Setting analytical goals for random analytical error in specific clinical monitoring situations

1990 ◽  
Vol 36 (9) ◽  
pp. 1625-1628 ◽  
Author(s):  
C G Fraser ◽  
P Hyltoft Peterson ◽  
M L Larsen
Keyword(s):  
Diabetes Mellitus ◽  
Renal Failure ◽  
Chronic Renal Failure ◽  
Clinical Chemistry ◽  
Statistical Significance ◽  
Test Results ◽  
Analytical Error ◽  
Analytical Goals ◽  
Analytical Imprecision ◽  
Clinically Significant

Abstract Strategies abound for the setting of analytical goals in clinical chemistry. Many, especially those more recently proposed for particular clinical situations, are concerned with tests used in diagnosis. We suggest a general theory for the setting of goals in situations that specifically involve the monitoring of individuals. Goals are calculated from the formula CVA less than [(delta c 2/2Z2)-CVB2]1/2, where CVA is the analytical imprecision (as coefficient of variation, CV); delta c is the percentage change in serial results that is considered clinically significant; Z is the Z-statistic, which depends only on the probability selected for statistical significance; and CVB is the average inherent within-subject biological variation (as CV). Examples given show applications in hematology and in monitoring diabetes mellitus, chronic renal failure, and hepatitis. The derived goals are for total random analytical error (imprecision and intermittent systematic variation), and provide objective criteria that should be achieved in practice. The effect of analytical variability on both variability in test results and the probability that a stated change can be considered significant should be calculated whether or not the goals are attained.

Comparison of some biochemical tests in different blood collection tubes in hemodialysis patients

2019 ◽  
Vol 45 (1) ◽  
pp. 26-36 ◽  
Author(s):  
Arzu Kösem ◽  
Canan Topçuoğlu ◽  
Sevilay Sezer ◽  
Şimal Köksal Cevher ◽  
Ezgi Coşkun Yenigün ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Statistical Significance ◽  
Blood Collection ◽  
Test Results ◽  
Biochemical Tests ◽  
Becton Dickinson ◽  
Two Samples ◽  
Clinically Significant ◽  
Roche Diagnostics ◽  
Blood Collection Tubes

Abstract Objective Blood collection tubes (BCTs) related interferences in test results can adversely influence on patient outcomes. We compared test results of samples in BD (Becton-Dickinson, Franklin Lakes, NJ, USA) Vacutainer Serum Separator Tubes (SST), BD Vacutainer® Barricor™ Plasma BCTs (Barricor™) and BD Vacutainer® Rapid Serum Tube (RST). Materials and methods Thirty-two samples were obtained from patients after the hemodialysis were included in this study. Eight routine clinical chemistry parameters (AST, creatinin, urea, PTH, glucose, LDH, K, calcium) were measured on Roche Cobas Analyzer (Roche Diagnostics, North America). The results of samples obtained from RST and Barricor™ were compared with SST as reference tubes. Results Results of Glucose, K, Urea, PTH from the SST and Barricor™ were statistically significantly different (p = 0.017, p < 0.001, p = 0.011, p < 0.001, respectively). In addition, results of PTH, LDH from SST and RST were significantly different (p < 0.001, p = 0.019). However, statistical significance of test results was not clinically significant for the biochemical parameters. Conclusion Working with Barricor™ may provide not just a fast, clean, high-quality plasma samples, safety results, but also time and cost-effectivity. Therefore, these types of tubes, which are less costly than other BCTs, may be preferred to obtain plasma.

scholarly journals Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Blood Collection ◽  
Test Results ◽  
Sample Collection ◽  
Rapid Separation ◽  
Cell Counts ◽  
Collection Device ◽  
Precision Study ◽  
Clinically Significant ◽  
Blood Specimens

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.

Kyrle's disease in diabetes mellitus and chronic renal failure

1998 ◽  
Vol 11 (1) ◽  
pp. 87-88 ◽  
Author(s):  
Mehmet Harman ◽  
Sema Aytekin ◽  
Sedat Akdeniz ◽  
Mehmet Derici
Keyword(s):  
Diabetes Mellitus ◽  
Renal Failure ◽  
Chronic Renal Failure

A Case of Verrucous Carcinoma Occurring in Patient with Diabetes Mellitus and Chronic Renal Failure

2001 ◽  
Vol 13 (3) ◽  
pp. 190
Author(s):  
You Son Chong ◽  
Seung Won Ahn ◽  
Myeung Nam Kim ◽  
Byung In Ro ◽  
Kye Yong Song
Keyword(s):  
Diabetes Mellitus ◽  
Renal Failure ◽  
Chronic Renal Failure ◽  
Verrucous Carcinoma

Uroangiographic Contrast Media-Induced Nephropathy: Correlations between Their Physicochemical Properties and Renal Damage

2005 ◽  
Vol 72 (4) ◽  
pp. 446-456
Author(s):  
C. Alberti ◽  
M. Piovano ◽  
A. Tizzani
Keyword(s):  
Diabetes Mellitus ◽  
Renal Failure ◽  
Acute Renal Failure ◽  
Chronic Renal Failure ◽  
Contrast Media ◽  
Renal Damage ◽  
Contrast Material ◽  
Vasoactive Mediators ◽  
Adequate Hydration ◽  
Hospital Acquired

Contrast media-induced nephropathy (CN) is an important cause of hospital-acquired acute renal failure. Patients with both diabetes mellitus and renal impairment are at high risk. CN pathophysiology involves activation of the tubulo-glomerular feedback and vasoactive mediators such as renin-angiotensin 2, endothelin, adenosine, ADH, etc. The risk of CN can be minimized by the use of non-ionic, low or isoosmolar, contrast material, adequate hydration and prophylactic pharmacological measures. In patients with chronic renal failure who are undergoing arteriography (e.g. coronary angiography and angioplasty), periprocedural hemofiltration appears effective in preventing further renal damage due to contrast agents.

scholarly journals PROFILE OF CHILDREN AND ADOLESCENTS WITH CHRONIC RENAL FAILURE FOLLOWED UP AT NEPHROLOGY UNITS

2013 ◽  
Vol 5 (3) ◽  
pp. 94-103
Author(s):  
Juliana Oliveira Freitas Miranda ◽  
Ayla Costa Maciel
Keyword(s):  
Diabetes Mellitus ◽  
Renal Failure ◽  
Chronic Renal Failure ◽  
Children And Adolescents

Objetivo: Caracterizar o perfil de crianças e adolescentes com insuficiência renal crônica acompanhados em unidades de nefrologia do município de Feira de Santana- Ba. Métodos: Pesquisa quantitativa, retrospectiva, descritiva, que investigou variáveis sócio-demográficas, clínicas e terapêuticas dos prontuários de 35 crianças e adolescentes acompanhados em unidades de nefrologia de Feira de Santana-BA até junho de 2010. Resultados: A principal etiologia foi a glomerulonefrite crônica (34,2%), 88,6% foram diagnosticados e iniciaram o tratamento entre 10 e 20 anos de idade. As comorbidades mais prevalentes foram hipertensão arterial sistêmica (HAS) (51,4%) e diabetes mellitus (48,6%). As principais manifestações clínicas associadas foram HAS (51,4%), uremia (48,6%), edema (42,9%) e anemia (31,4%). 97,1% realizaram hemodiálise. A maioria dos pacientes continuava em hemodiálise (40%) com até 2 anos de tratamento (54,3%). Conclusão: O estudo permitiu conhecer este perfil, até então desconhecido, podendo contribuir com o planejamento de ações assistenciais voltadas para esta clientela.

Plasma β-Thromboglobulin And Platelet Factor 4 In Patients With Chronic Renal Failure And Effect Of Hemodialysis

1981 ◽  
Author(s):  
Y Endo ◽  
M Mamiya ◽  
K Takahashi ◽  
Keyword(s):  
Renal Failure ◽  
Chronic Renal Failure ◽  
Statistical Significance ◽  
Normal Subjects ◽  
Statistical Correlation ◽  
Platelet Factor 4 ◽  
Cellulose Membrane ◽  
Heparin Infusion ◽  
Platelet Factor ◽  
The Difference

We have reported that jS-thromboglobulin (β-TG) and platelet factor 4 (PF4) increased in chronic renal failure. The purpose of the current study is to reveal a correlation between plasma β-TG (Amersham Corp. England) and renal function, a correlation between plasma β-TG and PF. (Abbott Lab., USA) and the effect of hemodialysis on patients with chronic renal failure.Significantly increased levels of plasma β-TG (76.8±25.5 ng/ml, p<0.01) were observed in 24 patients with chronic renal failure (BUN>20mg/dl), compared to normal subjects (13.2±5.6ng/ml). The increase in β-TG was highly correlated with BUN (r=0.651, p<0.01), creatinine (r=0.778, p<0.01) and creatinine clearance (r=-0.723, p<0.01). Although plasma PF4 (normal 5.0±2.0ng/ml) increased also, no statistical significance could be found. Statistical correlation between β-TG and PF4 was not found in these patients. This reason is thought to Be due to the difference of molecular weight (PF. 8000MW, β-TG 36000MW) and half-life (PF4 30min,β-TG 100min) The high levels of β-TG (89.4±3.4ng/ml) showed a further increase (109.4±5.8ng/dl, p<0.01) after dialysis. This is thought to be due to hemoconcentration, because of no adhesion of platelet to cellulose membrane but about 20% elevation in mean of other blood factors such as RBC, WBC, platelet, fibrinogen etc. The PF4 levels (before, 7.7±1.3ng/ml) which increased at 15min (55.2±19.6ng/ml, p<0.01) and 1 hr (23.7±8.4ng/ml, p< 0.01) are thought to be due to the influence of heparin infusion. The change in PF4. was not accompanied by the change in β-TG. During hemodialysis the decrease of other platelet functions such as adhesiveness, aggregation induced by ADP, collagen and PF3remained unchanged.

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