HemoScreen hematology analyzer compared to Sysmex XN for complete blood count, white blood cell differential, and detection of leukocyte abnormalities.

We compared a point-of-care HemoScreen hematology analyzer to an automated Sysmex XN analyzer for complete blood count (CBC) and white blood cell (WBC) differential, and evaluated its capacity to detect leukocyte abnormalities. A total of 100 K2-EDTA whole blood samples, median age 56 years (2 months to 92 years), were compared. For CBC and WBC differential we compared 74 samples with no confirmed abnormal leukocytes. For 26 samples both analyzers gave flagging regarding leukocytes and the accuracy of the flagging was compared. Abnormal leukocytes were confirmed with manual microscopy (200 cells). HemoScreen CBC and WBC differential were highly comparable to Sysmex XN for most of the essential parameters (r = 0.909-0.975). More variation was seen for basophil and monocyte counts (r = 0.452 and 0.753, respectively). Sysmex XN gave more false WBC abnormal flagging (n = 15 altogether) compared to HemoScreen. In addition, Sysmex XN, as well as HemoScreen, gave false WBC flagging for eight samples confirmed normal. The samples verified by microscopy review to truly contain leukocyte abnormalities (n = 18) were flagged abnormal with both analyzers. The specificity for analyzer flagging was 72% and 88% for Sysmex XN and HemoScreen, respectively. HemoScreen hematology analyzer is essentially comparable to Sysmex XN for CBC and WBC differential analysis. Most importantly, HemoScreen detected all the samples confirmed to include abnormal leukocytes. HemoScreen was less prone for false WBC flagging compared to Sysmex XN, thereafter requiring less microscopy review. These abilities increase its utility in small health care units. Studies with a larger number of abnormal leukocyte samples are needed to confirm HemoScreen performance.

Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

OBJECTIVES: Although laboratory result presentation may lead to information overload and subsequent missed or delayed diagnosis, little has been done in the past to improve this post-analytical issue. We aimed to investigate the efficiency, efficacy and user satisfaction of alternative report formats. METHODS: We redesigned cumulative (sparkline format) and single reports (improved tabular and z-log format) and tested these on 46 physicians, nurses and medical students in comparison to the classical tabular formats, by asking standardized questions on general items on the reports as well as on suspected diagnosis and follow-up treatment or diagnostics. RESULTS: Efficacy remained at a very high level both in the new formats as well as in the classical formats. We found no significant difference in any of the groups. Efficiency improved in all groups when using the sparkline cumulative format and marginally when showing the improved tabular format. When asking medical questions, efficiency and efficacy remained similar between report formats and groups. All alternative reports were subjectively more attractive to the majority of participants. CONCLUSIONS: Showing cumulative reports as a graphical display led to faster detection of general information on the report with the same level of correctness. Considering the familiarity bias of the classical single report formats, the borderline-significant improvement of the alternative tabular format and the non-inferiority of the z-log format, suggests that single reports might benefit from some improvements derived from basic information design.

Presentation and formatting of laboratory results: a narrative review on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group "postanalytical phase" (WG-POST).

In laboratory medicine, much effort has been put into analytical quality in the past decades, making this medical profession one of the most standardized with the lowest rates of error. However, even the best analytical quality cannot compensate for errors or low quality in the pre or postanalytical phase of the total testing process. Guidelines for data reporting focus solely on defined data elements, which have to be provided alongside the analytical test results. No guidelines on how to format laboratory reports exist. The habit of reporting as much diagnostic data as possible, including supplemental information, may lead to an information overload. Considering the multiple tasks physicians have to do simultaneously, unfiltered data presentation may contribute to patient risk, as important information may be overlooked, or juxtaposition errors may occur. As laboratories should aim to answer clinical questions, rather than providing sole analytical results, optimizing formatting options may help improve the effectiveness and efficiency of medical decision-making. In this narrative review, we focus on the underappreciated topic of laboratory result reporting. We present published literature, focusing on the impact of laboratory result report formatting on medical decisions as well as approaches, potential benefits, and limitations for alternative report formats. We discuss influencing variables such as, for example, the type of patient (e.g. acute versus chronic), the medical specialty of the recipient of the report, the display of reference intervals, the medium or platform on which the laboratory report is presented (printed paper, within electronic health record systems, on handheld devices, etc.), the context in which the report is viewed in, and difficulties in formatting single versus cumulative reports. Evidence on this topic, especially experimental studies, is scarce. When considering the medical impact, it is of utmost importance that laboratories focus not only on the analytical aspects but on the total testing process. The achievement of high analytical quality may be of minor value if essential results get lost in overload or scattering of information by using a non-formatted tabular design. More experimental studies to define guidelines and to standardize effective and efficient reporting are most definitely needed.

A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications).

European Union (EU) Directive 2013/55/EC (The Recognition of Professional Qualifications) allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge, skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically within the Union. The backbone of the European Federation of Clinical Chemistry and Laboratory Medicine's (EFLM) proposed Common Training Framework for non-medical Specialists in Laboratory Medicine is outlined here. It is based on an Equivalence of Standards in education, training, qualifications, knowledge, skills, competences and the professional conduct associated with specialist practice. In proposing the recognition of specialist practice EFLM has identified 15 EU Member States able to meet Equivalence and in whom the profession and/or its training is regulated (an additional EU Commission requirement). The framework supports and contributes to the Directive's enabling goals for increasing professional mobility, safeguarding consumers and ensuring a more equitable distribution of skills and expertise across the Member States. It represents EFLM's position statement and provides a template for professional societies and/or competent authorities to engage with the EU Commission.

Reporting Sysmex XN Absolute Neutrophil Count in Samples with Leukocyte Analyzer Flagging.

OBJECTIVE: To provide faster laboratory data reporting, we evaluated the accuracy of Sysmex XN (Sysmex Inc, Kobe, Japan) absolute neutrophil count (ANC) in the presence of analyzer flagging. METHODS: Sysmex XN and manual microscopy ANC were compared with 80 autovalidated control specimens and with 280 study specimens with analyzer flagging regarding immature granulocytes (IG) >3% or other leukocyte abnormalities. Specimens with ambiguous neutrophil clusters were excluded. RESULTS: A slight positive overall method bias was seen for Sysmex XN compared to manual microscopy (n = 280), 0.025 (95% confidence interval [CI], -0.023 to 0.069) × 109/L. With IG > 10% (n = 123) the bias was larger, but not clinically significant, 0.17 (95% CI, 0.060-0.25) × 109/L. No clinically significant difference was seen in neutropenic (ANC < 1.5 × 109/L) specimens (n = 91), 0.070 (95% CI, -0.013 to 0.14) × 109/L. CONCLUSION: These data indicate that Sysmex XN ANC can be reported in the presence of certain analyzer flagging to improve patient care.

Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults.

BACKGROUND: Booster vaccination against tetanus and diphtheria at 10-year intervals is commonly recommended. Reduced antigen content diphtheria and tetanus toxoids and acellular pertussis (dTpa) vaccines developed for booster vaccination of preschool children, adolescents, and adults are licensed for once-in-a-lifetime use in most countries. Objective. To evaluate decennial administration of a dTpa vaccine. Methods. Young adults vaccinated with dTpa or diphtheria and tetanus toxoids followed by acellular pertussis (DT+ap) 1 month later in a clinical trial 10 years previously received 1 dTpa dose. Blood samples were taken before and 1 month after vaccination. Antibody concentrations against vaccine antigens were measured by enzyme-linked immunosorbent assay. Solicited and unsolicited symptoms and serious adverse events were recorded. RESULTS: Eighty-two individuals were enrolled in the study. In the 75 individuals who had received the dTpa vaccine 10 years previously, prevaccination seroprotection or seropositivity rates were 98.8% (diphtheria), 97.5% (tetanus), 64.6% (pertussis toxoid), 100% (filamentous hemagglutinin), and 96.3% (pertactin). One month after the second booster, all study participants were seroprotected or seropositive against all vaccine antigens. Antibody concentrations increased by a similar magnitude as 10 years previously. During the 4-day follow-up, 9.9% of participants recorded grade 3 pain; 17.3% and 18.5% recorded redness and swelling of 50 mm or larger, respectively; and 8.6% recorded fever (temperature, 37.5 degrees C). No serious adverse events were considered causally related to the vaccine. CONCLUSIONS: A second dTpa booster was highly immunogenic and well tolerated in this population of young adults. This study supports the use of this vaccine as a decennial booster. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00610168 .

Quantification of alkylresorcinol metabolites in urine by HPLC with coulometric electrode array detection.

BACKGROUND: Whole-grain rye and wheat cereals contain high amounts of alkylresorcinols (ARs), phenolic lipids. ARs can be quantified in plasma. Two recently identified urinary AR metabolites, 3,5-dihydroxyphenylbenzoic acid (DHBA) and 3-(3,5-dihydroxyphenyl)-1-propanoic acid (DHPPA), may be useful as biomarkers of intake of whole-grain rye and wheat. METHODS: We evaluated 4 pretreatment protocols for quantifying urinary DHBA and DHPPA using HPLC coupled with a coulometric electrode array detector. Syringic acid was used as the internal calibrator. RESULTS: Measured urinary concentrations of DHBA and DHPPA were 0.8-115 micromol/L. The mean recoveries of all added concentrations were 85%-104% for DHBA and 86%-99% for DHPPA, depending on the degree of the purification. The protocol versions with less purification correlated well with the protocol including highest purification. The correlation coefficients (r(2)) were 0.9699-0.8153 for DHBA and 0.9854-0.8371 for DHPPA. CONCLUSION: Although the protocol with the most purification steps was most specific, all protocols were suitable for measuring DHBA and DHPPA in urine. The rapid protocol with simple hydrolysis could be used in large-scale clinical studies. Additional investigation is needed to clarify whether these metabolites are useful biomarkers of whole-grain intake and helpful in the exploration of its association with human diseases.

Alkylresorcinols from whole-grain wheat and rye are transported in human plasma lipoproteins.

Alkylresorcinols with alkyl chains C17:0-C25:0 are abundant in whole-grain wheat and rye. Concentrations in human plasma have been suggested to be biomarkers of dietary whole-grain intake. We measured human plasma, erythrocyte, and lipoprotein alkylresorcinol concentrations and alkylresorcinol homolog distribution, and evaluated the use of plasma alkylresorcinol concentration as a dietary biomarker of whole-grain intake compared with serum enterolactone. A total of 15 subjects (8 women) consumed whole-grain wheat or whole-grain rye crisp bread ( approximately 100 g/d) in a crossover design for 1 wk. The test bread periods were preceded by 1-wk periods of consuming refined wheat bread. Plasma, erythrocyte, lipoprotein alkylresorcinol, and serum enterolactone concentrations were measured before and after each period, and plasma alkylresorcinols and serum enterolactone were measured after habitual diet intake before and 1 wk after the trial. Plasma alkylresorcinols are transported in lipoproteins with VLDL and HDL being the main carriers. AR concentrations in plasma, erythrocytes, and lipoproteins were increased (P < 0.05) by whole-grain wheat bread and even more so with rye crisp bread, although interindividual variation was high. The alkylresorcinol homolog C17:0 to C21:0 ratio in plasma was higher after the whole-grain rye diet period compared with the whole-grain wheat diet period (P < 0.05). Serum enterolactone concentrations were increased significantly by whole-grain rye intake only in men. This is the first report to show that alkylresorcinols in human plasma are mainly transported in lipoproteins. The plasma alkylresorcinol C17:0 to C21:0 ratio reflects intake of whole-grain wheat and rye, and the plasma total alkylresorcinol concentration appears to be a useful biomarker of whole-grain cereal intake.