The primary goal in transfusion medicine is to promote high standards of quality in all aspects of transfusion, including production, management, and transfusion of blood components. To achieve this goal, a transfusion service quality management system should be established. Such a system should include several organizational structures, responsibilities, policies, processes, procedures, and resources with provided specifications and regulations. In this review, we summarize the current knowledge and practices regarding the quality management of hematology tests applied to the donor selection and production of blood components, including red blood cells, platelets, fresh frozen plasma, and cryoprecipitates in the field at blood centers.
Donor Selection ; Erythrocytes ; Hematology* ; Humans ; Plasma ; Social Control, Formal ; Tissue Donors ; Transfusion Medicine

BACKGROUND: The prognostic utility of cardiac biomarkers, high-sensitivity cardiac troponin I (hs-cTnI) and soluble suppression of tumorigenicity-2 (sST2), in non-cardiac surgery is not well-defined. We evaluated hs-cTnI and sST2 as predictors of 30-day major adverse cardiac events (MACE) in patients admitted to the surgical intensive care unit (SICU) following major non-cardiac surgery. METHODS: hs-cTnI and sST2 concentrations were measured in 175 SICU patients immediately following surgery and for three days postoperatively. The results were analyzed in relation to 30-day MACE and were compared with the revised Goldman cardiac risk index (RCRI) score. RESULTS: Overall, 30-day MACE was observed in 16 (9.1%) patients. hs-cTnI and sST2 concentrations differed significantly between the two groups with and without 30-day MACE (P < 0.05). The maximum concentration of sST2 was an independent predictor of 30-day MACE (odds ratio=1.016, P=0.008). The optimal cut-off values of hs-cTnI and sST2 for predicting 30-day MACE were 53.0 ng/L and 182.5 ng/mL, respectively. A combination of hs-cTnI and sST2 predicted 30-day MACE better than the RCRI score. Moreover, 30-day MACE was observed more frequently with increasing numbers of above-optimal cut-off hs-cTnI and sST2 values (P < 0.0001). Reclassification analyses indicated that the addition of biomarkers to RCRI scores improved the prediction of 30-day MACE. CONCLUSIONS: This study demonstrates the utility of hs-cTnI and sST2 in predicting 30-day MACE following non-cardiac surgery. Cardiac biomarkers would provide enhanced risk stratification in addition to clinical RCRI scores for patients undergoing major non-cardiac surgery.
Biomarkers ; Critical Care* ; Humans ; Prognosis ; Troponin I* ; Troponin*

Background: Kidney failure occurs frequently and is associated with high mortality during sepsis. Proenkephalin (PENK) is an emerging biomarker of kidney function. We explored whether PENK levels could predict severity, organ failure, and mortality in septic patients. Methods: We measured the PENK level in the plasma of 215 septic patients using the sphingotest penKid assay (Sphingotec GmbH, Hennigsdorf, Germany). This was analyzed in terms of sepsis severity, vasopressor use, 30-day mortality, sequential organ failure assessment (SOFA) renal subscore, the Chronic Kidney Disease Epidemiology Collaboration estimated glomerular filtration rate (CKD-EPI eGFR) categories, and renal replacement therapy (RRT) requirement. Results: The PENK levels were significantly higher in patients with septic shock, vasopressor use, and non-survivors than in patients with solitary sepsis, no vasopressor use, and survivors, respectively (P = 0.02, P = 0.007, P < 0.001, respectively). The PENK levels were significantly associated with SOFA renal subscore and CKD-EPI eGFR categories (both P < 0.001). The distribution of lower eGFR ( < 60 mL/min/1.73 m2 ), RRT requirement, SOFA renal subscore, and the number of organ failures differed significantly according to the PENK quartile (P for trend < 0.001 or 0.017). The 30-day mortality rate also differed significantly according to the PENK quartile (P for trend < 0.001). Conclusions PENK could be an objective and reliable marker to predict severity, organ failure, and 30-day mortality in septic patients.

Background: A rise and/or fall in cardiac troponin value with at least one value above the 99th percentile upper reference limit is essential for acute myocardial infarction (AMI) diagnosis. We evaluated the clinical usefulness of serial high-sensitivity cardiac troponin I (hs-cTnI) measurements in AMI diagnosis, in terms of the predictability of absolute and relative changes. Methods: For this retrospective, forward observational study, we enrolled 281 patients older than 18 years who presented with chest pain at the emergency department (ED) between August 2015 and December 2016. The patients were grouped as AMI and nonAMI, and 73 (26%) were diagnosed as having AMI. Hs-cTnI (Abbott Diagnostics, Abbott Park, IL, USA) was measured at presentation and 3 hours later. We assessed the diagnostic performance of the absolute and relative changes in hs-cTnI. Results: The cut-off values to predict AMI were 16.2 ng/L and 42.1% for the absolute and relative hs-cTnI changes, respectively. The area under the curve of hs-cTnI for AMI diagnosis was larger for absolute changes than for relative changes [0.96 (95% confidence interval [CI], 0.92–0.98) vs 0.89 (95% CI, 0.85–0.93)] (P = 0.014). Conclusions The absolute hs-cTnI change at 3 hours after presentation was superior to the relative change, and a rise and/or fall in hs-cTnI of > 16.2 ng/L at 3 hours after presentation was useful to identify AMI in patients presenting at the ED.

BACKGROUND: Soluble suppression of tumorigenicity 2 (sST2) has emerged as a novel biomarker for heart failure, and serum sST2 concentrations could be increased in inflammatory diseases. We explored whether sST2 is related to cardiac dysfunction/failure and has a prognostic role in patients with suspected sepsis. METHODS: In a total of 397 patients with suspected sepsis, sST2 concentrations were measured by using the Presage ST2 Assay (Critical Diagnostics, USA). sST2 concentrations were analyzed according to procalcitonin (PCT) concentrations, cardiovascular subscores of the sepsis-related organ failure assessment (SOFA) score, and clinical outcomes. RESULTS: sST2 concentrations were increased significantly according to the five groups of PCT concentrations and cardiovascular subscores of the SOFA score (P<0.000001 and P=0.036, respectively). In-hospital mortality was significantly higher among patients with sST2 concentrations above 35 ng/mL (P=0.0213) and among patients with increased concentrations of both sST2 and PCT (P=0.0028). CONCLUSIONS: sST2 seems to be related to both cardiac dysfunction/failure and severity in sepsis. Measurement of sST2 and PCT in combination would be useful for risk stratification and prognosis prediction in patients with suspected sepsis.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biomarkers/blood ; Calcitonin/blood ; Enzyme-Linked Immunosorbent Assay ; Female ; Hospital Mortality ; Humans ; Interleukin-1 Receptor-Like 1 Protein/*blood ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Prognosis ; Proportional Hazards Models ; Reagent Kits, Diagnostic ; Sepsis/*diagnosis/mortality/pathology ; Young Adult

BACKGROUND: Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) are increasingly important in immunocompromised patients. Nucleic acid extraction methods could affect the results of viral nucleic acid amplification tests. We compared two automated nucleic acid extraction systems for detecting CMV and EBV using real-time PCR assays. METHODS: One hundred and fifty-three whole blood (WB) samples were tested for CMV detection, and 117 WB samples were tested for EBV detection. Viral nucleic acid was extracted in parallel by using QIAsymphony RGQ and QIAcube (Qiagen GmbH, Germany), and real-time PCR assays for CMV and EBV were performed with a Rotor-Gene Q real-time PCR cycler (Qiagen). Detection rates for CMV and EBV were compared, and agreements between the two systems were analyzed. RESULTS: The detection rate of CMV and EBV differed significantly between the QIAsymphony RGQ and QIAcube systems (CMV, 59.5% [91/153] vs 43.8% [67/153], P=0.0005; EBV, 59.0% [69/117] vs 42.7% [50/117], P=0.0008). The two systems showed moderate agreement for CMV and EBV detection (kappa=0.43 and 0.52, respectively). QIAsymphony RGQ showed a negligible correlation with QIAcube for quantitative EBV detection. QIAcube exhibited EBV PCR inhibition in 23.9% (28/117) of samples. CONCLUSIONS: Automated nucleic acid extraction systems have different performances and significantly affect the detection of viral pathogens. The QIAsymphony RGQ system appears to be superior to the QIAcube system for detecting CMV and EBV. A suitable sample preparation system should be considered for optimized nucleic acid amplification in clinical laboratories.
Automation ; Cytomegalovirus/*genetics/isolation & purification ; Cytomegalovirus Infections/diagnosis/*virology ; DNA, Viral/*blood/isolation & purification/metabolism ; Herpesvirus 4, Human/*genetics/isolation & purification ; Humans ; Reagent Kits, Diagnostic ; Real-Time Polymerase Chain Reaction

Chronic myelogenous leukaemia (CML) is a myeloproliferative neoplasm that is almost always characterised by the presence of t(9;22)(q34;q11.2). Approximately 5% to 10% of CML patients lack cytogenetic evidence of t(9;22)(q34;q11.2) but have the breakpoint cluster region (BCR)/ABL1 fusion, as revealed by fl uorescence in situ hybridisation (FISH) or the reverse transcription-polymerase chain reaction (RT-PCR). We present a case of Philadelphia-negative CML with a cryptic insertion of BCR at 9q34. A 22-year-old woman incidentally presented with marked leucocytosis and anaemia. Her complete blood count results were as follows: white blood cells, 238.61x10(9)/L; haemoglobin, 9.6 g/dL; platelets, 395x10(9)/L. A peripheral blood smear showed leucocytosis with neutrophilia, basophilia, left-shifted neutrophils, and circulating blasts comprising 2% of the total leucocytes. The bone marrow showed a striking increase in megakaryocytes and granulocytic precursors. The myeloid/erythroid ratio was 7.4:1, and blasts comprised up to 1.8% of all nucleated cells. Bone marrow sections revealed active megakaryopoiesis and granulopoiesis with 100% cellularity. Chromosomal analysis revealed a normal karyotype. However, interphase FISH using a dual-colour BCR/ABL1 fusion probe showed an atypical pattern consisting of one red, two green, and one fusion (1R2G1F) signal in 97.5% of the 200 analysed cells. Metaphase FISH revealed a single BCR/ABL1 fusion signal on chromosome 9. RT-PCR was positive for BCR/ABL1 (b3a2). Quantitative PCR revealed a normalised copy number of 15.32. The patient started her treatment with imatinib, reached a complete molecular response eight months afterwards, and has been coping well without any adverse events.
Blood Cell Count ; Bone Marrow ; Chromosomes, Human, Pair 9 ; Cytogenetics ; Female ; Humans ; Interphase ; Karyotype ; Leukocytes ; Megakaryocytes ; Metaphase ; Neutrophils ; Polymerase Chain Reaction ; Strikes, Employee ; Young Adult ; Imatinib Mesylate

BACKGROUND: High-density lipoprotein cholesterol (HDL-C) is a complex mixture of subclasses with heterogeneous atheroprotective activities. We analyzed HDL-C subclass in relation to cardiovascular risk and metabolic syndrome (MetS) in a population with high HDL-C levels. METHODS: A total of 300 Korean individuals with high HDL-C levels (≥2.331 mmol/L) were enrolled following a comprehensive general medical examination including body composition analysis. HDL3-C levels were measured using the HDL3-EX SEIKEN kit (Randox Ltd., Crumlin, UK) and non-HDL3-C levels were calculated by subtracting HDL3-C levels from total HDL-C levels. RESULTS: HDL3-C levels and HDL3-C proportion had a weak positive correlation with low-density lipoprotein cholesterol (LDL-C) and triglycerides (r=0.21, r=0.25; r=0.26, r=0.34, respectively, all P<0.001); in contrast, non-HDL3-C levels had a weak negative correlation with these parameters (r=−0.17 and r=−0.25, respectively, both P<0.005). HDL3-C levels and HDL3-C proportion were significantly higher in the MetS group (N=8) than in the non-MetS group (0.71 vs 0.63 mmol/L, P=0.001; 29.7 vs 25.8%, P=0.001, respectively); these were the only predictors of MetS among the lipid variables (areas under the curves [AUC]=0.84 and 0.83, respectively, both P=0.001). CONCLUSIONS In populations with high HDL-C levels, HDL-C subclass may provide a greater amount of information on cardiovascular risk and MetS than HDL-C levels alone.

BACKGROUND: Soluble ST2 (sST2) has emerged as a biomarker of heart failure. Previous studies indicated 35 ng/mL of sST2 as the clinically prognostic cut-off value. This study aims to establish reference intervals in a Korean population using an sST2 assay and to evaluate the applicability of the cut-off value. METHODS: From March to May 2014, sST2 levels were assayed in serum samples of 255 cardio-healthy Koreans (128 men and 127 women) using the Presage ST2 ELISA kit (Critical Diagnostics, USA). The reference interval for sST2 was defined using the nonparametric percentile method according to the CLSI EP28-A3c guideline. RESULTS: The median sST2 concentrations were 23.8 ng/mL (interquartile range (IQR), 19.0-28.7), 26.6 ng/mL (IQR, 21.0-30.9), and 21.9 ng/mL (IQR, 17.3-26.5) for the entire cohort, men, and women, respectively. sST2 levels were significantly higher in men than in women (P<0.0001). The 97.5th percentile upper reference limits for sST2 were 43.8 ng/mL, 49.6 ng/mL, and 35.4 ng/mL for the cohort, men, and women, respectively. Gender-specific upper reference limits were similar to limits reported by other studies. CONCLUSIONS: We suggest that gender-specific reference intervals should be used for the Korean population, as application of a single cut-off value of 35 ng/mL may be overcautious of the possibility of false positivity, especially in men.
Cohort Studies ; Enzyme-Linked Immunosorbent Assay ; Female ; Heart Failure ; Humans ; Male ; Methods

BACKGROUND: A handheld blood gas analyser has been newly developed for mobile monitoring of blood gasses and electrolytes. We evaluated the performance of a portable blood gas analyser, Epoc(TM) (Epocal Inc., Canada) according to Clinical and Laboratory Standard Institute (CLSI) guidelines, and compared it to that of a conventional analyser used in clinical laboratories. METHODS: Precision and percent carry-over were determined using three levels of aqueous and hematocrit control materials according to CLSI EP10-A3. Linearity was determined using five levels of control materials according to CLSI EP6-A. The pH, pCO2, pO2, Na+, K+, Ca2+, glucose, lactate, and hematocrit levels were compared between the Epoc(TM) and Stat Profile Critical Care Xpress (STP CCX; Nova Biomedical, USA) analysers using whole blood samples from 40 subjects according to CLSI EP9-A2. RESULTS: The coefficient of variation of the within-run precision and total precision were 0.000% to 4.563% and 0.000% to 5.298%, respectively. The carry-over was within 5%. The Epoc(TM) analyser showed excellent linearity for all nine parameters evaluated. For the comparison study, the Epoc(TM) and conventional analysers showed comparable results (correlation coefficient [r]=0.900-0.995), except for hematocrit (r=0.764). CONCLUSIONS: The Epoc(TM) POC analyser shows reliable analytical precision and is comparable to the traditional bench-top blood gas analysers. It could be useful in clinical settings, especially in operating rooms and pediatric intensive care units.
Blood Gas Analysis ; Critical Care ; Electrolytes ; Glucose ; Hematocrit ; Hydrogen-Ion Concentration ; Intensive Care Units, Pediatric ; Lactic Acid ; Operating Rooms ; Point-of-Care Systems