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Between-assay variability of faecal calprotectin enzyme-linked immunosorbent assay kits

S J Whitehead [et.al] - Nama Orang;

Faecal calprotectin (f-Cp), a marker of intestinal inflammation, can be used to distinguish between functional
and organic bowel disease. F-Cp, following extraction, is commonly quantified using enzyme-linked immunosorbent
assays (ELISAs) but there are no data comparing the different f-Cp assays or sample extraction devices. We, therefore, evaluated and compared the performance of the Immunodiagnostik, Bu¨ hlmann and Eurospital f-Cp ELISA assays as well as the Roche, Immunodiagnostik and ScheBo Biotech commercial faecal extraction devices. We also briefly report results from a
pilot f-Cp external quality assurance (EQA) scheme.Methods: Imprecision, linearity, recovery, drift and limit of quantitation of the f-Cp assays were evaluated and between-assay variability assessed. The three commercial sample extraction devices were compared with the manual weighing method. Four faecal samples were distributed as part of a pilot EQA scheme to 15 laboratories using quantitative ELISA f-Cp assays. Results: The three f-Cp assays demonstrated adequate intra-/interbatch imprecision, linearity and recovery. The crosscomparison study and EQA data demonstrated that, for the same sample, the Bu¨ hlmann assay reports up to 3.8 times higher f-Cp concentrations than the Immunodiagnostik and Eurospital assays. On average, the commercial extraction devices led to a 7.8–28.1% under-recovery of f-Cp in comparison to the manual weighing method. Conclusions: Laboratories should be aware of the lack of the assay standardization, as demonstrated by the between-assay variability. A comparison between f-Cp concentrations reported by these assays and clinical markers of disease severity is required in order to determine their diagnostic accuracy. The EQA scheme represents the first available programme for f-Cp.


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Informasi Detail
Judul Seri
Annals of Clinical Biochemistry
No. Panggil
-
Penerbit
: SAGE Publications Ltd., 2013
Deskripsi Fisik
Annals of Clinical Biochemistry 2013; 50: 53–61
Bahasa
English
ISBN/ISSN
-
Klasifikasi
-
Tipe Isi
-
Tipe Media
-
Tipe Pembawa
-
Edisi
-
Subjek
BIOKIMIA
Info Detail Spesifik
-
Pernyataan Tanggungjawab
hasnidar/agus
Versi lain/terkait

Tidak tersedia versi lain

Lampiran Berkas
  • Between-assay variability of faecal calprotectin enzyme-linked immunosorbent assay kits
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