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[Detection of Aspergillus antigen galactomannan using ELISA method: validation of the performances of the method for accreditation].

Abstract：

:Diagnosis of invasive aspergillosis for patients with high risk of infection is based on the monitoring of Aspergillus antigenemia assessed by the detection of galactomannan in serum by a sandwich-type ELISA (Biorad(®)). The validation of the method was displayed according to the guide COFRAC SH GTA 04. The internal quality control system settled, involves two quality control samples made of pools of sera (negative and positive). The repeatability of the measurements, as estimated by the coefficients of variation (CV), obtained by two different technicians was found from 9 to 13.7% for the positive control. The CV of the negative control, for which the provider indicates it is not useful in the analytical process, was found from 7.1 to 30%. In our experience it could be an indicator of environmental contamination. The evaluation of the intermediary fidelity was 15.7% for the positive control and 22.5% for the negative one. In the lack of reference material (International Standard) and recommendation from scientific societies, performances obtained will be discussed according to the results reported in the technical form of the supplier and those obtained by 39 laboratories participating in the only available external quality assessment program organized in France by ProBioQual(®) where the CV of reproducibility are 44.7% of unit (mean index 0.131) for the negative control and 18% (mean index 1.089) for the positive one in 2011.

journal_name

J Mycol Med

journal_title

Journal de mycologie medicale

authors

Kauffmann-Lacroix C,Arvier M,Charron M,Rodier MH,Vassault A

doi

10.1016/j.mycmed.2012.12.048

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

33-9

issue

1

eissn

1156-5233

issn

1773-0449

pii

S1156-5233(12)00222-3

journal_volume

23

pub_type

杂志文章

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