Document 2699
 DOCN  M94A2699
 TI    Anti-HIV-1 kits inter- and intralot performance evaluation.
 DT    9412
 AU    Ueda M; Oliveira CA; Yamashiro R; Instituto Adolfo Lutz (IAL), Secretary
       of Health of Sao Paulo,; Brazil.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):245 (abstract no. PB0409). Unique
       Identifier : AIDSLINE ICA10/94369876
 AB    OBJECTIVE: To monitor the quality of performance of differents lots of
       HIV-1 antibody (Ab) EIA kits commercially available in Sao Paulo-Brazil.
       METHODS: In-house positive controls sera were made from individual blood
       donor samples screened by State Blood Bank. The controls were aliquoted
       and stored at -20 degrees C. The low positive reactor was produced by
       serially diluting the positive serum, and assayed the dilutions using
       HIV negative serum as diluent. These control sera were included daily on
       each HIV-1 testing run for monitoring inter- and intralot performance
       and reproducibility evaluation. Daily values for the external controls
       and cutoff were monitored by chart control method. RESULTS: Among 15
       lots of a HIV-1 EIA kit used at IAL (1992/93) 3 lots were classified as
       unsatisfactory where the values of the control serum included in 50 runs
       (lot A), 9 (lot B), and 20 (lot C) did not fall within acceptable limits
       in 14 (28%), 5 (55.6%), and 7 (35%) runs, respectively. The lack of
       consistency in good results production was detected by the occurrence of
       shifts and trends profiles on the chart control records. CONCLUSION:
       Unsatisfactory lots of HIV-1 Ab EIA kits seldom occur, but the interlot
       and intralot performance evaluation must be daily monitored using low
       positive reactor sera as external control, and observing whether these
       fall within the acceptable range on the chart control graph.
 DE    *AIDS Serodiagnosis  Blood Banks  Blood Donors  Brazil  Comparative
       Study  *Developing Countries  Human  HIV Antibodies/BLOOD  HIV
       Seropositivity/*DIAGNOSIS/IMMUNOLOGY  HIV-1/*IMMUNOLOGY  *Immunoenzyme
       Techniques  Quality Control  *Reagent Kits, Diagnostic  MEETING ABSTRACT

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