The United States of America, as Represented by the Secretary, Department of Health and Human Services

Chunfu Yang

Nicholas Wagar

Zhiyong Zhou

Joshua R DeVos

Renu B Lal

Danuta Pieniazek

Joshua R Devos

Provided herein are new methods, primers, and kits for genotyping HIV-1, including group M viral strains. The methods can be used for HIV-1 drug resistance surveillance and monitoring, for example in resource-poor countries. The disclosed methods can detected more mixed HIV-1 population than previous methods. Given the high efficiency in genotyping diverse HIV-1 group M viral strains from plasma and dried blood spot (DBS) samples and substantial reagent cost saving, the disclosed methods can be used for HIV-1 drug resistance genotyping in both antiretroviral therapy (ART)-naive and -experienced populations for surveillance purposes and patient monitoring.

HIV-1 genotyping assay for global surveillance of HIV-1 drug resistance

Reagents and assays for detecting HIV-1 groups M and O and optionally HIV-1 group N and SIVcpz are provided. The reagents are nucleic acid primers for the hybridization to, amplification and subsequent detection of HIV-1 groups M, N and O and SIVcpz in a biological sample. The primers are oligonucleotides that selectively hybridize to the highly conserved regions of the env and pol regions of HIV-1. Due to the high sensitivity of the assays, small concentrations of HIV in a biological sample can be detected, allowing diagnosis at an early stage of infection. The assays are qualitative or quantitative and are useful for viral load determinations of HIV-1 groups M, N or O in a patient undergoing treatment for HIV-1 infection. Viral load determinations can be used to monitor the progress of the treatment regimen, the development of drug resistance, and to predict disease progression.

Methods and reagents for molecular detection of HIV-1 groups M, N and O

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Lilburn, GA, United States of America

Chunfu Yang