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1.
Article in English | WPRIM | ID: wpr-874169

ABSTRACT

External quality assessment (EQA) is important for evaluating clinical laboratories and enhancing their testing quality. EQA schemes are variable; thus, it is crucial that the EQA organizers share their experiences to continuously improve the EQA scheme. The Korean Association of External Quality Assessment Service (KEQAS) has been the leading, authorized EQA institute for the standardization and quality management of laboratory testing in Korean medical institutions since 1976. The EQA scheme underwent a major change in 2016, and the number of EQA programs increased significantly since then. The key changes implemented in EQA scheme include a fully computerized assessment to accelerate feedback and unification of the testing and reporting methods. We provide an overview of the EQA schemes and performance evaluation criteria of the KEQAS and suggest directions for achieving the global harmonization of EQA.

2.
Article in English | WPRIM | ID: wpr-874155

ABSTRACT

Background@#Total cholesterol concentration measurement is important in the diagnosis of dyslipidemia and evaluation of cardiovascular disease risk factors. Measurement reliability for obtaining an accurate total cholesterol concentration requires procedure standardization. We evaluated the standardization status for total cholesterol concentration measurement through Korean external quality assessment (EQA) data analysis. @*Methods@#This study involved 1,670 laboratories that participated in the EQA of total cholesterol concentration measurements in 2019 for 32 products from different manufacturers. The target concentrations of three quality control (QC) materials (samples A, B, and C) were measured using the reference method and compared with EQA data. The performance criteria for total cholesterol concentration measurement were based on the National Cholesterol Education Program guidelines, with ± 3% inaccuracy. @*Results@#The target values and inaccuracies of the QC material based on the reference method measurements were 254.65 ± 7.64, 108.30 ± 3.25, and 256.29 ± 7.69 mg/dL (6.59 ± 0.20, 2.80 ± 0.08, and 6.63 ± 0.20 mmol/L) for samples A, B, and C, respectively.The performance criteria were not met in 42.7% laboratories for sample A, 68.4% of laboratories for sample B, and 38.0% laboratories for sample C. @*Conclusions@#Despite significant efforts to accurately measure total cholesterol concentrations, further actions are needed for measurement standardization. Manufacturers reporting values that differ from target values should check calibrator traceability; additional efforts to accurately measure total cholesterol concentrations are required for laboratories that use products from these manufacturers.

3.
Article in English | WPRIM | ID: wpr-874154

ABSTRACT

Background@#Accurate serum creatinine (Cr) concentration measurement is essential for evaluating kidney function. In 2011, the Korean Association of External Quality Assessment Service (KEQAS) launched an accuracy-based Cr proficiency testing (ABCr PT) survey. We analyzed long-term data of the KEQAS ABCr PT survey collected between 2011 and 2019 to assess recent trends in Cr assays in Korea. @*Methods@#The ABCr PT survey including three commutable fresh-frozen serum samples was performed twice a year. The target Cr concentration was assigned using isotope-dilution mass spectrometry. We analyzed data obtained from the participating laboratories, calculated the yearly bias, and evaluated bias trends for the major reagents and instruments. Outliers were excluded from all analysis. @*Results@#The mean percentage bias based on the total data of all participating laboratories was 10.8% in the 2011-A survey and 0.2% in 2019-B survey. Bias for the major reagents and instruments differed depending on the manufacturer. Enzymatic assays generally showed desirable bias ranging from –3.9% to 3.2% at all Cr concentrations and lower interlaboratory variability than non-enzymatic assays (enzymatic vs. non-enzymatic, 3.3%– 7.2% vs. 6.3%–9.1%). @*Conclusions@#Although the mean percentage bias of Cr assays tends to decrease over time, it is necessary to continuously strive to improve Cr assay accuracy, especially at low concentrations.

4.
Article in English | WPRIM | ID: wpr-785398

ABSTRACT

BACKGROUND: Differences in the performance of suggested warfarin dosing algorithms among different ethnicities and genotypes have been reported; this necessitates the development of an algorithm with enhanced performance for specific population groups. Previous warfarin dosing algorithms underestimated warfarin doses in VKORC1 1173C carriers. We aimed to develop and validate a new warfarin dosing algorithm for Korean patients with VKORC1 1173C.METHODS: A total of 109 patients carrying VKORC1 1173CT (N=105) or 1173CC (N=4) were included in this study. Multiple regression analysis was performed to deduce a new dosing algorithm. Following literature searches for genotype-guided warfarin dosing algorithms, 21 algorithms were selected and evaluated using the correlation coefficient (ρ) of actual dose and estimated dose, mean error, and root mean square error.RESULTS: The developed algorithm is as follows: maintenance dose (mg/week)=exp [3.223−0.009×(age)+0.577×(body surface area [BSA])+0.178×(sex)−0.481×(CYP2C9 genotype)+0.227×(VKORC1 genotype)]. Integrated variables explained 44% of the variance in the maintenance dose. The predicted and actual doses showed moderate correlation (ρ=0.641) with the best performance with a mean error of −1.30 mg/week. The proportion of underestimated groups was 17%, which was lower than with the other algorithms.CONCLUSIONS: This is the first study to develop and validate a warfarin dosing algorithm based on data from VKORC1 1173C carriers; it showed superior predictive performance compared with previously published algorithms.


Subject(s)
Genotype , Humans , Korea , Population Groups , Warfarin
5.
Laboratory Medicine Online ; : 185-196, 2020.
Article | WPRIM | ID: wpr-836926

ABSTRACT

The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in clinical laboratories is increasing and is likely to expand into even more clinical venues in the future. Mass spectrometry is the standard method for analyte identification in the clinical chemistry field; however, differences in mass spectrometry protocols and handling affect the accuracy and reliability of these tests and prevent direct comparisons of results between laboratories. For example, the results of laboratories using LC-MS/MS methods are less likely to be reproducible than those of laboratories using conventional, automated methods. This is due to inadequate handling of the equipment and/or poor quality control after the implementation of the method, which may result in unnecessary medical expenditures or even adverse outcomes for the patients. Unfortunately, guidelines to monitor the accuracy of LC-MS/MS-based clinical tests are still lacking. In general, the quality control methods used in conventional clinical tests could also be applied to LC-MS/MS. However, additional quality control methods specific to LC-MS/MS techniques must be continuously employed to maintain the same quality level achieved during method development and verification. This report is intended to help clinical laboratories that operate LC-MS/MS improve the accuracy and reliability of their testing by providing guidance for quality assurance and improvement, based on a collection of existing guidelines and expert opinions from the literature.

6.
Laboratory Medicine Online ; : 235-241, 2020.
Article | WPRIM | ID: wpr-836919

ABSTRACT

Background@#For effective management of blood components, periodic updates of the maximum surgical blood order schedule (MSBOS) using recent data are crucial. This study aimed to establish an updated MSBOS and red blood cell (RBC) mean transfusion units per patient according to the adjacent diagnosis related groups (ADRG) classification system. @*Methods@#This retrospective study was based on an audit of the medical records of inpatients at a tertiary hospital between January and December 2017. We investigated transfusion-related data to establish the MSBOS and determine the RBC mean transfusion units per patient according to the ADRG and compared these updated values with previous data. @*Results@#During the investigated period, a total of 5,607 RBC units were transfused in 17,382 patients. The revised MSBOS was similar to the previous MSBOS in most surgeries. Among the 130 ADRG codes analyzed, 34 codes showed an increase, while 96 codes showed a decrease in RBC mean transfusion units per patient, compared to data from 2007. Overall, the RBC mean transfusion units per patient in 2017 was 0.89 units less compared to that in 2007 after adjusting for age (95% CI: 0.853–0.912). @*Conclusions@#The revised MSBOS was similar to that of the previous versions. However, there were differences in the number of RBC transfusion units used in some surgeries and disease treatments compared to those in the past. Considering the changes within the medical environment, this study highlights the importance of periodic evaluation of MSBOS and RBC transfusion usage.

7.
Laboratory Medicine Online ; : 242-246, 2020.
Article | WPRIM | ID: wpr-836918

ABSTRACT

Cross-reactive carbohydrate determinants (CCDs) are simple carbohydrates linked to amino acid chains; they are found in pollens, vegetable foods, insect, and Hymenoptera venoms and are broadly cross-reactive with CCD-specific IgE antibodies. A man in his fifties was evaluated using a multiple allergen simultaneous test–immunoblot assay. On the PROTIA Allergy-Q 64 inhalant panel (ProteomeTech, Korea), reactions to 37 of 59 antigens were observed except mammalian antigens, and cross-reactivity owing to anti-CCD antibodies was suspected. After ProGlycAn CCD-blocker (ProGlycAn, Austria) treatment, the patient exhibited no response to CCD allergens, and the number of allergens showing positive reactions was reduced to 15. We further tested a total of 7 samples from patients who were suspected to have CCD-related cross-reactivity. For these 8 patients, the average number of positive reactions to allergens was reduced from 33 (range 24-36) to 8 (range 0-19) after CCD-blocker treatment. We concluded that CCD-blocker treatment in sample with anti-CCD antibodies can reduce the false positive reponse and provide more specific information about allergens.

9.
Laboratory Medicine Online ; : 161-165, 2019.
Article in Korean | WPRIM | ID: wpr-760500

ABSTRACT

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.


Subject(s)
Chemistry, Clinical , Korea , Mass Spectrometry
10.
Article in English | WPRIM | ID: wpr-760489

ABSTRACT

BACKGROUND: Blood culture is an important method for identifying infectious microorganisms and confirming that a selected antimicrobial treatment is appropriate. In this study, we investigated the annual changes in the frequencies of blood isolates and antibiotic susceptibility test (AST) results. METHODS: We created a large database comprising data on all patient-unique blood cultures obtained from January 2007 through December 2016. Blood specimens were cultured using the BD BACTEC FX system, and species identification and AST were performed using the VITEK 2 system. RESULTS: During the 10-year study period, a total of 203,651 blood culture results were collected. Of these, gram-positive cocci, gram-negative rods, and fungi were isolated in 2.15%, 0.55%, and 0.12% of the blood cultures, respectively. Escherichia coli was the most commonly isolated species (22.8%), followed by Staphylococcus epidermidis (16.8%), Klebsiella pneumoniae (8.1%), and Staphylococcus aureus (8.0%). Fungal species were isolated in 3.0% of all positive blood cultures. Candida albicans was the most commonly isolated species (1.1%), followed by Candida parapsilosis (0.6%). Methicillin resistance was seen in 55.2% of S. aureus isolates. The frequencies of vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA) were 13.1% and 10.9%, respectively. The isolation rates of MRSA, VRE, and CRPA showed different patterns each year. CONCLUSIONS: Among the isolates, E. coli was the most common, followed by S. epidermidis and K. pneumoniae. This study represents a long-term analysis of bloodstream infections, and the results can be used to identify trends in the microorganisms isolated and their drug resistance.


Subject(s)
Bacteremia , Candida , Candida albicans , Drug Resistance , Enterococcus , Escherichia coli , Fungi , Gram-Positive Cocci , Klebsiella pneumoniae , Korea , Methicillin Resistance , Methicillin-Resistant Staphylococcus aureus , Methods , Pneumonia , Pseudomonas aeruginosa , Staphylococcus aureus , Staphylococcus epidermidis
11.
Article in Korean | WPRIM | ID: wpr-741142

ABSTRACT

BACKGROUND: Standardization of creatinine assay is consistently performed and much effort has been put into improving the accuracy of the results. We aimed to analyze the results of accuracy-based proficiency testing of creatinine assays performed by the Korea Association of External Quality Assessment Service from 2011 to 2017 to assess the current state of creatinine assays in Korea. METHODS: From 2011 to 2017, the accuracy-based proficiency testing of creatinine was performed twice a year. We analyzed the results obtained from the participating laboratories and calculated the year-wise bias. The acceptable limit of bias was as follows: ±11.4% for creatinine concentration >1.0 mg/dL, and 0.114 mg/dL for creatinine concentration ≤1.0 mg/dL. The trend of bias with the major instruments and reagent manufacturers were analyzed. RESULTS: The number of participating laboratories was 54 in 2011, which gradually increased to 146–178 after 2015. For each of the three samples used in the survey, the percentage of laboratories whose biases in the results were within the acceptable limits was 33.3% for the first time in 2011, which gradually increased to 74.7%–85.0% after 2014. The mean biases in all the results of the participating laboratories were 11.1% in 2011 (1st trial) and 2.4% in 2017 (2nd trial). The biases in the results with the major instruments and reagents differed according to the manufacturers. CONCLUSIONS: The mean bias in the results obtained from the participating laboratories in the accuracy-based proficiency testing of creatinine surveys showed a decreasing trend.


Subject(s)
Bias , Creatinine , Indicators and Reagents , Korea
12.
Blood Research ; : 17-22, 2019.
Article in English | WPRIM | ID: wpr-739439

ABSTRACT

Genetic hemoglobin disorders are caused by mutations and/or deletions in the α-globin or β-globin genes. Thalassemia is caused by quantitative defects and hemoglobinopathies by structural defect of hemoglobin. The incidence of thalassemia and hemoglobinopathy is increased in Korea with rapid influx of people from endemic areas. Thus, the awareness of the disease is needed. α-thalassemias are caused by deletions in α-globin gene, while β-thalassemias are associated with decreased synthesis of β-globin due to β-globin gene mutations. Hemoglobinopathies involve structural defects in hemoglobin due to altered amino acid sequence in the α- or β-globin chains. When the patient is suspected with thalassemia/hemoglobinopathy from abnormal complete blood count findings and/or family history, the next step is detecting hemoglobin abnormality using electrophoresis methods including high performance liquid chromatography and mass spectrometry. The development of novel molecular genetic technologies, such as massively parallel sequencing, facilitates a more precise molecular diagnosis of thalassemia/hemoglobinopathy. Moreover, prenatal diagnosis using genetic testing enables the prevention of thalassemia birth and pregnancy complications. We aimed to review the spectrum and classification of thalassemia/hemoglobinopathy diseases and the diagnostic strategies including screening tests, molecular genetic tests, and prenatal diagnosis.


Subject(s)
Amino Acid Sequence , Anemia , Blood Cell Count , Chromatography, Liquid , Classification , Clinical Laboratory Techniques , Diagnosis , Electrophoresis , Erythrocytes , Genetic Testing , Hematology , Hemoglobinopathies , High-Throughput Nucleotide Sequencing , Humans , Incidence , Korea , Mass Screening , Mass Spectrometry , Molecular Biology , Parturition , Pregnancy Complications , Prenatal Diagnosis , Thalassemia
14.
Article in Korean | WPRIM | ID: wpr-718776

ABSTRACT

As part of the clinical chemistry programs of the Korean Association of External Quality Assessment Service, we organized trials to conduct external quality assessment of hemoglobin A1c (HbA1c) in 2016 and 2017. We delivered three commutable whole blood specimens for each trial. The overall response rates were 96.4% in 2016 and 98.4% and 99.6% in the first and second trials in 2017, respectively. Two types of reports were generated: a common report including the mean, standard deviation, coefficient of variation, median, minimum value, and maximum value according to manufacturer and instrument, as well as a summary report of the results from each participating laboratory, including a histogram for each specimen, Levey-Jennings chart for serial percent deviations, and table showing the target value, upper and lower limits, percent deviation, and grade. From 2016, the acceptance criterion was changed from ±8.0% to ±6.7%. The overall acceptable rates for the survey were 91.5%, 91.4%, 94.9%, and 89.0% for the first trial in 2016 through the second trial in 2017, respectively. The requisite continual improvement in the quality of HbA1c testing can be achieved through participation in similar accuracy-based proficiency testing programs.


Subject(s)
Chemistry, Clinical , Korea , Laboratory Proficiency Testing , Research Report
15.
Article in English | WPRIM | ID: wpr-717052

ABSTRACT

BACKGROUND: Following discontinuation of the recombinant immunoblot assay (RIBA), the only available supplementary test for the detection of hepatitis C virus (HCV) is the nucleic acid amplification test (NAAT). However, the NAAT does not adequately detect past HCV. Consequently, it is hard to distinguish between past HCV infection and biological false positivity with an anti-HCV result alone. We assessed the diagnostic performance of two immunoassays: the ARCHITECT anti-HCV chemiluminescent microparticle immunoassay (CMIA; Abbott Diagnostics, Wiesbaden, Germany) and the Access HCV Ab PLUS chemiluminescent immunoassay (CIA; Bio-Rad, Marnes-la-Coquette, France). We also explored an optimized algorithm to determine the anti-HCV results. METHODS: We tested 126,919 patients and 44,556 individuals who underwent a medical checkup. RIBA and NAAT were conducted for samples that tested anti-HCV-positive using CMIA and CIA. We assessed the optimal signal-to-cutoff (S/CO) ratio in HCV-positive samples. RESULTS: In total, 1,035 blood samples tested anti-HCV-positive. Of these, RIBA was positive in 512, indeterminate in 160, and negative in 363 samples. One hundred sixty-five samples were NAAT-positive. Diagnostic sensitivity and positive predictive value (PPV) were 96.7% and 52.1%, respectively, for CMIA, and 94.7% and 72.3%, respectively, for CIA. The optimal S/CO ratio was 5.2 for CMIA and 2.6 for CIA at 95% PPV. In total, 286 samples tested positive in CMIA and 444 in CIA, while 443 samples tested positive in both assays. CONCLUSIONS: It is hard to determine anti-HCV positivity based on the S/CO ratio alone. However, this study elucidated the role of the S/CO ratio by using the NAAT and RIBA.


Subject(s)
Hepacivirus , Humans , Immunoassay , Nucleic Acid Amplification Techniques
16.
Article in Korean | WPRIM | ID: wpr-716937

ABSTRACT

BACKGROUND: Newborn screening of tyrosinemia type 1 is important for identifying infants at risk for developing this disease before life-threatening symptoms occur. It is difficult to differentiate between tyrosinemia type 1 and transient neonatal tyrosinemia (TNT) by analyzing tyrosine alone. Thus, succinylacetone must be analyzed. In this study, we measured succinylacetone in dried blood spot (DBS) by HPLC-tandem mass spectrometry (HPLC-MS/MS) and established cut-off values. METHODS: We used the hydrazine derivatization method to measure succinylacetone in 127 DBSs showing normal results in the newborn screening test and 93 DBSs showing increased tyrosine levels. We established cut-off values using the 99.9th percentile value or median+5 standard deviation value. RESULTS: Succinylacetone levels determined by our method were well-correlated with the results recommended by the Centers for Disease Control and Prevention for proficiency testing (r=0.9968). The succinylacetone levels in normal newborn DBSs were significantly lower than those in DBSs with high tyrosine levels (P < 0.001). The cut-off values were calculated to be 1.3 µM from the results of 127 normal DBS samples and 2.2 µM from 220 DBSs, including in 93 newborns with TNT. CONCLUSIONS: Measurement of succinylacetone in DBSs by HPLC-MS/MS is useful in individuals with increased tyrosine concentrations and can be used for rapid differential diagnosis of tyrosinemia when an appropriate cut-off value is established.


Subject(s)
Diagnosis, Differential , Humans , Infant , Infant, Newborn , Mass Screening , Mass Spectrometry , Methods , Tandem Mass Spectrometry , Trinitrotoluene , Tyrosine , Tyrosinemias
17.
Article in Korean | WPRIM | ID: wpr-715913

ABSTRACT

BACKGROUND: The performance of the self-monitoring of blood glucose in patients with diabetes should be properly evaluated to ensure strict glycemic control. This study evaluated the self-testing Blood Glucose Monitoring System GlucoDr.S™ (All Medicus Co., Ltd., Korea). METHODS: This study recruited 120 patients. Use of the glucometer was evaluated according to ISO 15197:2013 guidelines. The YSI 2300 STAT PLUS Glucose Analyzer (YSI Life Sciences, USA) was used as the reference device. RESULTS: The standard deviation and coefficients of variation ranges for measurement repeatability and intermediate measurement precision conducted with 10 meters and 3 reagent lots on the same day were 2.7–3.2 mg/dL (0.99. The influence effect of hematocrit and the 24 interference agents was not significant, except for xylose. A system accuracy test was conducted with 100 subjects taking duplicate measurements from each of the 3 reagent lots. When glucose levels were 95% of the samples were within ±15 mg/dL and within ±15% of the average measured values of the reference measurement, respectively. In Consensus Error grid analysis, all results were distributed in zone A and B. The results of the user performance evaluation using 115 lay persons were also included in the acceptance range. CONCLUSION: The GlucoDr.S™ showed acceptable performance according to the ISO 15197:2013 guidelines and could be a clinically useful self-testing glucometer.


Subject(s)
Biological Science Disciplines , Blood Glucose , Consensus , Glucose , Hematocrit , Humans , Xylose
18.
Article in English | WPRIM | ID: wpr-714430

ABSTRACT

Measurement of thiopurine metabolites is helpful to monitor adverse effects and assess compliance in patients on thiopurine treatment. The purpose of this study was to develop and validate an analytical method for measurement of thiopurine metabolites, thioguanine nucleotides (6-TGN) and 6-methylmercaptopurine nucleotide (6-MMPN), in RBCs. We developed and validated a liquid chromatography–tandem mass spectrometry (LC-MS/MS) method for the quantification of 6-TGN and 6-MMPN and evaluated the stability of the thiopurine metabolites in RBC and whole blood states without any preprocessing at various storage conditions. The linear range was 0.1–10 µmol/L and 0.5–100 µmol/L for 6-TGN and 6-MMPN, respectively. The mean extraction recovery at the two concentrations was 71.0% and 75.0% for 6-TGN, and 102.2% and 96.4% for 6-MMPN. Thiopurine metabolites in preprocessed RBC samples were stable at 25℃ and 4℃ after storage for 4 hours and at −70℃ for up to 6 months. However, 6-TGN decreased by 30% compared with the initial concentration when stored at −20℃ for 180 days. In whole blood states, 6-TGN decreased by about 20% at four days after storage at 4℃. We validated a reliable LC-MS/MS method and recommend that the patient's whole blood sample be preprocessed as soon as possible.


Subject(s)
Compliance , Humans , Mass Spectrometry , Methods , Nucleotides , Thioguanine
19.
Laboratory Medicine Online ; : 128-134, 2017.
Article in Korean | WPRIM | ID: wpr-110640

ABSTRACT

BACKGROUND: Pyridoxal-5'-phosphate (P5P), a coenzyme of the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) reactions, is required to measure aminotransferase levels (IFCC method). However, a modified IFCC method that uses a reagent devoid of P5P is commonly used in laboratories in Korea. To determine the differences between the two methods, we compared aminotransferase levels measured by using the IFCC method and modified IFCC method. METHODS: Serum levels of AST and ALT, with and without P5P, were measured in 2,318 patients. Based on the allowable limits of performance set by the Royal College of Pathologists of Australasia (RCPA), differences between the two methods were analyzed under various conditions. RESULTS: Higher AST and ALT values were obtained by the IFCC method compared to modified IFCC method, showing significant differences between the two methods (AST, 5.8±14.2 IU/L; ALT, 2.8±6.9 IU/L) (P<0.001). Values exceeding RCPA criteria were more frequently observed in emergency orders (AST, 65.8%; ALT, 14.4%) than in routine orders (AST, 3.2%; ALT, 9.6%), as well as in inpatient wards (AST, 70.4%; ALT, 18.5%) compared to outpatient clinics (AST, 56.6%; ALT, 10.0%). However, the differences between the two methods were not significant among the disease groups, except for the acute myocardial infarction group. CONCLUSIONS: The method using reagents without P5P underestimated aminotransferase activity. The effect of P5P was more significant in patients with acute myocardial infarction, considered as P5P-deficient. In conclusion, the IFCC method with P5P should be applied for measuring AST and ALT serum levels.


Subject(s)
Alanine Transaminase , Ambulatory Care Facilities , Aspartate Aminotransferases , Australasia , Emergencies , Humans , Indicators and Reagents , Inpatients , Korea , Liver Function Tests , Methods , Myocardial Infarction , Pyridoxal Phosphate
20.
Laboratory Medicine Online ; : 135-140, 2017.
Article in Korean | WPRIM | ID: wpr-110639

ABSTRACT

BACKGROUND: The amino-terminal pro-brain natriuretic peptide (NT-proBNP) is a useful biomarker for the diagnosis of acute congestive heart failure. A point-of-care test (POCT) could rapidly detect the presence of NT-proBNP during emergencies. We evaluated the analytical performance of the new Samsung LABGEO PA CHF Test (Samsung Electronics, Korea). METHODS: Based on the guidelines of the Clinical and Laboratory Standards Institute (CLSI), we compared the precision, linearity, and method with those of the E170 (Roche Diagnostics, Switzerland). Matrix comparison between the NT-proBNP values in whole blood and plasma was also performed, and the reference interval was determined using residual samples from healthy adults selected based on the evaluation criteria. RESULTS: The Samsung LABGEO PA CHF Test provided results in approximately 18 min. The coefficient of variation (CV) of within-laboratory precision was below 6.8%. A desirable linearity was observed in the range of 0–10,000 pg/mL, with R²=0.99. The correlation with E170 was also excellent (N=108, r=0.96). NT-proBNP values in the whole blood were correlated with those in the plasma (N=36, r=0.99). The reference interval for the circulating NT-proBNP concentration was determined in 118 plasma samples from healthy subjects (26-75 yr of age). The 97.5th percentile was found to be 58.3 pg/mL. CONCLUSIONS: The Samsung LABGEO PA CHF Test demonstrated a good analytical performance. It could be a powerful tool as a POCT for clinical practice, particularly during emergencies.


Subject(s)
Adult , Diagnosis , Emergencies , Healthy Volunteers , Heart Failure , Humans , Methods , Plasma , Point-of-Care Systems , Point-of-Care Testing
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