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Immunoassay of anti-thyroid autoantibodies: high analytical variability in second generation methods.

Abstract：

:The use of highly sensitive immunometric methods in clinical laboratories to assay anti-thyroid antibodies has progressively expanded in recent years but it is not known whether the new techniques have improved the analytical variability connected with the preceding methodologies. The Italian Society of Laboratory Medicine Study Group on Autoimmune Diseases conducted a collaborative study with the biomedical industry to evaluate the degree of standardization of the new analytical procedures. Twelve companies agreed to participate in the study on the search for anti-thyroglobulin (anti-Tg) and anti-thyroperoxidase (anti-TPO) antibodies in nine sera from patients with autoimmune thyroiditis, and in six sera from patients with non-autoimmune thyroid disease; ten immunometric and three immunofluorescence methods were employed. Agreement of qualitative results was close to 90% for anti-Tg and 97% for anti-TPO, with no important differences between the methods; variability of the quantitative results, expressed as CV% of absolute (in lU/ml) and relative (in cut-off concentration multiples) values was 93.9% and 102.3%, respectively, for anti-Tg, and 75.5% and 62.9%, respectively, for anti-TPO. These findings show that despite the progressive improvement in the analytical techniques, the variability between methods for the assay of anti-Tg and anti-TPO is still unexpectedly high, and probably due to several factors such as uncertainty in defining the positive cutoff concentration, absence of adequate international reference preparations, modality of autoantigen purification, and analytical variability in the assay procedures.

journal_name

Clin Chem Lab Med

journal_title

Clinical chemistry and laboratory medicine

authors

Tozzoli R,Bizzaro N,Tonutti E,Pradella M,Manoni F,Vilalta D,Bassetti D,Piazza A,Rizzotti P,Italian Society of Laboratory Medicine (SIMeL) Study Group on the Laboratory Diagnosis of Autoimmune Diseases.

doi

10.1515/CCLM.2002.098

keywords:

subject

Has Abstract

pub_date

2002-06-01 00:00:00

pages

568-73

issue

eissn

1434-6621

issn

1437-4331

journal_volume

pub_type

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Immunoassay of anti-thyroid autoantibodies: high analytical variability in second generation methods.