Abstract
BackgroundEach of the currently available (1→3)-β-D-glucan (BDG) measurement kits follows a different measurement method and cut-off value. Comparisons of diagnostic performance for invasive fungal infections (IFIs) are desirable. Additionally, ecological considerations are becoming increasingly important in the development of new measurement kits.MethodsThe plasma BDG levels in clinical samples were measured using the following currently available kits: the Fungitec G test MKII, the Fungitec G test ES, Fungitell, the β-Glucan test Wako, and the newly developed Wako kit (Wako-Eu). Wako-Eu uses a pre-treatment solution that conforms to European regulations for the registration, evaluation, authorisation, and restriction of chemicals. The values obtained for the samples using each kit were studied and compared.ResultsOf the 165 patients evaluated, 12 had IFIs, including pneumocystis pneumonia, aspergillosis, and candidiasis. BDG values obtained using the kits were moderately correlated with each other. Clinical diagnoses of the evaluated cases indicated that 21 false positives were diagnosed by at least one kit. The sensitivity of the Fungitell kit was relatively low, but those of the other four were over 90%. The specificity was above 90% for all kits. For positive predictive value, the Wako and the Wako-Eu methods were superior to the others owing to fewer false positive results.ConclusionsThe newly developed Wako-Eu method, which considers ecological concerns, shows diagnostic performance equivalent to that of its predecessor. To improve the diagnostic accuracy of IFIs, it is necessary to interpret the results carefully, giving due consideration to the characteristics of each measurement kit.
Highlights
WakoEu kit (Wako)-Eu uses a pre-treatment solution that conforms to European regulations for the registration, evaluation, authorisation, and restriction of chemicals
Clinical diagnoses of the evaluated cases indicated that 21 false positives were diagnosed by at least one kit
The Wako and the Wako-Eu methods were superior to the others owing to fewer false positive results
Summary
When treating IFIs, early diagnoses and prompt initiation of appropriate antifungal agents generally result in better outcomes [1]. Conventional culture methods have relatively low sensitivity and require a long turnaround time to yield positive results [2–4]. Due to these circumstances, non-culture diagnostics have assumed importance as diagnostic adjuncts for IFIs. Due to these circumstances, non-culture diagnostics have assumed importance as diagnostic adjuncts for IFIs One such diagnostic adjunct is the concentration of serum (1!3)-β-Dglucan (BDG), a component of the fungal cell wall, in the blood [5–8]. BDG measurement assays have been widely employed as useful serological diagnostic methods for IFIs, including aspergillosis [7,8], candidiasis [6,9], and Pneumocystis jirovecii pneumonia (PCP) [10]. A BDG assay can be useful in clinical practice, substantial heterogeneity exists across different studies, and its limitations should be noted. Ecological considerations are becoming increasingly important in the development of new measurement kits
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