       Document 0758
 DOCN  M9610758
 TI    Preparation and characterization of human HIV type 1 neutralizing
       reference sera.
 DT    9601
 AU    Vujcic LK; Quinnan GV Jr; Center for Biologics Evaluation and Research,
       Food and Drug; Administration, Rockville, Maryland 20852-1448, USA.
 SO    AIDS Res Hum Retroviruses. 1995 Jul;11(7):783-7. Unique Identifier :
       AIDSLINE MED/96053840
 AB    Reference neutralizing antibody (NA) reagents are needed for
       laboratories to be able to compare results of neutralization assays that
       will be used to monitor HIV-1 vaccine recipients. In an effort to
       establish such reference reagents two asymptomatic, seropositive
       patients were identified with medium to high amounts of cross-reactive
       NA activity against a number of HIV-1 strains. Sera obtained from each
       individual at three or four sequential phlebotomies were pooled, and the
       two pools were each distributed in > 3000 aliquots into glass ampoules
       and lyophilized, and the ampoules were flame sealed. An HIV-1
       antibody-negative reference serum was prepared in a similar fashion
       after pooling serum from four individuals. Ampoules were tested for
       uniformity of fill, sterility, moisture content, residual oxygen,
       stability, infectivity, and presence of antibody. An international
       collaborative study was conducted to determine the potency of the
       samples in six laboratories, each using their own neutralization assays
       and reagents. The results indicated reasonable consistency between
       laboratories and that both sera have sufficient titers against a variety
       of strains for use as reference reagents. These reference sera have been
       included in the World Health Organization (WHO) AIDS Reagent Project and
       are available through the three AIDS reagent repositories.
 DE    Acquired Immunodeficiency Syndrome/BLOOD/*IMMUNOLOGY/VIROLOGY  AIDS
       Vaccines/*IMMUNOLOGY  Bias (Epidemiology)  Cell Line  Comparative Study
       Enzyme-Linked Immunosorbent Assay/METHODS/STANDARDS  Human  HIV
       Antibodies/*BLOOD  HIV Seropositivity/BLOOD/*IMMUNOLOGY/VIROLOGY
       HIV-1/*IMMUNOLOGY  Monitoring, Immunologic/METHODS/STANDARDS
       Neutralization Tests  Quality Control  Reference Values  Reproducibility
       of Results  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

