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Journal of Clinical Microbiology, December 2005, p. 5957-5962, Vol. 43, No. 12
0095-1137/05/$08.00+0 doi:10.1128/JCM.43.12.5957-5962.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.
Evaluation of a (1
3)-ß-D-Glucan Assay for Diagnosis of Invasive Fungal Infections
Jerry W. Pickering,1*
Howard W. Sant,1
Catherine A. P. Bowles,1,2
William L. Roberts,1,2 and
Gail L. Woods1,2
Associated Regional and University Pathologists, Inc. (ARUP), Institute for Clinical and Experimental Pathology, Salt Lake City, Utah 84108,1
Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah 841082
Received 8 June 2005/
Returned for modification 24 July 2005/
Accepted 22 September 2005
The Fungitell assay (Associates of Cape Cod, Inc.) is a commercial test that detects (1-3)-ß-D-glucan (BG) and is intended for diagnosis of invasive fungal infections. To evaluate the Fungitell assay, we tested serum and plasma samples from healthy blood donors and from patients with blood cultures positive for yeast or bacteria. All
36 blood donors were BG negative, and 13 of 15 candidemic patients were
BG positive. Of 25 bacteremic patients, 14 (10 with gram-positive
bacteremia) were BG positive. One of the latter patients with
Staphylococcus aureus bacteremia also had invasive
candidiasis, based on histological findings in a tissue biopsy;
therefore, the BG result was a true positive. The sensitivity,
specificity, and positive and negative predictive values of the
Fungitell assay, by patient, for these three groups were 93.3%, 77.2%,
51.9%, and 97.8%, respectively. We also performed the Fungitell assay
on sera that had been tested for Aspergillus galactomannan or
Histoplasma antigen. All six Histoplasma
antigen-positive patients and 31 of 32 Aspergillus
galactomannan-positive patients were also BG positive. BG results for
the 10 Histoplasma antigen-negative and the 32
Aspergillus galactomannan-negative patients varied, but we
were unable to confirm many of the results. Between-run coefficients of
variance (CVs) for the assay ranged from 3.2% to 16.8%; within-run CVs
were
4.8%. The correlation coefficient for an interlaboratory
reproducibility study was 0.9892. Concentrations of hemoglobulin,
bilirubin, and triglycerides that caused 20% interference were 588, 72,
and 466 mg/dl, respectively. Our results suggest that the Fungitel
assay may be most useful for excluding invasive fungal
infection.
* Corresponding author. Mailing address: ARUP Institute, 500 Chipeta Way, Salt Lake City, UT 84108. Phone: (801) 583-2787. Fax: (801) 584-5122. E-mail:
jerry.pickering{at}aruplab.com.
Journal of Clinical Microbiology, December 2005, p. 5957-5962, Vol. 43, No. 12
0095-1137/05/$08.00+0 doi:10.1128/JCM.43.12.5957-5962.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.
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