소야그린텍 Ampulab EDTA 및 Sodium Citrate 진공채혈관의 성능평가: BD Vacutainer 진공채혈관과 비교
A Comparison of the Performance of Soyagreentec Ampulab EDTA and Sodium Citrate Tubes with That of BD Vacutainer Tubes
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
배경: 정맥혈 채혈에 주로 사용되는 진공채혈관은 다양한 검사결과에 영향을 줄 수 있다. 따라서 새로 개발된 진공채혈관을 임상검사에 도입하기 전에는 엄격하고 객관적으로 그 성능을 평가해야 하기에, 본 연구자들은 국제적인 기준에 의거하여 새로이 개발된 Ampulab EDTA, sodium citrate 진공채혈관(Soyagreentec, Korea)의 성능을 평가하였다. 방법: 2개 이상의 서로 다른 장비로 결과를 검증하기 위해 중앙대학교병원과 서울대학교병원에서 다기관 연구를 시행하였다. CLSI GP34-A에 따라 정밀도를, CLSI EP09-A2-IR에 따라 정확도를, CLSI H1-A5에 따라 진공성능을 평가하였고, 추가로 안정성과 무균성 평가를 시행하였다. 정밀도, 정확도, 진공성능, 무균성에 대하여는 3로트의 진공채혈관을 검증하였다. 결과: 정밀도 평가에서 대부분 검사종목의 총 정밀도는 만족할 만하거나 허용가능한 수준이었다. Ampulab은 MCHC, PDW, Basophil, Reticulocyte 종목에서 허용범위를 넘어서는 크기의 비정밀도를 보였으나 Vacutainer (BD, USA)도 동일한 양상을 보였다. 정확도 평가는 MPV 한 종목을 제외하고는 Vacutainer (BD) 대비 허용범위를 넘어서는 바이어스는 관찰되지 않았다. 안정성 평가에서 Vacutainer (BD)와 동등한 성능을 보였고, 진공성능 및 무균성 평가에서는 모두 기준을 충족하였다. 결론: 소야그린텍사의 새로운 Ampulab EDTA, sodium citrate 진공채혈관은 국제기준에 따라 평가한 결과 BD사의 Vacutainer와 동등한 성능을 보였다.
Abstract
Background: Because blood collection tube can affect the results of various laboratory tests, it is necessary before using a newly developed product to verify its performance stringently and objectively. We compared the performance of Ampulab EDTA and sodium citrate tubes (Soyagreentec, Korea) with that of Vacutainer tubes (BD, USA) in accordance with international guidelines. Methods: This study was performed as a multicenter study of Chung-Ang University Hospital and Seoul National University Hospital to evaluate the performance of two different instrument platforms. We performed the precision test according to CLSI GP34-A, the accuracy test according to CLSI EP09-A2-IR, and the vacuum test according to CLSI H1-A5 as well as stability, and aseptic condition tests. We evaluated 3 lots of Ampulab tubes for their precision, accuracy, vacuum, and aseptic condition. Results: In precision test, the total precision levels of Ampulab tubes in most measurands were desirable or allowable. The results of mean corpuscular hemoglobin concentration, platelet distribution width, basophil, and reticulocyte counts for Ampulab tubes showed imprecision beyond allowable limits, but were similar to those of Vacutainer tubes. In the accuracy test, the bias in most measurands, except for the mean platelet volume, was within allowable limits. In the stability test, Ampulab showed similar performance to Vacutainer. In tests of the vacuum and aseptic conditions, Ampulab fulfilled both requirements. Conclusions: The performance of Ampulab EDTA and sodium citrate tubes was equivalent to that of Vacutainer tubes.
참고문헌 (14)
- 오수현, "49종의 검사에 대한 새로운 두 종류의 플라스틱 진공채혈관(Sekisui INSEPACK및 녹십자 Green Vac-Tube)과 BD Vacutainer 진공채혈관의 비교", Annals of Laboratory Medicine, 27(1), pp.69~75 (2007), 대한진단검사의학회
- 원은정, "새로운 국산 V-Tube 진공채혈관과 BD Vacutainer의 비교평가", Laboratory Medicine Online, 3(3), pp.145~154 (2013), 대한진단검사의학회
- CLSI, "Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection ; Approved Guideline. In. CLSI document GP34-A", Clinical and Laboratory Standards Institute, ~ (2010)
- Ricós C, "Current databases on biological variation: pros, cons and progress", Scand J Clin Lab Invest, 59, pp.491~500 (1999)
- "Desirable Specifications for Total Error, Imprecision, and Bias, derived from intra- and inter-individual biologic variation"[URL]
- CLSI, "Method Comparison and Bias Estimation Using Patient Samples ; Approved Guideline-Second Edition (Interim Revision). In. CLSI document EP09-A2-IR", Clinical and Laboratory Standards Institute, ~ (2010)
- CLSI, "Tubes and Additives for Venous Blood Specimen Collection ; Approved Standard-Fifth Edition. In. CLSI document H1-A5", Clinical and Laboratory Standards Institute, ~ (2003)
- Bowen RA, "Immunoassay interference by a commonly used blood collection tube additive, the organosilicone surfactant silwet L-720", Clin Chem, 51, pp.1874~1882 (2005)
- Bowen RA, "Impact of blood collection devices on clinical chemistry assays", Clin Biochem, 43, pp.4~25 (2010)
- Bowen RA, "Differential effect of blood collection tubes on total free fatty acids(FFA)and total triiodothyronine(TT3)concentration : a model for studying interference from tube constituents", Clin Chim Acta, 378, pp.181~193 (2007)
- Bush VJ, "Comparison of BD Vacutainer SST Plus Tubes with BD SST II Plus Tubes for common analytes", Clin Chim Acta, 306, pp.139~143 (2001)
- Li Z, "Evaluation of BD Vacutainer SST™ II Plus tubes for common tumor marker tests by Roche Diagnostics Modular E 170 analyzer", J Clin Lab Anal, 24, pp.418~421 (2010)
- CLSI, "Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays ; Approved Guideline, 5th ed. In. CLSI Document H21-A5", Clinical and Laboratory Standards Institute, ~ (2008)
- Versalovic J and American Society for Microbiology, "Manual of clinical microbiology", pp.286~301 (2011), ASM Press