요화학분석기 CYBOW R-600S 성능평가
Performance Evaluation of Urine Dipstick Analyzer CYBOW R-600S
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
배경: 저자들은 새로운 반자동 요화학분석기 CYBOW R-600S의 성능을 평가했다. 방법: 정밀도 평가에는 시판되는 정도관리물질 두 가지 농도를 사용하였다. 총 300개의 소변 잔여 검체를 UC-3500 (Sysmex, 일본) 과 AU5800 (Beckman Coulter, 미국)로 측정한 결과와 비교했으며, uACR 및 uPCR도 계산값도 포함하여 CYBOW R-600S의 분석 성능을 평가했다. 결과: 시행 내 및 검사일간 정밀도에 대한 12개 항목의 동일등급 일치율은 고농도 크레아티닌의 검사일간 94.4%를 제외하고 모두 97.5% 이상이었다. UC-3500과 AU5800의 결과와 비교하여 비중 (99.7%), pH (99.3%), 단백(96.7%), 백혈구(99.3%), 알부민(99.7%)을 제외하고는 ±1등급 이내 일치율 100%였다. CYBOW R-600S와 대조 장비의 uACR과 uPCR의 일치율은 각각 95.0%, 96.3%였다. 이들 중 uACR과 uPCR의 카파 계수는 각각 0.914 (95% 신뢰구간, 0.872- 0.956)와 0.819 (95% 신뢰구간, 0.724-0.915)였다. 특히, 정량값에서 환산한 uACR 항목에서 민감도, 양성예측도 및 음성예측도가 uPCR보다 높았다. 결론: CYBOW R-600S는 UC-3500과 AU5800과 비교했을 때 ±1 등급 차이 내에서 정밀도와 일치율이 좋은 성능을 보였고, 임상 검사 적용에 적합하였다.
Abstract
Background: We evaluated the performance of the currently marketed semi-automated urine analyzer CYBOW R-600S. Methods: Precision was measured using two commercially available quality-control materials. A total of 300 urine samples were used to compare the results of CYBOW R-600S (DFI Co., Korea), UC-3500 (Sysmex, Japan), and AU5800 (Beckman Coulter, USA). uACR and uPCR were also calculated to evaluate the analytical performance of the CYBOW R-600S. Results: The grade agreement rates of the 12 parameters for within-run and between-day precision were above 97.5%, except for high-level creatinine, for which it was 94.4% between days. Compared to the results of UC-3500 and AU5800, the agreement within the ±1 grade difference rate was 100% for all parameters, except for SG (99.7%), pH (99.3%), protein (96.7%), leukocyte esterase (99.3%), and albumin (99.7%). The concordance rates of uACR and uPCR between the CYBOW R-600S and the reference analyzers were 95.0% and 96.3%, respectively. The corresponding kappa coefficients were 0.914 (95% CI, 0.872–0.956) and 0.819 (95% CI, 0.724–0.915), respectively. The sensitivity, positive predictive value (PPV), and negative predictive value (NPV) of uACR converted from the quantitative value were higher than those of uPCR. Conclusions: CYBOW R-600S showed good precision and concordance rate performance within ±1 grade difference when compared with UC3500 and AU5800. Therefore, we conclude that CYBOW R-600S is suitable for clinical applications.
참고문헌 (14)
- Park IK, "Laboratory Medicine", pp.537~544 (2021), Panmuneducation
- Riley RS, "Henry’s Clinical Diagnosis and Management by Laboratory Methods", pp.448~449 (2021), Elsevier
- 한태희, "요검사: 요시험지봉 검사의 유용성과 한계", Childhood Kidney Diseases, 17(2), pp.42~48 (2013), 대한소아신장학회
- Jeon CH, "Annual report on external quality assessment scheme for urinalysis and faecal occult blood testing in Korea(2014)", J Lab Med Qual Assur, 37, pp.179~189 (2015)
- Chang-Ho Jeon, "Annual Report of the Korean Association of External Quality Assessment Service on Urinalysis and Fecal Occult Blood Testing (2019)", Laboratory Medicine and Quality Assurance, 42(4), pp.157~165 (2020), 대한진단검사정도관리협회[DOI]
- Kim YK, "Laboratory Evaluation of YeongDong’s Urine Analyzer URISCAN S-300 and Uriscan Strip", J Lab Med Qual Assur, 18, pp.295~304 (1996)
- Ko K, "Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis", J Clin Lab Anal, 30, pp.424~430 (2016)
- Kwon MJ, "Laboratory evaluation of automated urine analyzer ComboStick Reader 720(R)and reagent strip ComboStick 10", J Lab Med Qual Assur, 31, pp.215~223 (2009)
- Hartgrove K, "Validation study : clarity multistrip urocheck", Clin Lab Sci, 21, pp.158~161 (2008)
- Kim N, "Evaluation of an Automated Dipstick Device for Urinalysis-UriDoctor", J Lab Med Qual Assur, 36, pp.190~195 (2014)
- Evaluation of precision performance of quantitative measurement methods; Approved guideline—Second Edition, "Clinical and Laboratory Standards Institute", Clinical and Laboratory Standards Institute, ~, pp.CLSI document EP05-A2 (2004)
- "Guideline to establish performance evaluation of urine reagent strip" (2018)[URL]
- European Confederation of Laboratory Medicine, "European urinalysis guidelines", Scand J Clin Lab Invest Suppl, 231, pp.1~86 (2000)
- 유신애, "Performance Evaluation of MEDITAPE UC-11A Strip Test in Estimating the Urine Albumin-to-Creatinine Ratio and Urine Protein-to-Creatinine Ratio", Laboratory Medicine Online, 10(1), pp.52~57 (2020), 대한진단검사의학회