The accuracy-based lipid (ABL) proficiency testing (PT) program was started in 2016 by the Korean External Quality Assessment Service to minimize the matrix effect. We analyzed 3 years of the program. We made or purchased six kinds of commutable frozen sera based on the Clinical and Laboratory Standards Institute 37A guideline and distributed it in two rounds per year from 2016 to 2018. We obtained reference values for levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC), total glycerides, and triglycerides in each fresh frozen pool at the reference-measurement laboratories. We evaluated the average percent bias of the participating laboratories based on the National Cholesterol Education Program (NCEP) bias limit. The number of participating laboratories evaluating TC, HDLC, LDLC, total glycerides, and triglycerides increased from 164 to 223, 163 to 223, 158 to 214, 98 to 139, and 61 to 82, respectively. The average percent bias of all participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was +0.14%, −0.54%, +2.9%, −1.08%, and −1.32%, respectively. The average percent bias exceeded the NCEP bias limit only once or twice for TC, HDLC, and total glycerides but frequently for LDLC (eight out of 18 pools). The manufacturer-specific bias estimation report seemed useful for traceability. Although the average percent bias of participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was mostly within the bias limit provided by NCEP, cases of bias limit exceeding the NCEP bias limit occurred occasionally, especially for LDLC during the 3 years of the ABL PT program in Korea, suggesting that ABL PT can be used to keep maintaining traceability.
Bias (Epidemiology) ; Cholesterol ; Education ; Glycerides ; Korea ; Laboratory Proficiency Testing ; Lipoproteins ; Reference Values ; Triglycerides

The Clinical Mass Spectrometry Research Committee (CMSRC), in affiliation with the Korean Society of Clinical Chemistry (KSCC), conducted a questionnaire survey on opinions about the general status of clinical mass spectrometric analysis in Korea. As a result, we understand that this field has passed through the introductory stage and is settled as a field of clinical laboratory testing in Korea, with the number of new laboratories performing mass spectrometric analysis being low. In spite of the many difficulties in introducing and operating clinical mass spectrometric analysis, there is a strong interest in this field, and even though further expansion is expected, there are still many issues to be resolved. In the future, it will be necessary to make concrete and thorough efforts to further develop the laboratory tests using clinical mass spectrometric analysis in Korea, centering on the CMSRC affiliated with the KSCC.
Chemistry, Clinical ; Korea ; Mass Spectrometry

Gumiganghwal-tang is a traditional herbal medicine widely used for its anti-inflammatory,analgesic,and antipyretic effects.However,the safety and efficacy of its active ingredients based on an in vivo pharmacokinetic (PK) study have yet been investigated.We have established a sensitive and accurate UPLC-ESI-MS/MS method and conducted a PK study on 14 constituents of Gumiganghwal-tang through human plasma analysis.Analytical conditions were optimized according to the physicochemical prop-erties of the 14 compounds to facilitate efficient separation and eliminate overlap or interference be-tween peaks.KINETEX-C18 and lnertsil-C8 columns were used as UPLC stationary phases,and acetonitrile and aqueous formic acid were used as mobile phases.All the analytes were quantified with a triple quadrupole mass spectrometer using electrospray ionization in multiple reaction monitoring mode.The chromatograms of 14 bioactive compounds showed excellent elution and sensitivity,and each peak was selectively separated and quantified without interference with each other or impurities.The established analytical method was based on international guidelines and was successfully used to perform PK studies of 14 herbal ingredients in humans after oral administration with Gumiganghwal-tang tablets.The oral absorption of most active components of Gumiganghwal-tang was relatively rapid and remained considerably long in the body to be quantified in plasma up to 48 h after administration.

Background: Liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) is increasingly used for immunosuppressive drug tests. However, most LC-MS/MS tests are laboratory-developed and their agreement is unknown in different Korean laboratories.This interlaboratory comparison study evaluated test reproducibility and identified potential error sources. Methods: Test samples containing three concentrations of tacrolimus, sirolimus, everolimus, cyclosporine, and mycophenolic acid were prepared by pooling surplus samples from patients undergoing routine therapeutic drug monitoring and tested in duplicate in the participating 10 clinical laboratories. Reconstitution and storage experiments were conducted for the commonly used commercial calibrator set. The robust estimators of reproducibility parameters were calculated. Spearman’s rank correlation coefficient (rho, ρ) was used to evaluate the correlation between drugs. Multiple linear regression was used to determine whether the experimental conditions alter the calibration curves. Results: The reproducibility coefficient of variation exceeded 10% only for sirolimus concentrations 1 and 2 (10.8% and 12.5%, respectively) and everolimus concentrations 1 and 2 (12.3% and 11.4%, respectively). The percent difference values showed weak correlations between sirolimus and everolimus (ρ = 0.334, P = 0.175). The everolimus calibration curve slope was significantly altered after reconstitution following prolonged 5°C storage (P = 0.015 for 14 days; P = 0.025 for 28 days); the expected differences at 6 ng/mL were 0.598% for 14 days and 0.384% for 28 days. Conclusions LC-MS/MS test reproducibility for immunosuppressive drugs seems to be good in the Korean clinical laboratories. Continuous efforts are required to achieve test standardization and harmonization, especially for sirolimus and everolimus.

PURPOSE: In order to provide effective hospice care, adequate length of survival (LOS) in hospice is necessary. However the reported average LOS is much shorter. Analysis of LOS in hospice has not been reported from Korea. We evaluated the duration of LOS and the factors associated with LOS at our hospice center. MATERIALS AND METHODS: We retrospectively examined 446 patients who were admitted to our hospice unit between January 2010 and December 2012. We performed univariate and multivariate analysis for analysis of factors associated with LOS. RESULTS: The median LOS was 9.5 days (range, 1 to 186 days). The LOS of 389 patients (86.8%) was< 1 month. At the time of admission to hospice, 112 patients (25.2%) were completely bedridden, 110 patients (24.8%) had mouth care only without intake, and 134 patients (30.1%) had decreased consciousness, from confusion to coma. The median time interval between the day of the last anticancer treatment and the day of hospice admission was 75 days. By analysis of the results of multivariate analysis, decreased intake and laboratory results showing increased total white blood cell (WBC), decreased platelet count, increased serum creatinine, increased aspartate aminotransferase (AST), alanine aminotransferase (ALT), and lactate dehydrogenase (LDH) level were poor prognostic factors for survival in hospice. CONCLUSION: Before hospice admission, careful evaluation of the patient's performance, particularly the oral intake, and total WBC, platelet, creatinine, AST, ALT, and LDH level is essential, because these were strong predictors of shorter LOS. In the future, conduct of prospective controlled studies is warranted in order to confirm the relationship between potential prognostic factors and LOS in hospice.
Alanine Transaminase ; Aspartate Aminotransferases ; Blood Platelets ; Coma ; Consciousness ; Creatinine ; Hospice Care ; Hospices* ; Humans ; Korea ; L-Lactate Dehydrogenase ; Leukocytes ; Mouth ; Multivariate Analysis ; Platelet Count ; Prognosis ; Retrospective Studies ; Survival Analysis

No abstract available.
Intracranial Hemorrhages* ; Stroke*

BACKGROUND AND PURPOSE: In a recent pooled analysis of randomized clinical trials (RCTs), intravenous tissue plasminogen activator (TPA) improves the outcome in patients aged > or =80 years. However, it is uncertain whether the findings are applicable to clinical practice in Asian populations. METHODS: From a multicenter stroke registry database of Korea, we identified patients with acute ischemic stroke who were aged > or = 80 years. Using multivariable analysis and propensity score (PS)-matched analyses, we assessed the effectiveness and safety of intravenous TPA within 4.5 hours. RESULTS: Among 2,334 patients who met the eligible criteria, 236 were treated with intravenous TPA (mean age, 83+/-5; median NIHSS, 13 [IQR, 8-17]). At discharge, the TPA group compared to the no-TPA group had a favorable shift on the modified Rankin Scale (mRS) score (multivariable analysis, OR [95% CI], 1.51 [1.17-1.96], P=0.002; PS-matched analysis, 1.54 [1.17-2.04], P=0.002) and was more likely to achieve mRS 0-1 outcome (multivariable analysis, 2.00 [1.32-3.03], P=0.001; PS-matched analysis, 1.59 [1.04-2.42], P=0.032). TPA treatment was associated with an increased risk of symptomatic intracranial hemorrhage (multivariable analysis, 5.45 [2.80-10.59], P<0.001; PS-matched analysis, 4.52 [2.24-9.13], P<0.001), but did not increase the in-hospital mortality (multivariable analysis, 0.86 [0.50-1.48], P=0.58; PS-matched analysis, 0.88 [0.52-1.47], P=0.61). CONCLUSIONS: In the setting of clinical practice, intravenous TPA within 4.5 hours improved the functional outcome despite an increased risk of symptomatic intracranial hemorrhage in very elderly Korean patients. The findings, consistent with those from pooled analysis of RCTs, strongly support the use of TPA for this population.
Aged* ; Asian Continental Ancestry Group ; Hospital Mortality ; Humans ; Intracranial Hemorrhages ; Korea ; Propensity Score ; Stroke* ; Thrombolytic Therapy ; Tissue Plasminogen Activator*

Characteristics of stroke cases, acute stroke care, and outcomes after stroke differ according to geographical and cultural background. To provide epidemiological and clinical data on stroke care in South Korea, we analyzed a prospective multicenter clinical stroke registry, the Clinical Research Center for Stroke-Fifth Division (CRCS-5). Patients were 58% male with a mean age of 67.2+/-12.9 years and median National Institutes of Health Stroke Scale score of 3 [1-8] points. Over the 6 years of operation, temporal trends were documented including increasing utilization of recanalization treatment with shorter onset-to-arrival delay and decremental length of stay. Acute recanalization treatment was performed in 12.7% of cases with endovascular treatment utilized in 36%, but the proportion of endovascular recanalization varied across centers. Door-to-IV alteplase delay had a median of 45 [33-68] min. The rate of symptomatic hemorrhagic transformation (HT) was 7%, and that of any HT was 27% among recanalization-treated cases. Early neurological deterioration occurred in 15% of cases and were associated with longer length of stay and poorer 3-month outcomes. The proportion of mRS scores of 0-1 was 42% on discharge, 50% at 3 months, and 55% at 1 year after the index stroke. Recurrent stroke up to 1 year occurred in 4.5% of patients; the rate was higher among older individuals and those with neurologically severe deficits. The above findings will be compared with other Asian and US registry data in this article.
Asian Continental Ancestry Group ; Humans ; Korea ; Length of Stay ; Male ; National Institutes of Health (U.S.) ; Stroke ; Tissue Plasminogen Activator

On page 47, the definition of stroke progression was erroneously described in the previous version of article.

BACKGROUND AND PURPOSE: About 30%-40% of stroke patients are taking antiplatelet at the time of their strokes, which might increase the risk of symptomatic intracranial hemorrhage (SICH) with intravenous tissue plasminogen activator (IV-TPA) therapy. We aimed to assess the effect of prestroke antiplatelet on the SICH risk and functional outcome in Koreans treated with IV-TPA. METHODS: From a prospective stroke registry, we identified patients treated with IV-TPA between October 2009 and November 2014. Prestroke antiplatelet use was defined as taking antiplatelet within 7 days before the stroke onset. The primary outcome was SICH. Secondary outcomes were discharge modified Rankin Scale (mRS) score and in-hospital mortality. RESULTS: Of 1,715 patients treated with IV-TPA, 441 (25.7%) were on prestroke antiplatelet. Prestroke antiplatelet users versus non-users were more likely to be older, to have multiple vascular risk factors. Prestroke antiplatelet use was associated with an increased risk of SICH (5.9% vs. 3.0%; adjusted odds ratio [OR] 1.79 [1.05-3.04]). However, at discharge, the two groups did not differ in mRS distribution (adjusted OR 0.90 [0.72-1.14]), mRS 0-1 outcome (34.2% vs. 33.7%; adjusted OR 1.27 [0.94-1.72), mRS 0-2 outcome (52.4% vs. 52.9%; adjusted OR 1.21 [0.90-1.63]), and in-hospital mortality (6.1% vs. 4.2%; adjusted OR 1.19 [0.71-2.01]). CONCLUSIONS: Despite an increased risk of SICH, prestroke antiplatelet users compared to non-users had comparable functional outcomes and in-hospital mortality with IV-TPA therapy. Our results support the use of IV-TPA in eligible patients taking antiplatelet therapy before their stroke onset.
Hospital Mortality ; Humans ; Intracranial Hemorrhages* ; Odds Ratio ; Platelet Aggregation Inhibitors ; Prospective Studies ; Risk Factors ; Stroke ; Thrombolytic Therapy ; Tissue Plasminogen Activator