Challenges for Rapid Molecular HIV Diagnostics

Henry Jackson Foundation for the Advancement of Military Medicine, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20817, USA.
The Journal of Infectious Diseases (Impact Factor: 6). 04/2010; 201 Suppl 1(supplement 1):S1-6. DOI: 10.1086/650394
Source: PubMed


The introduction of serological point-of-care assays 10 years ago dramatically changed the way that human immunodeficiency virus (HIV) infection was identified and diagnosed. Testing at the point of care has lead to a dramatic increase in the number of individuals who are screened and, most importantly, receive their HIV test result. As the AIDS epidemic continues to mature and scientific advances in prevention and treatment are evaluated and implemented, there is a need to identify acute (viremic preseroconversion) infections and to discriminate "window phase" infections from those that are serologically positive, especially in resource-limited settings, where the majority of vulnerable populations reside and where the incidence of HIV infection is highest. Rapid testing methods are now at a crossroads. There is opportunity to implement and evaluate the incremental diagnostic usefulness of new test modalities that are based on sophisticated molecular diagnostic technologies and that can be performed in settings where laboratory infrastructure is minimal. The way forward requires sound scientific judgment and an ability to further develop and implement these tests despite a variety of technical, social, and operational hurdles, to declare success.

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Available from: Marco L Schito, Aug 28, 2014
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    • "Third, we need appropriate tests for individuals vaccinated with experimental HIV antigens in clinical trials [147, 148]. Vaccine volunteers mount specific immune responses to the vaccine constructs, which react with many serological diagnostic tests, making future HIV diagnosis difficult, potentially unblinding trial staff, and negatively impacting society [148]. "
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    ABSTRACT: Effective prevention of HIV/AIDS requires early diagnosis, initiation of therapy, and regular plasma viral load monitoring of the infected individual. In addition, incidence estimation using accurate and sensitive assays is needed to facilitate HIV prevention efforts in the public health setting. Therefore, more affordable and accessible point-of-care (POC) technologies capable of providing early diagnosis, HIV viral load measurements, and CD4 counts in settings where HIV is most prevalent are needed to enable appropriate intervention strategies and ultimately stop transmission of the virus within these populations to achieve the future goal of an AIDS-free generation. This review discusses the available and emerging POC technologies for future application to these unmet public health needs.
    AIDS research and treatment 01/2014; 2014(4):497046. DOI:10.1155/2014/497046
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    • "The HIV and AIDS clinical monitoring POC for CD4, viral load, haematology and clinical chemistry have been evaluated and recommended for use in resource limited settings as well111216. These systems have greatly revolutionized the monitoring of treatment for HIV/AIDS patients. "
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    ABSTRACT: HIV diagnostic and follow up testing are usually done in laboratory settings. However, in developing countries there is a need to decentralize testing as the majority of the population lives in rural settings. In developing countries stringent quality assurance (QA) practices, which include appropriate training, development of standard operating procedures, maintenance of operator proficiency, routine use of quality control (QC) specimens, standardized data management, equipment calibration and maintenance, and biohazard safety with proper disinfection/disposal procedures are not routinely followed to ensure reliability of results and a safe work environment. The introduction of point-of-care testing technologies involving the use of non-laboratorians in routine testing has further increased the complexity of QA. Therefore, a careful approach towards improvement of laboratories that encourages best practices, coupled with incentives, and review of government policies in point-of-care testing is needed to improve quality of testing as decentralization takes place. Development of a functional laboratory tiered network that facilitates communication, referral, training and problem solving could further enhance confidence in laboratory testing. There is also a need for special considerations in implementing a step-wise approach towards quality improvement, strengthening of the supply chain management, human capacity development, infrastructure upgrade, and strong public private partnerships to ensure long term sustainability of these efforts.
    The Indian Journal of Medical Research 12/2011; 134(6):779-86. DOI:10.4103/0971-5916.92625 · 1.40 Impact Factor
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    • "There are notable clinical differences in responsiveness to interferon-based therapy for treatment of chronic infection by GT, with GTs 1 and 4 being less responsive and requiring longer exposure time to treatment than types 2 and 3 [2-5]. GT has been associated with different patterns in HCV viremia during interferon treatment [6], and antiviral resistance [7,8]. Although some clinical conditions have been noted to differ by HCV GT, including insulin resistance [9], HIV and HIV disease progression [10], little is known regarding how different HCV GTs differ in virulence or pathogenicity [11]. "
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