[Show abstract][Hide abstract] ABSTRACT: The IFCC Reference Measurement System for hemoglobin (Hb)A(1c) (IFCC-RM) has been developed within the framework of metrologic traceability and is embedded in a network of 14 reference laboratories. This paper describes the outcome of 12 intercomparison studies (periodic evaluations to control essential elements of the IFCC-RM).
Each study included: unknown samples (to test individual network laboratories); known samples (controls); recently manufactured calibrators (to check calculated assigned value); stored calibrators (to test stability) and a calibration-set (to calibrate the IFCC-RM). The unknown samples are measured by use of the IFCC-RM and the designated comparison methods [DCMs; the National Glycohemoglobin Standardization Program (NGSP) in the US, Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/JSCC) in Japan, and Mono-S in Sweden] are used to investigate the stability of the Master Equation (ME), the relationship between IFCC-RM and DCMs.
A total of 105 IFCC-RM data sets were evaluated: 95 were approved, 5 were not, and for 5 no data were submitted. Trend analysis of the MEs, expressed as change in percentage HbA(1c) per year, revealed 0.000% (NGSP, not significant), -0.030%, (JDS/JSCC; significant) and -0.016% (Mono-S; not significant). Evaluation of long-term performance revealed no systematic change over time; 2 laboratories showed significant bias, 1 poor reproducibility. The mean HbA(1c) determined by laboratories performing mass spectrometry (MS) was the same as the mean determined by laboratories using capillary electrophoresis (CE), but the reproducibility at laboratories using CE was better. One batch of new calibrators was not approved. All stored calibrators were stable.
A sound reference system is in place to ensure continuity and stability of the analytical anchor for HbA(1c).
Full-text · Article · Mar 2008 · Clinical Chemistry
[Show abstract][Hide abstract] ABSTRACT: The measurement of glycated hemoglobin is central in the monitoring of glycemic control in patients with diabetes. There are at least 30 different laboratory assays commercially available to measure the proportion of HbA1c in blood. In 1995 the IFCC established a Working Group (IFCC WG-HbA1c) to achieve international standardization of HbA1c measurement. The main achievements can be summarized as follows: a) a reference measurement procedure has been established with purified primary calibrators; b) a network of reference laboratories has been developed worldwide; and c) work has begun on implementation of traceability to the IFCC reference system. The IFCC WG-HbA1c recognizes the recommendation of the IFCC-IUPAC Committee on Nomenclature, Properties and Units that the analyte measured by the IFCC reference measurement procedure has been defined as betaN1-deoxyfructosyl-hemoglobin and that the recommended measurement units are mmol/mol. The IFCC WG-HbA1c recommends maintaining the use of the name HbA1c in clinical practice.
Full-text · Article · Feb 2007 · Clinical Chemistry and Laboratory Medicine
[Show abstract][Hide abstract] ABSTRACT: To compare dual vs. triple antiplatelet pre-treatment in patients with non-ST-elevation acute coronary syndrome (NSTE ACS) who were planned for early catheterization.
A total of 328 consecutive patients with NSTE ACS were included and were randomized to pre-treatment with dual (n = 166, aspirin, clopidogrel 600 mg) or triple antiplatelet therapy (n = 162, aspirin, clopidogrel 300 mg, and Tirofiban). The primary endpoint was enzymatic infarct size, defined as cumulative LDH release (LDHQ(48)). Initial TIMI flow of the culprit vessel was a pre-specified secondary endpoint. Angiography was performed in 98% of patients at a median of 23 h after admission. Enzymatic infarct size (median, 25-75%) was 166 (60-349) IU/L in the triple group compared with 193 (75-466) IU/L in the dual group (P = 0.2). Initial TIMI 3 flow of the culprit vessel was significantly more often observed after triple antiplatelet therapy (67 vs. 47%, P = 0.002). At 30 days follow-up, myocardial infarction (MI) occurred in 46% of patients in the triple antiplatelet group, compared with 57% in the dual antiplatelet group, P = 0.052. No significant difference in bleeding was present.
This study showed that in patients with NSTE ACS, triple antiplatelet pre-treatment was associated with a non-significant reduction in enzymatic infarct size, a significantly better initial perfusion of the culprit vessel, and a trend towards a better survival without death or MI. Further, large-scale studies should be performed to find whether the beneficial trend in favour of triple antiplatelet pre-treatment can be reproduced.
Full-text · Article · Jul 2006 · European Heart Journal
[Show abstract][Hide abstract] ABSTRACT: Admission hyperglycaemia is associated with poorer prognosis in patients with an acute coronary syndrome (ACS). Whether hyperglycaemia is more important than prior long-term glucose metabolism, is unknown.
To investigate the prognostic value of admission glucose and HbA(1c) levels in patients with ACS.
We measured glucose and HbA(1c) at admission in 521 consecutive patients with suspected ACS. Glucose was categorized as <7.8 (n = 305), 7.8-11.0 (n = 138) or > or =11.1 mmol/l (n = 78); HbA(1c) as <6.2% (n = 420) or > or =6.2% (n = 101). Mean follow-up was 1.6 +/- 0.5 years.
The diagnosis of ACS was confirmed in 332 patients (64%), leaving 189 (36%) with atypical chest pain. In ACS patients, mortality by glucose category (<7.8, 7.8-11.0 or > or =11.1 mmol) was 9%, 8% and 25%, respectively (p = 0.001); mortality by HbA(1c) category (<6.2% vs. > or =6.2%) was 10% vs. 17%, respectively (p = 0.14). On multivariate analysis, glucose category was significantly associated with mortality (HR 3.0, 95% CI 1.1-8.3), but HbA(1c) category was not (HR 1.5, 95%CI 0.6-4.2).
Elevated admission glucose appears more important than prior long-term abnormal glucose metabolism in predicting mortality in patients with suspected ACS.
Preview · Article · May 2006 · QJM: monthly journal of the Association of Physicians
[Show abstract][Hide abstract] ABSTRACT: High-dose glucose-insulin-potassium infusion (GIK) has been suggested to be beneficial in acute myocardial infarction (MI). Recently new large trials have shown no effect of GIK on mortality. To investigate whether metabolic derangement could have negated the potential beneficial effect, we studied the relation between systemic glucose and potassium levels and outcome.
Patients with signs and symptoms of ST-segment-elevation MI and treated with primary percutaneous coronary intervention (PCI) were randomised to no infusion or high-dose GIK, i.e. 80 mmol potassium chloride in 500 ml 20% glucose at a rate of 3 ml/kg/hour and 50 units short-acting insulin in 50 ml 0.9% sodium chloride for 12 hours.
A total of 6991 glucose values and 7198 potassium values were obtained in 476 GIK patients and 464 controls. Mean serum glucose was significantly higher in the GIK group (9.3±4.5 mmol/l vs. 8.4±2.9 mmol/l, p<0.001). Mean potassium level was significantly higher in the GIK group (4.2±0.5 mmol/l vs. 3.9±0.4 mmol/l, p<0.001). Incidence of hyperglycaemia (glucose >11.0 mmol/l) occurred in 70.8% of GIK patients and 33.8% of controls (p<0.001). Hypokalaemia was less common in the GIK group (23.5 vs. 41.2%, p<0.001). Incidence of hyperkalaemia and hypoglycaemia did not differ significantly between the two groups. In multivariate analysis age, previous cardiovascular disease, Killip class >1, unsuccessful PCI and mean glucose after admission were associated with increased one-year mortality.
In ST-segment-elevation MI patients treated with primary PCI, high-dose GIK induced hyperglycaemia and prevented hypokalaemia. Derangement of the glucose metabolism was related to one-year mortality.
[Show abstract][Hide abstract] ABSTRACT: Elevated troponin after elective percutaneous coronary intervention (PCl) has been associated with a worse prognosis. Pretreatment with clopidogrel may be beneficial in patients undergoing PCl. Therefore, a prospective observational study was conducted to address the potential role of clopidogrel in reducing troponin release after elective PCl.Troponin T was measured 12 hours after elective PCl in 656 patients without elevated troponin before PCl. To assess the independent association between pre-treatment with clopidogrel and increased troponin, multivariate analyses were performed. Mean age of the 656 patients was 63.5 years (SD 10.2), 194 patients (30%) were female and 114 patients (17.4%) had diabetes. In 217 patients (33%) troponin was increased after PCl. Of the 330 patients who were not pre-treated with dopidogrel, 118 patients (34%) had increased troponin after the PCl compared to 99 patients (30%) of the 326 patients who were treated with clopidogrel longer than 24 hours before the procedure (p=0.14). Stratified analyses showed that patients with older age (p=0.03), previous PCl (p=0.013), angina CCS 4 (p=0.03) and multivessel disease (p=0.04) had a significantly lower risk of troponin increase after pre-treatment with clopidogrel compared to patients without pre-treatment. After adjusting for differences in the other variables, patients who were pre-treated with clopidogrel had a significant lower risk of post-PCl increase of troponin T (odds ratio 0.69, 95% confidence interval 0.49-0.99). Pre-treatment with clopidogrel is associated with a significantly lower incidence of increased troponin after elective PCl. Combined with results of other studies, pre-treatment should be advised in patients waiting for elective PCl.
No preview · Article · Feb 2006 · Thrombosis and Haemostasis
[Show abstract][Hide abstract] ABSTRACT: Elevated troponin after elective percutaneous coronary intervention (PCI) has been associated with a worse prognosis. Pretreatment with clopidogrel may be beneficial in patients undergoing PCI. Therefore, a prospective observational study was conducted to address the potential role of clopidogrel in reducing troponin release after elective PCI. TroponinT was measured 12 hours after elective PCI in 656 patients without elevated troponin before PCI. To assess the independent association between pre-treatment with clopidogrel and increased troponin, multivariate analyses were performed. Mean age of the 656 patients was 63.5 years (SD 10.2), 194 patients (30%) were female and 114 patients (17.4%) had diabetes. In 217 patients (33%) troponin was increased after PCI. Of the 330 patients who were not pre-treated with clopidogrel, 118 patients (34%) had increased troponin after the PCI compared to 99 patients (30%) of the 326 patients who were treated with clopidogrel longer than 24 hours before the procedure (p = 0.14). Stratified analyses showed that patients with older age (p = 0.03), previous PCI (p = 0.013), angina CCS 4 (p = 0.03) and multivessel disease (p = 0.04) had a significantly lower risk of troponin increase after pre-treatment with clopidogrel compared to patients without pre-treatment. After adjusting for differences in the other variables, patients who were pre-treated with clopidogrel had a significant lower risk of post-PCI increase of troponin T (odds ratio 0.69, 95% confidence interval 0.49-0.99). Pre-treatment with clopidogrel is associated with a significantly lower incidence of increased troponin after elective PCI. Combined with results of other studies, pre-treatment should be advised in patients waiting for elective PCI.
Full-text · Article · Feb 2006 · Thrombosis and Haemostasis
[Show abstract][Hide abstract] ABSTRACT: To examine whether anemia is associated with a higher incidence of recurrent falls.
Prospective cohort study.
Community-dwelling sample in The Netherlands.
Three hundred ninety-four participants aged 65 to 88 from the Longitudinal Aging Study Amsterdam.
Anemia was defined according to World Health Organization criteria as a hemoglobin concentration less than 12 g/dL in women and less than 13 g/dL in men. Falls were prospectively determined using fall calendars that participants filled out weekly for 3 years. Recurrent fallers were identified as those who fell at least two times within 6 months during the 3-year follow-up.
Of the 394 persons, 11.9% (18 women and 29 men) had anemia. The incidence of recurrent falls was 38.3% of anemic persons versus 19.6% of nonanemic persons (P=.004). After adjustment for sex, age, body mass index, and diseases, anemia was significantly associated with a 1.91 times greater risk for recurrent falls (95% confidence interval=1.09-3.36). Poor physical function (indicated by muscle strength, physical performance, and limitations) partly mediated the association between anemia and incidence of recurrent falls.
Late-life anemia is common and associated with twice the risk of recurrent falls. Muscle weakness and poor physical performance appear to partly mediate this association.
Full-text · Article · Jan 2006 · Journal of the American Geriatrics Society
[Show abstract][Hide abstract] ABSTRACT: Intensive glycemic control with insulin reduces the in-hospital mortality and length of stay in the hospital. Starting a program to measure glucose decentralization warrants a multidisciplinary endorsed protocol. Shared ideas were developed describing when to measure glucose concentration either in the laboratory or bedside with blood glucose monitors. A choice of glucose monitor was made. A barcode-protected glucose monitor was introduced for preventing unauthorized use. A specialized nurse for immediately answering questions from nurses and/or forwarding questions to a specialized laboratory customer care employee was assigned. The program is now monitored by the laboratory by yearly accreditation of the users of blood glucose monitors. The laboratory checks the quality control data and educates the users constantly to increase the awareness of problems. A docking station is utilized for collecting all the data in a central database, preventing loss of data and too often sampling patients. The same lot number for all glucose strips in the hospital was introduced to prevent deviations from lot to lot and to prevent switching of quality control bottles. All these aspects and especially the learning process during implementation of the program are addressed to guarantee the error-free application of decentralized blood glucose monitors.
No preview · Article · Nov 2005 · Point of Care The Journal of Near-Patient Testing & Technology
[Show abstract][Hide abstract] ABSTRACT: Favorable clinical outcomes have been observed with glucose-insulin-potassium infusion (GIK) in acute myocardial infarction (MI). The mechanisms of this beneficial effect have not been delineated clearly. GIK has metabolic, anti-inflammatory and profibrinolytic effects and it may preserve the ischemic myocardium. We sought to assess the effect of GIK infusion on infarct size and left ventricular function, as part of a randomized controlled trial.
Patients (n = 940) treated for acute MI by primary percutaneous coronary intervention (PCI) were randomized to GIK infusion or no infusion. Endpoints were the creatinine kinase MB-fraction (CK-MB) and left ventricular ejection fraction (LVEF). CK-MB levels were determined 0, 2, 4, 6, 24, 48, 72 and 96 hours after admission and the LVEF was measured before discharge.
There were no differences between the two groups in the time course or magnitude of CK-MB release: the peak CK-MB level was 249 +/- 228 U/L in the GIK group and 240 +/- 200 U/L in the control group (NS). The mean LVEF was 43.7 +/- 11.0 % in the GIK group and 42.4 +/- 11.7% in the control group (P = 0.12). A LVEF < or = 30% was observed in 18% in the controls and in 12% of the GIK group (P = 0.01).
Treatment with GIK has no effect on myocardial function as determined by LVEF and by the pattern or magnitude of enzyme release. However, left ventricular function was preserved in GIK treated patients.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Apart from diabetes itself, even minor glycometabolic dysregulation may be associated with an increased risk of cardiovascular disease. We analyzed the prevalence and predictive value of glycometabolic disturbances in patients with a suspected acute coronary syndrome (ACS). METHODS: In a prospective follow-up study, admission glucose and Hba1C levels in all consecutive patients with suspected ACS were measured. Dysglycemia was defined as a Hba1C of 5.6-6.1% with a non-fasting glucose above 7.8 mmol/L. Both predictors of glycometabolic disturbances and the predictive value of glycometabolic disturbances were studied. RESULTS: Of the 521 patients with a suspected ACS who were included in the study, 332 (64%) had an ACS and 189 (36%) had atypical chest pain. A total of 115 patients (22%) had diabetes and 65 (13%) had dysglycemia. Patients with diabetes or dysglycemia had an increased risk of a confirmed diagnosis of ACS (RR 2.3, 95% CI 1.5-3.4). Multivariate analyses did not change these findings. CONCLUSIONS: One in three patients with suspected ACS had a glucose metabolism disturbance. Glycometabolic disturbance was strongly associated with a confirmed diagnosis of ACS. Whether intensive treatment of patients with disturbed glucose metabolism may improve long-term prognosis needs to be assessed.
No preview · Article · Mar 2005 · European Journal of Internal Medicine
[Show abstract][Hide abstract] ABSTRACT: The IFCC has established a working group on HbA1c standardization, which developed a reference system to act as basis for global standardization of all glycohemoglobin/HbA1c assays. The reference system is based on HbA1c, defined as beta-N-1-deoxy fructosyl haemoglobin as component. Two reference methods specifically measure the glycated N-terminal residue of the beta chain of haemoglobin. The assay principle is peptide mapping after proteolytic cleavage of the molecule followed by measurement of the ratio of the glycated and non-glycated ss-N-terminal hexapeptides by HPLC/MS or HPLC/CE. An international network of 12 reference laboratories is in place. An overall CV below 2% is achieved in comparison studies, which guarantees a reliable value assignment to secondary reference materials. For implementation of the system, the relationship between IFCC and the existing Designated Comparison Methods in the US (NGSP), Sweden (MonoS) and Japan was calculated in seven method comparisons. In all cases, the correlation was exactly the same, making recalculation of the various systems to one IFCC reference system possible. IFCC values will be a reference range of 3-4% HbA1c with a target value of optimal treatment of 5% and change of therapy proposed at values >6%. The last item of the IFCC WG on HbA1c standardization is the adjustment of all the commercial methods to this new reference system. Three method comparison studies with all the major manufacturer methods were performed. This allowed us to first anchor all commercial methods to the IFCC reference system and thereafter recalculate the results to the new IFCC system. Secondary reference materials and a transfer protocol are provided to enable manufacturers to adjust their routine tests to the new reference system. The IFCC reference system for HbA1c will make it possible to improve the performance of routine HbA1c assays. The goal of this improved analytical performance is a within and between run CV of 2%. If this can be achieved, then the HbA1c results can be incorporated into the diagnostic strategies for detecting diabetes mellitus.
No preview · Article · Feb 2005 · Scandinavian journal of clinical and laboratory investigation. Supplementum
[Show abstract][Hide abstract] ABSTRACT: To evaluate the extent of platelet aggregation inhibition in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI), treated with different antiplatelet agents and dosages.
The extent of platelet aggregation inhibition is an independent predictor of major cardiac events after elective PCI. In STEMI patients undergoing PCI, routine dose of antiplatelet agents may be associated with less effective platelet aggregation inhibition.
Patients were treated with clopidogrel before angiography and randomized to abciximab, tirofiban, high-dose tirofiban, or no glycoprotein (GP) IIb/IIIa inhibitor; GP IIb/IIIa inhibitor bolus, followed by maintenance infusion, was administered after angiography, but before PCI. Platelet aggregation inhibition was assessed before angiography, immediately after PCI, and 1 and 6 h afterwards.
The total study population consisted of 112 patients. Platelet aggregation inhibition was variable for individuals and suboptimal for all agents, particularly in the periprocedural period. Only with high-dose tirofiban, mean periprocedural platelet aggregation inhibition exceeded 80%. Angiographic parameters after PCI were not different between the groups. No relationship was found between the level of platelet aggregation and parameters of PCI success (Thrombolysis In Myocardial Infarction frame count and myocardial blush grade), after combining the data from all four groups studied.
Platelet aggregation inhibition in STEMI patients undergoing PCI, treated with antiplatelet agents, is variable and suboptimal for all agents and dosages studied. Only with high-dose tirofiban, mean periprocedural platelet aggregation inhibition exceeded 80%. However, no relationship of platelet aggregation inhibition and angiographic outcome was found in this patient cohort.
Full-text · Article · Oct 2004 · Journal of the American College of Cardiology
[Show abstract][Hide abstract] ABSTRACT: Haemoglobin A1c (HbA1c) or glycohaemoglobin is one of the most important parameters in the management of patients with diabetes mellitus, but to date there is no international standard for determining HbA1c. Most of the routine HbA1c assays are standardised against one of the local standardisation schemes like the NGSP (USA) and other schemes (Japan, Sweden). Still, results of HbA1c tests diverge considerably, as do the accompanying clinical decision limits.
The IFCC Working Group on HbA1c Standardisation has developed a reference method and also set up a reference system for HbA1c, in which the analyte is defined as β-N-glycated haemoglobin. This reference system consists of a network of reference laboratories that uses the reference methods and certified reference materials for optimal measurement of HbA1c in human blood. The main task of the network is to assign values to secondary reference materials, to be used by manufacturers of routine HbA1c assays to calibrate their assays. The high specificity of the reference method results in lower HbA1c values in blood samples, since the unspecific components falsely identified as HbA1c in routine methods are not measured by the reference method. The reference range for the new reference method was determined as 3 to 4% and the clinical decision limits were translated from existing guidelines: goal of treatment 5% HbA1c, change of therapy advised at HbA1c greater than 6%. Despite these lower values, worldwide implementation of the IFCC reference system for HbA1c is recommended, in order to end the great divergence in HbA1c results, with which physicians and patients are confronted today.
[Show abstract][Hide abstract] ABSTRACT: Controversial reports have been published about the efficiency of potent platelet inhibitors in patients with coronary artery syndrome (CAS). We therefore questioned whether a functional change in platelets affects the patient's response to ASA.
Nineteen consecutive patients presenting with unstable coronary syndrome and 15 healthy volunteers were included. No platelet inhibitory drugs or coumarin were used in either group before the study. Platelet aggregation tests were performed on baseline samples and after a single dose of ASA. Afterwards, all patients underwent coronary angiography to exclude non-CAS.
In the patient group (n=15 after exclusion) no significant increase in bleeding constant was found after ASA, using a PFA analyser, in contrast to the control group. The maximal velocity and the maximal percentage optical platelet aggregation using ADP was significantly more reduced in the control group. ASA did not significantly reduce the thromboxane B2 production in the patient group.
ASA has less platelet inhibitory effects in patients with unstable CAS in comparison with healthy volunteers. Platelets, in the hyperactive state of unstable CAS, prove to be less subject to inhibition. This might add to the explanation of the lack of efficiency of platelet inhibitory drugs to prevent thrombotic complications after PTCA and platelet aggregation onto stent surfaces in patients with acute CAS.
[Show abstract][Hide abstract] ABSTRACT: In patients with acute myocardial infarction, estimation of infarct size by cumulative lactate dehydrogenase release at 72 h (LDHQ(72)) is a simple and widely used method. Our objective was to study the value of estimating infarct size, by the cumulative release of LDH over 72, 60, 48 and 36 h in predicting left ventricular ejection fraction (LV(ef)) and cardiac death at 1 year.
In the Zwolle Infarction Study infarct size estimated as LDHQ was calculated in 1224 patients treated with primary percutaneous coronary intervention for acute myocardial infarction between December 1993 and June 2001. Patients were categorized as having small (LDHQ(72)<800 U/L), medium (LDHQ(72) 800-2500 U/L) or large (LDHQ(72)>2500 U/L) myocardial infarction.
LDHQ(72) was closely correlated with LDHQ(60), LDHQ(48) and LDHQ(36) (r = 0.998, 0.993 and 0.987, respectively, P <0.0001). The relations between LDHQ infarct size classification and mean LV(ef) (51% vs 45% vs 35%, P <0.001) or cardiac death at 1 year (0-0.3% vs 0.7-1% vs 6-8%) showed a similar pattern, irrespective of whether LDH was measured up to 36, 48, 60 or 72 h.
Infarct size classification based on LDHQ(36) is an objective and widely available method for early risk stratification in patients treated with primary angioplasty for acute ST-segment elevation myocardial infarction.
Full-text · Article · Mar 2004 · Annals of Clinical Biochemistry
[Show abstract][Hide abstract] ABSTRACT: The national programs for the harmonization of hemoglobin (Hb)A(1c) measurements in the US [National Glycohemoglobin Standardization Program (NGSP)], Japan [Japanese Diabetes Society (JDS)/Japanese Society of Clinical Chemistry (JSCC)], and Sweden are based on different designated comparison methods (DCMs). The future basis for international standardization will be the reference system developed by the IFCC Working Group on HbA(1c) Standardization. The aim of the present study was to determine the relationships between the IFCC Reference Method (RM) and the DCMs.
Four method-comparison studies were performed in 2001-2003. In each study five to eight pooled blood samples were measured by 11 reference laboratories of the IFCC Network of Reference Laboratories, 9 Secondary Reference Laboratories of the NGSP, 3 reference laboratories of the JDS/JSCC program, and a Swedish reference laboratory. Regression equations were determined for the relationship between the IFCC RM and each of the DCMs.
Significant differences were observed between the HbA(1c) results of the IFCC RM and those of the DCMs. Significant differences were also demonstrated between the three DCMs. However, in all cases the relationship of the DCMs with the RM were linear. There were no statistically significant differences between the regression equations calculated for each of the four studies; therefore, the results could be combined. The relationship is described by the following regression equations: NGSP-HbA(1c) = 0.915(IFCC-HbA(1c)) + 2.15% (r(2) = 0.998); JDS/JSCC-HbA(1c) = 0.927(IFCC-HbA(1c)) + 1.73% (r(2) = 0.997); Swedish-HbA(1c) = 0.989(IFCC-HbA(1c)) + 0.88% (r(2) = 0.996).
There is a firm and reproducible link between the IFCC RM and DCM HbA(1c) values.
[Show abstract][Hide abstract] ABSTRACT: Various guidelines are in use for validating blood glucose meters. There are currently no analytical guidelines for validating procedures available for non-invasive or minimally invasive blood glucose meters. As a result manufacturers of these meters need to comply with different regulations in different countries with concomitant high costs. Some of the differences between different guidelines will be discussed in this article and recommendations for improvement will be presented.
No preview · Article · Oct 2003 · Clinical Chemistry and Laboratory Medicine