대규모 임상검체를 이용한 ADVIA Centaur XP와 cobas e801 장비 간 전립성특이항원 비교평가
Comparison Between ADVIA Centaur XP and cobas e801 for Prostate-Specific Antigen Assays using Large-Scale Clinical Samples
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
배경: 전립선특이항원(prostate specific antigen, PSA)은 전립선암의 선별검사로서 사용되고 있다. 하지만 PSA는 측정장비 사이에 큰 변동성을 보이는 것으로 알려져 있다. 본 연구에서는 cobas e801 (Roche Diagnostics, Germany; e801)에 의한 PSA의 정밀도, 직선성 및 Centaur XP (Siemens Healthineers, USA; Centaur XP)와의 PSA의 상관성을 평가하였고, 두 측정장비 간 바이어스에 의한 임상적 영향을 건강검진 수진자들의 PSA 양성률 변화를 통해 분석하였다. 방법: CLSI EP05-A3, EP06-A, EP09c 지침을 따라 e801로 측정한 PSA의 정밀도와 직선성, e801과 Centaur XP 간 상관성을 평가하였다. 두 장비에서 동시측정한 5,373건, Centaur XP로 측정한 97,271건(2016–2019년), e801로 측정한 51,640건(2020–2022년)의 PSA 결과를 비교 평가하였다. 결과: e801로 측정한 PSA의 반복정밀도는 2.04–2.68%, 검사실내정밀도는 1.34–1.57%였으며 0.06–99.70 ng/mL의 범위에서 최적의 다항식이 일차다항식이었다. 저농도(0.01–0.32 ng/mL)와 고농도(0.32–10,000 ng/mL)에서 두 측정장비 간 PSA 바이어스는 각각 -0.013 ng/mL (95% CI: -0.014 – -0.013), 14.0% (95% CI: 13.9–14.1)이었다. Passing-Bablok 회귀방정식은 y=-0.024+1.151x (R=0.952)이었다. 두 장비 간 바이어스는 14.3%로서 분석능 사양의 최소기준(16.0 %)을 만족하였으며, Cohen’s kappa 계수는 0.933이었다. 장비별 건강검진 수진자들의 PSA 양성률(cutoff: 3.0 ng/mL)은 3.93% (Centaur XP), 5.41% (e801)이었고 나이 분포의 유의한 차이가 없어 비교 평가가 가능했던 60대에서 유의한 PSA 양성률 차이를 보였다(Centaur XP 4.46% 대 e801 7.27%, P<0.001). 결론: e801에 의한 PSA는 적절한 정밀도, 직선성을 보였다. 두 측정장비 간 PSA의 바이어스는 허용가능한 범위 내 있었지만 장비 간 진단적 차이가 있었다. PSA 측정값의 임상 적용에 있어서 주의가 필요할 것이다.
Abstract
Background: Prostate-specific antigen (PSA) is the first-line test for screening prostate malignancy. However, PSA levels vary between measurement procedures (MPs). In this study, we evaluated the precision and linearity of cobas e801 (Roche Diagnostics, Germany) and evaluated the clinical impact based on the bias with ADVIA Centaur XP (Siemens Healthineers, USA) in subjects under medical checkup. Methods: This study followed the Clinical and Laboratory Standards Institute EP05-A3, EP06-A, and EP09c guidelines each for precision, linearity, and comparison. We evaluated simultaneously measured 5,373 patient samples and the health check examinee samples by Centaur XP (n=97,271) and cobas e801 (n=51,640). Results: The repeatability was 2.04%–2.68% and the within-laboratory precision was 1.34–1.57%. The best polynomial regression was the first order in the range of 0.06–99.70 ng/mL. The biases of lower and higher concentrations were -0.013 ng/mL (95% Confidence Interval (CI): -0.014 to -0.013) and 14.0% (95% CI: 13.9–14.1), respectively. Two MPs were correlated (y=-0.024+1.151x, R=0.952). However, the bias between the MPs (14.3%) was acceptable only with the minimum analytical performance specifications for bias (16.0%). The Cohen’s kappa was 0.933. The overall positive rate of PSA level (>3.0 ng/mL) was 3.93% (Centaur XP) and 5.41% (cobas e801). The positivity rate of the examinee in their sixties showed significant difference (Centaur XP 4.46% vs. cobas e801 7.27%, P<0.001), which was statistically comparable due to the similar age distribution. Conclusions: cobas e801 exhibited appropriate precision and linearity. Although the bias between two MPs was acceptable, there was diagnostic difference. Caution with clinical application of PSA levels would be required.
참고문헌 (27)
- Nadji M, "Prostatic-specific antigen : an immunohistologic marker for prostatic neoplasms", Cancer, 48, pp.1229~1232 (1981)
- Herrala AM, "Comparison of human prostate specific glandular kallikrein 2 and prostate specific antigen gene expression in prostate with gene amplification and overexpression of prostate specific glandular kallikrein 2 in tumor tissue", Cancer, 92, pp.2975~2984 (2001)
- Lintula S, "Relative concentrations of hK2", PSA mRNA in benign and malignant prostatic tissue, 2005, pp.63, 324~329
- Sung H, "Global Cancer Statistics 2020 : GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries", CA Cancer J Clin, 71, pp.209~249 (2021)
- Lilja H, "Prostate-specific antigen and prostate cancer : prediction, detection and monitoring", Nat Rev Cancer, 8, pp.268~278 (2008)
- Ilic D, "Prostate cancer screening with prostate-specific antigen(PSA)test : a systematic review and meta-analysis", BMJ, 362, pp.k3519~ (2018)
- Fenton JJ, "Prostate-specific antigen-based screening for prostate cancer : evidence report and systematic review for the US preventive services task force", JAMA, 319, pp.1914~1931 (2018)
- Foj L, "Variability of assay methods for total and free PSA after WHO standardization", Tumour Biol, 35, pp.1867~1873 (2014)
- Ferraro S, "Verification of harmonization of serum total and free prostate-specific antigen(PSA)measurements and implications for medical decisions", Clin Chem, 67, pp.543~553 (2021)
- Clinical and Laboratory Standards Institute, "Evaluation of precision of quantitative measurement procedures; Approved guideline" (2014), Clinical and Laboratory Standards Institute
- Carobene A, "Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer", Clin Chim Acta, 486, pp.185~191 (2018)
- Clinical and Laboratory Standards Institute, "Evaluation of the linearity of quantitative measurement procedures: a statistical approach: Approved guideline" (2003), Clinical and Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Measurement procedure comparison and bias estimation using patient samples; Approved gui-deline" (2018), Clinical and Laboratory Standards Institute
- Bland JM, "Measuring agreement in method comparison studies", Stat Methods Med Res, 8, pp.135~160 (1999)
- Cyr L, "Measures of clinical agreement for nominal and categorical data : the kappa coefficient", Comput Biol Med, 22, pp.239~246 (1992)
- Schwertman NC, "A simple more general boxplot method for identifying outliers", Computational Statistics & Data Analysis, 47, pp.165~174 (2004)
- Bonett DG, "Sample size requirements for estimating pearson, kendall and spearman correlations", Psychometrika, 65, pp.23~28 (2000)
- "NCCN guidelines for prostate cancer early detection V.1.2022" (2021)[URL]
- Lim S, "Evaluation of cobas 8000 analyzer series module e801 analytical performance", Ann Clin Lab Sci, 49, pp.372~379 (2019)
- Delgado R, "Why Cohen’s Kappa should be avoided as performance measure in classification", PLoS One, 14, pp.e0222916~ (2019)
- Boegemann M, "Discordant prostate specific antigen test results despite WHO assay standardization", Int J Biol Markers, 33, pp.275~282 (2018)
- Kim HS, "Annual Report on the external quality assessment scheme for immunoassay tests in Korea(2014)", J Lab Med Qual Assur, 37, pp.190~208 (2015)
- 조은정, "Commutability Assessment of Frozen Human Serum Pools for External Quality Assessment of Tumor Markers", Laboratory Medicine and Quality Assurance, 44(2), pp.111~120 (2022), 대한진단검사정도관리협회[DOI]
- Mion MM, "Analytical performance evaluation of the new GEM® PremierTM 5000 analyzer in comparison to the GEM® PremierTM 4000 and the RapidPoint® 405 systems", Clin Chim Acta, 486, pp.313~319 (2018)
- Oesterling JE, "Serum prostate-specific antigen in a community-based population of healthy men. Establishment of age-specific reference ranges", JAMA, 270, pp.860~864 (1993)
- Nadler RB, "Effect of inflammation and benign prostatic hyperplasia on elevated serum prostate specific antigen levels", J Urol, 154, pp.407~413 (1995)
- Baillargeon J, "The association of body mass index and prostate-specific antigen in a population-based study", Cancer, 103, pp.1092~1095 (2005)