비침습적 혈색소 검사법 2종의 성능 평가 = Evaluation of Two Noninvasive Hemoglobin Testing Devices

다국어 초록 (Multilingual Abstract)

Background: Determination of the hemoglobin (Hb) levels of prospective blood donors has been performed on capillary blood obtained by finger prick using a gravimetric CuSO4 method. Noninvasive Hb testing devices based on pulse oximetry technology have recently been developed. This study was conducted to evaluate the performance of two noninvasive Hb testing devices, NBM 200 and Pronto-7 as a predonation Hb screening test.
Methods: Hb levels of 993 blood donors (727 males, 266 females) were measured using five methods: two noninvasive methods, CuSO4 method, HemoCue, and hematology analyzer (Sysmex KX-21N). The hematology analyzer was considered as the reference method.
Results: Compared with Hb levels of the hematology analyzer, the bias was 0.7 g/dL for NBM 200, 0.1 g/dL for Prtonto-7, and 0.4 g/dL for HemoCue. The intraclass correlation coefficients of Hb measurements compared to the hematology analyzer were 0.57 (95% CI: 0.25∼0.73) for NBM 200, 0.73 (95% CI: 0.69∼0.75) for Pronto-7, and 0.87 (95% CI: 0.69∼0.93) for HemoCue. The ability to detect Hb ＜12.5 g/dL and ≥12.5 g/dL was 16.4% and 99.2% for NBM 200, 55.8% and 95.9% for Pronto-7, 60.0% and 98.6% for HemoCue and 81.8% and 95.2% for the CuSO4 method, respectively.
Conclusion: Unsatisfactory results were obtained using the noninvasive Hb testing devices for a predonation Hb screening test, although they have the apparent advantage of reducing pain and stress in donors thereby increasing donor satisfaction. However, for application in the blood donation setting, performance of these devices should be improved.

국문 초록 (Abstract)

배경: 헌혈 전 혈색소 농도는 손가락 모세혈을채취한 후 황산구리용액에 의한 혈액비중검사로측정하고 있다. 최근에는 맥박산소측정법(pulse oximetry)에 의한 비침습적 혈색소 검사 장비가개발되어 있어, 본 연구에서는 헌혈 전 혈색소 농도 사전 검사를 위하여 NBM 200, Pronto-7 등 두종의 비침습적 혈색소검사 장비 성능을 평가하였다.
방법: 헌혈자 993명(남성 727명, 여성266명)을대상으로 비침습적 혈색소 검사법 2종, 황산구리용액에 의한 혈액비중검사, HemoCue 및 혈액자동분석기 Sysmex KX-21N에 의한 혈색소 농도 검사 등 총 5가지 방법으로 혈색소 검사를 실시하였으며, 혈액자동분석기에 의한 혈색소 측정값을참고치로 하였다.
결과: 혈액자동분석기에서 측정된 혈색소 측정치를 참고치로 했을 때, NBM 200, Pronto-7, HemoCue의 바이어스는 각각 0.7 g/dL, 0.1 g/dL, 0.4 g/dL이었다. 급내상관계수(ICCs)는 NBM 200 이 0.57 (95%CI: 0.25∼0.73), Pronto-7이 0.73 (95% CI: 0.69∼0.75), HemoCue가 0.87 (95%CI: 0.69∼ 0.93)로 나타났다. Hb ＜12.5 g/dL를 검출하는 능력과 Hb ≥12.5 g/dL를 검출하는 능력은 각각NBM 200 16.4%와 99.2%, Pronto-7 55.8%과 95.9%, HemoCue 60.0%와 98.6% 그리고 황산구리용액에의한 혈액비중 측정법은81.8%와 95.2%였다.
결론: 비침습적 혈색소 검사방법은 헌혈자의고통과 스트레스를 경감시켜 헌혈자 모집 측면에서 긍정적인 측면이 있을 것으로 보이나, 현재로서는 이들 검사가 헌혈 현장에 적용되기 위해서는 장비의 성능 개선이 필요한 것으로 보인다.

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