Quality assurance and use of PCR in clinical trials.

P S Reichelderfer; J B Jackson

Quality assurance and use of PCR in clinical trials.

- Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA.

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May 2026, Vol. 36, No. 5

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Abstract

Qualitative and quantitative HIV-1 DNA and RNA PCR assays are proving to be useful in the diagnosis of HIV-1 infection in infants and in assessing the in vivo antiviral activity of new therapies and regimens in clinical trials. The use of these standardized commercial assays in conjunction with an external quality assurance program has ensured that results from different laboratories are comparable. In addition, real-time proficiency monitoring has the potential to detect problems immediately before patient data are compromised.

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Quality assurance and use of PCR in clinical trials.

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