Screening for chromosomal abnormalities using combined test in the first trimester of pregnancy

OBJECTIVE: This study was designed to review the screening performance of combined test at the Ewha Womans University Mokdong hospital. METHODS: All women admitted for routine antenatal care between January 1st 2008 and December 31st 2012 with a known pregnancy outcome were included in this study, totaling 1,156 women with singleton pregnancies presenting at 10 to 13 weeks of gestation. Women were offered screening using a combination of maternal serum pregnancy-associated plasma protein-A, free β-human chorionic gonadotropin and fetal nuchal translucency thickness. Those with an estimated risk of ≥1 in 250 of carrying a fetus with trisomy 21 or ≥1 in 300 risk of trisomy 18 were offered genetic counseling with the option of an invasive diagnostic test. RESULTS: The median of gestational age was 11+3 weeks, the median of crown-rump length was 47.1 mm, and the median age of the women was 31 years. The detection rate was 80% for trisomy 21 (4 of 5) and 100% for trisomy 13 and 18 (all 2). The false-positive rate was 7.73% for trisomy 21 and 1.21% for trisomy 18. CONCLUSION: This study was the first large population study performed with the aim of analyzing the performance of the combined test in Korea. This study demonstrated that the detection rates and other figures of the first trimester combined test are comparable to the results reported in other papers worldwide. Consequently, if strict conditions for good screening outcomes are achieved, the first trimester combined test might well be the earliest detectable screening, improving detection rates without increasing karyotyping or economic and other implications that inevitably ensue.

Screening for chromosomal abnormalities using combined test in the first trimester of pregnancy

OBJECTIVE: This study was designed to review the screening performance of combined test at the Ewha Womans University Mokdong hospital. METHODS: All women admitted for routine antenatal care between January 1st 2008 and December 31st 2012 with a known pregnancy outcome were included in this study, totaling 1,156 women with singleton pregnancies presenting at 10 to 13 weeks of gestation. Women were offered screening using a combination of maternal serum pregnancy-associated plasma protein-A, free β-human chorionic gonadotropin and fetal nuchal translucency thickness. Those with an estimated risk of ≥1 in 250 of carrying a fetus with trisomy 21 or ≥1 in 300 risk of trisomy 18 were offered genetic counseling with the option of an invasive diagnostic test. RESULTS: The median of gestational age was 11+3 weeks, the median of crown-rump length was 47.1 mm, and the median age of the women was 31 years. The detection rate was 80% for trisomy 21 (4 of 5) and 100% for trisomy 13 and 18 (all 2). The false-positive rate was 7.73% for trisomy 21 and 1.21% for trisomy 18. CONCLUSION: This study was the first large population study performed with the aim of analyzing the performance of the combined test in Korea. This study demonstrated that the detection rates and other figures of the first trimester combined test are comparable to the results reported in other papers worldwide. Consequently, if strict conditions for good screening outcomes are achieved, the first trimester combined test might well be the earliest detectable screening, improving detection rates without increasing karyotyping or economic and other implications that inevitably ensue.

Efficacy of Simulation-based Learning for Improving the Accuracy of Blood Loss Estimation in Postpartum Hemorrhage

PURPOSE: This study was designed to investigate an accuracy of visual estimation of blood loss and the usefulness of simulation-based educational program for postpartum hemorrhage. METHODS: The participants included 12 nurses and 8 residents who were working at Mother and Baby Center of Ewha Womans University Hospital. A simulation-based education for estimation of blood loss was conducted for all of the participants. Tests were performed before and after simulation-based education. Two additional tests were performed two and four weeks after the education. Self-confidence score for blood loss estimation was also investigated by questionnaire. RESULTS: Significant underestimation was observed in all questions of 450, 700, and 1,100 mL. Median for percent errors of each questions were -50%, -29%, and -9%, respectively. After simulation-based education, accuracy was improved with the medians of -5%, 0%, and 13%. Selfconfidence score in visual estimation of blood loss was also improved significantly after the education. There were no differences by profession or work experience. CONCLUSION: Significant underestimation was seen before simulation-based education. This study shows that the accuracy of visual blood loss estimation was improved after education. Accurate estimation of blood loss will contribute to a timely diagnosis and resuscitation in postpartum hemorrhage. Our study suggests that periodic education for visual estimation of blood loss in obstetrical hemorrhage might improve accuracy and clinical outcome.

Urinary nephrin: A new predictive marker for pregnancies with preeclampsia and small-for-gestational age infants

OBJECTIVE: The objective of this study was to determine the differences in urinary nephrin among controls, gravidas with preeclampsia (PE), and small-for-gestational age (SGA) infants. We also determined whether or not maternal urinary concentrations of nephrin are associated with the subsequent development of PE and SGA infants. METHODS: We analyzed maternal urinary levels of nephrin in women who were normal controls (n=50), women who were delivered SGA infants (n=40), and gravidas with PE (n=33) in the first, second and third trimesters. Urinary nephrin concentrations were measured with nephrin enzyme-linked immunosorbent assay kits. RESULTS: The levels of urinary nephrin were higher in gravida developing preeclampsia or SGA than in controls after adjusting serum creatinine (P<0.05 for both). Maternal urine concentrations of nephrin were higher in pregnancies complicated by SGA and PE in the third trimester (P<0.05), and also higher in pregnancies complicated by SGA in the first trimester (P<0.05). The sensitivity and specificity of nephrin in predicting SGA from normal pregnancies were 67% and 89% in the first trimester, 60% and 79% in the second trimester, and 80% and 84% in the third trimester, respectively. The sensitivity and specificity of nephrin in predicting PE from normal pregnancies were 67% and 83% in the first trimester and 73% and 79% in the third trimester, respectively. CONCLUSION: We suggest that urinary nephrin can be used as an early marker in pregnancies at risk for developing PE and SGA infants.

Cardiopulmonary Resuscitation Learning Experience, Knowledge, and Performance in Newly Graduated Nurses / 기본간호학회지

PURPOSE: The purpose of this study was to evaluate the learning experience, knowledge, and performance of cardiopulmonary resuscitation (CPR) in newly graduated nurses, and to identify differences related to learning experience. METHODS: The participants were 114 new nurses in the hospital. They were asked to complete a questionnaire, which included CPR learning experience. They were evaluated by a written test and a skill test using a manikin and check list. RESULTS: All participants attended CPR lectures and underwent practice while in university. Only 12.28% of participants were taught by a certified Basic Life Support (BLS) instructor. The mean scores of the written and skill tests were 79.82+/-12.69 and 64.41+/-11.71, respectively. The nurses lacked CPR knowledge related to checking breathing, the frequency of 30 chest compressions, compression rate, and automated external defibrillator use. They also lacked skill in performing CPR related to checking breathing and pulse and giving 2 breaths. CPR performance differed according to learning time (p=.047) and BLS educator (p=.029). CONCLUSION: The findings of this study reveal that CPR performance by newly graduated nurses is poor and suggest that CPR education by trained instructors, practice-based education, and reeducation programs must be provided to newly graduated nurses in the hospital.

Chromosoal Anomaly Diagnosed by Obstetric Ultra Sound / 이화의대지

No abstract available.

Prenatal detection of skeletal dysplasia using ultrasound and molecular diagnosis / 대한산부인과학회지

OBJECTIVE: To determine the accuracy and usefulness of prenatal ultrasonographic and molecular genetic diagnosis in detection of skeletal dysplasia. METHODS: This study was based upon data of the 17 cases of skeletal dysplasia diagnosed by prenatal ultrasound and 7 cases by molecular diagnosis performed among the 17 cases and the 2 cases who has familial skeletal dysplasia by molecular diagnosis during the first trimester at Ewha and Eulji University from March 1998 to August 2005. A final diagnosis was sought on the basis of radiographic studies, molecular testing, or both. RESULTS: The mean gestational age at diagnosis was 24.9 weeks (range, 17 to 35 weeks). Nine cases were diagnosed before 24 weeks. A final diagnosis was obtained in 16 cases (94.1%). There was 1 false-positive diagnosis. The antenatal diagnosis was correct in 14 cases (82.4%). The 8 cases were prenatally confirmed and 1 case was postpartum confirmed using molecular genetic testing and accurate antenatal diagnosis and prediction was done. We were able to rule out skeletal dysplasia through chorionic villus sampling during the first trimester in the 2 cases with the family history with skeletal dysplasia. CONCLUSION: Prenatal diagnosis of skeletal dysplasia can be a considerable diagnostic challenge. However, skeletal dysplasia is correctly diagnosed on the basis of prenatal meticulous ultrasound and antenatal prediction of lethality was highly accurate. Using prenatal molecular diagnosis, skeletal dysplasia can be diagnosed at first trimester of pregnancy and nonlethal skeletal dysplasia can be confirmed when prenatal ultrasound was nonspecific.

Association of preterm birth with IFN-gamma, IL-10, and CYP 1A1 gene in Korean women / 대한산부인과학회지

OBJECTIVE: To investigate the association between preterm birth and cytokine genes (IFN-gamma, interleukin (IL)-10) in intrauterine infection and enzyme gene (CYP1A1) in oxidative stress response. METHODS: This study involved a case-control study conducted at Ewha Womans University Hospital in Seoul, Korea. Subjects with preterm deliveries ( or =37 weeks of gestation) were selected from gravidas who had undergone prenatal examinations in the hospital and were followed until infant delivery. The weight, height, and blood samples of each participants were obtained according to standard protocols. We included subjects who gave birth to a singleton infant and had a gestational age between 24 and 42 weeks. Mutiple births, stillbirths, and congenital anomalies were excluded. Finally, 164 gravidas with preterm births and 305 normal controls with term deliveries were enrolled in the present study. RESULTS: Preterm delivery group and term delivery group had significant difference in gestational age and neonatal body weight (P0.05). CONCLUSION: In this study, IFN-gamma (874A/T), IL-10 (1082A/G), IL-10 (819C/T), IL-10 (592A/C) and CYP1A1 (T6235C), CYP1A1 (Ile462val [A/G]) genes had no significant association with preterm birth.

A Case of Successful Selective Abortion Using Radio-frequency Ablation in Twin Pregnancy Suffering from Severe Twin to Twin Transfusion Syndrome

Twin to twin transfusion syndrome (TTTS) is one of the major complication of monochorionic twin pregnancy which is mainly understood by placental vascular anastomosis. Perinatal mortality and morbidity is high as 80-100% if untreated and even higher if the disease is developed at early stage. Variety of methods of isolating or intercepting placental vascular anastomosis are introduced, but they are only available in centers where all the required equipments are prepared. We report here a case of TTTS complicated with severe polyhydroamnios during the second trimester. The blood supply to donor twin was interrupted successfully at 19+2 weeks of gestation by minimally invasive radio-frequency cord ablation, under ultrasound guidance. The normal recipient twin was delivered successfully at 35 weeks of gestation and had no eventful neonatal course.

A Case of Successful Selective Abortion Using Radio-frequency Ablation in Twin Pregnancy Suffering from Severe Twin to Twin Transfusion Syndrome

Twin to twin transfusion syndrome (TTTS) is one of the major complication of monochorionic twin pregnancy which is mainly understood by placental vascular anastomosis. Perinatal mortality and morbidity is high as 80-100% if untreated and even higher if the disease is developed at early stage. Variety of methods of isolating or intercepting placental vascular anastomosis are introduced, but they are only available in centers where all the required equipments are prepared. We report here a case of TTTS complicated with severe polyhydroamnios during the second trimester. The blood supply to donor twin was interrupted successfully at 19+2 weeks of gestation by minimally invasive radio-frequency cord ablation, under ultrasound guidance. The normal recipient twin was delivered successfully at 35 weeks of gestation and had no eventful neonatal course.

Comparison of levels of umbilical venous erythropoietin and nucleated erythrocytes between appropriate and small for gestational age preterm neonates / 대한산부인과학회지

OBJECTIVE: To evaluate any difference in levels of umbilical venous eryhthropoietin (EPO) and nucleated red blood cells (NRBC) between appropriate for gestational age (AGA) and small for gestational age (SGA) preterm neonates at birth and to evaluate the peripartal factors that influence the secretion of the nucleated red blood cells in preterm neonate. METHODS: 43 preterm singleton neonates born at the gestational age between 27 weeks and 37 weeks of gestation from January 1998 to December 2004 were enrolled and divided into 25 cases of AGA and 18 cases of SGA. At each delivery, umbilical venous blood gas values, concentration of EPO by radioimmunoassay and the NRBC count expressed per 100 white blood cell (WBC) were obtained. The placenta were examined microscopically for the presence of pathologic infarct and inflammation. Statistical analysis was done by Mann-Whitney U test, Fisher exact test, univariate and multiple regression analysis using SPSS statistical package. RESULTS: The median umbilical venous EPO concentration and fetal hemoglobin level in SGA preterm neonates were 48.0 mIU/mL and 15.7 g/dL, which were significantly higher than those in AGA preterm neonates (12.5 mIU/ML, 14.6 g/dL). The median NRBC in SGA group was 8.0 NRBC/100 WBC which was higher than in the AGA group (2.5 NRBC/100 WBC), showing no significant difference between groups. Stepwise multiple regression analysis identified O2 saturation, emergency cesarian section, infarct and inflammation in placental pathology and premature rupture of membranes as independent variables associated with the NRBC count. CONCLUSION: Measurement of the level of EPO and NRBC in umbilical venous blood at birth of the preterm neonates can be used as a helpful index for evaluation of intrauterine hypoxia. In addition, cord blood gas ananlysis and placental examination on the infarct and inflammation are informative value for the elevated NRBC.

Comparison of levels of umbilical venous erythropoietin and nucleated erythrocytes between appropriate and small for gestational age preterm neonates / 대한산부인과학회지

OBJECTIVE: To evaluate any difference in levels of umbilical venous eryhthropoietin (EPO) and nucleated red blood cells (NRBC) between appropriate for gestational age (AGA) and small for gestational age (SGA) preterm neonates at birth and to evaluate the peripartal factors that influence the secretion of the nucleated red blood cells in preterm neonate. METHODS: 43 preterm singleton neonates born at the gestational age between 27 weeks and 37 weeks of gestation from January 1998 to December 2004 were enrolled and divided into 25 cases of AGA and 18 cases of SGA. At each delivery, umbilical venous blood gas values, concentration of EPO by radioimmunoassay and the NRBC count expressed per 100 white blood cell (WBC) were obtained. The placenta were examined microscopically for the presence of pathologic infarct and inflammation. Statistical analysis was done by Mann-Whitney U test, Fisher exact test, univariate and multiple regression analysis using SPSS statistical package. RESULTS: The median umbilical venous EPO concentration and fetal hemoglobin level in SGA preterm neonates were 48.0 mIU/mL and 15.7 g/dL, which were significantly higher than those in AGA preterm neonates (12.5 mIU/ML, 14.6 g/dL). The median NRBC in SGA group was 8.0 NRBC/100 WBC which was higher than in the AGA group (2.5 NRBC/100 WBC), showing no significant difference between groups. Stepwise multiple regression analysis identified O2 saturation, emergency cesarian section, infarct and inflammation in placental pathology and premature rupture of membranes as independent variables associated with the NRBC count. CONCLUSION: Measurement of the level of EPO and NRBC in umbilical venous blood at birth of the preterm neonates can be used as a helpful index for evaluation of intrauterine hypoxia. In addition, cord blood gas ananlysis and placental examination on the infarct and inflammation are informative value for the elevated NRBC.

Study of umbilical cord blood adiponectin, IGF-I, IGFBP-1, insulin and leptin levels in small for gestational age neonates at birth / 대한산부인과학회지

OBJECTIVE: Intrauterine growth is influenced by multiple factors like genetic, nutritional, environmental and hormonal factors. As birth weight is reported to be related to perinatal morbidity and mortality, we aimed to compare umbilical cord blood adiponectin, IGF-I, IGFBP-1, insulin and leptin levels between small for gestational age (SGA) and appropriate for gestational age (AGA) neonates at birth to investigate the influence of these factors on birth weight and ponderal index. METHODS: We investigated retrospectively 30 pregnant women with SGA and 30 pregnant women with AGA who delivered at Ewha Womans University Hospital and their babies from January 2007 to December 2007. Fetal umbilical cord venous blood adiponectin, IGF-I, IGFBP-1, insulin and leptin levels from SGA and AGA neonates were obtained at the time of delivery. The definition used to identify cases of SGA was individual birth weight ratio of less than 10th percentile and the definition of ponderal index (PI) was [BW (g)/ (height (cm))3]x100. RESULTS: Umbilical cord blood adiponectin, IGF-I and IGF/IGFBP ratio were significantly lower (P<0.05) in SGA than AGA. And umbilical cord blood IGFBP-1 were significantly higher (P<0.05) in SGA than AGA. But there was no significant difference in umbilical cord blood insulin and leptin levels between SGA and AGA neonates. Positive correlation was noted between adiponectin and IGF-I, IGF/IGFBP ratio, insulin and leptin. Negative correlation was noted between adiponectin and IGFBP-1, IGF-I and IGFBP-1. On multiple regression analysis, adiponectin and IGF-I were significant factors associated with body weight (BW), but only IGFBP-1 was significant factor associated with PI. CONCLUSION: These results suggest that fetal adiponectin, IGF-I, IGFBP-1 may have an important role in regulation of intrauterine growth and we will expect that evaluation of adiponectin and IGF-I in SGA may be helpful in prediction of neonatal outcome, and IGFBP-1 may be useful in diagnosis of asymmetric intrauterine growth retardation (IUGR).

The expression of Thymosin beta4 with angiogenic factors in epithelial ovarian cancer / 대한산부인과학회지

OBJECTIVE: The aim of this study was to determine thymosin beta4 expression in epithelial ovarian cancer compared to normal ovarian tissue. METHODS: Normal and pathologic ovarian tissues were obtained from healthy women (n=18), and from patients with ovarian cancer (n=27). The expression of thymosin beta4 mRNA was examined by quantitative competitive polymerase chain reaction (QC PCR). Thymosin beta4 mRNA expression was examined with angiopoietic factors such as vascular endothelial growth factor, angiopoietin-1 and 2. RESULTS: The expression of thymosin beta4 mRNA in epithelial ovarian cancer was higher than that in the normal ovary (p<0.05). Thymosin beta4 mRNA expression was not correlated with ovarian cancer stages, pathologic types, preoperative CA125 levels, or metastasis to lymph nodes but was correlated with the expression vascular endothelial growth factor and angiopoietin-2 (p<0.05). CONCLUSIONS: Our results suggest that overexpression of thymosin beta4 mRNA may be a biologic marker to differentiate epithelial ovarian cancer from normal ovary and it may play a role in angiogenesis of epithelial ovarian cancer.

Tailored selective termination in second trimester in twin pregnancy / 대한산부인과학회지

OBJECTIVE: Recently, selective termination is employed in multifetal pregnancies, in the presence of an abnormal fetus, or in the complication of twin pregnancies. The purpose of this study is to evaluate effectiveness, safety of the tailored selective termination in multifetal pregnancies. METHODS: This study was retrospective and involved six cases. Indication of termination were 3 cases of structural anomalies (anencephaly, encephalocele, body stalk anomaly), 1 case of chromosomal anomaly (21 trisomy) and 2 cases of monochorionic twin complications (acardiac twin, twin to twin transfusion syndrome). RESULTS: We used KCL injection in 4 cases, they were all confirmed dichorionic twin, and in 2 cases of monochorionic twin, we used alcohol ablation of intra-abdominal umbilical artery in 1 case, and radiofrequency ablation of the cord in 1 case. CONCLUSION: All procedures were successful, and all normal infants were delivered in 3rd trimester. Tailored selective termination in 2nd trimester is effective and safe in abnormal multifetal pregnancies.

Association of genetic polymorphisms in the peroxisome proliferator-activated receptor-gamma and methylenetetrahydrofolate reductase with preeclampsia in Korean women / 대한산부인과학회지

OBJECTIVE: To investigate whether polymorphisms of genes encoding peroxisome proliferator-activated receptor-gamma (PPAR gamma) and methylenetetrahydrofolate reductase (MTHFR) are associated with preeclmapsia in Korean women and also to demonstrate whether there is any haplotypic association between preeclampsia and those genes. METHODS: DNA was extracted from whole blood of 226 preeclampsia patients and 235 healthy pregnant women. The genotypes of SNPs in PPAR gamma (-796A>G, P12A (C>G), H447H (161C>T)) and MTHFR (A222V (677C>T), E429A (1298A>C), R594Q (1793G>A)) were analyzed by a single base primer extension assay using a SNaPShot assay kit. Results were analyzed with the Student's t-test, Chi-square test, and Logistic regression analysis. Haplotype analyses were performed using Haploview 3.2 version. RESULTS: There were no significant differences in genotype or allele frequencies of PPAR gamma and MTHFR gene polymorphisms between preeclampsia patients and controls (p>0.05). No increase in the risk of preeclampsia for those genes was observed under any model of inheritance. Among SNPs of the PPAR gamma, MTHFR genes, only SNPs in MTHFR gene (677C>T, 1298A>C, 1793G>A) were in a strong linkage disequilibrium with each other (Lod score>2.0), but there were no significant differences in genotype distribution of haplotypes of MTHFR gene (TAG, CAG, CCA, CCG) between preeclampsia patients and controls (p>0.05). No statistically significant associations were observed between any haplotypes of MTHFR gene and preeclampsia risk. CONCLUSION: This study suggest that SNPs in PPAR gamma and MTHFR gene were not associated with preeclampsia in Korean women, and its haplotypes were also not associated with preeclampsia.

Prenatal ultrasonographic diagnosis of Fetus in Fetu at 2nd trimester: A case report / 대한산부인과학회지

Fetus in fetu is an very rare condition in which a vertebrate fetus is incorporated within its twin. Although a number of cases were reported at 3rd trimester of gestation or postnatally, the authors present a retroperitoneal fetus in fetu with 9 x 7 x 6 cm sized cystic mass that was diagnosed at 2nd trimester using ultrasonography and confirmed on a computed tomography scan after birth. The mass was successfully excised postnatally and consistent with a fetus in fetu by pathological confirmation. Solid mass was surrounded by a fluid-containing sac and showed highly ordered organogenesis around an axial vertebral column.

Tissue viability of human placental explants in normoxic and hypoxic culture / 대한산부인과학회지

OBJECTIVE: In vitro study systems for research of placental hypoxia are needed, among which human placental villous explant culture technique under experimentally variable condition is commonly used. So we performed this study to assess the viability of placental villous explant in normoxic and hypoxic culture that can provide validity for that system. METHOD: Placental villous explant tissues obtained from 9 cases of normal term pregnancies were incubated in normoxic (20% O2) and hypoxic (2~5% O2) condition for 72 hours. The viability of tissue was evaluated morphologically by microscopic examination and biochemically by LDH assay at variable time interval (0, 6, 12, 24, 48, 72 hours). The apoptosis of the tissue was assessed by TUNEL assay. RESULT: By light microscope, all of H&E stained placental explant tissue sections in normoxic and hypoxic culture showed intact villous integrities without definitive syncytial sloughing and fibrinoid necrosis as time elapsed. Tissue viability of LDH assay during 6, 24, 48, 72 hours of placental villous explants showed over all 52.3~67.6% and didn't show statistically significant difference between normoxic and hypoxic culture. Tissue viability in both groups maintained 61.2~67.6% for the first 24 hours and eventually decreased with time. TUNEL assay showed over all negative findings in normoxic and hypoxic culture at different time periods. CONCLUSION: In vitro human placental explant culture system can be a useful and feasible technique for research of placental hypoxia which is related to development of obstetrical complications such as preeclampsia, intrauterine fetal growth restriction and preterm labor and so on. But our in vitro placental explant system needs some modification in culture condition and technique for maximizing viability of the tissue.

Association of the vascular endothelial damage and estrogen, progesterone / 대한산부인과학회지

OBJECTIVE: The aim of this study were to examine the serum level of estradiol, estriol, progesterone, oxidized LDL in preeclamtic patients and to evaluate the protective effects of estrogen and progesterone against lysophosphatidylcholine (LPC) induced cell death in Human umbilical vein endothelial cells (HUVECs). METHODS: We analysed the serum level of estradiol, estriol, progesterone, oxidized LDL in patients with preeclampsia and control. We used LPC to induce cell death in HUVECs. For cytotoxic assay, we did LDL assay for cell death and Resazurin assay for cell viability. HUVECs were exposed to various concentrations of LPC, LPC+estrogen, LPC+progesterone and we did cytotoxic assay. RESULTS: The serum estradiol, estriol were lower in the preeclamptic patients (P<0.05). Oxidized LDL were higher in the preeclamptic patients(P<0.05). LPC induced cell death in a concentration-dependant manner. Estrogen or progesterone inhibited LPC-induced cell death in a concentration-dependant manner (P<0.05). CONCLUSION: Estrogen and progesterone attenuated LPC-induced cytotoxicity. The results suggest that Oxidized LDL induced endothelial damage in preeclampsia may be induced by low serum estradiol, estriol and progesterone levels and prevented by estrogen and progesterone addition.

Evaluation of Gluchec Fine Glucometer / 임상검사와정도관리

BACKGROUND: We evaluated the analytical performance of the recently developed glucometer Gluchec Fine (KMH Co., Ltd., Anyang, Gyeonggi, Korea) in Korea. METHODS: Within-run precision and total precision were assessed according to CLSI guideline EP5-A2 with control material of low and high level. Linearity was evaluated in the range of 51-473 mg/dL made by patient samples. Correlations with SureStep (Lifescan, Milpitas, CA, USA) and TBA200-FR (Toshiba, Tokyo, Japan) were evaluated using 99 patient samples in the range of 23-473 mg/dL. Interferences by acetaminophen, ascorbic acid, bilirubin, cholesterol, galactose, and uric acid were elvauated according to CLSI guideline EP7-A. Effect of hematocrit, user variability and reagent stability were assessed. RESULTS: The CVs of within-run precision were 2.5-3.0% and the CVs of total precision were 3.6-4.7%. The linearity was R(2)=0.998. The correlations with TBA200-FR (R=0.982) and Surestep (R=0.984) were acceptable. Glucose concentrations measured by Gluchec Fine were lower than those by TBA200-FR (mean 2.7%, 95% CI 0.3-5.1%) in the range of 23-473 mg/dL. Acetaminophen, galactose, and cholesterol did not interfere with glucose measurements on Gluchec Fine. High concentrations of ascorbic acid, bilirubin, and uric acid resulted in positive interferences. Hematocrit and user variability did not significantly influence the glucose concentration. Reagent was stable until one week after opening. CONCLUSIONS: Gluchec Fine glucometer showed acceptable and comparable analytical performance. This instrument can be used for therapeutic monitoring of diabetes patients.