Background Analysis of material from fine needle aspiration of cervical thyroglobulin nodules with Beckman Coulter reagents on the ACCESS equipment and Calcitonin using the Siemens reagent on the Immulite equipment. The matrix effect, linearity and the limit of analytical sensitivity were analyzed. This study aims to analyze the correlation between the serum/plasma results described in the suppliers' package inserts with the results obtained with the puncture matrix. Methods The performance characteristics were tested according to the laboratory's operating procedures, based on the recommendations of ANVISA RDC 166/2017. Such parameters involved doping, which corresponds to the introduction of a calibrator with a known and traceable value into a pool of puncture material that is known to be negative, in order to analyze the behavior of the results obtained, paying attention to the deviations that may eventually occur due to the interference of the characteristics of the puncture material. puncture. After doping the material, dilutions were performed up to the sensitivity limit of the test, also analyzing the functional sensitivity, where ten replicates of the material were dosed, thus obtaining CV%, mean and Standard Deviation values. The same process was carried out and evaluated using the serum material. During the entire process, the materials received and analyzed were centrifuged and always kept in a refrigerated environment. Results The recovery% of the matrix effect study for cervical aspirate puncture showed results within the expected range, ranging from 80% to 120%, as well as the results compared with serum/plasma referenced in the supplier's package insert. The functional sensitivity study for Thyroglobulin showed a CV% of 1.77%, being lower than that recommended by the package insert (2.2%) and for the Calcitonin analyte, the functional sensitivity study showed a CV% of 8.49%, being lower than recommended by the package leaflet (15.7%), in addition to having CV's lower than the 20% recommended by ANVISA. The results obtained with the matrix effect study for serum also showed values between 80% and 120%, both of which agreed. Conclusions The results showed excellent performance for material from fine needle aspiration for both Calcitonin and Thyroglobulin, being consistent with the serum data described by the suppliers' package inserts, thus making the reagent usable for the cervical aspirate puncture matrix.

中文翻译：

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A-104 甲状腺球蛋白和降钙素在颈部结节细针抽吸中的基质效应研究


背景 在 ACCESS 设备上使用 Beckman Coulter 试剂对宫颈甲状腺球蛋白结节的细针抽吸物进行分析，在 Immulite 设备上使用西门子试剂对降钙素进行分析。分析了基体效应、线性和分析灵敏度极限。本研究旨在分析供应商包装说明书中描述的血清/血浆结果与穿刺基质获得的结果之间的相关性。方法根据ANVISA RDC 166/2017的建议，按照实验室操作程序测试性能特征。这些参数涉及掺杂，这相当于将具有已知且可追踪值的校准器引入已知为负值的穿刺材料池中，以便分析所获得结果的行为，注意可能的偏差最终由于穿刺材料特性的干扰而发生。穿刺。掺杂材料后，进行稀释直至测试的灵敏度极限，同时分析功能灵敏度，其中对材料进行十次重复给药，从而获得 CV%、平均值和标准偏差值。使用血清材料进行相同的过程并进行评估。在整个过程中，接收和分析的材料均经过离心分离并始终保存在冷藏环境中。结果 宫颈穿刺穿刺基质效应研究的回收率显示结果在预期范围内（80% 至 120%），并且结果与供应商包装说明书中引用的血清/血浆进行了比较。甲状腺球蛋白的功能敏感性研究显示 CV% 为 1。77%，低于包装说明书推荐值 (2.2%)，对于降钙素分析物，功能敏感性研究显示 CV% 为 8.49%，低于包装说明书推荐值 (15.7%)，此外CV 低于 ANVISA 推荐的 20%。血清基质效应研究获得的结果也显示数值在 80% 到 120% 之间，两者一致。结论 结果表明，细针抽吸材料对降钙素和甲状腺球蛋白均具有优异的性能，与供应商包装说明书中描述的血清数据一致，从而使该试剂可用于宫颈抽吸穿刺基质。