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

被引:35
作者
Tozzoli, R
Bizzaro, N
Tonutti, E
Pradella, M
Manoni, F
Vilalta, D
Bassetti, D
Piazza, A
Rizzotti, P
机构
[1] Osped Civile, Lab Patol Clin, I-30027 S Dona Di Piave, VE, Italy
[2] Osped Civile, Lab Anal Chim Clin & Microbiol, Latisana, UD, Italy
[3] Azienda Osped S Maria della Misericordia, Ist Chim Clin, Udine, Italy
[4] Osped Castelfranco, Lab Anal Chim Clin & Microbiol, Veneto, TV, Italy
[5] Osped Chioggia VE, Lab Anal Chim Clin & Microbiol, Chioggia, Italy
[6] Azienda Osped S Maria degli Angeli, Serv Microbiol Immunol, Pordenone, Italy
[7] Osped S Chiara, Patol Clin 2, Trento, Italy
[8] Osped Geriatr, Lab Anal Chim Clin & Microbiol, Padua, Italy
[9] Osped Borgo Trento, Lab Chim Clin, Verona, Italy
关键词
autoimmune thyroid disease; anti-thyroid autoantibodies; immunoassay; thyroperoxidase; thyroglobulin;
D O I
10.1515/CCLM.2002.098
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
The use of highly sensitive immunometric methods in clinical laboratories to assay antithyroid 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 antithyroglobulin (anti-Tg) and antithyroperoxidase (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 IU/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.
引用
收藏
页码:568 / 573
页数:6
相关论文
共 30 条
[1]  
BEEVER K, 1989, CLIN CHEM, V35, P1949
[2]  
BETTERLE C, 1997, GLI AUTOANTICORPI, P61
[3]   Variability between methods to determine ANA, anti-dsDNA and anti-ENA autoantibodies: a collaborative study with the biomedical industry [J].
Bizzaro, N ;
Tozzoli, R ;
Tonutti, E ;
Piazza, A ;
Manoni, F ;
Ghirardello, A ;
Bassetti, D ;
Villalta, D ;
Pradella, M ;
Rizzotti, P .
JOURNAL OF IMMUNOLOGICAL METHODS, 1998, 219 (1-2) :99-107
[4]   PURIFICATION OF THE HUMAN THYROID PEROXIDASE AND ITS IDENTIFICATION AS THE MICROSOMAL ANTIGEN INVOLVED IN AUTOIMMUNE THYROID-DISEASES [J].
CZARNOCKA, B ;
RUF, J ;
FERRAND, M ;
CARAYON, P ;
LISSITZKY, S .
FEBS LETTERS, 1985, 190 (01) :147-152
[5]   Concordance of eight kits for antithyroid peroxidase autoantibodies determination [J].
d'Herbomez, M ;
Sapin, R ;
Gasser, F ;
Schlienger, JL ;
Wémeau, JL .
CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2000, 38 (06) :561-566
[6]  
Feldt-Rasmussen U, 1991, Autoimmunity, V9, P245, DOI 10.3109/08916939109007650
[7]  
FeldtRasmussen U, 1996, CLIN CHEM, V42, P160
[8]  
Finke R, 1994, EXP CLIN ENDOCRINOL, V102, P145
[9]  
FUJITA K, 1970, CLIN PATHOL, V50, P961
[10]   Distinct immunological and biochemical properties of thyroid peroxidase purified from human thyroid glands and recombinant protein produced in insect cells [J].
Gardas, A ;
Sutton, BJ ;
Piotrowska, U ;
Pasieka, Z ;
Barnett, PS ;
Huang, G ;
McGregor, AM ;
Banga, JP .
BIOCHIMICA ET BIOPHYSICA ACTA-PROTEIN STRUCTURE AND MOLECULAR ENZYMOLOGY, 1999, 1433 (1-2) :229-239