Comparison of Results According to Reaction Conditions of Thyroglobulin Test

Thyroglobulin 검사의 반응조건에 따른 결과 비교 분석

Purpose Thyroglobulin (Tg) is a biologic marker of differentiated thyroid carcinoma (DTC), produced by normal thyroid tissue or thyroid cancer tissue. Therefore, the Tg values of DTC patients is the most specific indicator for judging whether recurrence occur or whether the remaining thyroid cancer is present. Thyroid cancer is currently the most common cancer in Korea, of which 90% is differentiated thyroid cancer. The number of patients with thyroid disease of this application also increased, and an accurate and prompt results are required. However, the incubation time of the Tg commonly takes about 24 hours in our hospital, and the result reporting time is delayed, and We could not satisfied with the requirements of clinical departments and patients. In order to fulfill these requirements, experiments were conducted by shortening the incubation time between company B's Kit currently in use and company C's Kit used in other hospitals. Through these experiments, we could perform the correlation with the original method and shortening method, and could find the optimum reaction time to satisfy the needs of the departments and the patients, and we will improve the competitiveness with the EIA examination. Materials and Methods In September 2016, we tested 65 patients company B's kit and company C's kit by three incubation ways. First method $37^{\circ}C$ shaking 2hr/2hr, Second method RT shaking 3hr/2hr, Third method 1hr/1hr shaking at $37^{\circ}C$. Fourth method RT shaking 3hr method which is the original method of Company C's Kit. Fifth method, the incubation time was shortened under room temperature shaking 2hr, Sixth method $37^{\circ}C$ shaking 2hr. And we performed and compared the correlation and coefficient of each methods. Results As a result of performing shortening method on company B currently in use, when comparing the Original method of company B kit, First method $37^{\circ}C$ shaking 2hr/2hr was less than Tg 1.0 ng/mL and the ratio of $R^2=0.5906$, above 1.0 ng/mL In the value, $R^2=0.9597$. Second method RT shaking 3hr/2hr was $R^2=0.7262$ less than value of 1.0 ng/mL, $R^2=0.9566$ above than value of 1.0 ng/mL. Third method $37^{\circ}C$ shaking 1hr/1hr was $R^2=0.7728$ less than value of 1.0 ng/mL, $R^2=0.8904$ above than value of 1.0 ng/mL. Forth, Company C's The original method, RT shaking 3hr was $R^2=0.7542$ less than value of 1.0 ng/mL, and $R^2=0.9711$ above than value of 1.0 ng/mL. Fifth method RT shaking 2hr was $R^2=0.5477$ less than value of 1.0 ng/mL, $R^2=0.9231$ above than value of 1.0 ng/mL. Sixth method $37^{\circ}C$ shaking 2hr showed $R^2=0.2848$ less than value of 1.0 ng/mL, $R^2=0.9028$ above than value of 1.0 ng/mL. Conclusion Samples with both values of 1.0 ng/mL or higher in both of the six methods showed relatively high correlation, but the correlation was relatively low less than value of 1.0 ng/mL. Especially, the $37^{\circ}C$ shaking 2hr method of company C showed a sharp fluctuation from the low concentration value of 1.0 ng/mL or less. Therefore, we are planning to continuously test the time, equipment, incubation temperature and so on for the room temperature shaking 2hr method and $37^{\circ}C$ shaking 1hr/1hr of company C which showed a relatively high correlation. After that, we can search for an appropriate shortening method through additional experiments such as recovery test, dilution test, sensitivity test, and provide more accurate and prompt results to the department of medical treatment, It is competitive with EIA test.

Thyroglobulin (Tg)은 갑상선에서 특이적으로 생성되는 요오드단백질로써 분화갑상선 암(Differentiate Thyroid Carcinoma, DTC) 의 생물학적 표지자이다. 본 검사실의 Tg 검사법은 반응시간이 길어 진료과와 환자들의 결과보고 요청사항을 만족시키지 못하고 있는 상황이다. 이를 만족시키기 위해 Tg 검사의 반응시간을 단축하고자 현재 사용중인 B사 Kit와 타 병원에서 사용중인 C사 Kit의 반응시간을 단축시켜 실험을 진행하였다. 본원에 의뢰된 Tg 약 65명의 환자 검체를 대상으로 B사 Kit의 반응시간을 $37^{\circ}C$ shaking 2hr/2hr, 실온 shaking 3hr/2hr, $37^{\circ}C$ shaking 1hr/1hr으로, C사 Kit의 원법인 실온 shaking 3hr법과 반응시간을 단축한 실온 shaking 2hr, $37^{\circ}C$ shaking 2hr 방법으로 단축하여 기존에 시행하던 overnight법과 상관성검사를 실시하여 비교하였다. 그 결과 여섯가지 방법 모두 1.0 ng/mL 이상의 값에서는 높은 상관관계를 보였으나 1.0 ng/mL 이하의 값에서는 다소 흔들리는 경향이 있었다. 하지만 그 중 상대적으로 안정적이었던 B사 Kit $37^{\circ}C$ shaking 1hr/1hr 법과 C사 Kit 실온 shaking 2hr 법에 대해 다른 조건들을 재설정하여 적합한 방법을 찾는다면 진료과와 환자들의 요구 사항 충족은 물론, EIA법과의 경쟁력 면에서도 유용할 것이다.