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Articoli con TAG: variabilità biologica

Importanza dell’utilizzo di Biological Variation Data Critical Appraisal Checklist nel disegno sperimentale di studi di variabilità biologica. Valutazione a confronto di due pubblicazioni sulla variabilità biologica della proteina S100βe dell’enolasi neu
The importance of the Biological Variation Data Critical Appraisal Checklist when designing experimental studies on biological variation. Comparison of two papers reporting biological variation results for S100-β and neuron-specific enolase proteins
<p>The Biological Variation Data Critical Appraisal Checklist (BIVAC) has been designed to evaluate biological variation (BV) studies and the reliability of the associated BV estimates. To illustrate its utility, two studies delivering within-subject BV (CVI) data for S100-&beta; protein and neuron-specific enolase (NSE), markers typically used for melanoma and neuroendocrine tumors, respectively, were appraised using BIVAC. Data from the European Biological Variation Study (EuBIVAS) and the recently published Johnson et al. study (ref n 11) were scored using the 14 BIVAC quality items (QI), with alternatives A, B, C and/or D to verify whether the elements required to obtain reliable BV data, were present and appropriately documented. Grade A indicates compliance with all the QIs and D indicates non compliance. The sizes of the confidence interval (CI) around the CVI estimates were also compared. Johnson&rsquo;s study received a BIVAC grade C, EuBIVAS a grade A. EuBIVAS is a large scale study, with&nbsp;1609 and 1728 results for NSE and S100-&beta;, respectively. In Johnson&rsquo;s study, only 40 results were available. The EuBIVAS CVI estimates [NSE, 10.9% (10.3-11.5); S100-&beta; , 10.2% (9.6-10.7)] were clearly lower than Johnson&rsquo;s CVIs [NSE, 22.1% (9.9-34.3); S100-&beta;, 18.9% (8.5-29.4)]. The overlapping CI between the two estimates are caused by Johnson&rsquo;s CI being about 20 times larger than the corresponding EuBIVAS CI. It is likely that studies that do not comply with all BIVAC QI deliver less reliable, and possibly too high, CVI estimates. Adherence to the BIVAC ensures safe clinical application of BV estimates.</p><p>&nbsp;</p>
Biochimica Clinica ; 43(1) 059-066
Contributi Scientifici - Scientific Paper
Valutazione del sistema Optilite™ per la misura delle catene leggere libere delle immunoglobuline nel siero
Evaluation of the Optilite™ system for the determination of immunoglobulin free light chains in serum (sFLC)
<p>The measurement of sFLC<span style="font-size:14px"><span style="color:rgb(35, 31, 32); font-family:symbol">k</span></span> and l and <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>/<span style="color:#231F20; font-family:symbol; font-size:12.0pt">l</span> ratio calculation is recommended for evaluation and management of plasma cell disorders. However, some analytical issues persist in their measurements, among which a too large long-term imprecision seems to be the main challenge. We evaluated the new Optilite system (The Binding Site) for sFLC determination by comparing its performance with specifications for bias, imprecision (as CV) and total error derived from biological variation of sFLC. We collected data during one year of routine use by employing three reagent lots. The system alignment was checked using the two-level (L and H) Optilite control material by comparing the obtained long-term experimental mean (n=233, both levels) with the manufacturer&rsquo;s assigned values. The protocol for CV evaluation employed the liquid-frozen BioRad Liquichek Control and a frozen serum pool tested for 125 and 79 runs, respectively. Inaccuracy was evaluated by results of four UK-NEQAS exercises [system-specific (Optilite) consensus value as reference]. Average cumulative bias [1.1% (L) and -2.0% (H) for sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>; 5.4% (L) and 0.1% (H) for sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:16px">l</span>, respectively] fulfilled the desirable goals. CVs for sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span> (7.1% for Liquichek and 6.6% for the pool, respectively), sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:16px">l</span> (7.8% for both Liquichek and the pool) and <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>/<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:12pt">l&nbsp;</span>ratio (8.9% for Liquichek and 10.2% for the pool, respectively) failed however to reach minimum quality goals. In EQAS evaluation, all sFLC <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span> and <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:16px">l</span> and 3 out of 4 <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>/<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:12pt">l</span> ratio results were within the allowable total error. In our experience, the Optilite system shows a good method alignment suitable for sFLC interpretation using fixed cut-offs. However, the assay reproducibility is probably not suitable for optimal long-term monitoring of individual patients.</p>
Biochimica Clinica ; 42(1) 32-38
Contributi scientifici - Scientific papers
Variabilità biologica dei parametri dell’esame emocromocitometrico in soggetti sani
Biological variation estimates of complete blood count parameters in healthy subjects
<p>Background: the complete blood count (CBC) is the test more frequently requested in clinical practice. Therefore, estimating the biological variation (BV) of CBC parameters is essential for assessing the analytical performance of hematological analyzers and for enabling accurate data interpretation and appropriate clinical management. This study was aimed to define BV estimates and reference change value (RCV) of CBC parameters.<br />Methods: the study population consisted of 21 healthy volunteers, who had BV of CBC parameters assessed with Sysmex XN. The study protocol, the analytical measurements and the statistical analysis were carried out according to current recommendations of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM).<br />Results: Within-subject BV ranged between 0,3% for mean cell hemoglobin (MCH) and 19,7% for immature granulocytes (IG), whilst between-subjects BVs ranged between 0,9% for mean corpuscolar haemoglobin concentration (MCHC) and 66,6% for microcytic red blood cells (Micro-R). The RCV ranged between 2,3% for MCH and 73,5% for IG.<br />Conclusion: This study has allowed the estimation of BV of many CBC parameters, some of which have not been currently explored, thus leading the way to use RCV calculated according to time of monitoring and/or differentiated by sex.</p>
Biochimica Clinica ; 43(4) 384-393
Contributi Scientifici - Scientific Papers