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1 ORIGINAL ARTICLE Evaluation of Analytical Performance of the Cobas 8 Analyzer Series Module e62 Kiwoong Ko, Min-Jung Kwon, Hee-Yeon Woo, and Hyosoon Park Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Corresponding author: Min-Jung Kwon Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul , Korea Tel: Fax: mjkkmd@gmail.com Background: The e62, a module of the recently released cobas 8 modular analyzer series, is an automated system for immunoassays. In this study, we evaluated its analytical performance using 17 immunoassay analytes. Methods: The Clinical Laboratory Standards Institute guidelines were used to determine the efficiency of the cobas 8 e62 based on its precision, linearity, assay comparison, and reference range validation. Performance analyses were completed using two levels of quality control materials and pooled sera from our institution. The performance of the cobas 8 e62 was compared to that of the modular analytics E17. Statistical analyses were performed using Excel 21 (Microsoft Co., USA) and EP Evaluator Release 1 (Data Innovations, USA). Results: For all analytes, except level 1 total vitamin D, the coefficients of variation were <5%. The linearity results were within the allowable systemic error limits. The performance comparison revealed that the two systems are comparable, with correlation coefficients (r) >.975 for all analytes. The reference range validation was also within the allowable criteria. Conclusions: Taken together, these findings demonstrate that the cobas 8 e62 analyzer has good precision, linearity, performance comparison, and reference range validation. Thus, e62 is a useful module of the cobas 8 modular analyzer series. (J Lab Med Qual Assur 215;37:11-19) Key Words: Immunoassay, Performance, Evaluation pissn: eissn: Received January 26, 215, Revision received March 27, 215, Accepted April 16, 215 INTRODUCTION Copyright 215 The Korean Association of External Quality Assessment Service 11

2 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 MATERIALS AND METHODS 1. Materials 2. Methods 1) Repeatability and within-laboratory precision 3) Comparison 4) Reference range validation > < 2) Linearity 5) Statistics 12 J Lab Med Qual Assur 215;37:

3 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 RESULTS 1. Repeatability and Within-Laboratory Precision Table 1. Repeatability and within-laboratory precision of the Roche cobas 8 e62 Test item Quality Repeatability Within-laboratory precision Mean control SD %CV SD %CV Alpha fetoprotein Level Level Cancer antigen 15-3 Level Level Cancer antigen 19-9 Level Level Cancer antigen 125 Level Level Carcinoembryonic antigen Level Level Cytokeratin 19 fragment Level Level Ferritin Level Level Neuron specific enolase Level Level Prostate specific antigen Level Level Total vitamin D Level Level Estradiol Level Level Follicle stimulating hormone Level Level Insulin Level Level Osteocalcin Level Level Free triiodothyronine Level Level Free thyroxine Level Level Thyroid stimulating hormone Level Level J Lab Med Qual Assur 215;37:

4 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 Table 2. Linearity of the Roche cobas 8 e62 Test item Range Unit Linear regression analysis Allowable systemic % error Slope Intercept error (%) Alpha fetoprotein ng/ml Cancer antigen U/mL Cancer antigen U/mL Cancer antigen U/mL Carcinoembryonic antigen ng/ml Cytokeratin 19 fragment ng/ml Ferritin ng/ml Neuron specific enolase ng/ml Prostate specific antigen ng/ml Total vitamin D ng/ml Estradiol pg/ml Follicle stimulating hormone miu/ml Insulin U/mL Osteocalcin ng/ml Free triiodothyronine pg/ml Free thyroxine ng/dl Thyroid stimulating hormone IU/mL Linearity 3. Comparison of Performance of Cobas e62 and Modular Analytics E17 > Table 3. Comparisons of performance of the cobas 8 e62 and modular analytics E17 Test item No. Regression Slope Intercept r Alpha fetoprotein Cancer antigen Cancer antigen Cancer antigen Carcinoembryonic antigen Cytokeratin 19 fragment Ferritin Neuron specific enolase Prostate specific antigen Total vitamin D Estradiol Follicle stimulating hormone Insulin Osteocalcin Free triiodothyronine Free thyroxine Thyroid stimulating hormone J Lab Med Qual Assur 215;37:

5 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 A 3 B 4 C 4 e62 (ng/ml) 2 1 y= r= E17 (ng/ml) e62 ( U/mL ) y= r= E17 (U/mL) E17 (U/mL) e62 ( U/mL ) 3 2 y=1.14x r= D 2 E 4 F 15 e62 ( U/mL ) y=1.14x+.945 r= E17 (U/mL) e62 (ng/ml) 3 2 e62 (ng/ml) 5 1 y=.999x.551 y=1.27x.161 r=1. r= E17 (ng/ml) E17 (ng/ml) 1 G 8 H 3 I 3 e62 (ng/ml) 6 4 e62 (ng/ml) 1 2 y=.988x.183 y=1.31x+.138 r=1. r= E17 (ng/ml) E17 (ng/ml) 2 e62 (ng/ml) 2 1 y=1.75x.38 r= E17 (ng/ml) Fig. 1. Comparisons between the cobas e62 and modular analytics E17. (A) Alpha fetoprotein. (B) Cancer antigen (C) Cancer antigen (D) Cancer antigen 125. (E) Carcinoembryonic antigen. (F) Cytokeratin 19 fragment. (G) Ferritin. (H) Neuron specific enolase. (I) Prostate specific antigen. (J) Total vitamin D. (K) Estradiol. (L) Follicle stimulating hormone. (M) Insulin. (N) Osteocalcin. (O) Free triiodothyronine. (P) Free thyroxine. (Q) Thyroid stimulating hormone. 4. Reference Range Validation DISCUSSION J Lab Med Qual Assur 215;37:

6 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 J 8 K 8 L 15 e62 (ng/ml) y=1.71x r= E17 (ng/ml) e62 (pg/ml) y=1.46x+1.18 r= E17 (pg/ml) e62 ( miu/ml ) 1 5 y=1.36x.83 r= E17 (miu/ml) M 6 N 5 O 3 e62 ( U/mL ) 4 2 y=.97x.28 r= E17 ( U/mL) e62 (ng/ml) y=.929x.337 r= E17 (ng/ml) e62 (pg/ml) 2 1 y=1.75x.125 r= E17 (pg/ml) P 4 Q 3 e62 (ng/dl) y=1.74x.2 r= E17 (ng/dl) e62 ( IU/ML ) 2 1 y=1.89x.83 r= E17 ( IU/ML) Fig. 1. Contineud. 16 J Lab Med Qual Assur 215;37:

7 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 Table 4. Reference Range Validation of the Roche cobas 8 e62 Test item Proposed reference interval Unit Total count Outside count % Outside Alpha fetoprotein to 7.5 ng/ml 44 Cancer antigen 15-3 to 2 U/mL Cancer antigen 19-9 to 26.6 U/mL 22 Cancer antigen 125 to 39 U/mL 22 CEA (male) to 4.6 ng/ml 44 CEA (female) to 3.2 ng/ml Cytokeratin 19 fragment to 3.3 ng/ml 44 Ferritin (male) 59 to 57 ng/ml 22 Ferritin (female) 6 to 174 ng/ml Neuron specific enolase to 16.3 ng/ml 44 PSA (age, 59) to 3 ng/ml 22 PSA (age, 6) to 4 ng/ml 22 Total vitamin D 9.8 to 34.6 ng/ml Estradiol 5. to pg/ml Follicle stimulating hormone 2.5 to miu/ml Insulin 1.5 to 14.5 U/mL 44 Osteocalcin 7. to 41.8 ng/ml 22 Free triiodothyronine 2.5 to 4.2 pg/ml 43 Free thyroxine.97 to 1.68 ng/dl Thyroid stimulating hormone.27 to 4.2 IU/mL 44 Abbreviations: CEA, carcinoembryonic antigen; PSA, prostate specific antigen. > J Lab Med Qual Assur 215;37:

8 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 REFERENCES 1. Hendriks HA, Kortlandt W, Verweij WM. Analytical performance comparison of five new generation immunoassay analyzers. Ned Tijdschr Klin Chem 2;25: Wan B, Augustin R, Chan MK, Leblond J, Verjee Z, Adeli K. Analytical performance and workflow evaluation of the Roche E17 modular immunoassay analyzer in a pediatric setting. Clin Biochem 25;38: Hubl W, Zogbaum M, Boyd JC, Savory J, Schubert M, Meyer D, et al. Evaluation of analytical methods and workflow performance of the Architect ci82 integrated serum/plasma analyzer system. Clin Chim Acta 25; 357: Lippi G, Dipalo M, Musa R, Avanzini P, Ferrarini C, Pattini A, et al. Evaluation of the analytical performances of the novel Beckman Coulter AU58. Clin Biochem 212; 45: Kim SY, Jeong TD, Lee W, Chun S, Min WK. Performance Evaluation of the Roche-Hitachi cobas 8 c72 Chemistry Autoanalyzer. Lab Med Online 214;4: McEnroe RJ, Durham AP, Goldford MD, Kondratovich MV, Lababidi S, Magari R, et al. Evaluation of precision of quantitative measurement procedures: approved guideline. 3rd ed. CLSI document EP5-A3. Wayne (PA): Clinical and Laboratory Standards Institute, Tholen DW, Kroll M, Astles JR, Caffo AL, Happe TM, Krouwer J, et al. Evaluation of the linearity of quantitative mea surement procedures: a statistical approach: approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute, Budd JR, Durham AP, Gwise TE, Iriarte B, Kallner A, Linnet K, et al. Measurement procedure comparison and bias estimation using patient samples: approved guideline. 3rd ed. CLSI document EP9-A3. Wayne (PA): Clinical and Laboratory Standards Institute, Clinical and Laboratory Standards Institute. Defining, establishing, and verifying reference intervals in the clinical laboratory: approved guideline. 3rd ed. CLSI document C28-A3. Wayne (PA): Clinical and Laboratory Standards Institute, Chen Y, Kinney L, Bozovic A, Smith H, Tarr H, Diamandis EP, et al. Performance evaluation of Siemens ADVIA Centaur and Roche MODULAR Analytics E17 Total 25- OH Vitamin D assays. Clin Biochem 212;45: Wagner D, Hanwell HE, Vieth R. An evaluation of automated methods for measurement of serum 25- hydroxyvitamin D. Clin Biochem 29;42: Krouwer JS, Astles JR, Cooper WG, Gutman SI, Koch DD, Levine JB, et al. Estimation of total analytic error for clinical laboratory methods: approved guideline. CLSI document EP 21-A. Wayne (PA): Clinical and Laboratory Standards Institute, Westgard JO, Westgard SA. Total analytic error: from concept to application. Clin Chem News 213;39: J Lab Med Qual Assur 215;37:

9 Kiwoong Ko et al Performance Evaluation of Cobas 8 e62 Cobas 8 Analyzer Series Module e62 장비의성능평가고기웅 권민정 우희연 박효순성균관대학교의과대학강북삼성병원진단검사의학과 배경 : Cobas 8 e62 는자동화면역장비로최근에출시된 cobas 8 모듈시리즈중하나이다. 본연구에서는 cobas 8 e62 의 17 가지면역검사항목에대한분석적검사수행능을평가하였다. 방법 : Clinical Laboratory Standards Institute 지침에근거하여 cobas 8 e62 의재현성, 정밀도, 직선성, 상관성분석, 그리고참고치검증을평가하였다. 평가는두레벨의정도관리물질및본원의환자혈청을이용하였다. Cobas 8 e62 는 modular analytics E17 과상관성비교평가를시행하였다. 통계분석은 Excel 21 (Microsoft Co., USA) 및 EP Evaluator Release 1 (Data Innovations, USA) 을사용하였다. 결과 : 레벨 1 vitamin D 를제외한모든항목의변이계수는 <5% 였다. 직선성평가결과는모두허용오차이내에해당하였다. 두장비간비교평가시모든항목에대하여 correlation coefficient (r)>.975 로유의한상관관계를보였다. 참고치검증결과, 모두허용기준이내인것으로확인되었다. 결론 : Cobas 8 e62 의 17 가지항목에대하여정밀도, 직선성, 상관성분석, 그리고참고치검증에서모두우수한결과를보였다. 이장비는 cobas 8 모듈시리즈의일환으로유용하게사용될수있을것이다. (J Lab Med Qual Assur 215;37:11-19) 교신저자 : 권민정우 ) 서울시종로구새문안로 29, 성균관대학교의과대학강북삼성병원진단검사의학과 Tel: 2) , Fax: 2) , mjkkmd@gmail.com J Lab Med Qual Assur 215;37:

THE JOURNAL OF KOREAN INSTITUTE OF ELECTROMAGNETIC ENGINEERING AND SCIENCE. vol. 29, no. 10, Oct ,,. 0.5 %.., cm mm FR4 (ε r =4.4)

THE JOURNAL OF KOREAN INSTITUTE OF ELECTROMAGNETIC ENGINEERING AND SCIENCE. 2018 Oct.; 29(10), 799 804. http://dx.doi.org/10.5515/kjkiees.2018.29.10.799 ISSN 1226-3133 (Print) ISSN 2288-226X (Online) Method