Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea

The outbreak of coronavirus disease 2019 (COVID-19), which began in December 2019, is still ongoing in Korea, with >9,000 confirmed cases as of March 25, 2020. COVID-19 is a severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, and real-time reverse transcription-PCR is currently the most reliable diagnostic method for COVID-19 around the world. Korean Society for Laboratory Medicine and the Korea Centers for Disease Prevention and Control propose guidelines for diagnosing COVID-19 in clinical laboratories in Korea. These guidelines are based on other related domestic and international guidelines, as well as expert opinions and include the selection of test subjects, selection of specimens, diagnostic methods, interpretation of test results, and biosafety.

Effect of Accreditation on the Accuracy of Diagnostic Hematologic Tests: Standard Deviation Index Analysis

No abstract available.

Annual Report on the External Quality Assessment Scheme for Blood Bank Tests in Korea (2015)

We report here the results of the external quality assessment scheme (EQA) of blood bank tests in Korea carried out in 2015. The proficiency testing specimens used in the survey were prepared at Ajou University Hospital. The response rates from participating laboratories for the first and second trials were 98.7% (542/549) and 98.2% (544/554), respectively. No answers to tests were considered incorrect, and the average accuracy rates for six different test items on the standard survey were as follows: ABO grouping, 99.4% to 100.0%; RhD typing, 99.4% to 100.0%; crossmatching, 93.6% to 99.0%; direct antiglobulin test (DAT) using a polyspecific reagent, 92.9% to 98.3%; DAT using an IgG monospecific reagent, 94.6% to 100.0%; DAT using a C3d monospecific reagent, 84.2% to 98.6%; unexpected antibody screening test, 94.5% to 100.0%; and antibody identification test, 93.8% to 100.0%. We performed a pilot survey on reactivities to A1 (54 responses) and H (50 responses); Rh C, c, E, and e antigen testing (47 responses); and ABO antibody titration (10-34 responses). We obtained excellent results for this EQA, and these results will be helpful for improving or maintaining the quality of the participating laboratories.

Successful Transcatheter Embolization of Spontaneous Splenic Rupture in a Patient with Chronic Myeloid Leukemia / 대한내과학회지

We report a rare case of a patient who presented with pathological splenic rupture as the initial manifestation of chronic myeloid leukemia (CML) and was treated successfully by transcatheter arterial embolization. A 36-year-old man presented to the emergency department with a 1-day history of abdominal pain. Computed tomography showed gross hemoperitoneum with marked splenomegaly, with suspected focal rupture at the lower portion of the spleen and the extravasation of contrast material indicating active bleeding. Given the patient's hemodynamic stability, he was treated with partial splenic embolization by an interventional radiologist, and transfused with red blood cells. Examination of a bone marrow aspiration and biopsy led to a diagnosis of chronic phase CML. He was discharged from the hospital on day 13 post-embolization. Transcatheter arterial embolization should be considered as the initial treatment of spontaneous splenic rupture, especially in patients with hematological malignancies.

Annual Report on the External Quality Assessment Scheme for Blood Blank Tests in Korea (2014)

We report here the results of surveys on external quality assessment (EQA) of blood bank tests in Korea carried out in 2014. The proficiency testing specimens were prepared at Ajou University Hospital and the response rates for the 1st and 2nd trials were 94.3% (537/549) and 96.0% (545/554), respectively. No answers were considered incorrect, and the average accuracy rates of six different test items on the regular survey were as follows: ABO grouping, 98.5% to 100.0%; RhD typing, 98.1% to 99.4%; crossmatching, 91.2% to 99.6%; direct antiglobulin test (DAT) using a polyspecific reagent, 96.7% to 98.4%; DAT using an immunoglobulin-G monospecific reagent, 93.8% to 98.7%; DAT using a C3d monospecific reagent, 89.5% to 98.7%; unexpected antibody screening test, 96.2% to 100.0%; and antibody identification test, 69.8% to 100.0%. Test items for the pilot survey were reactivities to anti-A1 and anti-H, Rh subgrouping, and ABO antibody titration. Except for the result of the antibody identification test for specimens with multiple antibodies, we obtained excellent survey results for the EQA of blood bank tests carried out in 2014. In addition, the number of participating institutes was higher in 2014 than in 2013. The EQA of blood bank tests in 2014 should be helpful for improving the quality of the participating laboratories.

Usefulness of Procalcitonin in the Diagnosis of Early Neonatal Bacterial Infection

BACKGROUND: The use of several biochemical markers has improved the diagnosis of neonatal bacterial infection, which remains an important cause of morbidity and mortality. Recently, serum procalcitonin (PCT) has been investigated as a new marker for the detection of bacterial infection. The aim of this study was to assess the usefulness of PCT in early neonatal bacterial infection and compare the diagnostic utility of PCT with that of C-reactive protein (CRP). METHODS: We retrospectively studied 216 neonates (109 full term, 107 preterm) whose PCT was measured 24 hr after birth. Thirty-five were clinically classified into an infected group, of which 17.4% had positive cultures. Clinical data, PCT, CRP, leukocyte, and neutrophil counts were evaluated. The diagnostic performance of PCT and CRP was studied using receiver operating characteristic analysis. RESULTS: Compared to the non-infected group, the infected group displayed significantly higher median PCT (0.82 vs. 12.29 ng/mL, P<0.0001) and CRP (1.0 vs. 5.0 mg/L, P<0.0001) values, but similar leukocyte and neutrophil counts. The thresholds for PCT and CRP were 2.75 ng/mL (sensitivity, 97.1%; specificity, 76.7%) and 3.1 mg/L (sensitivity, 68.6%; specificity, 83.3%), respectively. The area under the curve for PCT was 0.937 (95% confidence interval [CI], 0.896-0.965) and 0.781 for CRP (95% CI, 0.720-0.834). CONCLUSIONS: During the first 24 hr after birth, PCT is a more sensitive marker than CRP for bacterial infection and has predictive value for early neonatal bacterial infection.

Annual Report on External Quality Assessment of Blood Bank Tests in Korea (2013) / 임상검사와정도관리

We report here the results of surveys for External Quality Assessment (EQA) of blood bank tests carried out in 2013. The proficiency testing specimens were prepared at Ajou University Hospital and sent to 548 and 545 institutes participating in the 1st and 2nd trial, respectively. Test items for the surveys were ABO grouping, RhD typing, crossmatching, direct antiglobulin test (DAT), antibody screening test, and antibody identification test. The response rates for the 1st and 2nd trials were 94.3% and 96.0%, respectively. No answers were considered incorrect answers, and the average accuracy rates of different test items of the survey were as follows: ABO grouping, 98.9% to 100%; RhD typing, 98.4% to 99.2%; crossmatching, 94.4% to 100.0%; DAT using polyspecific reagent, 94.5% to 99.7%; DAT using IgG monospecific reagent, 94.7% to 98.8%; DAT using C3d monospecific reagent, 91.3% to 98.6%; unexpected antibody screening test, 90.9% to 100%; and antibody identification test, 87.3% to 100.0%. Overall, we obtained excellent survey results for the EQA of blood bank tests carried out in 2013, and the number of participating institutes was higher in 2013 than in 2012.

Correlation Between Virulence Genotype and Fluoroquinolone Resistance in Carbapenem-Resistant Pseudomonas aeruginosa

BACKGROUND: Pseudomonas aeruginosa is a clinically important pathogen that causes opportunistic infections and nosocomial outbreaks. Recently, the type III secretion system (TTSS) has been shown to play an important role in the virulence of P. aeruginosa. ExoU, in particular, has the greatest impact on disease severity. We examined the relationship among the TTSS effector genotype (exoS and exoU), fluoroquinolone resistance, and target site mutations in 66 carbapenem-resistant P. aeruginosa strains. METHODS: Sixty-six carbapenem-resistant P. aeruginosa strains were collected from patients in a university hospital in Daejeon, Korea, from January 2008 to May 2012. Minimum inhibitory concentrations (MICs) of fluoroquinolones (ciprofloxacin and levofloxacin) were determined by using the agar dilution method. We used PCR and sequencing to determine the TTSS effector genotype and quinolone resistance-determining regions (QRDRs) of the respective target genes gyrA, gyrB, parC, and parE. RESULTS: A higher proportion of exoU+ strains were fluoroquinolone-resistant than exoS+ strains (93.2%, 41/44 vs. 45.0%, 9/20; P< or =0.0001). Additionally, exoU+ strains were more likely to carry combined mutations than exoS+ strains (97.6%, 40/41 vs. 70%, 7/10; P=0.021), and MIC increased as the number of active mutations increased. CONCLUSIONS: The recent overuse of fluoroquinolone has led to both increased resistance and enhanced virulence of carbapenem-resistant P. aeruginosa. These data indicate a specific relationship among exoU genotype, fluoroquinolone resistance, and resistance-conferring mutations.

Epidemiological Characterizations of Class 1 Integrons from Multidrug-Resistant Acinetobacter Isolates in Daejeon, Korea

BACKGROUND: Multidrug-resistant (MDR) Acinetobacter spp. acquire antimicrobial agent-resistance genes via class 1 integrons. In this study, integrons were characterized to investigate the antimicrobial resistance mechanisms of MDR Acinetobacter isolates. In addition, the relationship between the integron type and integron-harboring bacterial species was analyzed by using epidemiological typing methods. METHODS: Fifty-six MDR Acinetobacter spp.-A. baumannii (N=30), A. bereziniae (N=4), A. nosocomialis (N=5), and A. pittii (N=17)-were isolated. The minimum inhibitory concentrations (MICs) were determined on the basis of the results of the Epsilometer test (Etest). PCR and DNA sequencing was performed to characterize the gene cassette arrays of class 1 integrons. Multilocus sequence typing (MLST) and repetitive extragenic palindromic sequence (REP)-PCR were performed for epidemiological typing. RESULTS: Class 1 integrons were detected in 50 (89.3%) of the 56 isolates, but no class 2 or 3 integron was found within the cohorts. The class 1 integrons were classified into 4 types: 2.3-kb type A (aacA4-catB8-aadA1), 3.0-kb type B (aacA4-blaI(MP-1)-bla(OXA-2)), 3.0-kb type C (bla(VIM-2)-aacA7-aadA1), and 1.8-kb type D (aac3-1-bla(OXA-2)-orfD). Type A was most prevalent and was detected only in A. baumannii isolates, except for one A. bereziniae isolate; however, type B was amplified in all Acinetobacter isolates except for A. baumannii isolates, regardless of clone and separation time of the bacteria. CONCLUSIONS: Although class 1 integron can be transferred horizontally between unrelated isolates belonging to different species, certain types of class 1 integrons tend to transfer horizontally and vertically among A. baumannii or non-baumannii Acinetobacter isolates.

Diagnostic Effectiveness of PCR-based Tests Detecting BRAF Mutation for Treating Malignant Melanoma: A Systematic Review

BACKGROUND: We aimed to conduct a systematic review of previously published material to evaluate the diagnostic effectiveness of PCR-based tests in detecting BRAF mutation. METHODS: Eight Korean databases, including KoreaMed, Ovid-MEDLINE, and Ovid-EMBASE were used to identify relevant published studies. Nine studies describing usage of real-time PCR, dual-priming oligonucleotide (DPO)-multiplex real-time PCR and allele-specific PCR were included in the final assessment. Two reviewers screened all references independently for assessing the quality of the included articles and extracted data. RESULTS: The rate of detection of the BRAF mutations was lower in the Korean population (11.1-17.2%) than that in the Western population (36.7-82.2%). The diagnostic accuracy of the BRAF mutation tests was assessed on the basis of four previous reports, all of which employed real-time PCR on malignant melanoma. In fact, the diagnostic accuracy of real-time PCR was found to be higher than that of sequencing tests (pooled sensitivity, 0.96; pooled specificity, 0.83; and summary receiver operating characteristic area under the curve, 0.99). In addition, we found that there was no publication bias in meta-analysis. The concordance rate of the BRAF mutation tests compared with reference tests was 87.9-98.1%. CONCLUSIONS: Real-time PCR for the detection of the BRAF gene mutation is an effective technology for determining the appropriateness of treatment with BRAF kinase inhibitors in terminal stage cancer as well as metastatic and malignant melanoma.

The Genetic Characteristics of Multidrug-resistant Acinetobacter baumannii Coproducing 16S rRNA Methylase armA and Carbapenemase OXA-23

Acinetobacter baumannii is a gram-negative organism reported worldwide as a cause of health-care associated infections. Due to its increasing drug resistance, several studies on coproduction of armA and carbapenemase in South Korea and other parts of the world were reported, which can pose significant therapeutic threat. The aim of this study was to investigate genetic characteristics of multidrug-resistant A. baumannii coproducing armA and carbapenemase and its epidemiological relatedness. Forty-five multidrug resistant (MDR) A. baumannii clinical isolates were collected. Antimicrobial susceptibility was determined by agar dilution, Etest and VITEK 2 system. The presence of 16S rRNA methylase and carbapenemase were analyzed by polymerase chain reaction (PCR) and sequencing. Repetitive element palindromic (REP)-PCR was also performed for epidemiologic investigation. All of A. baumannii isolates harbored blaOXA-51 -like gene and 10 isolates showed an upstream ISAba1. 36 isolates (80%) showed amplification of OXA-23, all of which except one had an upstream ISAba1. 16S rRNA methylase armA was found in 44 isolates with high level resistance to aminoglycosides. The rate of coproduction was found in 36 isolates (80%). All isolates showed dominant two patterns in REP-PCR profile. The prevalence of MDR A. baumannii coproducing OXA-23 and armA was high, which the rate of blaOXA-23 coproduction was also high.

Nosocomial Infection by Sequence Type 357 Multidrug-Resistant Acinetobacter baumannii Isolates in a Neonatal Intensive Care Unit in Daejeon, Korea

Acinetobacter baumannii is an important microorganism responsible for a number of nosocomial outbreaks, in particular, in intensive care units (ICUs). We investigated a nosocomial infection caused by multidrug-resistant (MDR) A. baumannii in a neonatal intensive care unit (NICU) in Korea. A. baumannii isolates were characterized using Etest (AB Biodisk, Sweden), two multiplex PCR assays, and multilocus sequence typing (MLST) scheme. PCR and PCR mapping experiments were performed for detecting and characterizing the determinants of antimicrobial resistance. Eight strains isolated from an NICU belonged to European (EU) clone II and revealed only one sequence type (ST), namely, ST357. All the isolates were susceptible to imipenem but were resistant to amikacin, gentamicin, ceftazidime, cefepime, and ciprofloxacin. To the best of our knowledge, this is the first report of a nosocomial infection in an NICU in Korea caused by ST357 MDR/carbapenem-susceptible A. baumannii strains. This result demonstrates that nosocomial outbreaks of MDR/carbapenem-susceptible strains as well as MDR/carbapenem-resistant isolates may occur in NICUs.

Serum Hepcidin Level as an Early Marker of Hematopoietic Activity after Allogeneic Peripheral Blood Stem Cell Transplantation / 임상검사와정도관리

BACKGROUND: Hepcidin plays a central role in the regulation of iron metabolism, and hepatic iron production is stimulated by iron load and inflammation. Recent animal studies have shown that hepcidin levels increase when hematopoiesis is blocked. We aimed to monitor pre- and post-stem cell transplantation hepcidin levels and evaluate its association with hematologic recovery. METHODS: The study group comprised 12 patients with hematologic malignancies (7 with AML, 4 with ALL, and 1 with refractory anemia with excess blasts-2) undergoing allogeneic peripheral blood stem cell transplantation (PBSCT). One day before and 3 days, 1 week, 2 weeks, 4 weeks, and 8 weeks after PBSCT, reticulocyte count and levels of Hb, ferritin, and C-reactive protein were monitored; serum hepcidin-25 was measured by ELISA. RESULTS: The median serum hepcidin-25 levels (ng/mL) were significantly higher until 1 week after PBSCT (103.6, 103.3, and 96.5) than those at 2, 4, and 8 weeks after PBSCT (63.9, 53.9, and 56.6, respectively). The reticulocyte count also significantly increased from 2 weeks after PBSCT. The hepcidin level showed an inverse correlation with reticulocyte count (r=-0.56, P or =63.9) tended to demonstrate lower Hb recovery at 8 weeks than patients with low hepcidin levels did (P=0.15), but without any differences in the incidence of complications. CONCLUSIONS: These findings indicate that hepcidin production is associated with erythropoietic activity and that hepcidin level may be used as an early marker of hematopoietic recovery in PBSCT.

Performance Evaluation of the Automated Coagulation Analyzer Coapresta 2000 / 임상검사와정도관리

BACKGROUND: The Coapresta 2000 (Sekisui Medical Co., Japan) is a newly developed, fully automated coagulation analyzer that can perform clotting time assays using the synthetic substrate method and the latex turbidimetric method. In this study, we evaluated the analytical performance of the Coapresta 2000 for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT), and compared the results to those of the CA-7000 (Sysmex Co., Japan) and ACL-9000 (Instrumentation Laboratory, USA) analyzers. METHODS: The Coapresta 2000 was evaluated for its precision at measuring PT and aPTT in fresh normal plasma and fresh abnormal plasma. Three hundred venous blood specimens were collected in 3.2% sodium citrate tubes, and PT and aPTT results were compared among the Coapresta 2000, ACL-9000, and CA-7000 analyzers. RESULTS: The coefficients of variation of both intra- and inter-assays for the Coapresta 2000 were <5% for PT and aPTT in the normal and pathological ranges. The results obtained using the Coapresta 2000 analyzer correlated well with those obtained using the ACL-9000 analyzer (r in the range of 0.9799-0.9886) except for aPTT (r=0.7626) and with those obtained using the CA-7000 analyzer (r in the range of 0.8258 - 0.9735). CONCLUSIONS: The Coapresta 2000 provided satisfactory precision, and the results obtained correlated well with those obtained using the existing CA-7000 and ACL-9000 coagulation analyzers. We conclude that the Coapresta 2000 would be a useful analyzer for routine coagulation tests.

Dissemination of an AbaR-type Resistance Island in Multidrug-resistant Acinetobacter baumannii Global Clone 2 in Daejeon of Korea / 대한임상미생물학회지

BACKGROUND: Acinetobacter baumannii resistance islands (AbaRs) are transposons that have the role of important vehicles for the acquisition of antimicrobial resistance genes, and are associated with multidrug resistance (MDR). In this study, we aimed to determine the AbaRs in MDR A. baumannii global clone 2 (GC2) clinical isolates obtained from a university hospital in Daejeon, Korea. METHODS: This study included 17 MDR A. baumannii strains isolated in Daejeon, Korea. The minimal inhibitory concentrations (MICs) were determined by Etest. A. baumannii isolates were characterized using 2 multiplex PCR assays and a multilocus sequence typing (MLST) scheme. To detect and characterize AbaRs, PCR and PCR mapping experiments were performed. RESULTS: All 17 MDR A. baumannii isolates tested in this study belonged to GC2 and contained 5 sequence types (STs): 75, 92, 137, 138, and 357. Tn6166 that contains antimicrobial resistance genes and is also known as AbaR4a was found in all 17 GC2 strains. This is the first report of Tn6166 in MDR A. baumannii GC2 isolates in Korea. In contrast, AbaR4 was not found in the GC2 isolates. CONCLUSION: Tn6166 has been disseminated among MDR A. baumannii GC2 isolates in Korea. Further investigation is needed to recover the various types of AbaRs in MDR A. baumannii GC2 isolates in Korea are responsible for the multiple antimicrobial resistance mechanisms.

Expression of Sme Efflux Pumps and Multilocus Sequence Typing in Clinical Isolates of Stenotrophomonas maltophilia

BACKGROUND: Stenotrophomonas maltophilia has emerged as an important opportunistic pathogen, which causes infections that are often difficult to manage because of the inherent resistance of the pathogen to a variety of antimicrobial agents. In this study, we analyzed the expressions of smeABC and smeDEF and their correlation with antimicrobial susceptibility. We also evaluated the genetic relatedness and epidemiological links among 33 isolates of S. maltophilia. METHODS: In total, 33 S. maltophilia strains were isolated from patients in a tertiary hospital in Daejeon. Minimum inhibitory concentrations (MICs) of 11 antimicrobial agents were determined by using agar dilution method and E-test (BioMerieux, France). Real-time PCR analysis was performed to evaluate the expression of the Sme efflux systems in the S. maltophilia isolates. Additionally, an epidemiological investigation was performed using multilocus sequence typing (MLST) assays. RESULTS: The findings of susceptibility testing showed that the majority of the S. maltophilia isolates were resistant to beta-lactams and aminoglycosides. Twenty-one clinical isolates overexpressed smeABC and showed high resistance to ciprofloxacin. Moreover, a high degree of genetic diversity was observed among the S. maltophilia isolates; 3 sequence types (STs) and 23 allelic profiles were observed. CONCLUSIONS: The smeABC efflux pump was associated with multidrug resistance in clinical isolates of S. maltophilia. In particular, smeABC efflux pumps appear to perform an important role in ciprofloxacin resistance of S. maltophilia. The MLST scheme for S. maltophilia represents a discriminatory typing method with stable markers and is appropriate for studying population structures.

Evaluation of the Seeplex(R) Meningitis ACE Detection Kit for the Detection of 12 Common Bacterial and Viral Pathogens of Acute Meningitis

BACKGROUND: Bacterial meningitis is an infectious disease with high rates of mortality and high frequency of severe sequelae. Early identification of causative bacterial and viral pathogens is important for prompt and proper treatment of meningitis and for prevention of life-threatening clinical outcomes. In the present study, we evaluated the value of the Seeplex Meningitis ACE Detection kit (Seegene Inc., Korea), a newly developed multiplex PCR kit employing dual priming oligonucleotide methods, for diagnosing acute meningitis. METHODS: Analytical sensitivity of the kit was studied using reference strains for each pathogen targeted by the kit, while it's analytical specificity was studied using the human genome DNA and 58 clinically well-identified reference strains. For clinical validation experiment, we used 27 control cerebrospinal fluid (CSF) samples and 78 clinical CSF samples collected from patients at the time of diagnosis of acute meningitis. RESULTS: The lower detection limits ranged from 101 copies/microL to 5x101 copies/microL for the 12 viral and bacterial pathogens targeted. No cross-reaction was observed. In the validation study, high detection rate of 56.4% was obtained. None of the control samples tested positive, i.e., false-positive results were absent. CONCLUSIONS: The Seeplex Meningitis ACE Detection kit showed high sensitivity, specificity, and detection rate for the identification of pathogens in clinical CSF samples. This kit may be useful for rapid identification of important acute meningitis-causing pathogens.

Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer

BACKGROUND: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. METHODS: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. RESULTS: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. CONCLUSIONS: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.

Evaluation of the Performance of ARKRAY ADAMS HA-8180 HbA1c Analyzer

BACKGROUND: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. METHODS: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. RESULTS: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. CONCLUSIONS: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.

Bacterial Contamination Conditions in Ambulances and their Equipment in South Korea

PURPOSE: Many patients in South Korea are brought to hospitals by ambulance. As such, bacterial contamination within the ambulance and their critical or semi-critical equipment may be dangerous, especially for immunocompromised patients. No previous studies have examined the distribution patterns of pathogenic bacteria in ambulances or the bacterial contamination rate associated with riding in an ambulance in South Korea. The purpose of this study was to determine the distribution of pathogenic bacteria species in ambulances, and to investigate the bacterial contamination rate associated with ambulances and their equipment, in South Korea. METHODS: Thirty ambulances (17 from private facilities and 13 from regional emergency centers) were enlisted for this study. We took 955 swabs and isolated the resulting bacteria. We surveyed the intervals between cleaning and disinfecting of the ambulances and their equipment. We compared the distributional of the bacterial species, following Spaulding's classification, between critical equipment (CE), semi-critical equipment (SCE) and non-critical equipment (NCE) in the ambulances, using the chi-square test. RESULTS: The ambulances were cleaned and disinfected every 5 and 8 days, respectively. The equipment was cleaned and disinfected once every 22 and 30 days, respectively. Of the 955 swabs, 159 (16.6%) were found to be contaminated by bacteria. Fourteen pathogenic bacteria were isolated from the CE and SCE, but no methicillin-resistant or vancomycin-resistant bacteria were found. CONCLUSION: Approximately 16.6% of the ambulances and their equipment were contaminated by bacteria, and pathogenic bacteria were found on both CE and SCE. Consequently, in South Korea, we find a risk associated with the hazard presented by bacterial contamination in ambulance CE and SCE.