RESUMEN
BACKGROUND: Essential trace elements play key roles in multiple biological systems, and hemodialysis patients are at risk for deficiency of essential trace elements. The aim of the study was to assess the essential element status in end stage renal disease patients undergoing online hemodiafiltration (online HDF) in outpatient dialysis clinic. METHODS: A total of 28 Korean patients with regular online HDF were included. Blood samples were collected before and after one HDF session, and serum concentrations of zinc, copper, selenium, and manganese were simulta-neously measured by inductively coupled plasma mass spectrometry. RESULTS: Selenium, zinc, copper deficiencies were observed in 71.4%, 35.8%, and 21.4%, compared with the reference range. No patients revealed manganese deficiency. After the HDF, the post-HDF level significantly increased in all trace elements, compared with the pre-HDF (11.2% for selenium, 10.7% for copper, and 6.6% for zinc). However, 50% patients were still deficient for selenium at the post-HDF. CONCLUSIONS: Our data suggest that the patients undergoing online HDF are at an increased risk of trace element deficiency, especially for selenium.
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Hemodiafiltración , Selenio , Oligoelementos , Anciano , Cobre , Humanos , ZincRESUMEN
Anti-cyclic citrullinated peptide antibodies (anti-CCPs) are important diagnostic markers for rheumatoid arthritis (RA). We evaluated the analytical and clinical performance of the QUANTA Flash CCP3 (INOVA Diagnostics, USA), a fully automated third-generation anti-CCP assay, in comparison with three second-generation anti-CCP (CCP2) assays. A total of 300 sera (67 from RA patients, 64 from other rheumatic diseases, 43 from osteoarthritis [OA], and 126 from other conditions) were tested with QUANTA Flash CCP3, Kallestad Anti-CCP II (Bio-Rad, USA), Elecsys Anti-CCP (Roche Diagnostics GmbH, Germany), and ARCHITECT Anti-CCP (Abbott Diagnostics, USA). Within-run and total imprecision (% coefficient of variation) of the QUANTA Flash CCP3 were <6%, and its linearity was acceptable over the claimed range (4.0-2,749.7 chemiluminescent units). The frequency of anti-CCP was similar between QUANTA Flash CCP3 and the other CCP2 assays in the RA (67.2% vs. 62.7-70.1%), other rheumatic diseases (7.8% vs. 6.3%), and OA (2.3% vs. 0-2.3%) groups. The concordance rate between QUANTA Flash CCP3 and the other assays ranged from 96.3% to 97.7% (kappa from 0.87 to 0.92). For the diagnosis of RA, the sensitivity/specificity was 67.2%/95.7%, 62.7%/98.3%, 70.2%/96.6%, and 67.2%/97.9%, and the areas under the receiver operating characteristic curves were 0.851, 0.791, 0.853, and 0.867 for QUANTA Flash CCP3, Kallestad, Elecsys, and ARCHITECT assays, respectively. The performance of the QUANTA Flash CCP3 was satisfactory and comparable to that of the three CCP2 assays. This fully automated assay would be a practical and reasonable option in clinical laboratories.
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Anticuerpos Antiproteína Citrulinada/sangre , Artritis Reumatoide/diagnóstico , Automatización de Laboratorios/normas , Inmunoensayo/normas , Osteoartritis/diagnóstico , Adulto , Anciano , Artritis Reumatoide/sangre , Artritis Reumatoide/inmunología , Artritis Reumatoide/patología , Biomarcadores/sangre , Diagnóstico Diferencial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Osteoartritis/sangre , Osteoartritis/inmunología , Osteoartritis/patología , Curva ROCRESUMEN
BACKGROUND: Quantification of glycated hemoglobin (HbA1c) is a challenge in patients with hemoglobin (Hb) variants. We evaluated the impact of various Hb variants on five routine HbA1c assays by comparing with the IFCC reference measurement procedure (RMP). METHODS: Whole blood samples showing warning flags or no results on routine HPLC HbA1c assays were confirmed for Hb variants and were submitted to HbA1c quantification using Sebia Capillarys 2 Flex Piercing, Roche Tina-quant HbA1c Gen. 2, Bio-Rad Variant II Turbo 2.0, ADAMS HA-8180, Tosoh G8 standard mode, and IFCC RMP using LC-MS. RESULTS: Among 114 samples, the most common variants were Hb G-Coushatta (n=47), Queens (n=41), Ube-4 (n=11), Chad (n=4), Yamagata (n=4), G-His-Tsou (n=2), G-Taipei (n=1), Fort de France (n=1), Hoshida (n=1), and two novel variants (Hb α-globin, HBA 52 Gly>Cys and Hb ß-globin, HBB 146 His>Asn). In terms of control samples, all the result of HbA1c were "acceptable", within the criteria of ±7% compared to IFCC RMP target values. However, percentage of "unacceptable" results of samples with Hb variants were 16% for Capillarys 2, 7% for Tina-quant, 51% for Variant II Turbo 2.0, 95% for G8 standard mode, and 89% for HA-8180. The Capillarys 2 and HA-8180 assay did not provide the results in 5 and 40 samples with Hb variants, respectively. CONCLUSIONS: HbA1c results from five routine assays in patients with relatively common Hb variants in Korea showed various degrees of bias compared to those of IFCC RMP. Therefore, laboratories should be aware of the limitation of their methods with respect to interference from Hb variants found commonly in their local population and suggest an alternative HbA1c quantification method.
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Análisis Químico de la Sangre/métodos , Hemoglobina Glucada/análisis , Hemoglobina Glucada/genética , Análisis Químico de la Sangre/normas , Cromatografía Líquida de Alta Presión , Humanos , Espectrometría de Masas , Mutación , Estándares de Referencia , República de CoreaRESUMEN
INTRODUCTION: The results of urine sediment analysis have been reported semiquantitatively. However, as recent guidelines recommend quantitative reporting of urine sediment, and with the development of automated urine sediment analyzers, there is an increasing need for quantitative analysis of urine sediment. Here, we developed a protocol for urine sediment analysis and quantified the results. METHODS: Based on questionnaires, various reports, guidelines, and experimental results, we developed a protocol for urine sediment analysis. The results of this new protocol were compared with those obtained with a standardized chamber and an automated sediment analyzer. Reference intervals were also estimated using new protocol. RESULTS: We developed a protocol with centrifugation at 400 g for 5 min, with the average concentration factor of 30. The correlation between quantitative results of urine sediment analysis, the standardized chamber, and the automated sediment analyzer were generally good. The conversion factor derived from the new protocol showed a better fit with the results of manual count than the default conversion factor in the automated sediment analyzer. CONCLUSIONS: We developed a protocol for manual urine sediment analysis to quantitatively report the results. This protocol may provide a mean for standardization of urine sediment analysis.
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Urinálisis/métodos , Centrifugación , Servicios de Laboratorio Clínico , Humanos , Guías de Práctica Clínica como Asunto , Estándares de Referencia , Valores de Referencia , Urinálisis/normasRESUMEN
BACKGROUND: Vancomycin is the treatment of choice for serious methicillin-resistant Staphylococcus aureus (MRSA) infections. The area under the concentration-time curve from 0 to 24 hr (AUC24 )/minimum inhibitory concentration (MIC) ratio was recently introduced as a parameter for assessing clinical outcome by S. aureus. This study was purposed to apply the vancomycin AUC24 /MIC in patients with MRSA pneumonia. METHODS: Forty-seven patients with confirmed lower respiratory infection caused by MRSA during 2011 were enrolled. All patients were treated with vancomycin. Clinical characteristics and laboratory data were collected. AUC24 /MIC values were calculated as previously reported and patients were divided into two groups based on the bacteriologic response, which was eradicated or not, and an AUC24 /MIC value (above or below 400). RESULTS: MRSA infections were eradicated in 39 patients but 8 patients had persistent MSRA infection in the following cultures. The mean AUC24 /MIC values and vancomycin concentrations were not statistically different between patients with and without MRSA eradication. All 13 patients with a vancomycin MIC of 2 mg/L had an AUC24 /MIC below 400. CONCLUSION: AUC24 /MIC might not be a reliable indicator for assessing treatment response of vancomycin in MRSA pneumonia. Relationship between vancomycin AUC24 /MIC and therapeutic outcome needs to undergo further studies, including sufficiently large sample size.
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Antibacterianos/uso terapéutico , Staphylococcus aureus Resistente a Meticilina/efectos de los fármacos , Staphylococcus aureus Resistente a Meticilina/metabolismo , Vancomicina/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antibacterianos/sangre , Área Bajo la Curva , Farmacorresistencia Bacteriana , Femenino , Humanos , Masculino , Meticilina/efectos adversos , Pruebas de Sensibilidad Microbiana , Persona de Mediana Edad , Estudios Retrospectivos , Estadísticas no Paramétricas , Vancomicina/sangre , Adulto JovenRESUMEN
CYP2D6 is primarily responsible for the metabolism of clomiphene citrate (CC). The purpose of the present study was to investigate the relationship between CYP2D6 genotypes, concentrations of CC and its major metabolites and drug response in infertility patients. We studied 42 patients with ovulatory dysfunction treated with only CC. Patients received a dose of 100 mg/day CC on days 3-7 of the menstrual cycle. CYP2D6 genotyping and measurement of CC and the major metabolite concentrations were performed. Patients were categorized into CC responders or non-responders according to one cycle response for the ovulation. Thirty-two patients were CC responders and 10 patients were non-responders with 1 cycle treatment. The CC concentrations were highly variable within the same group, but non-responders revealed significantly lower (E)-clomiphene concentration and a trend of decreased concentrations of active metabolites compared to the responders. Nine patients with intermediate metabolizer phenotype were all responders. We confirmed that the CC and the metabolite concentrations were different according to the ovulation status. However, our results do not provide evidence for the contribution of CYP2D6 polymorphism to either drug response or CC concentrations.
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Clomifeno/uso terapéutico , Citocromo P-450 CYP2D6/genética , Infertilidad/tratamiento farmacológico , Polimorfismo Genético , Adulto , Cromatografía Líquida de Alta Presión , Clomifeno/sangre , Clomifeno/metabolismo , Antagonistas de Estrógenos/análisis , Antagonistas de Estrógenos/metabolismo , Antagonistas de Estrógenos/uso terapéutico , Femenino , Genotipo , Humanos , Infertilidad/genética , Inducción de la Ovulación , Fenotipo , República de Corea , Espectrometría de Masas en TándemRESUMEN
Acute cholecystitis is a rare complication of scrub typhus. Although a few such cases have been reported in patients with scrub typhus, the clinical course is not well described. Of 12 patients, acute cholecystitis developed in 66.7% (8/12) of patients older than 60 yr. The scrub typhus group with acute cholecystitis had marginal significant longer hospital stay and higher cost than the group without cholecystitis according to propensity score matching. Scrub typhus should be kept in mind as a rare etiology of acute cholecystitis in endemic areas because the typical signs of scrub typhus such as skin rash and eschar can present after the abdominal pain.
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Colecistitis Aguda/diagnóstico , Colecistitis Aguda/etiología , Tifus por Ácaros/complicaciones , Tifus por Ácaros/diagnóstico , Anciano , Anciano de 80 o más Años , Colecistitis Aguda/terapia , Diagnóstico Diferencial , Femenino , Humanos , Masculino , República de Corea , Tifus por Ácaros/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: Microalbuminuria tests are used as screening tools for diseases, such as diabetic nephropathy, cardiovascular disease, and hypertension. The purpose of this study was to evaluate the utility of a newly introduced semiquantitative urine dipstick, URiSCAN Super cassette ACR (URiSuper-ACR [where ACR is albumin/creatinine ratio]; YD Diagnostics Corp., Korea), as a screening tool for microalbuminuria. METHODS: Albumin and creatinine levels in randomly selected spot urine samples of 1,040 patients were semiquantitatively measured using URiSuper-ACR. Results using URiSuper-ACR system were compared to measurements obtained by quantitative analyzer. We also calculated diagnostic sensitivity, specificity, precision, linearity, and categorical concordance rates for the diagnosis of microalbumiuria using this system. Furthermore, we performed interference tests using standard controls to evaluate possible influence of various factors. RESULTS: URiSuper-ACR test showed 88.8% and 86.3% sensitivity and 90.1% and 93.8% specificity for albumin concentration and ACR, respectively. It also showed 91.1% and 92.6% positive predictive values and 87.6% and 88.5% negative predictive values, respectively. The concordance rate between URiSuper-ACR and quantitative method for albumin and creatinine concentration within the same category were 78.4% and 67.1%, respectively, and for the ±1 category were 98.8% and 99.5%, respectively. For ACR, an 80.0% concordance rate was seen within the same category. The within-run coefficients of variation (CVs) were 3.0â¼15.4% and 5.2â¼23.5% for albumin and creatinine, respectively, showing good linearity. In interference tests, no interference was observed except for cases with high specific gravity. CONCLUSIONS: URiSuper-ACR showed good diagnostic performance for the detection of microalbuminuria and may be a useful screening test in clinical laboratories.
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Albúminas/metabolismo , Albuminuria/orina , Creatinina/metabolismo , Tamizaje Masivo , Juego de Reactivos para Diagnóstico , Urinálisis/métodos , Humanos , Sensibilidad y EspecificidadRESUMEN
Background: Anti-Müllerian hormone (AMH) is one of the most reliable markers of ovarian reserve. Automated AMH assays are widely used in clinical laboratories, but reference intervals for the Elecsys AMH assay for Asian populations have not yet been determined. We aimed to determine reference intervals in healthy Korean women. Methods: The study included 1,450 women aged 19 to 54 years who participated in the Korea National Health and Nutrition Examination Survey between 2013 and 2016. The study participants were divided into seven 5-year age groups. AMH and progesterone concentrations were measured using Roche Elecsys assays, and bone morphogenetic protein-15 (BMP15) was genotyped for the detection of major variants. Age group-specific reference intervals for AMH were established as recommended by the CLSI EP28-A3c guidelines. Results: The mean age was 37.4 years. AMH concentrations decreased with increasing age, especially after 40 years, with the median AMH decreasing from 30.9 pmol/L in participants of 19-24 years to 0.071 pmol/L in participants of 50-54 years. The mid-95 percentile AMH reference intervals decreased from 7.93-81.21 pmol/L in participants of 19-24 years to 0.07-3.86 pmol/L in participants of 50-54 years. Disease-associated BMP15 variants were not detected. Conclusions: We determined Elecsys AMH assay reference intervals in healthy Korean women. The results may provide basic information for the interpretation of AMH concentrations and assessment of ovarian reserve in Korean women.
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Hormona Antimülleriana , Reserva Ovárica , Adulto , Pueblo Asiatico/genética , Femenino , Humanos , Encuestas Nutricionales , Valores de ReferenciaRESUMEN
BACKGROUND: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is widely used for therapeutic drug monitoring of immunosuppressants given to transplant recipients. This study evaluated the performance of the newly introduced MassTrak Immunosuppressant XE Kit (Waters Corporation; "the Kit") in the determination of everolimus and cyclosporin A (CsA) using LC-MS/MS. METHODS: The linearity, precision, detection limit, carryover and matrix effect of the Kit and comparison of the in-house method and Kit procedure were evaluated according to Clinical and Laboratory Standards Institute guidelines. RESULTS: The Kit afforded good linearity in the measurement of everolimus from 2 to 26 ng/mL (R² = 0.996) and of CsA from 42.6 to 1407 ng/mL (R² = 0.995). The between- and within-run assay coefficients of variation were 2.3% - 8.0% for everolimus and 1.1% - 3.1% for CsA. The lower limit of quantitation of everolimus and CsA were 1.1-4.1 ng/mL, respectively. A comparison of CsA values obtained using inhouse reagents indicated good correlation with Kit results (R = 0.9909). The average matrix effect ranged from 15% - 39% for everolimus and 3% -10% for CsA, and ion enhancement was mostly observed for the matrix effect. The effect on analyte/internal standard ratios ranged from 1%-8% for everolimus and 1%-16% for CsA. CONCLUSIONS: The Kit employing isotopically labeled internal standards provides reliable measurements of immunosuppressant levels over a broad range of concentrations.
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Cromatografía Líquida de Alta Presión , Ciclosporina/sangre , Inmunosupresores/sangre , Sirolimus/análogos & derivados , Cromatografía Líquida de Alta Presión/normas , Ciclosporina/normas , Everolimus , Humanos , Inmunosupresores/normas , Marcaje Isotópico , Juego de Reactivos para Diagnóstico , Estándares de Referencia , Sirolimus/sangre , Sirolimus/normas , Espectrometría de Masas en Tándem/normasAsunto(s)
Cromosomas Humanos Par 11/ultraestructura , Cromosomas Humanos Par 14/ultraestructura , Cromosomas Humanos Par 8/ultraestructura , Mieloma Múltiple/genética , Proteínas de Mieloma/genética , Proteínas de Fusión Oncogénica/genética , Translocación Genética , Aberraciones Cromosómicas , Cromosomas Humanos Par 11/genética , Cromosomas Humanos Par 14/genética , Cromosomas Humanos Par 8/genética , Progresión de la Enfermedad , Genes de Inmunoglobulinas , Genes myc , Humanos , Inmunoglobulina D/análisis , Inmunoglobulina D/genética , Cadenas lambda de Inmunoglobulina/análisis , Cadenas lambda de Inmunoglobulina/genética , Hibridación Fluorescente in Situ , Cariotipificación , Masculino , Persona de Mediana Edad , Mieloma Múltiple/patologíaRESUMEN
Hand washing plays a key role in preventing respiratory infection in many clinical settings. However, its effectiveness in preventing acute respiratory illness (ARI) during field training in military training facilities has been not studied.A quasi-interventional study was performed to evaluate the prevalence of ARIs over 4 weeks in a Korean army training center in South Korea from January 2009 to February 2009. A total of 1291 recruits participating in military training for 4 weeks were randomly distributed to 2 battalions (one with 631 and the other with 660). After noticing there is a difference between the 2 battalions in terms of the development of ARIs at the end of 2 weeks of training, we conducted interviews with the battle commanders to determine factors that may be related to one battalion having a higher incidence of ARI. Thereafter, we performed an intervention, which consists of instructing the battalion having a higher incidence of ARI to implement field hand washing from the third week. Following the intervention, we compared the cumulative rate of ARI during 4 weeks of training.The interviews revealed that there were no major differences between the 2 battalions in terms of the training schedules, living environments, or indoor hand washing methods. However, there was difference in terms of hand washing during field training for the first 2 weeks; whereas one battalion (the early hand washing group) implemented hand washing during field training starting in the first week, the other battalion did not implement hand washing for the first 2 weeks but instead began in the third week (the late hand washing group). The cumulative incidence rate of ARI during 4 weeks of training was significantly lower in the early hand washing group (13.0%, 95% confidence interval [CI]: 10.6%-15.9%) than in the late hand washing group (28.0%, 95% CI, 24.7%-31.5%).Our study suggests that outdoor hand washing during field training may be an effective precaution for reducing ARI incidence among recruits participating in military training.
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Desinfección de las Manos/métodos , Higiene Militar/métodos , Personal Militar/educación , Enfermedades Profesionales/prevención & control , Infecciones del Sistema Respiratorio/prevención & control , Humanos , Incidencia , Instalaciones Militares , Ensayos Clínicos Controlados no Aleatorios como Asunto , Enfermedades Profesionales/epidemiología , Prevalencia , República de Corea/epidemiología , Infecciones del Sistema Respiratorio/epidemiologíaRESUMEN
BACKGROUND: The associations of vitamin D deficiency with various clinical conditions highlighted the importance of vitamin D testing. Currently, clinicians measure only the total 25-hydroxyvitamin D [25(OH)D] concentration, regardless of its bioavailability. We aimed to determine the effect of vitamin D-binding protein (VDBP) on 25(OH)D bioavailability. METHODS: Serum samples were collected from 60 healthy controls, 50 pregnant women, and 50 patients in intensive care units (ICUs). Total 25(OH)D was quantified by liquid chromatography with tandem mass spectrometry, and VDBP levels were determined by using an ELISA kit (R&D Systems, USA). The bioavailable 25(OH)D levels were calculated by using total 25(OH)D, VDBP, and albumin concentrations. RESULTS: In comparison with healthy controls, the total 25(OH)D concentration was significantly lower in ICU patients (median, 11.65 vs 18.25 ng/mL; P<0.00001), but no significant difference was noted between pregnant women (18.25 ng/mL) and healthy controls. The VDBP level was significantly lower in ICU patients (95.58 vs 167.18 µg/mL, P=0.0002) and higher in pregnant women (225.01 vs 167.18 µg/mL, P=0.008) compared with healthy controls. Nonetheless, the calculated bioavailable 25(OH)D levels of ICU patients and pregnant women were significantly lower than those of healthy controls (1.97 and 1.93 ng/mL vs 2.56 ng/mL; P=0.0073 and 0.0027). CONCLUSIONS: A single marker of the total 25(OH)D level is not sufficient to accurately evaluate vitamin D status, especially in pregnant women. In cases where VDBP concentrations may be altered, VDBP measurements and bioavailable 25(OH)D calculations may help to determine vitamin D status accurately.
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Proteína de Unión a Vitamina D/sangre , Vitamina D/sangre , Adulto , Anciano , Cromatografía Líquida de Alta Presión , Ensayo de Inmunoadsorción Enzimática , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Embarazo , Mujeres Embarazadas , Albúmina Sérica/análisis , Espectrometría de Masas en TándemRESUMEN
BACKGROUND: For correct interpretation of the high-density lipoprotein cholesterol (HDL-C) data from the Korea National Health and Nutrition Examination Survey (KNHANES), the values should be comparable to reference values. We aimed to suggest a way to calibrate KNHANES HDL-C data from 2008 to 2015 to the Centers for Disease Control and Prevention (CDC) reference method values. METHODS: We derived three calibration equations based on comparisons between the HDL-C values of the KNHANES laboratory and the CDC reference method values in 2009, 2012, and 2015 using commutable frozen serum samples. The selection of calibration equation for correcting KNHANES HDL-C in each year was determined by the accuracy-based external quality assurance results of the KNHANES laboratory. RESULTS: Significant positive biases of HDL-C values were observed in all years (2.85-9.40%). We created the following calibration equations: standard HDL-C=0.872×[original KNHANES HDL-C]+2.460 for 2008, 2009, and 2010; standard HDL-C=0.952×[original KNHANES HDL-C]+1.096 for 2012, 2013, and 2014; and standard HDL-C=1.01×[original KNHANES HDL-C]-3.172 for 2011 and 2015. We calibrated the biases of KNHANES HDL-C data using the calibration equations. CONCLUSIONS: Since the KNHANES HDL-C values (2008-2015) showed substantial positive biases compared with the CDC reference method values, we suggested using calibration equations to correct KNHANES data from these years. Since the necessity for correcting the biases depends on the characteristics of research topics, each researcher should determine whether to calibrate KNHANES HDL-C data or not for each study.
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HDL-Colesterol/sangre , Encuestas Nutricionales , Algoritmos , Calibración , HDL-Colesterol/normas , Humanos , Valores de Referencia , República de CoreaRESUMEN
BACKGROUND: Since the 99th percentile reference limit for cardiac troponin (Tn) can vary depending on the reference population, Sandoval et al. published systematic selection criteria. In this study, these systematic criteria were applied for the first time to obtain the 99th percentile reference limits for 6 Tn tests. METHODS: The reference population was selected in accordance with the systematic criteria, and reference limits were set with respect to the six types of Tn assays. The coefficient of variation (CV) at the reference limit was determined using 3-4 concentrations of frozen serum. RESULTS: In total, 641 South Koreans (303 males, 338 females) were selected as the reference population. The 99th percentile reference limit of Tn in the six assays ranged from 13.4 to 34.2pg/ml. The measurable fractions among the reference population ranged from 1.3% to 80.5%. The CVs at the reference limit ranged from 5.3% to 43.0%, and three were <10%. CONCLUSIONS: In this study, a reference population was selected for the first time in accordance with the systematic criteria of Sandoval et al., and the reference limit for South Koreans was established. The values obtained in this study are different from those proposed by manufacturers, which confirms the importance of having a reference population. Four out of six assays did not fulfill the criteria for high-sensitivity tests.
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Análisis Químico de la Sangre/normas , Miocardio/metabolismo , Selección de Paciente , Troponina/sangre , Adulto , Anciano , Anciano de 80 o más Años , Animales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valores de Referencia , Adulto JovenRESUMEN
Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.
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Pruebas de Farmacogenómica/métodos , Anticoagulantes/uso terapéutico , Antidepresivos/uso terapéutico , Antimetabolitos Antineoplásicos/uso terapéutico , Antituberculosos/uso terapéutico , Arilamina N-Acetiltransferasa/genética , Clopidogrel , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Enfermedad de la Arteria Coronaria/genética , Citocromo P-450 CYP2C19/genética , Citocromo P-450 CYP2C9/genética , Citocromo P-450 CYP2D6/genética , Trastorno Depresivo/tratamiento farmacológico , Trastorno Depresivo/genética , Genotipo , Isoniazida/uso terapéutico , Laboratorios de Hospital/normas , Metiltransferasas/genética , Pruebas de Farmacogenómica/normas , Inhibidores de Agregación Plaquetaria/uso terapéutico , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/genética , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Tuberculosis/tratamiento farmacológico , Tuberculosis/genética , Vitamina K Epóxido Reductasas/genética , Warfarina/uso terapéuticoRESUMEN
OBJECTIVES: This study aimed to determine the 99th percentile upper reference limit (URL) concentration of cardiac troponin I (cTnI) with a high-sensitivity assay in a Korean population. DESIGN AND METHODS: Cardio-healthy males and females were enrolled between March 2014 and March 2015. Participants with possible subclinical conditions were excluded on the basis of laboratory measures (primary: estimated glomerular filtration rate and glycated hemoglobin; secondary: B-type natriuretic peptide). Serum cTnI was measured using ARCHITECT STAT High-Sensitive Troponin-I Assay (Abbott Diagnostics, USA). RESULTS: A total of 1204 participants completed a self-reporting questionnaire for inclusion in the study. Of these, we excluded 349 (29.0%) participants on the basis of primary (n=283) and secondary (n=66) laboratory measures. Ultimately, we included 854 participants (mean age, 49.8±10.2years) in the final analysis. The 99th percentiles of cTnI concentrations were 18 (90% confidence interval [CI], 14-35) ng/L for all participants, 20 (90% CI, 15-69) ng/L for males and 19 (90% CI, 11-41) ng/L for females. In both males and females, the median cTnI concentrations were significantly higher in participants aged 50years and older than in those younger than 50years old. CONCLUSIONS: In this study, the reference population with Korean ethnicity had lower overall and male 99th percentile URLs than other reference populations. Our data suggest that 99th percentile URLs may be influenced by factors such as ethnicity, age distribution of participants, and selection criteria used to define a healthy reference population.
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Biomarcadores/sangre , Enfermedades Cardiovasculares/diagnóstico , Inmunoensayo/métodos , Troponina I/sangre , Troponina T/sangre , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/sangre , Femenino , Estudios de Seguimiento , Humanos , Laboratorios , Masculino , Persona de Mediana Edad , Sistemas de Atención de Punto , Pronóstico , Curva ROC , Valores de Referencia , Adulto JovenRESUMEN
The functionality and viability of stored human red blood cells (RBCs) is an important clinical issue in transfusions. To systematically investigate changes in stored whole blood, the hematological properties of individual RBCs were quantified in blood samples stored for various periods with and without a preservation solution called citrate phosphate dextrose adenine-1 (CPDA-1). With 3-D quantitative phase imaging techniques, the optical measurements for 3-D refractive index (RI) distributions and membrane fluctuations were done at the individual cell level. From the optical measurements, the morphological (volume, surface area and sphericity), biochemical (hemoglobin content and concentration), and mechanical parameters (dynamic membrane fluctuation) were simultaneously quantified to investigate the functionalities and progressive alterations of stored RBCs. Our results show that stored RBCs without CPDA-1 had a dramatic morphological transformation from discocytes to spherocytes within two weeks which was accompanied by significant decreases in cell deformability and cell surface area, and increases in sphericity. However, the stored RBCs with CPDA-1 maintained their morphology and deformability for up to 6 weeks.
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Conservación de la Sangre/métodos , Deformación Eritrocítica , Transfusión Sanguínea , Citratos/administración & dosificación , Glucosa/administración & dosificación , Hemoglobinas/metabolismo , HumanosRESUMEN
At diagnosis, fewer than 10% of chronic myelogenous leukemia (CML) patients have additional cytogenetic abnormalities (ACAs), which are frequently found in transformation to blast crisis. We report a case of CML-chronic phase (CML-CP) that showed t(1;15) at diagnosis. A 64-year-old man presented with sustained leukocytosis and thrombocytosis. His bone marrow (BM) was hypercellular with 2.5% blasts and BCR-ABL1 rearrangement. The karyotype in the BM was 46,XY,t(1;15)(q32;p13),t(9;22)(q34;q11.2)[20], while the karyotype in the peripheral blood was 46,XY[20]. This is the first report on the presence of t(1;15) at diagnosis of CML-CP, and its clinical significance remains unclear.
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Aberraciones Cromosómicas , Cromosomas Humanos Par 15/genética , Cromosomas Humanos Par 1/genética , Leucemia Mielógena Crónica BCR-ABL Positiva/diagnóstico , Leucemia Mielógena Crónica BCR-ABL Positiva/genética , Translocación Genética , Humanos , Cariotipificación , Masculino , Persona de Mediana EdadRESUMEN
Mixed phenotype acute leukemia (MPAL) includes biphenotypic leukemia, bilineal leukemia, or its combination by the 2008 WHO classification. A few cases of combined biphenotypic/bilineal MPAL have been reported so far; they all had biphenotypic expressions in only one of the two distinct leukemic populations. A 43-year-old female presented with leukocytosis and bicytopenia. Her complete blood counts were: hemoglobin, 6.9 g/dL; white blood cells, 62.8×10(9)/L; and platelets, 83×10(9)/L. Neither lymphadenopathy nor organomegaly was observed. Blasts and promonocytes/monoblasts were increased in her peripheral blood (42%) and bone marrow (60.1%). Flow cytometric analysis revealed two distinct populations of leukemic cells, which expressed CD11c, CD19, and cytoplasmic CD79a in common. Additionally, the first population expressed CD10 and CD117 (B/myeloid), and the second one expressed CD14 and CD20 (B/monocytic). She had a karyotype of 46,XX,inv(9)(p12q13),t(9;22)(q34;q11.2)[20] and BCR/ABL1 rearrangement. To the best of our knowledge, this is the first reported case of biphenotypic/bilineal MPAL with B/myeloid and B/monocytic expressions.