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Journal of Clinical Microbiology, June 1998, p. 1612-1616, Vol. 36, No. 6
Department of Medical Microbiology,
Received 16 December 1997/Returned for modification 9 February
1998/Accepted 10 March 1998
The intra- and interlaboratory reproducibilities of a commercial
sandwich enzyme-linked immunosorbent assay (ELISA) for the detection of
Aspergillus galactomannan in serum (Platelia Aspergillus; Sanofi Diagnostics Pasteur, Marnes-La-Coquette, France) were evaluated in six laboratories of university hospitals. Twenty serum samples were
obtained from 12 neutropenic patients including 6 with invasive aspergillosis. These samples were blinded and sent to each center together with eight blinded ELISA-negative serum samples spiked with
known concentrations of galactomannan. The centers were provided with
ELISA microtiter plates from a single batch and a detailed protocol.
Ten clinical samples showed ELISA reactivity, while 10 samples were
ELISA negative. The mean coefficient of variation (CV) of the optical
density values was 4.24% within a single assay and 25.6% between
runs. The interassay CV of the ratios for the serum samples tested was
18.6%. Analysis of ordinal interpretation of the ELISA result (i.e.,
negative, gray zone, or positive) showed excellent reproducibility.
Recalculation of the cutoff values for positive and negative samples
suggested that the cutoff level recommended by the manufacturer could
be lowered from 1.0 to 0.8 for negative samples and from 1.5 to 1.0 for
positive samples. The intra- and interlaboratory reproducibilities were
excellent when the ELISA results were interpreted as ordinal data, but
considerable variation in optical density values and, to a lesser
extent, in the ratios for the serum samples tested, was observed
between runs. High assay variability was also found for serum samples spiked with known concentrations of galactomannan. Therefore, antigen
titers in serum samples from a single patient, measured in different
runs, should be compared with caution.
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.
Detection of Antigen in Sera of Patients with
Invasive Aspergillosis: Intra- and Interlaboratory
Reproducibility
*
Corresponding author. Mailing address: Department of
Medical Microbiology, University Hospital Nijmegen, P.O. Box 9101, Geert Grooteplein 24, 6500 HB Nijmegen, The Netherlands. Phone:
31-24-3614356. Fax: 31-24-3540216. E-mail:
p.verweij{at}mmb.azn.nl.
Journal of Clinical Microbiology, June 1998, p. 1612-1616, Vol. 36, No. 6
0095-1137/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.
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