Analysis of Marine Toxins—Techniques, Method Validation, Calibration Standards, and Screening Methods

2008 ◽  
pp. 39-68
2019 ◽  
Vol 57 (5) ◽  
pp. 648-658 ◽  
Author(s):  
Hong Liu ◽  
Lingkai Wong ◽  
Sharon Yong ◽  
Qinde Liu ◽  
Tang Lin Teo ◽  
...  

Abstract Background The measurement of hemoglobin A1c (HbA1c) is important for diagnosing diabetes mellitus as well as assessing glycemic control in diabetic patients. Commutable whole blood certified reference materials (CRMs) are needed in the measurement of HbA1c for method validation and/or as quality controls. Methods We developed three levels of hemolyzed whole blood CRMs for HbA1c. The certified values were determined using liquid chromatography-isotope dilution tandem mass spectrometry method (LC-IDMS/MS) where two “signature” hexapeptides of HbA1c and hemoglobin A0 (HbA0) were used as the calibration standards. The concentrations of the hexapeptide solutions were determined by amino acid analysis by the LC-IDMS/MS method using amino acid CRMs as the calibration standards. The commutability study was conducted by measuring 25 patient specimens and the whole blood CRMs by both LC-IDMS/MS method and various routine methods using six different clinical analyzers. Results The certified values were determined to be 35.1±2.0, 50.3±1.9 and 65.8±2.6 mmol/mol, respectively. These CRMs showed good commutability on five of the six clinical analyzers but showed poor commutability on one of the clinical analyzers that used similar method as two other analyzers where good commutability was observed. Conclusions With certified target values based on metrological traceability and good commutability on most of the clinical analyzers, the developed whole blood CRMs can be used for method validation or as quality control materials in the measurement of HbA1c. The commutability study results also underscored the need of commutability testing of clinical CRMs using various clinical analyzers.


Author(s):  
V. V. Damiano ◽  
R. P. Daniele ◽  
H. T. Tucker ◽  
J. H. Dauber

An important example of intracellular particles is encountered in silicosis where alveolar macrophages ingest inspired silica particles. The quantitation of the silica uptake by these cells may be a potentially useful method for monitoring silica exposure. Accurate quantitative analysis of ingested silica by phagocytic cells is difficult because the particles are frequently small, irregularly shaped and cannot be visualized within the cells. Semiquantitative methods which make use of particles of known size, shape and composition as calibration standards may be the most direct and simplest approach to undertake. The present paper describes an empirical method in which glass microspheres were used as a model to show how the ratio of the silicon Kα peak X-ray intensity from the microspheres to that of a bulk sample of the same composition correlated to the mass of the microsphere contained within the cell. Irregular shaped silica particles were also analyzed and a calibration curve was generated from these data.


1978 ◽  
Vol 17 (01) ◽  
pp. 36-40 ◽  
Author(s):  
J.-P. Durbec ◽  
Jaqueline Cornée ◽  
P. Berthezene

The practice of systematic examinations in hospitals and the increasing development of automatic data processing permits the storing of a great deal of information about a large number of patients belonging to different diagnosis groups.To predict or to characterize these diagnosis groups some descriptors are particularly useful, others carry no information. Data screening based on the properties of mutual information and on the log cross products ratios in contingency tables is developed. The most useful descriptors are selected. For each one the characterized groups are specified.This approach has been performed on a set of binary (presence—absence) radiological variables. Four diagnoses groups are concerned: cancer of pancreas, chronic calcifying pancreatitis, non-calcifying pancreatitis and probable pancreatitis. Only twenty of the three hundred and forty initial radiological variables are selected. The presence of each corresponding sign is associated with one or more diagnosis groups.


1964 ◽  
Vol 11 (02) ◽  
pp. 506-512 ◽  
Author(s):  
V. A Lovric ◽  
J Margolis

SummaryAn adaptation of “kaolin clotting time” and prothrombin time for use on haemolysed capillary blood provided simple and sensitive screening tests suitable for use in infants and children. A survey of three year’s experience shows that these are reliable routine laboratory tests for detection of latent coagulation disorders.


1997 ◽  
Vol 78 (05) ◽  
pp. 1360-1365 ◽  
Author(s):  
G Freyburger ◽  
S Javorschi ◽  
S Labrouche ◽  
P Bernard

SummaryThe aim of the present study was to evaluate the relative performance of five screening methods for APC resistance caused by the factor V:Q506 mutation: the original method Coatest® APC™ Resistance Chromogenix, a modified method using the same reagents but a predilution 1+4 of the plasma in a factor V deficient plasma from Stago (Stago deficient V) or from Chromogenix (V-DEF Plasma), the Coatest® APC™ Resistance V (Chromogenix), and Accelerimat™ from bioMérieux. Normalization was done against a pool of normal plasmas for the methods from Chromogenix. The study included 350 subjects, 219 were genotyped (174 FV:R506R, 42 FV:Q506R, 3 FV:Q506Q) and most of them were assessed by more than one method. Uncertainty in predicting the FV genotype was evaluated by statistical analysis, which provided a way to quantitate the performance of the different diagnostic approaches. Performance of each test was evaluated by its sensitivity, specificity, R.O.C. curves, positive and negative likelihood ratios (LR), and the overall performance was determined by two parameters derived from the LR curves : the maximum LR value obtained at the crossover of the two curves, and the distance between the two curves for LR = 10. Coatest® APC™ Resistance V and Accelerimat™ were proven to be the methods most able to discriminate for factor V:Q506, while normalization was not shown to improve the screening performance. The original method from Chromogenix was confirmed to undergo many influences (factor XII, PAI-1, thrombin- antithrombin complexes, antithrombin III, hematocrit). Although a very good improvement was provided by the newest methods, they were shown to be influenced by protein S and/or factor V levels in the sample plasma.


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