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Updated: Aug 20, 2026

Amplifying and Quantifying HIV-1 RNA in HIV Infected Individuals with Viral Loads Below the Limit of Detection by Standard Clinical Assays
Published on: September 26, 2011
[Establishment of the reference panel for HIV RNA]
Chun-tao Zhang1, Ai-jing Song, Xiu-hua Li
1Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Objective:
To establish a national reference panel for HIV RNA diagnostic reagents.
Methods:
Sera from patients with HIV infection and healthy blood donors were collected and tested for HIV and HCV antibodies and HBsAg by using ELISA. The HIV antibody positive samples with ELISA were confirmed with HIV Blot 2.2 (Genelabs). The quantitative samples for HIV RNA were calibrated with the WHO HIV RNA standard. The stability of the panel was evaluated with acceleration method.
Results:
After screening and calibration, 8 negative samples, 8 positive samples, 3 quantitative samples, 6 sensitivity samples and 5 samples for linear analysis were composed of the national reference panel for HIV RNA. The convinced international units (IU) for the quantitative samples were obtained by seven independent calibration and the logarithm of international units for the quantitative samples (b1-b3) were less than x +/- s. The results showed that this panel may stabilize for 4 days at 4 degrees C.
Conclusion:
A national reference panel for HIV RNA reagents has been established. It may provide the basis for evaluating HIV RNA diagnostic reagents.

