Validation and comparison of tumor-associated trypsin inhibitor (TATI) immunoassays

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• 作者：Elisabete Janeiro^a ; ^b ; Joana Guimarã ; es^a ; ^b ; Ulf-Hå ; kan Stenman^a ; ^c ; Manuela Catarino^b ; Outi Itkonen^a ; ^c ; ^{outi.itkonen@hus.fi}
• 关键词：ELISA ; enzyme-linked immunosorbent assay ; MAb ; monoclonal antibody ; PSTI ; pancreatic secretory trypsin inhibitor ; RIA ; radioimmunoassay ; TATI ; tumor-associated trypsin inhibitor ; TBS ; Tris-buffered saline ; TR-IFMA ; time-resolved immunofluorometric assay
• 刊名：Clinica Chimica Acta
• 出版年：2012
• 期刊代码：54_00098981
• 类别：med
• 出版时间：16 August, 2012
• 卷：413
• 期：15-16
• 页码：1244-1248
• 文件大小：337 K

摘要

Background

Tumor-associated trypsin inhibitor (TATI) is mainly proposed as a tumor marker for ovarian cancer. However, recent discoveries of TATI in cancer and inflammatory diseases show that assay of TATI in biological samples is of increasing interest.

Methods

We validated a previously described TR-IFMA and a newly developed dual-monoclonal sandwich ELISA for TATI. These methods were compared with a commercial radioimmunoassay (RIA). We studied preanalytical factors affecting serum TATI concentrations and established age- and gender specific reference intervals using serum samples from 195 healthy volunteers.

Results

The assay range and precision were 0.8-45 渭g/L and < 9.1%for the ELISA, and 0.13 渭g/L-150 渭g/L and < 12.5%for the TR-IFMA, respectively. Both assays correlated well with a RIA. Type of blood sample and nutritional status were not critical and TATI was stable in serum samples when stored at + 4 掳C and 鈭?#xA0;20 掳C for 4 weeks and at 鈭?#xA0;80 掳C for 8 weeks. The 95%reference limits for serum TATI in adults were 5.2-15.3 渭g/L in the age group 18-70 years and 7.5-21.3 渭g/L in the age group > 70 years.

Conclusions

Significantly higher concentrations of serum TATI were observed in elderly women and in men. Both ELISA and TR-IFMA technologies can be employed to develop sensitive and robust immunoassays for TATI using monoclonal antibodies.