Indirect Determination of Hematological Reference Intervals in Healthy Moroccan Adults Using Outpatient Data.

BACKGROUND: Reference intervals are essential for the interpretation of clinical laboratory tests and patient management. This study aims to determine age and gender reference intervals of complete blood count (CBC) in the Moroccan population by using the indirect approach. METHODS: The study used data of ostensibly healthy adults collected retrospectively using the laboratory information system (LIS) of the Laboratory for Research and Medical Analysis of the Fraternal Royal Gendarmerie in Rabat (Morocco), between January 2018 and February 2020. The study included 5,898 men and 10,172 women ranging in age from 18 to 90 years. The lower and upper reference limits of CBC parameters were calculated using the nonparametric technique, as suggested by the Clinical and Laboratory Standards Institute (CLSI). RESULTS: All hematological parameters showed no clinically significant gender-related differences, except small differences in the values of hemoglobin (HB), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). There were also no clinically significant agerelated differences for median values of all hematology analytes in both genders, except for platelet count (PLT) that continued to decline with increasing age in men and women, and Red blood cell count (RBC), Hematocrit (HCT), and hemoglobin (HB) that tended to increase with age but decrease in older age groups in men while they tended to increase with age in women. CONCLUSIONS: The indirect method can be used to establish reference intervals for CBC, with appropriate selection criteria and statistical tools. Our findings differed from the reference ranges provided in the textbook and also in other countries' reports.

Biophysical and rheological biomarkers of red blood cell physiology and pathophysiology.

PURPOSE OF REVIEW: This review summarizes the significant biophysical and rheological aspects of red blood cell physiology and pathophysiology in relation to recent advances in microfluidic biomarker assays and emerging targeted or curative intent therapies. RECENT FINDINGS: Alterations in red cell biophysical properties and blood rheology have been associated with numerous hematologic and circulatory disorders. Recent advances in biomarker assays enable effective assessment of these biophysical and rheological properties in normoxia or physiological hypoxia in a clinically meaningful way. There are emerging targeted or curative therapies that aim to improve red cell pathophysiology, especially in the context of inherited hemoglobin disorders, such as sickle cell disease. SUMMARY: Red cell pathophysiology can be therapeutically targeted and the improvements in membrane and cellular biophysics and blood rheology can now be feasibly assessed via new microfluidic biomarker assays. Recent advances provide a new hope and novel treatment options for major red cell ailments, including inherited hemoglobin disorders, membrane disorders, and other pathologies of the red cell, such as malaria.

Personalized Reference Intervals in Laboratory Medicine: A New Model Based on Within-Subject Biological Variation.

BACKGROUND: The concept of personalized medicine has received widespread attention in the last decade. However, personalized medicine depends on correct diagnosis and monitoring of patients, for which personalized reference intervals for laboratory tests may be beneficial. In this study, we propose a simple model to generate personalized reference intervals based on historical, previously analyzed results, and data on analytical and within-subject biological variation. METHODS: A model using estimates of analytical and within-subject biological variation and previous test results was developed. We modeled the effect of adding an increasing number of measurement results on the estimation of the personal reference interval. We then used laboratory test results from 784 adult patients (>18 years) considered to be in a steady-state condition to calculate personalized reference intervals for 27 commonly requested clinical chemistry and hematology measurands. RESULTS: Increasing the number of measurements had little impact on the total variation around the true homeostatic set point and using ≥3 previous measurement results delivered robust personalized reference intervals. The personalized reference intervals of the study participants were different from one another and, as expected, located within the common reference interval. However, in general they made up only a small proportion of the population-based reference interval. CONCLUSIONS: Our study shows that, if using results from patients in steady state, only a few previous test results and reliable estimates of within-subject biological variation are required to calculate personalized reference intervals. This may be highly valuable for diagnosing patients as well as for follow-up and treatment.

Standardization for obtaining blood viscosity: A systematic review.

INTRODUCTION: There is evidence to suggest that blood viscosity (BV) is involved in several pathological processes. In this review, we evaluated the different methods of BV acquisition, analyzing the sample storage time, the storage temperature, the acquisition time, the acquisition temperature, sample volume, and shear rates, in order to standardize this technique. METHODS: We selected 50 articles with methods of obtaining BV, evaluating pathologies through BV, comparing rheological equipment, monitoring, and regulating BV. RESULTS AND CONCLUSION: Measurements should be obtained as soon as possible, to reduce hemorheological changes. It is necessary to refrigerate them at 4°C when the storage time is long. The acquisition time is related to the equipment used. BV measurements at 37°C will represent the real BV in vivo more faithfully. In order to understand the BV phenomena, the shear rates must be between 0.1 and 1000 s-1. There is a wide variety of equipment available for measuring the BV.

Prognostic association of routinely measured biomarkers in patients admitted to critical care: a systematic review.

PURPOSE: To examine reported prognostic associations of routine blood measurements in the intensive care unit. MATERIALS AND METHODS: We searched PubMed, EMBASE through 28th May 2020 to identify all studies in adult critical care investigating associations between parameters measured routinely in whole blood, plasma or serum, and length of stay or mortality. Registration: PROSPERO; CRD42019122058. RESULTS: A total of 128 studies, reporting 28 different putative prognostic biomarkers, met eligibility criteria. Those most frequently examined were red cell distribution width, neutrophil-to-lymphocyte ratio, C-reactive protein, and platelet count. A higher red cell distribution width, a lower platelet count, and a higher neutrophil-to-lymphocyte ratio were consistently associated with both increased mortality and length of stay. A lower level of albumin was consistently associated with greater mortality. C-reactive protein was inconsistent. Most studies (n = 110) used regression modelling with wide variation in variable selection and covariate-adjustment; none externally validated the proposed predictive models. CONCLUSIONS: Simple regression models have so far proved inadequate for the complexity of data available from routine blood sampling in critical care. Adoption of a direct causal framework may help better assess mechanistic processes, aid design of future studies, and guide clinical decision making using routine data.

Non-specific blood tests as proxies for COVID-19 hospitalisation: are there plausible associations after excluding noisy predictors?

This study applied causal criteria in directed acyclic graphs for handling covariates in associations for prognosis of severe coronavirus disease 2019 (COVID-19) cases. To identify non-specific blood tests and risk factors as predictors of hospitalisation due to COVID-19, one has to exclude noisy predictors by comparing the concordance statistics (area under the curve - AUC) for positive and negative cases of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Predictors with significant AUC at negative stratum should be either controlled for their confounders or eliminated (when confounders are unavailable). Models were classified according to the difference of AUC between strata. The framework was applied to an open database with 5644 patients from Hospital Israelita Albert Einstein in Brazil with SARS-CoV-2 reverse transcription - polymerase chain reaction (RT-PCR) exam. C-reactive protein (CRP) was a noisy predictor: hospitalisation could have happened due to causes other than COVID-19 even when SARS-CoV-2 RT-PCR is positive and CRP is reactive, as most cases are asymptomatic to mild. Candidates of characteristic response from moderate-to-severe inflammation of COVID-19 were: combinations of eosinophils, monocytes and neutrophils, with age as risk factor; and creatinine, as risk factor, sharpens the odds ratio of the model with monocytes, neutrophils and age.

A Reference chart for clinical biochemical tests of hemolyzed serum samples.

BACKGROUND: Although the effect of hemolysis has been extensively evaluated on clinical biochemical tests, a practical guidance for laboratory staff to rapidly determine whether a hemolyzed blood sample is acceptable and how to interpret the results is lacking. Here, we introduce a chart as a convenient reference for dealing with such samples. METHODS: Serum samples with 0.1%, 0.3%, 1%, 3%, and 10% hemolysis were prepared from sonicated endogenous red blood cells and received 35 wet and 22 dry clinical biochemical tests, respectively. The contributing part in the biochemical test result at each hemolysis condition was derived by subtracting the original test result of this sample with no hemolysis. The net results were used for analyses and preparation of the reference chart. RESULTS: The reference chart displayed the analytically calculated hemolysis interference and related statistical analyses. The chart also provided the color appearance of serum samples at each hemolysis condition for clinical staffs to determine whether a hemolyzed sample could be accepted. CONCLUSION: In clinical laboratories, preparation of such a reference chart is extremely useful in dealing with hemolyzed blood samples for clinical biochemical tests.

Establishment of improved review criteria for hematology analyzers in cancer hospitals.

BACKGROUND: Although hematologic review criteria for general hospitals have been established, they may be insufficient for cancer hospitals. This study aimed to establish the appropriate review criteria for hematology analyzers in cancer hospitals. METHODS: A total of 1003 samples from our hospital were randomly selected for blood smear preparation and microscopic review. The review criteria of the International Consensus Group for Hematology Review (ICGH) and Chinese consensus group were used to obtain the review, true-negative (TN), true-positive (TP), false-negative (FN), and false-positive (FP) rates, as well as the triggered rules. Our review criteria were established by comparing flag or numeric value information of TP and FP samples, adjusting rules to obtain better efficiency, a low slide review rate, and an acceptable FN rate. RESULTS: Overall, 197 (19.64%) samples showed positive smear findings. Compared to the ICGH criteria, the slide review rate of the newly established criteria declined from 51.25% to 39.28%, and the TP and TN rates increased from 17.85% and 46.06% to 23.13% and 55.83%, respectively. The FN rate of the newly established criteria was 3.69%. Another set of samples used to validate the newly established criteria yielded the review, FN, and FP rates as 33.49%, 1.86%, and 25.58%, respectively. CONCLUSION: The newly established review criteria for hematology analyzers enabled the prompt identification, smear, and further verification of doubtful specimens, without a significant increase in the workload, thus improving the efficiency of the review process. This study provided data support for other cancer hospitals to establish review criteria.

Three years' experience of quality monitoring program on pre-analytical errors in china.

BACKGROUND: Various errors in the procedure of specimen collection have been reported as the primary causes of pre-analytical errors. The aim of this study was to monitor and assess the reasons and frequencies of rejected samples in China. METHODS: A pre-analytical external quality assessment (EQA) scheme involving six quality indicators (QIs) was conducted from 2017 to 2019. Rejection rate was calculated for each QI. The difference of the rejection rates over the time was checked by Chi-square test. Furthermore, the 25th, 50th, and 75th percentiles of the results from total laboratories each year were calculated as optimum, desirable, and minimum level of performance specifications. RESULTS: In total, 423 laboratories submitted data continuously for six EQA rounds. The overall rejection rates were 0.2042%, 0.1709%, 0.1942%, 0.1689%, 0.1593%, and 0.1491%, respectively. The most common error was sample hemolysed (0.0514%-0.0635%), and the least one was sample not received (0.0008%-0.0014%). A significant reduction in percentages was observed for all QIs. For biochemistry and immunology, hemolysis accounted for more than half of the rejection causes, while for hematology, the primary cause shifted from incorrect fill level to sample clotted. The quality specifications had improved over time, except for the optimum level. CONCLUSION: The significant reduction in error rates on sample rejection we observed suggested that laboratories should pay more attention to the standardized specimen collection. We also provide a benchmark for QIs performance specification to help laboratories increase awareness about the critical aspects in the need of improvement actions.

The automated processing algorithm to correct the test result of serum neuron-specific enolase affected by specimen hemolysis.

INTRODUCTION: Serum neuron-specific enolase (NSE) is an important tumor marker for small cell lung cancer and neuroblastoma. However, the test of serum NSE compromised by specimen hemolysis is presented as a falsely higher result, which seriously disturbs clinical decision. This study aimed to establish a solution integrated with laboratory information system to clear the bias from hemolysis on serum NSE test. METHODS: The reference range of serum hemolysis index (HI) was first established, and specimen hemolysis rate was compared between HI test and visual observation. NSE concentration in serum pool with normal HI was spiked with serial diluted lysates from red blood cells to deduce individual corrective equation. The agreement between individual corrective equation and original NSE test was assayed by Bland and Altman plots. RESULTS: The high HI existed in 32.6% of specimens from patients. The NSE median of hemolyzed specimens was significant higher than the baseline (p = 0.038), while the corrected NSE median had no difference compared with the baseline (p = 0.757). The mean difference of corrected NSE and initial NSE was 1.92%, the SD of difference was 5.23%, and furthermore, the difference was independent of tendency of HI (Spearman r = -0.069, p = 0.640). The 95% confidence interval of mean difference (from -8.33% to 12.17%) was less than the acceptable bias range (±20%). CONCLUSION: The agreement between individual correction equation and NSE assay was satisfied. Our automated processing algorithm for serum NSE could provide efficient management of posttest data and correct positive bias from specimen hemolysis.

Comparison of Conventional Lipoprotein Tests and Apolipoproteins in the Prediction of Cardiovascular Disease.

BACKGROUND: Total cholesterol and high-density lipoprotein cholesterol (HDL-C) measurements are central to cardiovascular disease (CVD) risk assessment, but there is continuing debate around the utility of other lipids for risk prediction. METHODS: Participants from UK Biobank without baseline CVD and not taking statins, with relevant lipid measurements (n=346 686), were included in the primary analysis. An incident fatal or nonfatal CVD event occurred in 6216 participants (1656 fatal) over a median of 8.9 years. Associations of nonfasting lipid measurements (total cholesterol, HDL-C, non-HDL-C, direct and calculated low-density lipoprotein cholesterol [LDL-C], and apolipoproteins [Apo] A1 and B) with CVD were compared using Cox models adjusting for classical risk factors, and predictive utility was determined by the C-index and net reclassification index. Prediction was also tested in 68 649 participants taking a statin with or without baseline CVD (3515 CVD events). RESULTS: ApoB, LDL-C, and non-HDL-C were highly correlated (r>0.90), while HDL-C was strongly correlated with ApoA1 (r=0.92). After adjustment for classical risk factors, 1 SD increase in ApoB, direct LDL-C, and non-HDL-C had similar associations with composite fatal/nonfatal CVD events (hazard ratio, 1.23, 1.20, 1.21, respectively). Associations for 1 SD increase in HDL-C and ApoA1 were also similar (hazard ratios, 0.81 [both]). Adding either total cholesterol and HDL-C, or ApoB and ApoA, to a CVD risk prediction model (C-index, 0.7378) yielded similar improvement in discrimination (C-index change, 0.0084; 95% CI, 0.0065, 0.0104, and 0.0089; 95% CI, 0.0069, 0.0109, respectively). Once total and HDL-C were in the model, no further substantive improvement was achieved with the addition of ApoB (C-index change, 0.0004; 95% CI, 0.0000, 0.0008) or any measure of LDL-C. Results for predictive utility were similar for a fatal CVD outcome, and in a discordance analysis. In participants taking a statin, classical risk factors (C-index, 0.7118) were improved by non-HDL-C (C-index change, 0.0030; 95% CI, 0.0012, 0.0048) or ApoB (C-index change, 0.0030; 95% CI, 0.0011, 0.0048). However, adding ApoB or LDL-C to a model already containing non-HDL-C did not further improve discrimination. CONCLUSIONS: Measurement of total cholesterol and HDL-C in the nonfasted state is sufficient to capture the lipid-associated risk in CVD prediction, with no meaningful improvement from addition of apolipoproteins, direct or calculated LDL-C.

Paraprotein implicated in hardware failures in nucleic acid testing of blood donors.

BACKGROUND AND OBJECTIVES: Analyser blockage due to gel formation by paraproteins leading to invalid results is a rare problem in viral nucleic acid testing (NAT) at New Zealand Blood Service (NZBS) despite many blood samples tested without problems from individuals with known paraproteins. This study aimed to identify common factors in samples causing blockages. METHOD: Retrospective data were gathered on blood samples known to have blocked analysers at NZBS testing sites. Patients with plasma cell dyscrasia undergoing haematopoietic stem cell (HSC) harvest formed the comparator arm. These patients were identified from registry data of individuals undergoing autologous stem cell transplantation at Auckland City Hospital between 2013 and 2017. RESULTS: Four individuals were identified as having blocked analysers between 2010 and 2018. A total of 184 HSC transplant patients were identified, with contemporaneous paraprotein levels available for 177 (96%). Patients with intact immunoglobulin subtypes (134, 73%) were further analysed. Of these, 119 patients (65%) also had total protein and globulin levels available. Mean paraprotein (37.5 g/l), total protein (95.3 g/l), globulin levels (51.5 g/l) and proportion of lambda subtype (75%) were higher in the blocker group compared with non-blocking comparators (4.7 g/l, 66.8 g/l, 27.7 g/l, 36.6% respectively) (P = 0·03, 0·02, 0·007, 0·12). The highest paraprotein and total protein levels from the non-blocking cohort overlapped with the lowest of the blocker group. DISCUSSION: High protein levels (paraprotein >20 g/l, total protein >75 g/l) and a trend towards lambda subtype were associated with NAT analyser blockage. The overlap with non-blocking donor samples suggests factors in addition to protein quantity that are also important.

Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects.

Background The complete blood count (CBC) is a basic test routinely ordered by physicians as a part of initial diagnostic work-up on their patients. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are needed to establish analytical performance specifications. Our aim was to define the BV of CBC parameters using a rigorous protocol that is compliant with the Biological Variation Data Critical Appraisal Checklist (BIVAC) provided by the European Federation of Clinical Chemistry and Laboratory Medicine. Methods Blood samples drawn from 41 healthy Chinese subjects (22 females and 19 males; 23-59 years of age) once monthly for 6 consecutive months were analyzed using an ABX Pentra 80 instrument. The instrument was precisely calibrated. All samples were analyzed in duplicate for 13 CBC parameters. The data were assessed for outliers, normality, and variance homogeneity prior to nested ANOVA. Gender-stratified within-subject (CVI) and between-subject (CVG) BV estimates were calculated. Results The number of remaining data for each subject was 442-484 after removing outliers. No significant differences existed between female/male CVI estimates. Except for leukocytes, neutrophils, and lymphocytes, the mean values of 10 parameters differed significantly between genders, rendering partitioning of CVG data between genders. No significant differences were detected between most BV estimates and recently published estimates representing a Europid population. Conclusions Most BV estimates in BIVAC-compliant studies are similar. The turnover time of blood cells and age distribution of participants should be considered in a CBC BV study. Our study will contribute to global BV estimates and future studies.

Risk assessment of the total testing process based on quality indicators with the Sigma metrics.

Background Evidence-based evaluation of laboratory performances including pre-analytical, analytical and post-analytical stages of the total testing process (TTP) is crucial to ensure patients receiving safe, efficient and effective care. To conduct risk assessment, quality management tools such as Failure Mode and Effect Analysis (FMEA) and the Failure Reporting and Corrective Action System (FRACAS) were constantly used for proactive or reactive analysis, respectively. However, FMEA and FRACAS faced big challenges in determining the scoring scales and failure prioritization in the assessment of real-world cases. Here, we developed a novel strategy, by incorporating Sigma metrics into risk assessment based on quality indicators (QIs) data, to provide a more objective assessment of risks in TTP. Methods QI data was collected for 1 year and FRACAS was applied to produce the risk rating based on three variables: (1) Sigma metrics for the frequency of defects; (2) possible consequence; (3) detection method. The risk priority number (RPN) of each QI was calculated by a 5-point scale score, where a value of RPN > 50 was rated as high-risk. Results The RPNs of two QIs in post-analytical phase (TAT of Stat biochemistry analyte and Timely critical values notification) were above 50 which required rigorous monitoring and corrective actions to eliminate the high risks. Nine QIs (RPNs between 25 and 50) required further investigation and monitoring. After 3 months of corrective action the two identified high-risk processes were successfully reduced. Conclusions The strategy can be implemented to reduce identified risk and assuring patient safety.

Comprehensive hematological reference intervals in a healthy adult male population.

Reference intervals (RIs) are important tools for improving medical decision-making. Hematology reference values can be influenced by important covariates such as genetic and environmental factors, rendering it essential to define RIs for specific populations. Therefore, we aimed to establish accurate and robust RIs for hematological markers in a healthy adult male Iranian population. This cross-sectional study was conducted in a population of 723 males aged 20-60 years old. Hematological parameters were routinely measured using a Sysmex auto analyser system (KX-21 N). The quality of assays was monitored using commercial quality control samples. The nonparametric rank method, as recommended by the Clinical and Laboratory Standards Institute (CLSI) guidelines, was used to calculate the 2.5th and 97.5th percentiles as the lower and upper reference limits, respectively. Of the 12 hematological parameters assessed, only mean platelet volume (MPV) demonstrated significant age-specific differences, requiring two partitions from 20 to 35 years (8.7-12.2 fL) and 35 to 65 years (8.5-11.5 fL). The remaining hematological parameters (e.g. leukocyte, erythrocyte, and platelet parameters) could be defined by one age range. This study established RIs for 12 routinely used hematological parameters in a healthy male population living in the northeastern region of Iran. Established RIs differed from those previously reported by other cohorts, highlighting the importance of population-specific RIs.

Comparison of Hemoglobin Measurements by 3 Point-of-Care Devices With Standard Laboratory Values and Reliability Regarding Decisions for Blood Transfusion.

BACKGROUND: We compared the accuracy of 3 point-of-care testing (POCT) devices with central laboratory measurements and the extent to which between-method disagreements could influence decisions to transfuse blood. METHODS: Hemoglobin concentrations [Hb] were measured in 58 adult patients undergoing cardiothoracic surgery using 2 Ilex GEM Premier 3500 blood gas analyzers (BG_A and BG_B) and a HemoCue Hb-201 device (HemoCue). Measurements were compared with our central laboratory's Siemens Advia 2120 flow cytometry system (laboratory [Hb] [Lab[Hb]]), regarded as the gold standard. We considered that between-method [Hb] differences exceeding 10% in the [Hb] range 6-10 g/dL would likely erroneously influence erythrocyte transfusion decisions. RESULTS: The 70 Lab[Hb] measurements ranged from 5.8 to 16.7 g/dL, of which 25 (36%) were <10.0 g/dL. Measurements by all 4 devices numbered 57. Mean POCT measurements did not differ significantly (P > .99). Results of the Bland-Altman analyses revealed statistically significant bias, with predominant underestimations by all 3 POCTs predominating. HemoCue upper and lower limits of agreement (LOA) were narrower, and the 95% confidence intervals (95% CIs) of the LOAs did not overlap with those of BG_A and BG_B. Similarly, a narrow mountain plot demonstrated greater precision for the HemoCue. Comparing BG_A with BG_B revealed no bias and narrow LOA. Error grid analysis within the [Hb] range 6-10 g/dL revealed that 5.3% of HemoCue measurements were beyond the permissible 10.0% error zone in contrast to 19.0% and 16.0% of the blood gas measurements. Possible inappropriate transfusion decisions based on POCT values generally erred toward unnecessary transfusions. Calculations of Cohen κ statistic indicated better chance-corrected agreement between HemoCue and Lab[Hb] regarding erythrocyte transfusions than the blood gas analyzers. CONCLUSIONS: All 3 POCT devices underestimated the Lab[Hb] and cannot be used interchangeably with standard laboratory measurements. BG_A and BG_B can be considered to be acceptably interchangeable with each other. Whereas the HemoCue had little bias and good precision, the blood gas analyzers revealed large bias and poor precision. We conclude that the tested HemoCue provides more reliable measurements, especially within the critical 6-10 g/dL range, with reduced potential for transfusion errors. Decisions regarding erythrocyte transfusions should also be considered in the light of clinical findings.

Variation of Hemoglobin Detection for Lipemic Blood Samples.

BACKGROUND: Blood status is closely related to the hemoglobin test results in clinical laboratory. This paper discusses a case of which hemoglobin test results were not interfered by the "milky" blood status. METHODS: Complete Blood Count with Differential (CBC + Diff) was detected for these two specimens with a Sysmex XN-9000. RESULTS: The results of red cell indices for patient I were as follows: red blood cell count (RBC), 5.10 x 1012/L; hematocrit (HCT), 0.455 L/L; hemoglobin (HGB), 167 g/L; mean corpuscular hemoglobin concentration (MCHC), 367 g/L, and triglycerides (TG), 1.59 mmol/L. There was no "turbidity" warning message. However, there was a "turbidity" warning message for patient II and his red cell indices were RBC, 4.74 x 1012/L; HCT, 0.492 L/L; HGB, 182 g/L; MCHC, 370 g/L, and TG, 12.98 mmol/L. After the plasma exchange, there was no "turbidity" warning message for patient I and his red cell indices were RBC, 4.83 x 1012/L; HCT, 0.444 L/L; HGB, 164 g/L; MCHC, 369 g/L which were consistent with the results before the plasma exchange. For patient II, the "turbidity" warning message disappeared and his results were RBC, 3.87 x 1012/L; HCT, 0.398 L/L; HGB, 135 g/L; MCHC, 339 g/L. CONCLUSIONS: Our case provided an explanation of the normal hemoglobin detection results in the visible lipemic specimen for the first time.

Designing and Validating Autoverification Rules for Hematology Analysis in Sysmex XN-9000 Hematology System.

BACKGROUND: Hematology analysis is a common test among patients in hospital. However, manual verification of hematology analysis is time consuming and tedious, with variation between inter-individual laboratory workers. This study was to establish and validate a set of autoverification rules for hematology analysis in the department of laboratory medicine, Zhongshan Hospital of Sun Yatsen University. METHODS: Hematology analysis was measured by a Sysmex XN-9000 hematology system in the Department of Laboratory Medicine, Zhongshan Hospital of Sun Yatsen University. SYSMEX Laboman EasyAccess 6.0 and the laboratory information system were used to construct the algorithm and design the autoverification rules of hematology analysis according to Clinical and Laboratory Standards Institute document Auto 10A and 41 rules of Hematology Review Criteria. The laboratory turnaround time (TAT), autoverification pass rates, false positive, false negative, and the average error rate were verified after implementing autoverification rules. RESULTS: Approximate 1,300 specimens were collected daily and transferred to our laboratory for hematology analysis; that is necessary to build a database and to design autoverification rules. The average autoverification passing rate was 81%; the false positive rate was 13.6%; the false negative rate and the average error rate was nearly zero, indicating that incorrect reports were almost eliminated. Moreover, since implementing autoverification, the TAT was reduced by 27.0% in in-patient reports, by 21.9% in out-patient reports, and by 39.0% in emergency reports, which enhanced the productivity in our laboratory. CONCLUSIONS: Our laboratory accelerated verification and decreased TAT and the odds of human review errors in the released results since implementing the autoverification. Thus, we can save more time and concentrate on verifying the abnormal results and processing emergency tests.

Diagnostic Accuracy of Intestinal Fatty Acid Binding Protein for Acute Intestinal Ischemia: a Systematic Review and Meta-Analysis.

BACKGROUND: Some studies have investigated the diagnostic value of intestinal fatty acid binding protein (I-FABP) for acute intestinal ischemia (II), but the results were not always consistent. Therefore, we performed a systematic review and meta-analysis to determine the diagnostic accuracy of I-FABP for II. METHODS: Publications included in the PubMed and EMBASE before April 7, 2019 were retrieved to identify studies investigating the diagnostic accuracy of I-FABP for II. The Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) was used to assess the quality of eligible studies. Diagnostic accuracy of I-FABP in all eligible studies was pooled by a bivariate model. Summary receiver operating characteristic (ROC) curves (AUC) were constructed to calculate the overall diagnostic accuracy of I-FABP. RESULTS: A total of 10 studies with 1,265 (219 IIs and 1,046 controls) subjects were included in this systematic review and meta-analysis. The major design weaknesses of included studies were patient selection bias. The overall diagnostic sensitivity, specificity, and AUC of I-FABP were 0.75 (95% CI: 0.68 - 0.82), 0.85 (95% CI: 0.74 - 0.92), and 0.82 (95% CI: 0.79 - 0.86), respectively. In patients with acute abdominal pain, the sensitivity, specificity, and AUC of I-FABP were 0.71 (95% CI: 0.59 - 0.81), 0.89 (95% CI: 0.69 - 0.97) and 0.80 (95% CI: 0.76 - 0.83), respectively. CONCLUSIONS: I-FABP has moderate diagnostic accuracy for II. Due the patient selection bias of available studies, further studies with rigorous design are needed to evaluate the diagnostic accuracy of I-FABP for II.

Determination of Hematological Reference Intervals for Healthy Adults in Northeast Ethiopia.

BACKGROUND: Hematological reference interval is the range between two reference values that are used for inter-pretation of test results. It is affected by various physiological and environmental factors; thus, locally derived hematological reference values are essential for accurate diagnosis and treatment of patients. The main goal of this study was to establish hematological reference intervals for healthy adults at Kemise, Northeast Ethiopia. METHODS: A cross-sectional study was conducted from January to April, 2019, with 170 male and 159 female apparently healthy adult blood donors at Kemise Blood Bank. A structured pretested questionnaire was used for socio demographic and clinical data collection. About 4 mL of blood was collected in an EDTA test tube and analyzed using Sysmex XP-300 to enumerate the hematological parameters. The data were collected and entered into Epi-Inf7 and then transferred to SPSS version 20 for analysis. Dixon and Reed 1/3 rule was used for outlier detection. Mann-Whitney U test was used to determine reference intervals. Harris and Boyd test were used to determine the reference intervals that need partition. The 2.5th and 97.5th percentiles were determined non-parametrically with 95% confidence interval. RESULTS: The 2.5th - 97.5th percentiles reference intervals for red blood cell males: 3.9 - 6 x 1012/L, females: 3.3 - 5.3 x 1012/L; hemoglobin males: 12 - 17.9 g/dL, females: 10.5 - 16.3 g/dL; and hematocrit males: 34.8 - 51.4%, females: 30.2 - 47%. The combined reference intervals for both genders, were mean corpuscular volume: 77.1 - 95.5 fL, mean corpuscular hemoglobin: 25.6 - 34 pg, mean corpuscular hemoglobin concentration: 31.5 - 36.7 g/dL, red cell distribution width: 11.3 - 15.4%, white blood cells: 3.1 - 10.6 x 109/L, lymphocytes: 1 - 3.7 x 109/L, mixed: 0.3 - 1.7 x 109/L, neutrophils: 1.4 - 7 x 109/L, and platelets: 136 - 425 x 109/L. CONCLUSIONS: The established reference intervals in this study were different from previous studies which were conducted in different regions of Ethiopia or African countries or in Caucasian population, and in text books. The RBC, PCV, and Hgb reference intervals were different in gender. So, using of locally determined reference interval is essential.