Abstract：
OBJECTIVE:A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method. RESEARCH DESIGN AND METHODS:The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8-10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites. RESULTS:Over a wide range of HbA1c values (4.0%-15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of -0.6% (-0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of -0.9% (-0.06% HbA1c). The total imprecision of the POC results ranged from 0.74-2.13% CV across the analytic measurement range compared to 0.81-3.23% CV for the routine laboratory methods. CONCLUSIONS:The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.
journal_name
Clin Biochemjournal_title
Clinical biochemistryauthors
Sobolesky PM,Smith BE,Saenger AK,Schulz K,Apple FS,Scott MG,Wu AHB,Little RR,Fitzgerald RLdoi
10.1016/j.clinbiochem.2018.09.007subject
Has Abstractpub_date
2018-11-01 00:00:00pages
18-22eissn
0009-9120issn
1873-2933pii
S0009-9120(18)30786-0journal_volume
61pub_type
杂志文章,多中心研究abstract：OBJECTIVES:The present study was designed to (a) evaluate and compare plasma ammonia levels (PAL) in patients with acute liver failure (ALF) and chronic liver disease (CLD) with or without hepatic encephalopathy (HE); (b) correlate the severity of HE with PAL; and (c) correlate PAL with clinical features of raised intr...
journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2005.04.013
更新日期：2005-08-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章,评审
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abstract：OBJECTIVE:Determine the relation of xanthine oxidase (XO) activity and the outcome of septic patients and its relation to oxidative damage and clinical parameters of sepsis severity. DESIGN AND METHODS:Patients admitted over a 6-month period were enrolled. Patients were assigned to groups according to the diagnosis of...
journal_title：Clinical biochemistry
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更新日期：2008-10-01 00:00:00
abstract：OBJECTIVES:We studied the stability of maternal blood markers for screening for Down syndrome (alpha-fetoprotein, unconjugated estriol, intact human chorionic gonadotropin (hCG) and free beta-human chorionic gonadotropin) upon repeated freeze-thaw cycles. DESIGN AND METHODS:Forty-three samples collected from second tr...
journal_title：Clinical biochemistry
pub_type： 杂志文章
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journal_title：Clinical biochemistry
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更新日期：2010-03-01 00:00:00
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pub_type： 杂志文章
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journal_title：Clinical biochemistry
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journal_title：Clinical biochemistry
pub_type： 杂志文章,多中心研究
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/s0009-9120(02)00339-9
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journal_title：Clinical biochemistry
pub_type： 杂志文章
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journal_title：Clinical biochemistry
pub_type： 杂志文章
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2009.06.030
更新日期：2009-10-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2007.03.005
更新日期：2007-06-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2008.12.009
更新日期：2009-04-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/s0009-9120(00)00162-4
更新日期：2000-10-01 00:00:00
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pub_type： 杂志文章
doi：10.1016/0009-9120(90)80024-d
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pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2007.11.017
更新日期：2008-02-01 00:00:00
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pub_type： 杂志文章
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更新日期：2003-02-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2011.05.029
更新日期：2011-08-01 00:00:00
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pub_type： 杂志文章
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更新日期：1982-04-01 00:00:00
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pub_type： 杂志文章
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更新日期：2013-11-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2018.01.009
更新日期：2018-07-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章,评审
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更新日期：2009-12-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
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更新日期：2015-10-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2019.12.011
更新日期：2020-03-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/s0009-9120(78)80027-7
更新日期：1978-10-01 00:00:00
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journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/j.clinbiochem.2018.03.010
更新日期：2018-05-01 00:00:00
abstract：:In hepatobiliary disease, the level of bile acids in the peripheral circulation is greatly increased due to impaired liver function. It has been suggested that serum bile acids are of greater value in confirming hepatobiliary dysfunction than the currently assayed conventional biochemical parameters. Fifty patients wi...
journal_title：Clinical biochemistry
pub_type： 杂志文章
doi：10.1016/s0009-9120(81)91052-3
更新日期：1981-12-01 00:00:00
