No abstract available.

BACKGROUND: The Global harmonization task force (GHTF) recommends a separate regulation system for in vitro diagnostic medical devices (IVDD), because false test results can pose a risk to individual and/or public health. However, in Korea, many reagents for IVDD are not monitored, although IVD analyzers and some reagents are monitored under the Medical Device Act and Pharmaceutical Affairs Act, respectively. Our aim was to propose a draft for a Korean coding and classification system for IVDD. METHODS: For preparing the draft, we reviewed the Korean Current Procedural Terminology for Health Insurance and principles of the coding and classification system for IVDD of the GHTF, the USA, Japan, Canada, Australia, and the EU. The draft was reviewed by consultants from relevant societies, such as Korean Medical Association, Korean Society for Laboratory Medicine, The Korea Association of Medical Technologists, and Korea Association for Diagnostic Laboratory Reagents, and was then publicly discussed at a conference. RESULTS: IVDD were classified into 4 classes on the basis of the risks they pose to individual (IR) and public health (PR): class 1 (low IR and low PR), class 2 (moderate IR and low PR), class 3 (high IR and/or moderate PR), and class 4 (high IR and high PR). IVD analyzers, reagents and other general laboratory equipments were categorized and coded using the letter D and 7 (2+3+2) digits. CONCLUSIONS: This draft for the Korean IVDD classification and coding system could be used for effective management and regulation of IVDD in Korea.
Advisory Committees ; Australia ; Canada ; Clinical Coding ; Consultants ; Current Procedural Terminology ; Humans ; Indicators and Reagents ; Insurance, Health ; Japan ; Korea ; Medical Laboratory Personnel ; Public Health ; Reagent Kits, Diagnostic

BACKGROUND: The Global harmonization task force (GHTF) recommends a separate regulation system for in vitro diagnostic medical devices (IVDD), because false test results can pose a risk to individual and/or public health. However, in Korea, many reagents for IVDD are not monitored, although IVD analyzers and some reagents are monitored under the Medical Device Act and Pharmaceutical Affairs Act, respectively. Our aim was to propose a draft for a Korean coding and classification system for IVDD. METHODS: For preparing the draft, we reviewed the Korean Current Procedural Terminology for Health Insurance and principles of the coding and classification system for IVDD of the GHTF, the USA, Japan, Canada, Australia, and the EU. The draft was reviewed by consultants from relevant societies, such as Korean Medical Association, Korean Society for Laboratory Medicine, The Korea Association of Medical Technologists, and Korea Association for Diagnostic Laboratory Reagents, and was then publicly discussed at a conference. RESULTS: IVDD were classified into 4 classes on the basis of the risks they pose to individual (IR) and public health (PR): class 1 (low IR and low PR), class 2 (moderate IR and low PR), class 3 (high IR and/or moderate PR), and class 4 (high IR and high PR). IVD analyzers, reagents and other general laboratory equipments were categorized and coded using the letter D and 7 (2+3+2) digits. CONCLUSIONS: This draft for the Korean IVDD classification and coding system could be used for effective management and regulation of IVDD in Korea.
Advisory Committees ; Australia ; Canada ; Clinical Coding ; Consultants ; Current Procedural Terminology ; Humans ; Indicators and Reagents ; Insurance, Health ; Japan ; Korea ; Medical Laboratory Personnel ; Public Health ; Reagent Kits, Diagnostic

Six trials with 3 samples for each trial for external quality assessment of general chemistry and blood gas were performed in 2009. All the control materials were sent in specifically-made boxes at the same time. The response rates were 87.5% in general chemistry and 89.3% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2008), change of the methods of analysis was not remarkable. The peer group coefficient of variation and the VIS scores of general chemistry items were slightly improved.
Bilirubin ; Calcium ; Chemistry, Clinical ; Cholesterol ; Creatinine ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Peer Group ; Phosphorus ; Potassium ; Sodium ; Uric Acid

BACKGROUND: Primary human cytomegalovirus (CMV) infection during pregnancy is a major cause of congenital malformation. We detected primary CMV infection in pregnant Korean women by using an algorithm that comprises CMV IgG, IgM, and IgG avidity tests. METHODS: During a 2-month period, 744 pregnant women who were at 10-19 weeks of gestation were consecutively enrolled in this study. Human anti-CMV IgG and IgM levels in their sera were determined by chemiluminescence immunoassays. Serum samples from the women who were positive for CMV IgG and IgM were assayed by the ARCHITECT CMV IgG avidity test in order to distinguish primary from non-primary CMV infection. Gross examination of the neonates of the women who were positive for CMV IgM was conducted. RESULTS: The seroprevalence of CMV IgG and IgM was estimated to be 98.1% and 1.7%, respectively. The samples from all the women who were positive for CMV IgM or with grey zone results contained high avidity CMV IgG. Seven women with positive CMV IgG and IgM results who completed follow-up up to delivery showed no gross evidence of in utero CMV transmission. CONCLUSIONS: Maternal primary CMV infection was not detected in any of the pregnant women included in this study cohort. CMV IgG avidity test enabled the identification of women who were at a low risk of transmitting CMV infection and provided informative for subsequent pregnancy outcomes. Compared to previous studies, the seroprevalence of CMV IgG antibody across pregnant Korean women remained unchanged.
Adult ; Antibodies, Viral/*blood ; Asian Continental Ancestry Group ; Chemiluminescent Measurements ; Cytomegalovirus/*immunology ; Cytomegalovirus Infections/*diagnosis/epidemiology ; Enzyme-Linked Immunosorbent Assay ; Female ; Gestational Age ; Humans ; Immunoglobulin G/*blood ; Immunoglobulin M/blood ; Pregnancy ; Pregnancy Complications, Infectious/*diagnosis/epidemiology ; Republic of Korea ; Seroepidemiologic Studies ; Young Adult

Six trials with 3 samples for each trial for external quality assessment of general chemistry and blood gas were performed in 2008. All the control materials were sent in specifically-made boxes at the same time. The response rates were 93.5% in general chemistry and 88.1% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2007), change of the methods of analysis and the peer group coefficient of variation was not remarkable and the VIS scores of general chemistry items were slightly improved.
Bilirubin ; Calcium ; Chemistry, Clinical ; Cholesterol ; Creatinine ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Peer Group ; Phosphorus ; Potassium ; Sodium ; Uric Acid

Six trials with 3 samples for each of external quality assessment for general chemistry and blood gas were performed in 2007. All the control materials were sent in specifically-made boxes at the same time. The response rates were 92.0% in general chemistry and 95.5% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2006), the methods of analysis were slightly changed and the coefficient of variation and VIS scores of general chemistry items were not significantly changed.
Bilirubin ; Calcium ; Chemistry, Clinical ; Cholesterol ; Creatinine ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Phosphorus ; Potassium ; Sodium ; Uric Acid

BACKGROUND: Serological tests detecting antibodies specific to antigens of Treponema pallidum are useful tools for diagnosis and screening of syphilis. Nevertheless, conventional non-treponemal tests, which are commonly being used thanks to their low cost, have limited consistency in procedures and interpretations because of lack of automation. Moreover, they have innate lower sensitivity and specificity. Therefore, clinical use of non-treponemal tests has been significantly substituted by more reliable treponemal antibody assays. Considering such trend, diagnostic sensitivity of a recently introduced automatic chemiluminescent immunoassay, ARCHITECT Syphilis TP (Abbott Japan, Tokyo, Japan), was evaluated with comparison to existing methods to validate its clinical sensitivity. METHODS: Fifty stored sera with reactive results on a non-treponemal syphilis test done by requests from the attending physicians were collected consecutively. Diagnosis of syphilis was confirmed when two or more positive results were obtained among 3 treponemal antibody tests, a hemagglutination, an automated latex turbidimetry and ARCHITECT Syphilis TP. RESULTS: All 50 sera were confirmed as syphilis-infected. Diagnostic sensitivity of ARCHITECT Syphilis TP was estimated to 100%, whilst that of the hemagglutination and the latex turbidimetry was 94% and 98%, respectively. Correlation coefficient between S/COs of ARCHITECT Syphilis TP and quantitative results on the latex turbidimetry was caculated as 0.865. Compared to the hemagglutination titers, better quantitative correlation was observed with S/COs of ARCHITECT Syphilis TP. CONCLUSIONS: ARCHITECT Syphilis was thought to be a reliable test with good sensitivity and its automated feature was thought to be additionally beneficial. Although it is being used for a qualitative purpose, it seemed possible to expand its utility into quantitative use considering its acceptable quantitative correlation with the hemagglutination assay as well as the automated latex turbidimetric assay.
Antibodies ; Automation ; Hemagglutination ; Immunoassay ; Japan ; Latex ; Luminescence ; Mass Screening ; Nephelometry and Turbidimetry ; Sensitivity and Specificity ; Serologic Tests ; Syphilis ; Tokyo ; Treponema pallidum

BACKGROUND: Serological tests detecting antibodies specific to antigens of Treponema pallidum are useful tools for diagnosis and screening of syphilis. Nevertheless, conventional non-treponemal tests, which are commonly being used thanks to their low cost, have limited consistency in procedures and interpretations because of lack of automation. Moreover, they have innate lower sensitivity and specificity. Therefore, clinical use of non-treponemal tests has been significantly substituted by more reliable treponemal antibody assays. Considering such trend, diagnostic sensitivity of a recently introduced automatic chemiluminescent immunoassay, ARCHITECT Syphilis TP (Abbott Japan, Tokyo, Japan), was evaluated with comparison to existing methods to validate its clinical sensitivity. METHODS: Fifty stored sera with reactive results on a non-treponemal syphilis test done by requests from the attending physicians were collected consecutively. Diagnosis of syphilis was confirmed when two or more positive results were obtained among 3 treponemal antibody tests, a hemagglutination, an automated latex turbidimetry and ARCHITECT Syphilis TP. RESULTS: All 50 sera were confirmed as syphilis-infected. Diagnostic sensitivity of ARCHITECT Syphilis TP was estimated to 100%, whilst that of the hemagglutination and the latex turbidimetry was 94% and 98%, respectively. Correlation coefficient between S/COs of ARCHITECT Syphilis TP and quantitative results on the latex turbidimetry was caculated as 0.865. Compared to the hemagglutination titers, better quantitative correlation was observed with S/COs of ARCHITECT Syphilis TP. CONCLUSIONS: ARCHITECT Syphilis was thought to be a reliable test with good sensitivity and its automated feature was thought to be additionally beneficial. Although it is being used for a qualitative purpose, it seemed possible to expand its utility into quantitative use considering its acceptable quantitative correlation with the hemagglutination assay as well as the automated latex turbidimetric assay.
Antibodies ; Automation ; Hemagglutination ; Immunoassay ; Japan ; Latex ; Luminescence ; Mass Screening ; Nephelometry and Turbidimetry ; Sensitivity and Specificity ; Serologic Tests ; Syphilis ; Tokyo ; Treponema pallidum

Ten trials of external quality assessment for Clinical Chemistry in general chemistry and blood gas were performed in 2005. All the control materials were sent in specifically-made boxes at the same time. The response rates were 90.1% in general chemistry and 84.8% in blood gas. The items included sodium, potassium, chloride, BUN, glucose, calcium, phosphorus, uric acid, creatinine, bilirubin, total protein, albumin, total cholesterol, triglyceride, AST, ALT, ALP, LD and GGT in general chemistry and pH, pCO2 and pO2 in blood gas. Compared with the previous year (2004), the methods of analysis were changed and the coefficient of variation and VIS scores of general chemistry items were increased.
Bilirubin ; Calcium ; Chemistry ; Chemistry, Clinical* ; Cholesterol ; Creatinine ; Glucose ; Hydrogen-Ion Concentration ; Korea* ; Phosphorus ; Potassium ; Sodium ; Triglycerides ; Uric Acid