핵의학 체외검사실에서 시약 lot간 parallel test 시 변이 분석

• 영문명: Analysis of Variation for Parallel Test between Reagent Lots in in-vitro Laboratory of Nuclear Medicine Department
• 발행기관: 대한핵의학기술학회
• 저자명: 채홍주(Hong Joo Chae) 천준홍(Jun Hong Cheon) 이선호(Sun Ho Lee) 유소연(So Yeon Yoo) 유선희(Seon Hee Yoo) 박지혜(Ji Hye Park) 임수연(Soo Yeon Lim)
• 간행물 정보: 『핵의학기술』Vol.23 No.2, 51~58쪽, 전체 8쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2019.10.30

영문 초록

Purpose In in-vitro laboratories of nuclear medicine department, when the reagent lot or reagent lot changes Comparability test or parallel test is performed to determine whether the results between lots are reliable. The most commonly used standard domestic laboratories is to obtain %difference from the difference in results between two lots of reagents, and then many laboratories are set the standard to less than 20% at low concentrations and less than 10% at medium and high concentrations. If the range is deviated from the standard, the test is considered failed and it is repeated until the result falls within the standard range. In this study, several tests are selected that are performed in nuclear medicine in-vitro laboratories to analyze parallel test results and to establish criteria for customized percent difference for each test. Materials and Methods From January to November 2018, the result of parallel test for reagent lot change is analyzed for 7 items including thyroid-stimulating hormone (TSH), free thyroxine (FT4), carcinoembryonic antigen (CEA), CA-125, prostate-specific antigen (PSA), HBs-Ab and Insulin. The RIA-MAT 280 system which adopted the principle of IRMA is used for TSH, FT4, CEA, CA-125 and PSA. TECAN automated dispensing equipment and GAMMA-10 is used to measure insulin test. For the test of HBs-Ab, HAMILTON automated dispensing equipment and Cobra Gamma ray measuring instrument are used. Separate reagent, customized calibrator and quality control materials are used in this experiment. Results 1. TSH [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(low concentration) [14.8 / 4.4 / 3.7 / 0.0 ] C-2(middle concentration) [10.1 / 4.2 / 3.7 / 0.0] 2. FT4 [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(low concentration) [10.0 / 4.2 / 3.9 / 0.0] C-2(high concentration) [9.6 / 3.3 / 3.1 / 0.0 ] 3. CA-125 [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(middle concentration) [9.6 / 4.3 / 4.3 / 0.3] C-2(high concentration) [6.5 / 3.5 / 4.3 / 0.4] 4. CEA [%diffrence Max / Mean / median] (P-value by t-test > 0.05) C-1(low concentration) [9.8 / 4.2 / 3.0 / 0.0] C-2(middle concentration) [8.7 / 3.7 / 2.3 / 0.3] 5. PSA [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(low concentration) [15.4 / 7.6 / 8.2 / 0.0] C-2(middle concentration) [8.8 / 4.5 / 4.8 / 0.9] 6. HBs-Ab [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(middle concentration) [9.6 / 3.7 / 2.7 / 0.2] C-2(high concentration) [8.9 / 4.1 / 3.6 / 0.3] 7. Insulin [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(middle concentration) [8.7 / 3.1 / 2.4 / 0.9] C-2(high concentration) [8.3 / 3.2 / 1.5 / 0.1] In some low concentration measurements, the percent difference is found above 10 to nearly 15 percent in result of target value calculated at a lower concentration. In addition, when the value is measured after Standard level 6, which is the highest value of reagents in the dispensing sequence, the result would have been affected by a hook effect. Overall, there was no significant difference in lot change of quality control material (p-value>0.05). Conclusion Variations between reagent lots are not large in immunoradiometric assays. It is likely that this is due to the selection of items that have relatively high detection rate in the immunoradiometric method and several remeasurements. In most test results, the difference was less than 10 percent, which was within the standard range. TSH control level 1 and PSA control level 1, which have low concentration target value, exceeded 10 percent more than twice, but it did not result in a value that was near 20 percent. As a result, it is required to perform a longer period of observation for more homogenized average results and to obtain laboratory-specific acceptance criteria for each item. Also, it is advised to study observations considering various variables.

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대상 및 방법

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키워드

Lot-to lot variation reagent parallel test immunoassay radioimmunoassay