[Establishment of the reference panel for HIV RNA].
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.


CONCLUSIONS
A national reference panel for HIV RNA reagents has been established. It may provide the basis for evaluating HIV RNA diagnostic reagents.
Zhang
Chun-tao
CT
Department of Cell Biology, National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Song
Ai-jing
AJ
Li
Xiu-hua
XH
Li
Juan
J
Wang
You-chun
YC
D001782:Blood Donors; D002138:Calibration; D004355:Drug Stability; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000097:blood / Q000821:virology*; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification; D006514:Hepatitis B Surface Antigens / Q000097:blood; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007202:Indicators and Reagents / Q000592:standards; D012367:RNA, Viral / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D006514:Hepatitis B Surface Antigens; D018937:Hepatitis C Antibodies; D007202:Indicators and Reagents; D012367:RNA, Viral