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Clinical and Diagnostic Laboratory Immunology, May 2000, p. 422-426, Vol. 7, No. 3
Institut für Hygiene und
Laboratoriumsmedizin, Klinikum Krefeld,
Krefeld,1 and Abteilung für
Pädiatrie, Klinikum Wuppertal,
Wuppertal,2 Germany
Received 15 November 1999/Accepted 24 January 2000
Measuring antibodies to Bordetella pertussis antigens
is mostly done by enzyme-linked immunosorbent assays (ELISAs). We
compared the performance of five commercially available ELISA kits with the help of 65 serum specimens which were repetitively tested for
evaluation of the kits. The specimens contained 20 paired serum samples
from patients with clinical pertussis, 15 samples were from children
vaccinated with a diphtheria-tetanus-acellular pertussis vaccine, seven
specimens were taken from an interlaboratory comparison of ELISAs, and
there were three reference preparations from the Food and Drug
Administration's (FDA's) Laboratory of Pertussis and from our
laboratory. Reference values were obtained from the FDA or from results
obtained with an in-house ELISA. Commercial ELISAs were compared with
respect to their reproducibility and variability, their ability to
detect significant titer rises in paired serum samples, their ability
to detect an immune response after vaccination, and the comparability
of semiquantitative and quantitative results. Reproducibility was
generally good (>89%), intra-assay variation ranged from 2.4 to
28.7%, and indeterminate results were recorded in up to 18.5% of all
specimens. Most kits correctly identified the antibody response to an
acellular pertussis vaccine. None of the commercial kits identified all
cases of pertussis correctly, and the sensitivity ranged between 60 and
95%. All five commercial ELISAs showed great discrepancies when
comparing semiquantitative results and contained obviously different
antigen preparations. Our data suggest that the five commercial ELISAs tested here need further improvement and standardization.
1071-412X/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.
Comparison of Five Commercial Enzyme-Linked Immunosorbent Assays
for Detection of Antibodies to Bordetella
pertussis
*
Corresponding author. Mailing address: Institut
für Hygiene und Laboratoriumsmedizin, Klinikum Krefeld,
Lutherplatz 40, 47805 Krefeld, Germany. Phone: 49-2151-322431. Fax:
49-2151-322079. E-mail: koesters_hyg{at}klinikum-krefeld.de.
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