As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

OBJECTIVETo study the use of hypertension related physical examinations, laboratory tests and anti-hypertension drugs among district and community based hospitals in Beijing and to analyze the possible hardware (examination, test, drug) problems under the application of the "China Hypertension Guide" in those hospitals.

METHODSThe survey was carried out in 40 hospitals in Chaoyang and Haidian districts, including 9 district level hospitals, and the rest at community level. Questionnaire survey and in-depth interview were used to collect information from the leaders of related departments in those hospitals.

RESULTS(1) The hardware condition of district hospital satisfied the implicit requirements of hypertension evaluation and treatment in "China hypertension Guide". (2) 64.5% of the community level hospitals had the basic equipments and routine laboratory tests for diagnosis and treatment on hypertension, but 35.5% of them lack of tests on blood chemistry (potassium, sodium, creatinine) and urine protein. (3) 71.0% of community level hospitals could not judge the patient's "target organ damage" independently. (4) Both district and community level hospitals had all major types of anti-hypertension drugs in there pharmacy except ARB.

CONCLUSIONWhen necessary laboratory tests for both district and community level hospitals were provided, they could accomplish the tasks of hypertension treatment and management. However, the community level hospitals should cooperate with hospitals at higher level to have a comprehensive clinical understanding of patients with high blood pressure.

China ; Clinical Laboratory Techniques ; statistics & numerical data ; Cross-Sectional Studies ; Diagnostic Services ; statistics & numerical data ; Hospitals, Community ; statistics & numerical data ; Humans ; Hypertension ; diagnosis ; drug therapy ; Pharmaceutical Services ; statistics & numerical data ; Surveys and Questionnaires

OBJECTIVE: To analyze the clinical and genetic features of two children suspected for arginylsuccinuria aciduria. METHODS: The patients were subjected to high-throughput sequencing using a gene panel. RESULTS: Both patients had high citrulline (87.37-156.10 μmol/L) measured by mass spectrometry/mass spectrometry (MS/MS) upon neonatal screening but had no symptoms. Two compound heterozygous variants of the ASL gene were detected in patient 1 (exon 6: c.467C>T inherited from her father and exon 7: c.556C>T inherited from her mother), among which c.556C>T is novel. Patient 2 had mental retardation and two full siblings who had died of hyperammonemia. Two compound heterozygosity variants of the ASL gene were detected (exon 3: c.281G>T inherited from his father and intron: c.208-15T>A inherited from his mother). Both were novel mutations. CONCLUSION Variants of the ASL gene probably underlie the argininosuccinic aciduria in the two patients. Above findings have enriched the spectrum of ASL mutations.
Argininosuccinic Aciduria ; Child ; Female ; Genetic Testing ; Humans ; Hyperammonemia ; Infant, Newborn ; Neonatal Screening ; Tandem Mass Spectrometry

PURPOSE: The purpose of this micro-ethnography is to examine whether science and societal changes impact family communication patterns among a convenience sample of 16 Korean women. METHODS: The authors observed family communication in the context of a new breast cancer genetic screening and diagnostic testing program to detect BRCA gene mutations in Korean women at highest risk. RESULTS: Analysis of in-depth interviews and field notes taken during participant observation illustrated that communication patterns in families vary according to a woman's position in the family. If a grandmother tests positive for a gene mutation, her daughters make decisions on her behalf; they open and maintain the communication channel among family members. If a housewife is diagnosed with cancer and a genetic mutation, she immediately consults her husband and her sisters. The husband creates an open communication channel between his wife, his parents and his siblings. As a result, a woman's cancer is a concern for the whole family not merely a woman's secret or crisis. CONCLUSION: Cultural differences are important to consider when designing new genetic service programs in different countries.
Anthropology, Cultural ; Breast ; Breast Neoplasms ; Diagnostic Tests, Routine ; Female ; Genes, vif ; Genetic Counseling ; Genetic Services ; Genetic Testing ; Health Communication ; Humans ; Nuclear Family ; Parents ; Siblings ; Spouses

PURPOSE: Problem-based learning(PBL) experiences applied in the field of screening for chronic disease during the course of Community Medicine for the 3rd grade medical students were summarized. This study was aimed to train medical students the health appraisal ability and also the ability for public health education and promotion with health-oriented concept rather than disease-oriented one. And also it was aimed to train students to know what to learn and how to search the informations they need for themselves. STUDY SUBJECT AND METHOD: Three to four students in one team spent one and half days(Friday and Saturday) of one-week practical course of Community Medicine. Assigned materials were the medical records which are the files with the results of automated multiphasic screening tests which were applied to generally healthy people. Students were supposed to find, evaluate, solve or manage the real problems encountered from the multiphasic screening test results. RESULTS: The students accepted this self-directed learning process and small group discussion and also health-oriented human approach as new experiences and stimulants.
Chronic Disease* ; Community Medicine ; Education ; Humans ; Learning ; Mass Screening* ; Medical Records ; Multiphasic Screening ; Problem-Based Learning ; Public Health ; Students, Medical

OBJECTIVES: Developing mental health services and systems to identify children with Attention Deficit/Hyperactivity Disorder (ADHD) and providing early therapeutic interventions for them are important to prevent further impairments or disturbances associated with the disorder. The purpose of this study is to examine the clinical validities and efficiencies of Korean Child Behavior Checklist (K-CBCL) and Korean ADHD Rating Scale (K-ARS) for screening and identifying children with ADHD in community. METHODS: Randomly selected 1st to 3rd graders of the two elementary schools (n=1668) in the City of Gunsan participated in the study. K-CBCL and K-ARS were used as screening instruments. Diagnoses were determined by clinical psychiatric interviews and confirmed by Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version-Korean Version (K-SADS-PL-K) using DSM-IV criteria. RESULTS: The rate of inclusion above the T score of 60 with regard to the attention problems profile of K-CBCL was 4.5%. There was a significant correlation (p<.01) between parent and teacher reports of K-ARS, and the rate of inclusion was 2.5% when 90th percentile cut-off points were applied for both of the reports. Of the 46 subjects who underwent clinical psychiatric interviews, 33 (71.7%) were diagnosed as ADHD. The T score of 60 with regard to the attention problems profile of K-CBCL resulted in a reasonable level of sensitivity or positive predictive value in the diagnosis of ADHD. 90th percentile cut-off scores in both parent and teacher reports of K-ARS resulted in a high level of predictive value. The highest level of specificity and positive predictive value were computed when K-CBCL (T> or =60 in attention problems) and K-ARS (parent/teacher total> or =90th percentile) reports were combined. CONCLUSION: These findings suggest that the K-CBCL and K-ARS together could serve as a rapid and useful screening instrument to identify children with ADHD in epidemiologic case definitions.
Checklist ; Child Behavior ; Child* ; Community Mental Health Services* ; Diagnosis ; Diagnostic and Statistical Manual of Mental Disorders ; Humans ; Jeollabuk-do ; Mass Screening* ; Mental Health ; Mental Health Services ; Mood Disorders ; Parents ; Sensitivity and Specificity

BACKGROUND: Alcohol Use Disorders Identification Test (AUDIT) is effective in identifying problem drinking. This study purposed to evaluate the usefulness of AUDIT in identifying problem drinking among Korean university students whose drinking characteristic is different from adults. METHODS: The subjects were 235 students who had visited the Health Service Center of Chungnam National University. All subjects had a diagnostic interview for the presence of at-risk drinking and alcohol use disorder. At-risk drinking was defined according to the criteria of the National Institute on Alcohol Abuse and Alcoholism. Alcohol use disorder was diagnosed by the criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR). At-risk drinking or alcohol use disorder was classified into problem drinking. At the same time, a survey was conducted using three screening tools: AUDIT, cut down, annoyed, guilty feelings, eye opener (CAGE), and cut down, under influence, guilty feelings, eye opener (CUGE). Area under receiver operating characteristic curve (AUROC) of the questionnaires to the results of interviews were compared. RESULTS: Seventy one students were at-risk drinkers and 46 had alcohol use disorder, and 75 were classified into problem drinkers. For identification of problem drinking, AUROC of AUDIT was 0.970 in men and 0.989 in women. For CAGE, it was 0.650 in men and 0.747 in women. For CUGE, it was 0.689 in men and 0.745 in women. CONCLUSION: Above results suggest that AUDIT is most effective in identifying university students' problem drinking.
Diagnostic and Statistical Manual of Mental Disorders ; Drinking ; Eye ; Female ; Health Services ; Humans ; Male ; Mass Screening ; National Institute on Alcohol Abuse and Alcoholism (U.S.) ; ROC Curve

PURPOSE: To investigate which factors are associated with the causes and results of medical malpractice claims on emergency medical facilities. The study analyzed the alteration of judicial precedents between before and after 1995 when the court ruled that the burden of proof was to be placed upon the accused as well as the plaintiff. METHODS: We collect 213 medical malpractice claims covering from 1953 to 2008, using a database of closed claims maintained by the Supreme Court of Korea. Of the 213 claims, 31 involved emergency medical facilities. The cases were divided into 4 groups according to the physician's specialty and the causes and results of the claims were compared among each group. The causes and results were also compared between before and after 1995. RESULTS: In the medical department, the physicians were mainly accused in connection with mis- or delayed diagnosis. In the surgical and emergency departments, the plaintiff denounced the physician generally for neglect of duty in the emergency medical service system. The tendency of the court's ruling related to the distribution of the burden of proof has been changed after 1995 and the rate of physician legal victory in the judicial precedents has declined since then. CONCLUSION: Medical malpractice claims on emergency medical facilities were mostly related to misdiagnosis or emergency medical service system. Due to the change in the court's ruling regarding the distribution of the burden of proof, emergency physicians with medical malpractice claims need to change their attitude with regards to the activeness in the claims.
Delayed Diagnosis ; Diagnostic Errors ; Emergencies ; Emergency Medical Services ; Korea ; Malpractice

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

PURPOSE: Diagnosis of congestive heart failure (CHF) is difficult in the emergency care setting using clinical diagnostic tests. Although echocardiography is important for making the diagnosis of left ventricular dysfunction, its cost and lack of availability limit its use as a routine screening test. The utility of N-terminal probrain natriuretic peptide (NT-proBNP) testing in the emergency department for differentiating between systolic (SHF) and diastolic heart failure (DHF) are not well established. METHODS: One-hundred-seven consecutive patients with acute dyspnea, who visited our emergency medical center from January 2006 to August 2006 were prospectively recruited. Patients with acute coronary syndrome and chronic renal failure were excluded from study enrollment. The diagnosis of DHF was based on European study group guidelines on diastolic heart failure. The diagnostic accuracy of NT-proBNP was assessed by receiver operating characteristic curve analysis. RESULTS: The mean age was 69+/-11 years, and 59% of the patients were women. The median NT-proBNP level among 41 patients (38%) who had SHF was 3817 and 26 patients (24%) who had DHF was 1781 pg/ml versus 550 pg/ml for those 40 patients (37%) who did not have acute CHF (p=0.01). The area under the receiver operating characteristic curve was 0.89 (95% CI of 0.82-0.96). At a cutoff of 700 pg/ml, NT-proBNP had a sensitivity of 87%, a specificity of 78%, and an overall accuracy of 84% for acute CHF (p<0.01). NT-proBNP levels were correlated well with left ventricular systolic and diastolic dysfunction. But, although SHF had significant higher NT-proBNP levels than those with DHF, NT-proBNP levels were unable to differentiate systolic versus diastolic heart failure. CONCLUSION: NT-proBNP appears to be useful as an aid in the diagnosis of CHF in acute dyspnea patients to the emergency department. Whereas NT-proBNP could not differentiate SHF from DHF, therefore, its clinical major role is still the separation of patients with CHF from those without CHF.
Acute Coronary Syndrome ; Diagnosis ; Diagnostic Tests, Routine ; Dyspnea ; Echocardiography ; Emergencies ; Emergency Medical Services ; Emergency Service, Hospital ; Female ; Heart Failure ; Heart Failure, Diastolic* ; Humans ; Kidney Failure, Chronic ; Mass Screening ; Prospective Studies ; ROC Curve ; Sensitivity and Specificity ; Ventricular Dysfunction, Left