On July 20, 2017, Cepheid received World Health Organization (WHO) prequalification for its Xpert® HIV-1 Viral Load (VL) test. The Xpert® HIV-1 VL test measures Human Immunodeficiency Virus type 1 (HIV-1) RNA in human plasma from individuals infected with HIV-1 in less than 90 minutes. Measurement of blood plasma HIV-1 RNA concentration (known as HIV viral load) using nucleic acid-based molecular diagnostic assays has been established as the standard of care in assessing HIV-positive patient prognosis and response to antiretroviral therapy. The Xpert® HIV-1 VL test is run on Cepheid’s GeneXpert System, the world’s most prevalent molecular diagnostics platform. By automating highly complex and time-consuming manual procedures, the GeneXpert allows institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases.
The Xpert HIV-1 VL test earned this notable WHO prequalification after meeting the WHO’s stringent performance, quality, safety and reliability standards. Inclusion on the WHO prequalification list also means that the Xpert® HIV-1 VL test met the sensitivity and accuracy specifications that the WHO requires before allowing broad deployment of a new technology by global health participants and in many developing countries.
“With the prequalification status of the Xpert® HIV-1 VL test, the WHO will enable healthcare providers around the globe to stem the spread of HIV,” said David H. Persing, M.D., Ph.D., the Executive Vice President, Chief Medical & Technology Officer at Cepheid. “Access to the test will also enhance patient care, as measurement of HIV viral load informs treatment plans.”
Approximately 1.7 million adults were newly infected with HIV in 2016.1 Key to preventing this transmission is treating HIV-positive individuals to help them maintain an undetectable viral load.2 People who have a very low or undetectable viral load are much less likely to transmit HIV.3 The WHO recommends viral load testing as the preferred approach to monitoring the success of antiretroviral therapy and diagnosing treatment failure, complementing clinical and immunological monitoring of people receiving antiretroviral therapy.4
Dr. Ali Elbireer, CEO of the African Society for Laboratory Medicine, expressed the enthusiasm of the laboratory medicine community regarding the prequalification. “This test will increase laboratory capacity and access to diagnostics in both urban and rural medical settings in Africa.”
By: Mr. Nqobile Ndlovu, ASLM
Editors: Ms. Bethanie Rammer, ASLM; Dr. Ali Elbireer, ASLM
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Considerations for adoption and use of multidisease testing devices in integrated laboratory networks. World Health Organization. June 2017.
1 Ending AIDS: progress towards the 90–90–90 targets. Geneva: UNAIDS; 2016
2 UNAIDS Public health and HIV viral load, 2017
3 HIV Risk Reduction Tool, Beta Version. US Centers for Disease Control and Prevention (CDC), https://wwwn.cdc.gov/hivrisk/increased_risk/viral_load/ [Accessed 20 Jul 2017.]
4 WHO Consolidated ARV Guidelines, June 2013
Established in 2011, the African Society for Laboratory Medicine is a pan-African professional body endorsed by the African Union with support from the World Health Organization, the African Union, the United States (US) Centers for Disease Control and Prevention, the US President’s Emergency Plan for AIDS Relief, the World Bank, the Clinton Foundation, UNAIDS, and others. ASLM is focused on improving healthcare by strengthening all aspects of laboratories including workforce strengthening, quality improvement and accreditation, harmonization of regulations, strengthening of networks, and strengthening advocacy and communications. Laboratory testing is pivotal for disease diagnosis, epidemiological surveillance, outbreak investigation, and initiation and monitoring of treatment, as well as research and development. ASLM addresses these challenges by working collaboratively with governments; national, regional and international organizations; implementing partners, the private sector and other agencies to achieve its Strategic Vision goals.
About Cepheid, GeneXpert Systems and Xpert Tests
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.
With more than 10,000 systems in 182 countries, the GeneXpert System is the world’s most popular molecular diagnostics’ instrument. The GeneXpert System’s modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time. As a result, the GeneXpert System meets the throughput requirements of customers of all sizes – from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.
GeneXpert Systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 25 tests outside the US, and 20 tests in the US. For more information on the GeneXpert System and the Xpert tests, visit www.cepheid.com.
About the Xpert HIV-1 viral load test
The Xpert HIV-1 VL Test is designed specifically to aid in patient management by providing fast and accurate assessment of viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. Xpert HIV-1 VL is part of a comprehensive portfolio of Xpert tests available internationally from Cepheid, including Xpert HIV-1 Qual, Xpert HCV Viral Load, Xpert CT/NG, Xpert Ebola, Xpert MTB/RIF, and Xpert MTB/RIF Ultra, which all run on the GeneXpert® System. Xpert HIV-1 VL is available outside the United States. For more information on Cepheid’s GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheidinternational.com.
About WHO Prequalification
The WHO Prequalification Team: medicines (PQTm) was first established as the “Prequalification of Medicines Programme” in 2001, in response to the HIV/AIDS pandemic. Its aim was to guide United Nations agencies and other international organizations with respect to the quality of antiretroviral medicines, for supply to low-income countries. Its services now cover assessment, not only of a range of finished pharmaceutical products, in several therapeutic areas, but also assessment of active pharmaceutical ingredients, and of quality control laboratories. It also provides technical assistance and conducts extensive training activities.
UNAIDS, UNICEF, UNFPA, the World Bank and many other organizations consider WHO medicines prequalification to be a concrete contribution to the United Nations priority goal of addressing high-burden diseases in countries with limited access to quality medicines. WHO medicines prequalification primarily benefits populations requiring treatment for priority diseases, and women and girls in need of medicines to ensure their reproductive health. It also supports procurers, regulators, medicine quality control laboratories, manufacturers and donors, in reaching their public health objectives. For more information, visit https://extranet.who.int/prequal/