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Evaluation Brief

J Lab Med Qual Assur 2017; 39(1): 47-51

Published online March 31, 2017

https://doi.org/10.15263/jlmqa.2017.39.1.47

Copyright © Korean Association of External Quality Assessment Service.

Performance Evaluation of ADVIA Centaur XPT

Eun Jung Cho, Kyoung-Jin Park, Woochang Lee, Sail Chun, Won-Ki Min

Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Correspondence to:Won-Ki Min Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea Tel: +82-2-3010-4503 Fax: +82-2-478-0884 E-mail: wkmin@amc.seoul.kr
민원기 우)05505 서울시 송파구 올림픽로 43길 88, 울산대학교 의과대학 서울아산병원 진단검사의학과 Tel: 02)3010-4503, Fax: 02)478-0884, E-mail: wkmin@amc.seoul.kr

Received: August 16, 2016; Revised: September 6, 2016; Accepted: September 6, 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We have evaluated the performance of a recently developed immunoassay analyzer, ADVIA Centaur XPT (Siemens, Germany). Precision, linearity, and comparison studies were performed according to the CLSI guidelines. The test items evaluated were ferritin, folate, human epidermal growth factor receptor 2/neu, homocysteine, vitamin B12, B-type natriuretic peptide, creatine kinase–myocardial band, myoglobin, procalcitonin, troponin I. Bio-Rad control materials, linearity materials, and patients’ samples were used for the evaluation. For the correlation study, ADVIA Centaur XP (Siemens) were used as comparative methods. The total coefficients of variations (CVs) of the analytes were between 2.5% and 7.0%. The results of linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were good. The overall analytical performance of ADVIA Centaur XPT is acceptable for the immunology analyzer. Therefore, ADVIA Centaur XPT is expected to be widely used.

Keywords: ADVIA Centaur XPT, Performance, Evaluation

면역 측정 장비인 ADVIA Centaur XPT (Siemens, Erlangen, Germany)의 측정 성능을 평가해보았다. 평가한 검사항목은 ferritin, folate, human epidermal growth factor receptor 2 (HER-2)/neu, homocysteine, vitamin B12, B-type natriuretic peptide (BNP), creatine kinase-myocardial band (CK-MB), myoglobin, procalcitonin, 그리고 troponin I로 총 10종목이다. 평가는 정밀도, 직선성 및 기존 장비와의 상관성에 대하여 이루어졌다. 정밀도는 세 가지 농도의 정도관리물질(Bio-Rad Immunoassay plus control lot no. 40310, Bio-Rad Cardiac marker plus control lot no. 29830, Bio-rad Homocysteine control lot no. 34990 [Bio-Rad Laboratories, Hercules, CA, USA]; SIEMENS H2n control lot no. 4213960, SIEMENS PCT control lot no. 2908370 [Siemens])을 이용하여 평가하였다. Clinical and Laboratory Standards Institute (CLSI) EP05-A3에 따라 각각의 정도관리물질을 20일 동안 매일 2 run씩, run당 2회씩 반복 측정하여 평가하였다[1]. 직선성은 CLSI EP06-A에 따라 평가하였다[2]. 검사종목 중 ferritin, folate, homocysteine, vitamin B12, BNP, CK-MB, myoglobin, troponin I은 5가지 농도를 가진 AUDIT Microcontrols Linearity FD Anemia Siemens Centaur (ferritin, folate, vitamin B12: lot no. 06535; AUDIT MicroControls Inc., Eatonton, GA, USA), LQ Homocysteine (homocysteine, lot no. 06564), FD Cardiac markers (CK-MB, myoglobin, troponin I: lot no. 06574), FD BNP (BNP, lot no. 06542)를, HER-2/neu는 7가지 농도를 가진 SIEMENS Centaur Master Curve Material Her-2/neu (lot no. 54873, Siemens)를 이용하여 평가하였고, procalcitonin에 대해서는 환자 검체 혼합물을 이용하여 평가하였다. 이들을 각각 4회씩 반복 측정하여 그 결과를 이용하여 직선성을 평가하였다. 상관성은 CLSI EP09-A3에 따라 기존 검사실에서 사용 중인 ADVIA Centaur XP (Siemens)와 비교하였다[3]. 각 종목별로 다양한 농도를 가진 40개 이상의 환자 검체를 이용하여 두 장비에서 각각 2회씩 반복 측정하여 그 결과를 비교하였다. 각 종목별 정밀도 평가결과를 Table 1에 제시하였다. Fig. 1은 직선성 평가결과를 보여주는 그래프이고, Fig. 2는 상관성 평가결과를 보여주고 있다. 각 항목별 정밀도 평가결과, total coefficients of variation는 1.8%에서 7.0% 수준으로 모두 만족할 만한 수준이었다. 직선성 평가에서 임상적으로 중요한 농도 범위에서 slope 0.914-1.040, intercept -6.3-1.9으로 우수한 직선성이 확인되었고, 제조사가 제시하는 직선성의 범위를 만족하였다. 기존 장비와의 상관성 평가결과, R은 0.9907에서 0.9996으로 전반적으로 우수한 것으로 나타났다. 따라서 ADVIA Centaur XPT는 임상검사실에서 면역 측정장비로서 유용하게 사용할 수 있을 것으로 기대된다.

Table 1 . The precision profile of ADVIA Centaur XPT.

   AnalyteQuality control levelMeanCoefficients of variation (%)

Within-runBetween-runBetween-dayTotal
Ferritin (ng/mL)Low57.2592.20.01.32.5
Middle147.0302.51.82.33.8
High386.4702.40.62.33.3
Folate (ng/mL)Low2.3265.93.70.07.0
Middle6.8203.50.02.74.4
High10.3023.23.40.04.7
Human epidermal growth factor receptor 2/neu (ng/mL)Low15.3103.50.02.44.3
High103.4903.90.03.25.1
Homocysteine (µmol/L)Low4.6903.50.02.14.1
Middle11.0303.30.01.93.8
High27.1703.10.01.83.5
Vitamin B12 (pg/mL)Low417.293.71.22.04.4
Middle554.474.20.02.85.0
High885.802.81.50.93.3
B-type natriuretic peptide (pg/mL)Low93.531.60.01.22.0
Middle371.951.50.40.81.8
High1441.611.40.41.11.8
Creatine kinase–myocardial band (ng/mL)Low3.0302.50.01.42.9
Middle13.2031.60.11.01.9
High61.0941.91.00.82.3
Myoglobin (ng/mL)Low54.242.20.90.02.4
Middle143.372.40.00.92.5
High294.732.00.31.22.4
Procalcitonin (ng/mL)Low0.31493.94.90.06.3
High7.74612.63.93.96.1
Troponin I (ng/mL)Low1.27462.41.60.73.0
Middle6.95172.40.01.52.8
High26.82392.00.00.52.1

Figure 1.

Linearity analyses using ADVIA Centaur XPT. (A) Ferritin. (B) Folate. (C) Human epidermal growth factor receptor 2/neu. (D) Homocysteine. (E) Vitamin B12. (F) B-type natriuretic peptide. (G) Creatine kinase–myocardial band. (H) Myoglobin. (I) Procalcitonin. (J) Troponin I.


Figure 2.

Comparison of ADVIA Centaur XPT and ADVIA Centaur XP. For each analyte, a scatter plot and a bias plot are shown. (A) Ferritin. (B) Folate. (C) Human epidermal growth factor receptor 2/neu. (D) Homocysteine. (E) Vitamin B12. (F) B-type natriuretic peptide. (G) Creatine kinase–myocardial band. (H) Myoglobin. (I) Procalcitonin. (J) Troponin I.


References

  1. Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods: approved guideline. 2nd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2014.
  2. Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures: a statistical approach: approved guideline. Wayne (PA): Clinical and Laboratory Standards Institute, 2003.
  3. Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patient samples: approved guideline. 3rd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2013.

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