Pesce Michael A, Strauss Shiela M, Rosedale Mary, Netterwald Jane, Wang Hangli
Department of Pathology, Columbia University Medical Center, New York Presbyterian Hospital, New York University, New York, NY
College of Nursing, New York University, New York, NY.
Lab Med. 2015 Fall;46(4):290-8. doi: 10.1309/LM9SISYYKBA2ZDBY.
To validate an ion exchange high-pressure liquid chromatography (HPLC) method for measuring glycated hemoglobin (HbA1c) in gingival crevicular blood (GCB) spotted on filter paper, for use in screening dental patients for diabetes.
We collected the GCB specimens for this study from the oral cavities of patients during dental visits, using rigorous strategies to obtain GCB that was as free of debris as possible. The analytical performance of the HPLC method was determined by measuring the precision, linearity, carryover, stability of HbA1c in GCB, and correlation of HbA1c results in GCB specimens with finger-stick blood (FSB) specimens spotted on filter paper.
The coefficients of variation (CVs) for the inter- and intrarun precision of the method were less than 2.0%. Linearity ranged between 4.2% and 12.4%; carryover was less than 2.0%, and the stability of the specimen was 6 days at 4°C and as many as 14 days at -70°C. Linear regression analysis comparing the HbA1c results in GCB with FSB yielded a correlation coefficient of 0.993, a slope of 0.981, and an intercept of 0.13. The Bland-Altman plot showed no difference in the HbA1c results from the GCB and FSB specimens at normal, prediabetes, and diabetes HbA1c levels.
We validated an HPLC method for measuring HbA1c in GCB; this method can be used to screen dental patients for diabetes.
验证一种离子交换高效液相色谱(HPLC)法,用于测定滤纸上斑点状龈沟血(GCB)中的糖化血红蛋白(HbA1c),以用于筛查牙科患者的糖尿病情况。
我们在牙科就诊期间从患者口腔中收集本研究的GCB标本,采用严格策略获取尽可能无碎屑的GCB。通过测量精密度、线性、残留、GCB中HbA1c的稳定性以及GCB标本中HbA1c结果与滤纸上指尖血(FSB)标本的相关性,来确定HPLC法的分析性能。
该方法批间和批内精密度的变异系数(CVs)均小于2.0%。线性范围在4.2%至12.4%之间;残留小于2.0%,标本在4°C下的稳定性为6天,在-70°C下多达14天。比较GCB和FSB中HbA1c结果的线性回归分析得出相关系数为0.993,斜率为0.981,截距为0.13。Bland-Altman图显示,在正常、糖尿病前期和糖尿病HbA1c水平下,GCB和FSB标本的HbA1c结果无差异。
我们验证了一种用于测定GCB中HbA1c的HPLC方法;该方法可用于筛查牙科患者的糖尿病情况。