현장검사 화학 분석 장비 Piccolo xpress Chemistry Analyzer 성능 평가
Performance Evaluation of the Piccolo xpress Point-of-care Chemistry Analyzer
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초록
배경 : 현장검사는 신속하고 간편하여 환자의 진단과 치료효 과 판정에 빠르게 적용할 수 있기 때문에 점차 그 적용범위가 늘 어나고 있다. 저자들은 현장검사 화학분석장비인 Piccolo xpress Chemistry Analyzer (Abaxis, USA)의 성능을 평가하였다. 방법 : Comprehensive Metabolic Reagent 디스크에 100 mcL의 검체를 이용하여 14가지 항목(나트륨, 칼륨, 염소, 칼슘, 총 이산화탄소, AST, ALT, 알칼리인산분해효소, 총 빌리루빈, 혈당, 혈액요소질소, 크레아티닌, 알부민, 총 단백질)을 동시에 측정하였다. 검사차례내 정밀도와 총 정밀도는 CLSI EP15-A 에 준하여 평가하였으며, 직선성은 CLSI EP6-A에 준하여 평 가하였다. 중앙검사실 장비와의 상관성은 144개의 환자 검체를 이용하여 평가하였다. 결과 : 검사차례내 정밀도와 총 정밀도의 변이계수(CV)는 낮 은 농도의 총 이산화탄소, ALT, 알칼리인산분해효소, 총 빌리 루빈, 크레아티닌과 중간농도의 크레아티닌을 제외하고 모두 5% 미만이었다. 14가지 항목의 측정값은 임상 검체에서 흔하게 나타나는 범위에서 직선성을 유지하였다(r2≥0.98). 그러나 나 트륨, AST, ALT, 혈당, 혈액요소질소의 경우 CLIA의 수행능 평가 요구조건에 부합하지 않는 검체가 10% 이상인 점은 임상 환경에서 사용 시 주의가 필요하다. 결론 : Piccolo xpress Chemistry Analyzer는 소량의 전혈 로 짧은 시간에 여러 항목을 측정할 수 있다. 정밀도, 직선성, 중 앙검사실 장비와의 상관성은 수용할 만하였다. Piccolo xpress Chemistry Analyzer는 이동식 진료실, 응급 후송차, 군대의 야전 진료소와 많은 양의 채혈이 어려운 소아 환자 검사 등에서 유용할 것으로 생각한다.
Abstract
Background : Point-of-care (POC) tests are used increasingly due to fast results and simple test procedures, which enables rapid diagnosis and therapeutic monitoring. We evaluated the performance of the Piccolo xpress Chemistry Analyzer (Abaxis, USA) a POC chemistry analyzer. Methods : Fourteen analytes, Na+, K+, Cl-, Ca2+, total carbon dioxide, AST, ALT, total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, albumin, total protein, and glucose; were measured simultaneously with a 100 μL of whole blood sample using a Comprehensive Metabolic Reagent disk. Within-run and total precision and linearity were evaluated according to CLSI EP15-A and EP6-A guidelines, respectively. Comparison with a central laboratory chemistry analyzer was performed using 144 patient samples. Results : The coefficients of variations of within-run and total precision were all within 5% for three levels except for total carbon dioxide, ALT, alkaline phosphatase, total bilirubin, and creatinine in low level, and creatinine in middle level. The results of 14 analytes were linear within a commonly encountered range in clinical samples (r2≥0.98). More than 10% of samples in Na+, AST, ALT, glucose, BUN did not satisfy CLIA analytical quality requirement. Conclusions : The Piccolo xpress Chemistry Analyzer can analyze multiple analytes with a minimal amount of whole blood in a short time. It showed an acceptable performance for precision, linearity and comparison with central laboratory analyzer. It can be useful as a screening tests modality in mobile clinics, ambulances, and field clinics for military use, and for pediatric patients from whom enough sample volume is difficult to obtain.
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