV Test Detects HIV 1/2 antibodies and HIV-1 p24 in 20 minutes

Alere Inc.(NYSE: ALR), a global leader in rapid diagnostic tests, today announced it has received CE Marking in Europe for Alere HIV Combo, a 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. Alere HIV Combo detects all known subtypes and recombinants of the virus more prevalent in Africa, Europe, Asia and Latin America.

Using serum, plasma, fingerstick or venous whole blood specimens, Alere HIV Combo can deliver fast, accurate results in 20 minutes. The test will initially be launched in the UK, France, Switzerland and Spain. Alere is also applying for WHO prequalification to expand availability of the 4th generation HIV point of care tests to Africa. Further global registrations are underway in Asia and will begin in Latin America.

Avi Pelossof, Alere Global President of Infectious Disease said:

“The failure to diagnose acute infections at the point of care represents an important public health problem. The new Alere HIV Combo test will increase opportunities for case finding, particularly in high-risk communities that would not be detected using 2nd and 3rd generation antibody-only tests.”

Alere HIV Combo detects acute infection, which is defined as the interval between the appearance of HIV RNA in plasma and the detection of HIV-1 specific antibodies. Persons with acute infection may be up to 10 times more likely to transmit HIV than individuals with established infection. With use of Alere HIV Combo, HIV can be detected earlier, facilitating fast and appropriate linkage to care.

Including the new addition of Alere HIV Combo, Alere offers diagnostic solutions for the complete continuum of HIV care from initial screening and diagnosis to staging and ongoing monitoring.

Note: Alere HIV Combo is not approved for sale in the U.S. Alere Determine™ HIV-1/2 Ag/Ab Combo is CLIA-waived and available in the U.S.

Read the full press release here

Alere to Support Organisation of African First Ladies Against HIV/AIDS (OAFLA) in New Effort to End Mother-to-Child Transmission of HIV and Syphilis

POSTED October 10, 2014

100,000 HIV/Syphilis Duo Rapid Tests Donated to African First Ladies to Launch OAFLA’s Push to Eliminate Mother-to-Child Transmission of HIV and Syphilis in Their Countries 

Representatives from the Organisation of African First Ladies Against HIV/AIDS, UNAIDS, the International Planned Parenthood Federation (IPPF) and Alere (NYSE: ALR), the world leader in rapid HIV screening and diagnostics products, called for intensified efforts to increase awareness of HIV status in young people, reduce the spread of HIV/AIDS on the continent and, in particular, eliminate mother-to-child transmission of HIV.

At the “African First Ladies Advocating for Health” conference held in New York on 23 September, 2014, Alere announced that it will initially donate 100,000 HIV/Syphilis Duo Rapid tests to countries in Africa to support OAFLA’s efforts to reduce mother-to-child transmission of HIV/AIDS and syphilis, help pregnant women and adolescent girls know their HIV status and reduce child mortality in the continent.

African First Ladies

Representatives of the OAFLA pictured at the conference

Namal Nawana, Alere Interim CEO said:

“We are honored to support Africa’s First Ladies in their renewed effort to reduce maternal and child mortality, end mother-to-child HIV infections, and work towards the elimination of congenital syphilis.”

Read the full press release here

New Alere™ q Point-of-Care Early Infant Diagnosis Test Prototype Accurately Detects HIV in Infants with High Sensitivity and Specificity in Primary Health Clinics in Mozambique.

POSTED July 15, 2014

Alere Inc. (NYSE: ALR) today announced the publication of a study demonstrating the viability of accurate and rapid HIV screening among infants at the point of care (POC). The study was conducted in five clinics in Maputo, Mozambique, with the prototype of Alere’s new POC nucleic acid test, the Alere™ q HIV-1/2 Detect assay. Results of the study have been published ahead of print in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). 

Alere™ q HIV-1/2 Detect assay

Willem Pretorius, Global Product Manager – HIV Care, Alere said:

“Results of this study suggest that point-of-care early infant diagnosis is clinically feasible when administered by non-laboratory personnel, can improve access to screening and treatment, and can help keep people who initiate therapy retained in care.”

Read the full press release here

Alere Determine™ HIV-1/2 Ag/Ab Combo now available in the U.S.

POSTED October 30, 2013

Alere Inc. (NYSE: ALR), the world’s leading provider of point-of-care rapid diagnostic and health information solutions, has 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.

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.

Learn More

Join us at the International AIDS Society Conference

POSTED June 26, 2013

Join us at the International AIDS Society Conference

From 30 June – 03 July 2013, join Alere at the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur, Malaysia.

Visit Alere at booth #201 to learn more about our innovative diagnostic products that are revolutionising HIV chronic disease management at the point-of-care.

Be among the first to see a preview of the Alere™ q HIV-1/2 Viral Load assay, the world’s first point-of-care method for HIV-1 and HIV-2 viral load monitoring and molecular HIV diagnosis.

Making the HIV Spend More Efficient – How POC testing can contribute towards health economics improvements

POSTED April 24, 2013

In this webisode, Tienie Stander, CEO of Hexor, speaks about the economic model developed to demonstrate the impact that point-of-care technologies can have on the HIV treatment cascade.


Arguing that we can make the HIV dollar spend more efficient by focussing on health system improvements such as point-of-care, the model demonstrates that POC testing could contribute towards a reduction in population level viral load which could translate into significant public health and economic improvements.

Point-of-care CD4 testing is a strategy that is cost saving and promotes efficiency in scarce health care resource use. These findings were recently presented at the South African HIV Clinicians Society Conference.

Alere Awarded Gates Foundation Grant for TB and HIV Projects

POSTED April 19, 2013

In an exciting development for the future of point-of-care TB and HIV testing Alere has been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill & Melinda Gates Foundation. The $21.6 million grant will fund the development of a tuberculosis assay, which will be designed for use in both resource-constrained and well-resourced settings.

In addition, the Gates Foundation will provide below-market loans of up to $20.6 million for the expansion and scale up of Alere’s manufacturing facilities in Jena, Germany for both the POC TB Nucleic Acid Test and the POC HIV Viral Load Test currently in the final stages of development.

Alere’s manufacturing facilities in Jena, Germany

Bill Gates, co-chair of the Bill and Melinda Gates Foundation said:

“Alere has a track record of diagnostic innovation and leveraging cost-effective technologies to improve health outcomes for individuals living with HIV in the most remote parts of the world. The Gates Foundation has put its support behind the company to apply these same principles in addressing the TB epidemic and potentially saving millions of lives.”

Read the full press release here

Package Inserts & Product Brochures Now Available on

POSTED February 25, 2013

Package Inserts, User Guides and Product Brochures are now available for download on

If you are in need of a Package Insert, User Guide or Product Brochure for any of the products in the AlereHIV Chronic Disease Management portfolio, simply visit the Specifications page for your product of interest and you will be able to download these items for immediate use.

Specifications page

Alere Pima™ CD4

Visit the Alere Pima™ CD4 Specifications page for access to

  • Product Brochure
  • User Guides

Alere Determine™ HIV-1/2 Ag/Ab Combo

Visit the Alere Determine™ HIV-1/2 Ag/Ab Combo Specifications page for access to

  • Product Brochure
  • Package Inserts

Alere Determine™ TB LAM Ag

Visit the Alere Determine™ TB LAM Ag Specifications page for access to

  • Product Brochure
  • Package Inserts