BACKGROUND: Chlamydia trachomatis is one of the most common causative agents of the sexual transmitted diseases, and the accurate diagnosis and early treatment are very important to prevent the transmission. So, we evaluated the polymerase chain reaction (PCR) and QuickVue(TM) (Quidel Corp. San Diego, CA) EIA method as a routine clinical laboratory test. METHODS: The 80 cervical swab samples including pelvic inflammatory disease, cervicitis and tube-ovarian abscess were tested using PCR with plasmid specific primers T1, T2 and commercially available QuickVue(TM) EIA kit. RESULTS: The positivities of the PCR and QuickVue(TM) EIA test were 17.5% (14/80 samples) and 12.5% (10/80 samples), respectively. There were 95% (76/80 samples) of positive or negative result concordance rates and 5% (4/80 samples) of disconcordance between the two methods, in which showed PCR positive and EIA negative results. CONCLUSIONS: We assume that PCR and QuickVue(TM) method are highly confident as a routine clinical laboratory diagnostic test for C. trachomatis infection. But more careful interpretation of QuickVue(TM) EIA and the additional study for variable samples will be needed.
Abscess ; Chlamydia trachomatis* ; Chlamydia* ; Diagnosis* ; Diagnostic Tests, Routine ; Female ; Pelvic Inflammatory Disease ; Plasmids ; Polymerase Chain Reaction* ; Uterine Cervicitis

BACKGROUND: Among the many methods estimating the quantity of beta-hCG for pregnancy testing in urine, immunochromatography is one of most widely used semi-quantitative detection method for its convenience to use and also for its rapid result reporting system. PREG-Q(TM) is a newly introduced semi-quantitative immunochromatography method for detecting b-hCG. Clinical usefulness of PREG-Q(TM) was evaluated as a screening test for early pregnancy detection. METHODS: Accuracy, detection limit, cross-reactivity with various glycoprotein hormones, interference study, and comparison study using total 100 urine samples from pregnant (50 samples) and non-pregnant women (50 samples) was evaluated. RESULTS: All the 50 urine samples of pregnant women showed positive results, and another 50 urine samples of non-pregnant women showed negative results with PREG-Q(TM). The lower detection limit of PREG-Q(TM) was 25 mIU/mL and the result was not affected by addition of glycoprotein hormones tested. Interfering substance causing false negative or false positive results enrolled didn't affect the test results in this study. CONCLUSIONS: We conclude PREG-Q(TM) is an excellent test kit for pregnancy test, and is valuable especially for detecting early pregnancy.
Female ; Glycoproteins ; Humans ; Immunochromatography ; Limit of Detection ; Mass Screening* ; Pregnancy Tests ; Pregnancy* ; Pregnant Women

BACKGROUND: Helicobacter pylori (H. pylori) infection has been known closely related with gastritis, duodenal ulcer and gastric cancer and is prevalent among Koreans. However, the infection route and the time are unclear, especially during perinatal period. The aim of this study is to investigate the relationship of H. pylori IgG and IgM antibody prevalences and titers between maternal, neonatal, and cord blood. METHODS: We collected 45 simultaneous maternal, neonatal, and cord bloods and 150 single cord bloods during delivery. The specific H. pylori IgG and IgM antibody levels were measured by enzyme-linked immunosorbent assay (ELISA) method. RESULTS: The H. pylori IgG antibody-positive rate for maternal, neonatal, and cord bloods were equal as 35.6% (16/45). The H. pylori IgG antibody levels of neonatal and cord bloods were 52.7% and 70.7% of maternal blood level. The H. pylori IgG antibody levels between maternal and cord bloods (r2 = 0.9725, p<0.05), maternal and neonatal bloods (r2 = 0.8569, p<0.05), and neonatal and cord bloods (r2 = 0.9437, p<0.05) were well correlated. Only one case of maternal blood was H. pylori IgM antibody positive and it's antibody level was 52.3 U/mL. CONCLUSIONS: In this study, we provided the sero-prevalence of H. pylori IgG and IgM antibodies and the relationship of antibody level of H. pylori IgG in maternal, neonatal and cord bloods. To elucidate the exact route and time of H. pylori infection, further studies including serial measurement of H. pylori IgG and IgM level in neonates will be needed.
Antibodies* ; Duodenal Ulcer ; Enzyme-Linked Immunosorbent Assay ; Fetal Blood* ; Gastritis ; Helicobacter pylori* ; Helicobacter* ; Humans ; Immunoglobulin G* ; Immunoglobulin M* ; Infant, Newborn ; Korea* ; Prevalence ; Seroepidemiologic Studies* ; Stomach Neoplasms

BACKGROUND: The triple marker test with maternal serum during 15~20 weeks gestation is a useful prenatal screening technique. However established reference level is determined for Caucasians and there has not been Korean reference level determined from triple marker results of normal pregnant women without adverse outcome. We intended to determine the Median for triple marker respectively from results which have been done in Samsung Medical Center (SMC), considering the pregnancy outcome in this study. METHODS: The study population was derived from women undergoing triple marker screening at SMC between January, 2000 and July, 2001. alpha-fetoprotein (AFP) and human chorionic gonadotropin (hCG) were measured by ACS: CentaurTM (Bayer Diagnostics, Chicago, USA) and unconjugated estriol (uE3) was measured by T21 Screening ELISA (Gamma S.A., Liege-Angleur, Belgium). We reviewed the pregnancy outcome, ultrasonographic finding and amniocentesis result in each case. RESULTS: Eighty two (4.3%) patients of the 1,918 women screened were identified as positive. Two patients with chromosomal abnormalities (trisomy 21) were found in the 64 patients (78%) who underwent chromosomal analysis of amniotic fluid. With reference to total 1,830 cases, we determined the median of AFP, hCG and uE3, categorized by gestational age. Also, we calculated the Multiples of Median (MoM) of each result according to the newly determined median. CONCLUSIONS: Although triple marker test appears to be an effective method detecting chromosomal abnormalities and neural tube defect (NTD), it is most important to determine the median of our own population for the correct prenatal screening.
alpha-Fetoproteins ; Amniocentesis ; Amniotic Fluid ; Chorionic Gonadotropin ; Chromosome Aberrations ; Enzyme-Linked Immunosorbent Assay ; Estriol ; Female ; Gestational Age ; Humans ; Mass Screening ; Neural Tube Defects ; Pregnancy ; Pregnancy Outcome ; Pregnant Women ; Prenatal Diagnosis

BACKGROUND: Refrigeration is the most common method of preservation for 24 hour urine collection. We tried to find out if the concentrations of the frequently measured chemicals in urine refrigerated for 24 hours were different from those in fresh urine. METHODS: The concentration of calcium, phosphorus, uric acid, creatinine, sodium, potassium, chloride, and protein was measured in fresh urine specimens for routine urine analysis. After refrigeration of the rest of the urine specimens for 24 hours, the same tests were performed, and the results of them were compared with those of fresh urine. Some urine specimens showed precipitation and decreased uric acid concentration after precipitation, and the chemical properties of them were determined statistically. RESULTS: The concentrations of the protein, phosphorus, creatinine, sodium, potassium, and chloride of refrigerated urine was not different statistically from those of the fresh one, but calcium and uric acid showed statistical difference between fresh and refrigerated samples (P<0.05). Urine specimens with precipitation and decreased uric acid showed chemical characteristics of high uric acid concentration and low pH. CONCLUSIONS: For the measurements of total protein, phosphorus, creatinine, sodium, potassium, and chloride, the urine can be refrigerated while collection of 24 hours, but additional procedure is recommended for the measurement of calcium and uric acid.
Calcium ; Creatinine ; Hydrogen-Ion Concentration ; Phosphorus ; Potassium ; Refrigeration ; Sodium ; Uric Acid ; Urine Specimen Collection

BACKGROUND: Neutrophil hypersegmentation (NH) in peripheral blood is known to be usually associated with deficiency of vitamin B12 or folate. Iron deficiency anemia (IDA) is another suggested cause of NH based on a limited number of studies, but the mechanism is uncertain. There was no such study in Korea. METHODS: The study groups were 41 patients with IDA (four males, 37 females ; mean age, 43.63+/-15.71) and 39 hematologically normal patients (five males, 34 females ; mean age, 46.64+/-19.12). We counted the number of nuclear lobes for 100 neutrophils on Wright-stained peripheral blood smear. Two lobes were regarded as separate only if there was a clear filament or the isthmus between them contained no nuclear material. The neutrophils with uncertainty in nuclear lobe count were classified as 'folded'. RESULTS: NH was observed in 14.6% (6/41) of patients with IDA and 7.6% (3/39) of normal controls. Mean neutrophil lobe counts were 2.48+/-0.28 and 2.43+/-0.27, respectively. There was no statistical significance in these differences. CONCLUSION: We could not find significant relation between NH and IDA in Korean, which is different from studies performed in other countries. This result may suggest the possibility of racial differences in the mechanism connecting IDA and NH, if there is any.
Anemia, Iron-Deficiency* ; Female ; Folic Acid ; Humans ; Iron* ; Korea ; Male ; Neutrophils* ; Uncertainty ; Vitamin B 12

BACKGROUND: For the diagnosis of malaria, examination of blood smear slides by light microscopy is used as standard, and commercial kits detecting malarial antibodies and antigens are available, and molecular methods such as polymerase chain reaction (PCR) are used additionally. But, these diagnostic methods can be performed when clinicians request them, so problems of misdiagnosing the patients who are not suspected malaria may be occurred. METHODS: In 42 Korean patients with malaria, the author analyzed the characteristic signals of malaria using granularity (90 degrees depolarized) versus lobularity (90 degrees polarized) graph of Cell-Dyn 4000 (CD4000) automatic hematologic analyzer. And, the author examined the presence of malaria in 421 random samples by CD4000 and Giemsa stain. RESULTS: The usefulness of CD4000 in diagnosing malaria are as follows, 93.0% sensitivity, 99.3% specificity, 93.0% positive-predictive value, and 99.3% negative-predictive value. CONCLUSION: CD4000 automatic hematology analyzer has high diagnostic sensitivity and specificity in diagnosing malaria. Because complete blood count (CBC) is the routine test for most patients, this method has advantage of time and cost effectiveness and can even detect malaria in unsuspected cases.
Antibodies ; Azure Stains ; Blood Cell Count ; Cost-Benefit Analysis ; Diagnosis* ; Hematology* ; Humans ; Malaria* ; Microscopy ; Polymerase Chain Reaction ; Sensitivity and Specificity

The importance of quality control for dramatically growing genetic tests continues to be emphasized with increasing clinical demands. Diagnostic genetics subcommitee of KSQACP performed two trials for cytogenetic study in 2003. Cytogenetic surveys were performed by 33 laboratories and answered correctly in most laboratories except some problems in nomenclature and analysis for FISH and complex cytogenetic abnormalities in neoplasia. The molecular genetic test surveys include M. tuberculosis, HBV, HPV, leukemia/lymphoma, ApoE genotyping, Duchenne muscular dystrophy, myoclonic epilepsy and ragged red muscle fibers, and spinal and bulbar muscular atrophy. HPV, myoclonic epilepsy and ragged red muscle fibers, and spinal and bulbar muscular atrophy were the first challenge of the genetic survey. Molecular genetic survey showed excellent results in most participants, however, HPV tests should be improved by quality control in a few laboratories. External quality assessment program for cytogenetic analysis could be helpful to give participants many chances of continuous education and of interesting case materials.
Apolipoproteins E ; Chromosome Aberrations ; Cytogenetic Analysis ; Cytogenetics ; Education ; Epilepsies, Myoclonic ; Genetics* ; Korea* ; Molecular Biology ; Muscle Fibers, Slow-Twitch ; Muscular Disorders, Atrophic ; Muscular Dystrophy, Duchenne ; Quality Control ; Tuberculosis

The trial of external quality assessment for inborn error of metabolism was performed in 2003. A total 10 specimens for neonatal screening tests were distributed to 43 laboratories with a response rate of 83%. All the control materials were sent as a filter paper form. Each laboratory replied the test result as the screening items they were doing as a rountine test at the reception of the specimen among PKU screening, neonatal TSH, neonatal T4(total/free), galactosemia screen, homocytinuria screen and histidinemia screen. The mean, SD, and CV were analyzed.
Galactosemias ; Infant, Newborn ; Korea* ; Mass Screening ; Metabolism* ; Neonatal Screening

Two trials of external quality assessment for Therapeutic Drug Monitoring (TDM) subcommittee of Korean Association of Quality Assurance for Clinical Pathology (KAQACP) were performed in 2003. Number of participating laboratories were 80 which is similar to those of the previous year. Response rates were elevated to 100.0% for both trials. Two kinds of control materials were requested to be tested in each trial so that each institution could know the possible systematic error. In both trials, 20 test items were responded at least from one laboratory. The average drug item was 7.0 per institution, which was elevated slightly from 6.5 in recent 5 years. The most common test items were valproic acid, digoxin, phenytoin, carbamazepine, theophylline, and phenobarbital, which were peformed in more than 75% of participating laboratories, followed by cyclosporine, lithium, methotrexate, tacrolimus, vancomycin, amikacin, gentamycin, salicylate, tobramycin, acetaminophen, primidone, free phenytoin, and amitryptyline. The most widely used TDM analyzer was Abbott TDx/TDxFLx (52%), but its proportion were decreased slightly comparing with the previous years. The interlaboratory coefficients of variations were not greatly improved comparing with previous years. In conclusion, the TDM external quality assessment of 2003 showed grossly similar pattern comparing with those of previous year, except that the response rate was elevated to 100% and two levels of control material were used in each trials.
Acetaminophen ; Amikacin ; Carbamazepine ; Cyclosporine ; Digoxin ; Drug Monitoring* ; Gentamicins ; Korea* ; Lithium ; Methotrexate ; Pathology, Clinical ; Phenobarbital ; Phenytoin ; Primidone ; Tacrolimus ; Theophylline ; Tobramycin ; Valproic Acid ; Vancomycin