미세유체역학 혈액점도계 Viscore-300의 분석적 성능 평가 및 참고범위 설정
Analytical Performance and Reference Interval of a Microfluidic Viscometer, Viscore-300 for the Measurement of Whole Blood Viscosity
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배경: 전혈 점도는 혈액이 혈관을 통과할 때 발생하는 내부 저항을 의미한다. 이러한 전혈 점도는 기존의 연구를 통해 심혈관 및 뇌혈관질환을 비롯한 많은 질병과 관련이 있는 것으로 밝혀졌다. 본연구에서는 전혈 점도 측정을 위해 새로 개발된 미세유체역학 혈액점도계 Viscore-300 (NanoBiz, Korea)의 분석적 성능 평가와 참고범위를 설정하였다. 방법: 세 가지 정도관리물질을 사용하여 20일 동안 240번의 측정을 통하여 정밀도 평가를 수행하였다. 재현성 평가를 위해 3개의전혈 검체를 하루 동안 60번 측정하였다. 또한 정확도 평가를 위해CLSI 가이드라인에 따라 100개의 전혈 검체를 이용하여 회전식 점도계 DV3T (Brook eld, USA)와 비교하였다. 전혈 점도의 참고범위를 122명의 건강인을 대상으로 설정하였다. 결과: 정밀도 및 재현성 평가 결과 세 가지 물질과 두 전단율 모두에서 5% 미만의 변이 계수를 보였다. 정확도 평가 결과, 평가장비와비교장비의 평균 차이는 10 s–1과 300 s–1의 전단율에서 각각 0.09 cP 및 –0.07 cP이었다. 전혈 점도의 참고범위는 남자에서 저전단율10 s–1하에서 6.88–13.52 cP, 고전단율 300 s–1하에서 4.32–6.43 cP로측정되었다. 여자에서는 저전단율 10 s–1하에서 5.74–13.29 cP, 고전단율 300 s–1하에서 3.60–6.12 cP로 측정되었다. 결론: Viscore-300은 기존 회전식 점도계 DV3T와 비교했을 때 정밀도가 우수하였고, 정확한 점도 측정 결과를 보였다. 따라서 본연구에서 평가한 새로운 혈액점도계는 임상검사실에서 임상 진료과의 요구에 맞춰 정확하고 신속하게 전혈 점도를 보고할 수 있을것으로 판단되었다.
Abstract
Background: Whole blood viscosity (WBV) refers to the internal resistance that occurs when blood flows through blood vessels. WBV is known to be related to many diseases including cardiovascular and neurovascular diseases. We have investigated the analytical performance and established reference intervals for a newly developed microfluidic viscometer, Viscore-300 (NanoBiz, Korea), used for the measurement of WBV. Methods: We performed a precision test of 240 measurements over 20 days using three control materials. For evaluation of repeatability, a total of 60 WBV measurements were made in 3 whole blood samples 20 times a day. A total of 100 whole blood samples were used to evaluate the accuracy of the Viscore-300 in comparison to a rotating viscometer, DV3T (Brookfield, USA), in accordance with the the Clinical and Laboratory Standards Institute’s guidelines. To establish the reference intervals, 122 healthy individuals were enrolled in this study. Results: The precision and repeatability results showed that the CV was less than 5% for three samples and two shear rates. In the accuracy test, the mean differences between two viscometers were 0.09 cP (0.9%) and –0.07 cP (–1.4%) at shear rates of 10 s–1 and 300 s–1, respectively. The reference intervals of WBV for men were 6.88–13.52 cP at 10 s–1 and 4.32–6.43 cP at 300 s–1; those of women were 5.74–13.29 cP at 10 s–1 and 3.60–6.12 cP at 300 s–1. Conclusions: Viscore-300 showed excellent precision and accuracy and it might be a good instrument for reporting WBV quickly and accurately.
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