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1994-10-25
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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).