Munier Perrine, Courtier Françoise, Barrial Kildie, Chikh Karim, Claustrat Francine, Le Bricon Thierry, Bronner Jacques, Sanabria Edgar
Laboratoire de biologie médicale, Centre hospitalier de Valence, Valence, France.
Ann Biol Clin (Paris). 2011 Nov-Dec;69(6):721-5. doi: 10.1684/abc.2011.0635.
Thyroglobuline (Tg) is a large molecule of high molecular weight mainly indicated in monitoring differentiated thyroid cancer (DTC), its measurement remains difficult. We report the case of a patient who underwent total thyroidectomy for a poorly differentiated thyroid insular carcinoma. Despite several (131)I treatments, a progressive elevation of serum Tg is observed. A control performed in another laboratory using an immunoradiometric assay (IRMA Cisbio) returns an undetectable value (< 0,2 mg/L). A new sample was simultaneously sent to different laboratories. Three nonisotopic immunometric assays showed high values of Tg while the IRMA assay, considered the gold standard, gave a result below the detection threshold. The absence of Tg antibodies and of anti-mouse antibodies was confirmed. The IRMA Kit manufacturer agreed to carry out an expertise. After changing their detection antibody, the presence of a high Tg was demonstrated, in agreement with non-isotopic techniques. The expertise conclusion was a lack of detection by the IRMA Tg assay. This incident was notified to AFSSAPS by the manufacturer.
甲状腺球蛋白(Tg)是一种高分子量的大分子,主要用于监测分化型甲状腺癌(DTC),但其检测仍存在困难。我们报告了一例因低分化甲状腺岛状癌接受全甲状腺切除术的患者。尽管进行了多次(131)I治疗,但血清Tg仍呈进行性升高。在另一家实验室使用免疫放射分析(IRMA Cisbio)进行的检测结果显示为不可检测值(<0.2mg/L)。同时将一份新样本送往不同实验室。三种非同位素免疫分析显示Tg值较高,而被视为金标准的IRMA分析结果低于检测阈值。确认不存在Tg抗体和抗鼠抗体。IRMA试剂盒制造商同意进行专业鉴定。更换检测抗体后,证实存在高Tg,与非同位素技术结果一致。专业鉴定结论是IRMA Tg分析检测不到。制造商已将此事件通知法国卫生安全与健康产品局(AFSSAPS)。