본문 바로가기
KERD
논문KCI 등재

Recent Trends in Creatinine Assays in Korea: Long-Term Accuracy-Based Proficiency Testing Survey Data by the Korean Association of External Quality Assessment Service (2011–2019)

2

조회

0

다운로드

9

인용

0

참고문헌

키워드

주제분류병리학

초록

Background: Accurate serum creatinine (Cr) concentration measurement is essential for evaluating kidney function. In 2011, the Korean Association of External Quality Assessment Service (KEQAS) launched an accuracy-based Cr proficiency testing (ABCr PT) survey. We analyzed long-term data of the KEQAS ABCr PT survey collected between 2011 and 2019 to assess recent trends in Cr assays in Korea. Methods: The ABCr PT survey including three commutable fresh-frozen serum samples was performed twice a year. The target Cr concentration was assigned using isotope-dilution mass spectrometry. We analyzed data obtained from the participating laboratories, calculated the yearly bias, and evaluated bias trends for the major reagents and instruments. Outliers were excluded from all analysis. Results: The mean percentage bias based on the total data of all participating laboratories was 10.8% in the 2011-A survey and 0.2% in 2019-B survey. Bias for the major reagents and instruments differed depending on the manufacturer. Enzymatic assays generally showed desirable bias ranging from –3.9% to 3.2% at all Cr concentrations and lower interlaboratory variability than non-enzymatic assays (enzymatic vs. non-enzymatic, 3.3%–7.2% vs. 6.3%–9.1%). Conclusions: Although the mean percentage bias of Cr assays tends to decrease over time, it is necessary to continuously strive to improve Cr assay accuracy, especially at low concentrations.

Abstract

Background: Accurate serum creatinine (Cr) concentration measurement is essential for evaluating kidney function. In 2011, the Korean Association of External Quality Assessment Service (KEQAS) launched an accuracy-based Cr proficiency testing (ABCr PT) survey. We analyzed long-term data of the KEQAS ABCr PT survey collected between 2011 and 2019 to assess recent trends in Cr assays in Korea. Methods: The ABCr PT survey including three commutable fresh-frozen serum samples was performed twice a year. The target Cr concentration was assigned using isotope-dilution mass spectrometry. We analyzed data obtained from the participating laboratories, calculated the yearly bias, and evaluated bias trends for the major reagents and instruments. Outliers were excluded from all analysis. Results: The mean percentage bias based on the total data of all participating laboratories was 10.8% in the 2011-A survey and 0.2% in 2019-B survey. Bias for the major reagents and instruments differed depending on the manufacturer. Enzymatic assays generally showed desirable bias ranging from –3.9% to 3.2% at all Cr concentrations and lower interlaboratory variability than non-enzymatic assays (enzymatic vs. non-enzymatic, 3.3%–7.2% vs. 6.3%–9.1%). Conclusions: Although the mean percentage bias of Cr assays tends to decrease over time, it is necessary to continuously strive to improve Cr assay accuracy, especially at low concentrations.

참고문헌 (20)

  1. Stevens LA, "Assessing kidney function—measured and estimated glomerular filtration rate", N Engl J Med, 354, pp.2473~2483 (2006)
  2. "Kidney disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease", Kidney Int Suppl, 3, pp.1~150 (2013)
  3. 정태동, "Accuracy Assessment of Five Equations Used for Estimating the Glomerular Filtration Rate in Korean Adults", Annals of Laboratory Medicine, 37(5), pp.371~380 (2017), 대한진단검사의학회
  4. 박설희, "Estimated Glomerular Filtration Rates Show Minor but Significant Differences Between the Single and Subgroup Creatinine-Based Chronic Kidney Disease Epidemiology Collaboration Equations", Annals of Laboratory Medicine, 39(2), pp.205~208 (2019), 대한진단검사의학회[DOI]
  5. "Kidney disease: Improving global outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO clinical practice guideline for acute kidney injury", Kidney Int Suppl, 2, pp.1~138 (2012)
  6. Levey AS, "National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification", Ann Intern Med, 139, pp.137~147 (2003)
  7. Miller WG, "The role of proficiency testing in achieving standardization and harmonization between laboratories", Clin Biochem, 42, pp.232~235 (2009)
  8. Miller WG, "Proficiency testing", external quality assessment: current challenges and future directions, 2011, pp.57, 1670~1680
  9. 정태동, "Accuracy-Based Proficiency Testing of Creatinine Measurement: 7 Years’ Experience in Korea", Laboratory Medicine and Quality Assurance, 41(1), pp.13~23 (2019), 대한진단검사정도관리협회[DOI]
  10. Killeen AA, "Recent trends in performance and current state of creatinine assays", Arch Pathol Lab Med, 137, pp.496~502 (2013)
  11. CLSI, "Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; approved guideline" (1999), Clinical and Laboratory Standards Institute
  12. Carobene A, "Evaluation of the impact of standardization process on the quality of serum creatinine determination in Italian laboratories", Clin Chim Acta, 427, pp.100~106 (2014)
  13. Helmersson-Karlqvist J, "Lower creatinine concentration values and lower inter-laboratory variation among Swedish hospital laboratories in 2014 compared to 1996: results from the Equalis external quality assessment program", Clin Chem Lab Med, 57, pp.838~844 (2019)
  14. Levey AS, "Expressing the Modification of Diet in Renal Disease Study equation for estimating glomerular filtration rate with standardized serum creatinine values", Clin Chem, 53, pp.766~772 (2007)
  15. Stevens LA, "Impact of creatinine calibration on performance of GFR estimating equations in a pooled individual patient database", Am J Kidney Dis, 50, pp.21~35 (2007)
  16. Myers GL, "Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program", Clin Chem, 52, pp.5~18 (2006)
  17. "The EFLM Biological Variation Database"[URL]
  18. Cobbaert CM, "Prime time for enzymatic creatinine methods in pediatrics", Clin Chem, 55, pp.549~558 (2009)
  19. Piéroni L, "A multicentric evaluation of IDMS-traceable creatinine enzymatic assays", Clin Chim Acta, 412, pp.2070~2075 (2011)
  20. Drion I, "Clinical evaluation of analytical variations in serum creatinine measurements: why laboratories should abandon Jaffe techniques", BMC Nephrol, 13, pp.133~ (2012)

관련 논문AI추천

In Vitro Diagnostics Certification for Creatinine Assays in Korea over 7 Years: Achievements and Future OutlookCho Chan-Ik, Cho Eun-Jung, Chun Sail, Jeong Tae-Dong, Kim Sollip, Lee Hyunae, Lee Woochang, Min Won-Ki, Ryu Jeayeon, Seo Jiwoo, Yu Joonsang대한진단검사의학회 · Annals of Laboratory Medicine2025 · 제45권 제5호Siemens CRE2 시약의 Creatinine 측정 수행능 평가구선회, 권계철, 김선영, 김지명, 김현진, 임진숙대한진단검사의학회 · Laboratory Medicine Online2019 · 제9권 제1호Jaffe법과 효소법으로 측정한 Roche Modular D, Cobas 8000 c702 및 Beckman Coulter AU5800 장비 간의 혈청 Creatinine 비교박형두, 오종원대한진단검사의학회 · Laboratory Medicine Online2020 · 제10권 제1호콩팥기능이상의 신속 정확한 진단을 위하여 Roche 효소법 검사와 일치시킨 Nova CCX 혈액가스분석기를 이용한 크레아티닌 검사 평가김정호, 김효식, 박형천, 정성필대한진단검사의학회 · Laboratory Medicine Online2011 · 제1권 제4호Standardization Status of Total Cholesterol Concentration Measurement: Analysis of Korean External Quality Assessment DataChun Sail, Kim Sollip, Lee Kyunghoon, Lee Yong-Wha, Min Won-Ki, Park Hyung-Doo, Yoon Young Ahn대한진단검사의학회 · Annals of Laboratory Medicine2021 · 제41권 제4호Proposed Imprecision Quality Goals for Urinary Albumin/Creatinine Ratio고대현, 김현수, 박민정, 신동훈, 이성우, 현정원대한진단검사의학회 · Annals of Laboratory Medicine2018 · 제38권 제5호

이 간행물의 다른 논문 (15건)