URiSCAN 2 ACR 요시험지봉을 이용한 요 알부민- 크레아티닌비 현장검사의 진단적 유용성
Diagnostic Utility of the URiSCAN 2 ACR Strip as a Point-of-care Test for Estimating Urine Albumin–Creatinine Ratios
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
배경: 요의 알부민-크레아티닌비(UACR)를 이용한 알부민뇨의 평가는 당뇨나 고혈압 환자에서 신질환의 초기 검출에 중요하다. 현재 UACR을 측정할 수 있는 몇 가지 현장검사법이 개발되어 이용되고 있다. 저자들은 두 가지 반정량 현장검사법의 진단적 정확성을 비교하고자 하였다. 방법: 총 219개의 수시방출뇨 검체에서 요 알부민과 크레아티닌이 Toshiba TBA-200FR NEO 화학분석기를 이용하여 측정되었으며 UACR이 산출되었다. 또한 두 가지 현장검사법인 CLINITEK Microalbumin 2 Strip (Siemens, NY, USA)과 URiSCAN 2 ACR Strip (YD diagnostics, Yongin, Korea)을 사용하여 UACR을 측정하였다. 결과: 정량분석법에 의한 UACR을 기준으로 한 CLINITEK의 민감도 및 특이도는 96.7%, 62.7%, URiSCAN의 민감도 및 특이도는 45.9%, 84.8%였다. 양성 및 음성예측도의 경우 CLINITEK은 50.0%, 98.0%였고 URiSCAN은 53.8%, 80.2%였다. 현장검사법 CLINITEK의 UACR값과 비교한 URiSCAN의 UACR값의 일치도는 정상구간(<30 mg/g)에서는 91.1%, 비정상구간(≥30 mg/g)에서는 36.4%였다. 결론: URiSCAN 현장검사법은 CLINITEK 현장검사법에 비해 위양성 결과를 줄여 특이도는 향상되었으나 낮은 민감도에 의한 높은 위음성으로 인해 유의하게 낮은 음성예측도가 초래되었다. URi-SCAN 현장검사법을 알부민뇨의 배제검사로 적용하기 위해서는 요 알부민의 검출감도를 향상시키는 것이 필요할 것으로 사료되었다.
Abstract
Background: Diagnosing albuminuria by measuring the urinary albumin-creatinine ratios (UACR) is important for the early detection of kidney diseases in patients with diabetes or hypertension. Currently, a few point-of-care testing (POCT) systems exist for estimating the UACR. Here, we evaluated the performance characteristics of two semi-quantitative UACR POCT assays. Methods: Albumin and creatinine levels were quantified for 219 randomly acquired urine samples with the Toshiba TBA-200FR NEO analyzer, and the UACR were calculated. The results were compared to UACR measured using the CLINITEK Microalbumin 2 Strip (Siemens, USA) and URiSCAN 2 ACR Strip (YD diagnostics, Korea) POCT assays. Results: Semi-quantitative results from the CLINITEK and URiSCAN UACR assays showed that the sensitivity and specificity of each test were, respectively, 96.7% and 62.7%, and 45.9% and 84.8%. Positive and negative predictive values of the CLINITEK and URiSCAN tests were, respectively, 50.0% and 98.0%, and 53.8% and 80.2%. The rate of agreement between URiSCAN test and CLINITEK test was 91.1% in the normal UACR range (<30 mg/g), but it was as low as 36.4% in the abnormal UACR range (≥30 mg/g). Conclusions: The URiSCAN test showed higher specificity than did the CLINITEK test owing to the lower false positive results. However, the high rate of false negatives for the URiSCAN test significantly lowered its sensitivity and negative predictive values. Therefore, the sensitivity of the URiSCAN device in detecting urine albumin needs to be improved before its adoption as a reliable rule-out testing system.
참고문헌 (15)
- Zhang QL, "Prevalence of chronic kidney disease in population-based studies : systematic review", BMC Public Health, 8, pp.117~ (2008)
- Keane WF, "Proteinuria, albuminuria, risk, assessment, detection, elimination (PARADE): a position paper of the National Kidney Foundation", Am J Kidney Dis, 33, pp.1004~1010 (1999)
- Sacks DB, "Position statement executive summary : guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus", Diabetes Care, 34, pp.1419~1423 (2011)
- Hishiki S, "Circadian variation of urinary microalbumin excretion and ambulatory blood pressure in patients with essential hypertension", J Hypertens, 16, pp.2101~2108 (1998)
- Levey AS, "Definition and classification of chronic kidney disease : a position statement from Kidney Disease : Improving Global Outcomes(KDIGO)", Kidney Int, 67, pp.2089~2100 (2005)
- Wilde HM, "Evaluation of the Bayer® microalbumin", creatinine urinalysis dipstick, 2008, pp.393, 110~113
- Guy M, "Diagnostic accuracy of the urinary albumin : creatinine ratio determined by the CLINITEK Microalbumin and DCA 2000+ for the rule-out of albuminuria in chronic kidney disease", Clin Chim Acta, 399, pp.54~58 (2009)
- Omoruyi FO, "Evaluation of the performance of urine albumin, creatinine and albumin-creatinine ratio assay on two POCT analyzers relative to a central laboratory method", Clin Chim Acta, 413, pp.625~629 (2012)
- McTaggart MP, "The diagnostic accuracy of a urine albumin-creatinine ratio point-of-care test for detection of albuminuria in primary care", Am J Kidney Dis, 60, pp.787~794 (2012)
- Mogensen CE, "Prevention of diabetic renal disease with special reference to microalbuminuria", Lancet, 346, pp.1080~1084 (1995)
- Rowe DJ, "Microalbuminuria in diabetes mellitus : review and recommendations for the measurement of albumin in urine", Ann Clin Biochem, 27, pp.297~312 (1990)
- Claudi T, "Comparison of urinary albumin excretion rate in overnight urine and albumin creatinine ratio in spot urine in diabetic patients in general practice", Scand J Prim Health Care, 19, pp.247~248 (2001)
- Graziani MS, "Diagnostic accuracy of a reagent strip for assessing urinary albumin excretion in the general population", Nephrol Dial Transplant, 24, pp.1490~1494 (2009)
- White SL, "Diagnostic accuracy of urine dipsticks for detection of albuminuria in the general community", Am J Kidney Dis, 58, pp.19~28 (2011)
- Kvam C, "Development and performance of an albumin-creatinine ratio assay on the Afinion AS100 analyzer", Point of Care, 8, pp.16~20 (2009)