使用全血样本的HemoCue B-葡萄糖分析仪的性能特征。

Performance characteristics of the HemoCue B-Glucose analyzer using whole-blood samples.

作者信息

Voss E M, Cembrowski G S

机构信息

Clinical Laboratory, Park Nicollet Medical Center, Minneapolis, Minn. 55416.

出版信息

Arch Pathol Lab Med. 1993 Jul;117(7):711-3.

PMID:8323435

Abstract

We evaluated the HemoCue B-Glucose (HemoCue Inc, Mission Viejo, Calif) analyzer for accuracy, precision, linearity, and recovery. One hundred eighteen capillary whole-blood samples were analyzed in duplicate on the HemoCue B-Glucose and the YSI 2300 STAT Glucose/L-Lactate (Yellow Springs [Ohio] Instruments) analyzers; corresponding plasma glucose levels were measured in duplicate on the Roche Cobas MIRA (Roche Diagnostic Systems, Nutley, NJ) analyzer. Plasma glucose levels were converted to whole-blood equivalent glucose levels by using a factor of 1.11. The following regression equations were obtained: HemoCue = 1.02 (YSI) + 0.19, Sy/x = 0.52, r2 = .984; and HemoCue = 0.98 (whole-blood equivalent glucose levels) + 0.26, Sy/x = 0.55, r2 = .982. Within-run coefficients of variation were 4.0%, 3.5%, 2.2%, and 1.0% at glucose concentrations of 3.9, 5.4, 8.7, and 17.1 mmol/L (71, 97, 156, and 308 mg/dL), respectively. Between-run imprecision and total imprecision using lyopholized materials with three lot numbers of cuvettes were 4.2% and 5.6% at 2.1 mmol/L (37 mg/dL) and 2.4% and 2.7% at 5.2 mmol/L (95 mg/dL), respectively. The HemoCue B-Glucose analyzer displayed linearity between 0 and 22.2 mmol/L (0 and 400 mg/dL), and the percent recovery averaged 98.7% +/- 4.5% (mean +/- SD). The HemoCue B-Glucose analyzer is a rapid, simple, and reliable method for determinations of whole-blood glucose levels.

摘要

我们评估了HemoCue B - 葡萄糖分析仪（HemoCue公司，加利福尼亚州米申维耶霍）的准确性、精密度、线性和回收率。对118份毛细血管全血样本在HemoCue B - 葡萄糖分析仪和YSI 2300 STAT葡萄糖/ L - 乳酸分析仪（俄亥俄州黄泉仪器公司）上进行了双份检测；在罗氏Cobas MIRA分析仪（罗氏诊断系统公司，新泽西州纳特利）上对相应的血浆葡萄糖水平进行了双份测量。通过使用1.11的系数将血浆葡萄糖水平转换为全血等效葡萄糖水平。得到了以下回归方程：HemoCue = 1.02（YSI）+ 0.19，Sy/x = 0.52，r2 = 0.984；以及HemoCue = 0.98（全血等效葡萄糖水平）+ 0.26，Sy/x = 0.55，r2 = 0.982。在葡萄糖浓度分别为3.9、5.4、8.7和17.1 mmol/L（71、97、156和308 mg/dL）时，批内变异系数分别为4.0%、3.5%、2.2%和1.0%。使用三种不同批次比色杯的冻干材料时，批间不精密度和总不精密度在2.1 mmol/L（37 mg/dL）时分别为4.2%和5.6%，在5.2 mmol/L（95 mg/dL）时分别为2.4%和2.7%。HemoCue B - 葡萄糖分析仪在0至22.2 mmol/L（0至400 mg/dL）之间显示出线性，回收率平均为98.7%±4.5%（平均值±标准差）。HemoCue B - 葡萄糖分析仪是一种测定全血葡萄糖水平的快速、简单且可靠的方法。