Quality in the extra-analytical phases of urinalysis

The chemical, physical and morphologic urine examination has undergone radical changes over the last few years, so that the time has come for introducing further changes and modifications in various steps of this important test. The breakthroughs of new technologies have allowed making the laboratory report much more informative for the stakeholders. Nevertheless, important considerations for improving the quality throughout the testing process were also raised, especially in the preanalytical phase. Currently, it might be advisable to pursue consolidation and standardization of the analytical phase, as well as redefinition of clinical targets through construction of a complete, integrated and much more clinically meaningful report. This article aims to review the state of the art in urinalysis, as well as providing useful information for achieving more standardization and quality of this useful diagnostic test

Quality in the extra-analytical phases of urinalysis

The chemical, physical and morphologic urine examination has undergone radical changes over the last few years, so that the time has come for introducing further changes and modifications in various steps of this important test. The breakthroughs of new technologies have allowed making the laboratory report much more informative for the stakeholders. Nevertheless, important considerations for improving the quality throughout the testing process were also raised, especially in the preanalytical phase. Currently, it might be advisable to pursue consolidation and standardization of the analytical phase, as well as redefinition of clinical targets through construction of a complete, integrated and much more clinically meaningful report. This article aims to review the state of the art in urinalysis, as well as providing useful information for achieving more standardization and quality of this useful diagnostic test

A Preliminary Proposal for Quality Control Assessment and Harmonization of Leukocytes Morphology-Structural Parameters (Cell Population Data Parameters)

Background: The cell population data (CPD) measured by Sysmex XN-9000 can be used for screening many hematological and non-hematological disorders. Since little information is available on harmonization of CPD among different instrumentation and clinical laboratories, this study aimed at assessing the current degree of CPD harmonization between separate Sysmex XN modules allocated to the same laboratory.Methods: A total number of 78291 data were used for verification of within-run imprecision, analyzers harmonization, reference ranges and assessment of blood sample stability of CPD parameters, including results of daily quality control testing and those generated in samples collected from blood donors and healthy volunteers.Results: Within-run imprecision of CPD parameters ranged between 0.4 and 14.1%. Good agreement was found among five different XN-modules, especially when values were adjusted after calculation of instrument-specific alignment factors. The bias of all parameters remained always lower than the reference change values in samples stored for up to 8 hours, regardless of storage temperature.Conclusions: The imprecision of CPD parameters was acceptable, except for those reflecting the dispersion of cellular clusters. Due to the lack of reference control materials, we showed that the use of data generated on a large number of normal routine samples (i.e., a Moving Average population) may be a reliable approach for testing analyzers harmonization. Nevertheless, availability of both calibration and quality control materials for these parameters is highly advisable in the future. We finally showed that whole blood samples may be stable for up to 2-4 hours for most CPD parameters

Automated cerebrospinal fluid cell counts using the new body fluid mode of Sysmex UF-1000i

Background: We evaluated the new body fluid module on Sysmex UF1000i (UF1000i-BF) for analysis of white blood cell (WBC) and red blood cell (RBC) in cerebrospinal fluid (CSF). Methods: WBC and RBC counting were compared between UF1000i-BF and Fuchs-Rosenthal counting chamber in 67 CSF samples. This study also included the evaluation of between-day precision, limit of blank (LoB), limit of detection (LoD), functional sensitivity (limit of quantitation, LoQ), carryover and linearity. Diagnostic agreement for differentiation between normal and increased WBC counts (>= 5.0 x 10(6)/L) was also assessed. Results: The agreement between UF1000i-BF and manual WBC counts was otpiaml in all CSF samples (r = 0.99; y = 1.05x + 0.09). A modest overestimation was noticed in samples with WBC = 18 x 10(6)/L (r = 0.98; y = 1.01x + 8.90). Between-day precision was good, with coefficient of variations (CVs) lower than 7.2% for both WBC and RBC. The LoBs were 0.1 x 10(6) WBC/L and 1.2 x 10(6) RBC/L, the LoDs were 0.7 x 10(6) WBC/L and 5.5 x 10(6) RBC/L, the LoQswere 2.4x10(6) WBC/L and 18.0 x 10(6) RBC/L, respectively. Linearity was excellent (r = 1.00 for bothWBC and RBC). Carryover was negligible. Excellent diagnostic agreement was obtained at 4.5 x 10(6) WBC/L cut-off (sensitivity, 100%; specificity, 97.4%). Conclusion: The UF1000i-BF provides rapid and accurate WBC and RBC counts in clinically relevant values of CSF cells. The use of UF1000i-BF may hence allow to replace routine optical counting, except for samples displaying abnormal WBC counts or abnormal scattergram distribution, for which differential cell counts may still be required. (C) 2015 Wiley Periodicals, Inc

Association between periodontal disease and Interleukin-1β +3953 and vitamin D receptor Taq1 genetic polymorphisms in an Italian caucasian population

Periodontal diseases entail a variety of conditions affecting the periodontium. The pathogenesis results from a complex interaction of genetic and environmental factors. Although there are evidences to confirm a role of genetic determinants, the outcome of the available studies is controversial and the largest part of the research has been carried out in Asian populations. Methods: We investigated two polymorphisms in the genes encoding Interelukin-1β (IL-1β +3953 C>T; rs1143634) and vitamin D receptor (VDR Taq1; rs731236) in 42 Caucasian patients with chronic periodontal disease and 39 Caucasian subjects, matched for age and gender. Results: The IL-1β C allele was present in 100% of cases and 92% of controls (p=0.07), the T allele was present in 19% of cases and in 44% controls(p=0.017). The prevalence of the VDR Taq1 tt genotype was lower in patients as compared with controls (i.e., 10 versus 59%; p<0.01), whereas the tT and TT genotypes were disproportionally higher in patients than in cases (i.e., 62 versus 33% for tT and 29% versus 8% for TT; p<0.01). The t allele was present in 71% of cases and 92% of controls (p=0.016), whereas the T allele was present in 90% of patients with periodontal disease and in 41% controls (p<0.01). Conclusion: The results of this case control study attest that the T allele of VDR Taq1 is strongly associated with periodontal disease, whereas the t allele of the IL-1β +3953 confers a slightly protection against the risk of periodontitis

A specific abnormal scattergram of peripheral blood leukocytes suggestive for the presence of proerythroblast

A specific abnormal scattergram of peripheral blood leukocytes suggestive for the presence of proerythroblast

Validation rules for blood smear revision after automated hematological testing using Mindray CAL-8000

This article was aimed to test the use of validation rules for blood smear review after automated hematological testing using Mindray CAL-8000 (two hematological analyzers and one autoslider)

Lack of harmonization in high fluorescent cell automated counts with body fluids mode in ascitic, pleural, synovial, and cerebrospinal fluids

INTRODUCTION. Cellular analysis in body fluids (BFs) provides important diagnostic information in various pathological settings. This study was hence aimed at comparing automated cell count obtained with Mindray BC-6800 (BC-BF) vs Sysmex XN-series (XN-BF) and evaluating other quantitative and qualitative information provided by these analyzers in ascitic (AF), pleural (PF), synovial (SF), and cerebrospinal (CSF) fluids. METHODS: Three hundred and fifty-one samples (99 AFs, 45 PFs, 75 SFs, and 132 CSFs) were analyzed in parallel with BC-BF, XN-BF, and optical microscopy (OM). The study also included the assessment of diagnostic agreement among BC-BF, XN-BF, and OM. RESULTS: The comparison of BC-BF vs XN-BF yielded slopes of Passing and Bablok regression always comprised between 0.9 and 1.0 except for EO-BF and HF-BF, whilst the intercepts ranged from -0.4 for MN-BF and 12.0 for PMN-BF. The bias was comprised between -103.3% and 67.1% for HF-BF and EO-BF, respectively. A significant bias was found for TC-BF, WBC-BF, HF-BF (negative bias) and for PMN-BF and EO-BF (positive bias). The agreement (Cohen's kappa) between XN-BF and BC-BF was always ≥0.7, ranging between 0.87 in CSFs and 0.94 in AFs, and that with OM was similar (ie, 0.85 and 0.96). CONCLUSION: The cytometric analysis of BF samples using BC-BF and XN-BF is clinically favorable when appropriately combined with OM. Quantitative and qualitative parameters displayed optimal agreement, whilst instrument-specific cut-offs should be defined and implemented for HF-BF and EO-BF. Further efforts should be made for achieving better harmonization in cytometric analysis of BF samples

Biological variation of platelet parameters determined by the Sysmex XN haematology analyzer

This study was aimed to define the short- and medium-term biological variation (BV) estimates, the index of individuality and the reference change value (RCV) of platelet count, platelet distribution width, mean platelet volume, platelet larger cell ratio, plateletcrit and immature platelet fraction