• The Korean Journal of Nuclear Medicine Technology
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• v.26 no.2
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• pp.43-47
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• 2022

Purpose Radioimmunoassay implement quality control by systematizing the internal quality control system for quality assurance of test results. This study aims to contribute to the quality assurance of radioimmunoassay results and to implement systematic quality control by measuring the average CV of internal quality control and external quality control by plenty of institutions for reference when setting the laboratory's own acceptable range. Materials and Methods We measured the average CV of internal quality control and the bounce rate of more than 10.0% for a total of 42 items from October 2020 to December 2021. According to the CV result, we classified and compared the upper group (5.0% or less), the middle group (5.0~10.0%) and the lower group (10.0% or more). The bounce rate of 10.0% or more was compared by classifying the item of five or more institutions into tumor markers, thyroid hormones and other hormones. The average CV was measured by the overall average and standard deviation of the external quality control results for 28 items from the first quarter to the fourth quarter of 2021. In addition, the average CV was measured by the overall average and standard deviation of the proficiency results between institutions for 13 items in the first half and the second half of 2021. The average CV of internal quality control and external quality control was compared by item so we compared and analyzed the items that implement well to quality control and the items that require attention to quality control. Results As a result of measuring the precision average of internal quality control for 42 items of six institutions, the top group (5.0% or less) are Ferritin, HGH, SHBG, and 25-OH-VitD, while the bottom group (≤10.0%) are cortisol, ATA, AMA, renin, and estradiol. When comparing more than 10.0% bounce rate of CV for tumor markers, CA-125 (6.7%), CA-19-9 (9.8%) implemented well, while SCC-Ag (24.3%), CA-15-3 (26.7%) were among the items that require attention to control. As a result of comparing the bounce rate of more than 10.0% of CV for thyroid hormones examination, free T4 (2.1%), T3 (9.3%) showed excellent performance and AMA (39.6%), ATA (51.6%) required attention to control. When comparing the bounce rate of 10.0% or more of CV for other hormones, IGF-1 (8.8%), FSH (9.1%), prolactin (9.2%) showed excellent performance, however estradiol (37.3%), testosterone (37.7%), cortisol (44.4%) required attention to control. As a result of measuring the average CV of the whole institutions participating at external quality control for 28 items, HGH and SCC-Ag were included in the top group (≤10.0%), however ATA, estradiol, TSI, and thyroglobulin included in bottom group (≥30.0%). Conclusion As a result of evaluating 42 items of six institutions, the average CV was 3.7~12.2% showing a 3.3 times difference between the upper group and the lower group. Cortisol, ATA, AMA, Renin and estradiol tests with high CV will require continuous improvement activities to improve precision. In addition, we measured and compared the overall average CV of the internal quality control, the external quality control and the proficiency between institutions participating of six institutions for 41 items excluding HBs-Ab. As a result, ATA, AMA, Renin and estradiol belong to the same subgroup so we require attention to control and consider setting a higher acceptable range. It is recommended to set and control the acceptable range standard of internal quality control CV in consideration of many things in the laboratory due to the different reagents and instruments, and the results vary depending on the test's proficiency and quality control materials. It is thought that the accuracy and reliability of radioimmunoassay results can be improved if systematic quality control is implemented based on the set acceptable range.

• Korean Journal of Clinical Laboratory Science
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• v.37 no.2
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• pp.65-70
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• 2005

Those specifications of the CLIA analytical tolerance limits are consistent with the performance goals in Six Sigma Quality Management. Six sigma analysis determines performance quality from bias and precision statistics. It also shows if the method meets the criteria for the six sigma performance. Performance standards calculates allowable total error from several different criteria. Six sigma means six standard deviations from the target value or mean value and about 3.4 failures per million opportunities for failure. Sigma Quality Level is an indicator of process centering and process variation total error allowable. Tolerance specification is replaced by a Total Error specification, which is a common form of a quality specification for a laboratory test. The CLIA criteria for acceptable performance in proficiency testing events are given in the form of an allowable total error, TEa. Thus there is a published list of TEa specifications for regulated analytes. In terms of TEa, Six Sigma Quality Management sets a precision goal of TEa/6 and an accuracy goal of 1.5 (TEa/6). This concept is based on the proficiency testing specification of target value +/-3s, TEa from reference intervals, biological variation, and peer group median mean surveys. We have found rules to calculate as a fraction of a reference interval and peer group median mean surveys. We studied to develop total error allowable from peer group survey results and CLIA 88 rules in US on 19 items TP, ALB, T.B, ALP, AST, ALT, CL, LD, K, Na, CRE, BUN, T.C, GLU, GGT, CA, phosphorus, UA, TG tests in chematology were follows. Sigma level versus TEa from peer group median mean CV of each item by group mean were assessed by process performance, fitting within six sigma tolerance limits were TP ($6.1{\delta}$/9.3%), ALB ($6.9{\delta}$/11.3%), T.B ($3.4{\delta}$/25.6%), ALP ($6.8{\delta}$/31.5%), AST ($4.5{\delta}$/16.8%), ALT ($1.6{\delta}$/19.3%), CL ($4.6{\delta}$/8.4%), LD ($11.5{\delta}$/20.07%), K ($2.5{\delta}$/0.39mmol/L), Na ($3.6{\delta}$/6.87mmol/L), CRE ($9.9{\delta}$/21.8%), BUN ($4.3{\delta}$/13.3%), UA ($5.9{\delta}$/11.5%), T.C ($2.2{\delta}$/10.7%), GLU ($4.8{\delta}$/10.2%), GGT ($7.5{\delta}$/27.3%), CA ($5.5{\delta}$/0.87mmol/L), IP ($8.5{\delta}$/13.17%), TG ($9.6{\delta}$/17.7%). Peer group survey median CV in Korean External Assessment greater than CLIA criteria were CL (8.45%/5%), BUN (13.3%/9%), CRE (21.8%/15%), T.B (25.6%/20%), and Na (6.87mmol/L/4mmol/L). Peer group survey median CV less than it were as TP (9.3%/10%), AST (16.8%/20%), ALT (19.3%/20%), K (0.39mmol/L/0.5mmol/L), UA (11.5%/17%), Ca (0.87mg/dL1mg/L), TG (17.7%/25%). TEa in 17 items were same one in 14 items with 82.35%. We found out the truth on increasing sigma level due to increased total error allowable, and were sure that the goal of setting total error allowable would affect the evaluation of sigma metrics in the process, if sustaining the same process.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.6 no.1
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• pp.24-31
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• 2003

Purpose: As diagnostic tools for Hirschsprung's disease (HD), barium enema and rectal biopsy have radiation exposure and invasiveness respectively; however anorectal manometry does not have these disadvantages. We therefore performed this study to evaluate the diagnostic efficacy of anorectal manometry. Methods: We reviewed medical records of infants with one or two symptoms of vomiting, abdominal distension, chronic diarrhea or constipation who had a anorectal manometry followed by barium enema and/or biopsy from July 1995 to May 2002. We evaluated the sensitivity, specificity and predictive value of anorectal manometry and barium enema for diagnosis of HD. We also measured sphincter length, median value of balloon volume at which rectoanal inhibitory reflex (RAIR) occurred. Results: All 61 patients received anorectal manometry, 33 of 61 received barium enema. 18 of 61 were diagnosed as HD according to histology and 43 of 61 were evaluated as a control. The sensitivity, specificity, positive predictive value, negative predictive value of anorectal manometry and barium enema for diagnosis of HD were 1.00, 0.91, 0.82, 1.00 and 0.93, 0.67, 0.70, 0.92 respectively. The mean value of sphincter length in control was $1.68{\pm}0.67$ cm and correlated with age, weight and significantly longitudinal length. The median value of balloon volume at which RAIR occurred was 10 mL and did not correlated with age, weight and longitudinal length. Conclusion: This study suggests that anorectal manometry is an excellent initial screening test for Hirschsprung's disease because of its safety and accuracy.

• Journal of Intelligence and Information Systems
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• v.21 no.4
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• pp.93-110
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• 2015

The recommender system is a system which recommends products to the customers who are likely to be interested in. Based on automated information filtering technology, various recommender systems have been developed. Collaborative filtering (CF), one of the most successful recommendation algorithms, has been applied in a number of different domains such as recommending Web pages, books, movies, music and products. But, it has been known that CF has a critical shortcoming. CF finds neighbors whose preferences are like those of the target customer and recommends products those customers have most liked. Thus, CF works properly only when there's a sufficient number of ratings on common product from customers. When there's a shortage of customer ratings, CF makes the formation of a neighborhood inaccurate, thereby resulting in poor recommendations. To improve the performance of CF based recommender systems, most of the related studies have been focused on the development of novel algorithms under the assumption of using a single profile, which is created from user's rating information for items, purchase transactions, or Web access logs. With the advent of big data, companies got to collect more data and to use a variety of information with big size. So, many companies recognize it very importantly to utilize big data because it makes companies to improve their competitiveness and to create new value. In particular, on the rise is the issue of utilizing personal big data in the recommender system. It is why personal big data facilitate more accurate identification of the preferences or behaviors of users. The proposed recommendation methodology is as follows: First, multimodal user profiles are created from personal big data in order to grasp the preferences and behavior of users from various viewpoints. We derive five user profiles based on the personal information such as rating, site preference, demographic, Internet usage, and topic in text. Next, the similarity between users is calculated based on the profiles and then neighbors of users are found from the results. One of three ensemble approaches is applied to calculate the similarity. Each ensemble approach uses the similarity of combined profile, the average similarity of each profile, and the weighted average similarity of each profile, respectively. Finally, the products that people among the neighborhood prefer most to are recommended to the target users. For the experiments, we used the demographic data and a very large volume of Web log transaction for 5,000 panel users of a company that is specialized to analyzing ranks of Web sites. R and SAS E-miner was used to implement the proposed recommender system and to conduct the topic analysis using the keyword search, respectively. To evaluate the recommendation performance, we used 60% of data for training and 40% of data for test. The 5-fold cross validation was also conducted to enhance the reliability of our experiments. A widely used combination metric called F1 metric that gives equal weight to both recall and precision was employed for our evaluation. As the results of evaluation, the proposed methodology achieved the significant improvement over the single profile based CF algorithm. In particular, the ensemble approach using weighted average similarity shows the highest performance. That is, the rate of improvement in F1 is 16.9 percent for the ensemble approach using weighted average similarity and 8.1 percent for the ensemble approach using average similarity of each profile. From these results, we conclude that the multimodal profile ensemble approach is a viable solution to the problems encountered when there's a shortage of customer ratings. This study has significance in suggesting what kind of information could we use to create profile in the environment of big data and how could we combine and utilize them effectively. However, our methodology should be further studied to consider for its real-world application. We need to compare the differences in recommendation accuracy by applying the proposed method to different recommendation algorithms and then to identify which combination of them would show the best performance.

• The Journal of the Korea Contents Association
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• v.9 no.12
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• pp.683-690
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• 2009

The purpose of this study is to evaluate the usefulness of high-b-values diffusion weighted magnetic resonance imaging for the preoperative detection of focal rectum cancers. 60patients with diffusion weighted imaging were evaluated for the presence of rectal cancers. Forty were male and twenty were female, and their ages ranged from 38 to 71 (mean, 56) years. Used equipment was 1.5Tesla MRI((GE, General Electric Medical System, Excite HD). Examination protocols were used the fast spin echo T2, T1 weighted imaging. All examination protocols were performed by the same location with diffusion weighted imaging for accuracy detection. The b-values used in DWI were 250, 500, 750, 1000. 1500, 2000$(s/mm^2)$. The rectum, bladder to tumor contrast-to-noise ratio (CNR) of MR images were quantitativlely analyzed using GE software Functool tool, four experienced radiologists and three radiotechnologists qualitatively evaluated image quality in terms of image artifacts, lesion conspicuity and rectal wall. These data were analysed by using ANOVA and Freedman test with each b-value(p<0.05). Contrast to noise ratio of rectum, bladder and tumor in b-value 1000 were 27.21, 24.44, respectively(p<0.05) and aADC value was $0.73\times10^{-3}$. As a qualitative analysis, the conspicuity and discrimination from the rectal wall of lesions were high results as $4.0\pm0.14$, $4.4\pm0.16$ on b-value 1000(p<0.05), image artifacts were high results as $4.8\pm0.25$ on b-value 2000(p<0.05). In conclusion, DWI was provided useful information with depicting the pre-operative detection of rectal cancers, High-b-value 1000 image was the most excellent DWI value.

• Journal of the Korean Society of Clothing and Textiles
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• v.29 no.12 s.148
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• pp.1595-1607
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• 2005

Three-dimensional(3-D) body scanners used to capture anthropometric measurements are now becoming a common research tool far apparel. This study had two goals, to test the accuracy and reliability of 3-D measurements of dynamic postures, and !o analyze the change in upper body surface measurements between the standard anthropometric position and various dynamic positions. A comparison of body surface measurements using two different measuring methods, 3-D scan measurements using virtual tools on the computer screen and traditional manual measurements for a standard anthropometric posture and for a posture with shoulder flexion were $-2\~20mm$. Girth items showed some disagreement of values between the two methods. None of the measurements were significantly different except f3r the neckbase girth for any of the measuring methods or postures. Scan measurements of the upper body items showed significant linear surface change in the dynamic postures. Shoulder length, interscye front and back, and biacromion length were the items most affected in the dynamic postures. Changes of linear body surface were very similar for the two measuring methods within the same posture. The repeatability of data taken from the 3-D scans using virtual tools showed satisfactory results. Three times repeated scan measurements f3r the scapula protraction and scapula elevation posture were proven to be statistically the same for all measurement items. Measurements from automatic measuring software that measured the 3-D scan with no manual intervention were compared with the measurements using virtual tools. Many measurements from the automatic program were larger and showed quite different values.

• Journal of Food Hygiene and Safety
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• v.31 no.5
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• pp.327-334
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• 2016

This study was conducted to establish the standard method for the contents of biotin in milk formulas. To optimize the method, we compared several conditions for liquid extraction, purification and instrumental measurement using spiked samples and certified reference material (NIST SRM 1849a) as test materials. LC-MS/MS method for biotin was established using $C_{18}$ column and binary gradient 0.1% formic acid/acetonitrile, 0.1% formic acid/water mobile phase is applied for biotin. Product-ion traces at m/z 245.1 ${\rightarrow}$ 227.1, 166.1 are used for quantitative analysis of biotin. The linearity was over $R^2=0.999$ in range of $5{\sim}60{\mu}g/L$. For purification, chloroform was used as a solvent for eliminating lipids in milk formula. The linearity was over 0.999 in range of 5~60 ng/mL. The detection limit and quantification limit were 0.10, 0.31 ng/mL. The accuracy and precision of LC-MS/MS method using CRM were 103%, 2.5% respectively. Optimized methods were applied in sample analysis to verify the reliability. All the tested milk formulas were acceptable contents of biotin compared with component specification and standards for nutrition labeling. The standard operating procedures were prepared for biotin to provide experimental information and to strengthen the management of nutrient in milk formula.

• Childhood Kidney Diseases
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• v.5 no.1
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• pp.22-29
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• 2001

Purpose : 99mTc DMSA renal scan have been widely used not only for tile evaluation of renal scars but also for the diagnosis of acute pyelonephritis. Recent studies have shown SPECT images have higher accuracy than the planar images with some controversy. We evaluated the availability of the SPECT images adding to planar images for the diagnosis of acute pyelonephritis(APN) and renal scar in children with urinary tract infection (UTI). Methods : 130 children with UTI (260 kidney units) and 22 follow-up children (44 kidney units) were included between January 1, 1997 and July 31, 1999 at Ewha University Mokdong Hospital. Planar Anterior and posterior images and SPECT axial and coronal images of 99mTc DMSA renal scan were obtained with Starcam 4000-i U.S.A. GE at 3 hours after 99mTc DMSA I.V. injection. The data were analyzed by Chi square test after Yates's correction. Results : The detection rate of the acute pyelonephritis by SPECT images was 12.3$\%$ higher than that of planar images ($47.7\%\;vs\;35.4\%$) by the patient and 6.9$\%$ higher also ($31.9\%\;vs\;25.4\%$) by the kidney unit. 18 kidney units with negative planar images had focal defect in 10 kidney units (3.8$\%$) and multifocal defect in 8 kidney units (3.1$\%$) on SPECT images, but 1 kidney unit with positive planar image had negative SPECT image. SPECT images were superior to tile planar images in 17.3$\%$. identical in 82.3$\%$ and inferior in 0.4$\%$ to planar image. The detection rate of tile renal scars by SPECT images was 13.7$\%$ higher than planar images by the patient ($68.2\%\;vs\;54.5\%$) and 6.8$\%$ higher also ($43.2\%\;vs\;36.4\%$) by the kidney unit. SPECT images were superior to the planar images in 17.3$\%$ and identical in 82.3$\%$ to planar image. Conclusion SPECT images had shown higher detection rate and better image than planar images for the diagnosis of the acute pyelonephritis and the evaluation of the renal scars. (J. Korean Soc Pediatr Nephrol 5 : 22- 9, 2001)

• Research in Community and Public Health Nursing
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• v.14 no.2
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• pp.334-350
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• 2003

The purpose of this descriptive study was to evaluate the clinical validity of QSCCII (Questionnaire for the Sasang Constitution Classification), whose high accuracy as a constitutional diagnostic tool has been recognized by medical professionals. The subjects of this study were 568 clients from an A university hospital in Suwon. Of the subjects, 259 were health center visitors and 292 were ambulatory clinic visitors. Data were collected using self-reported questionnaire and were analyzed by $X^2$-test and one-way ANOVA. The results of this study as follows: 1. In 4 types of constitution, Soeumin type was found in 41.5% of the subjects. Taeumin type in 39.2%.,and Soyangin type in 19.2%, respectively. There was no Tayangin type found in this study. There were no significant differences on types of constitution by demographic characteristics such as age, sex, marital status, education, religion, and economic status. 2. As for 15 item-selective questionnaire, there were statistically significant differences on the response rate of the 12 items, except items such as A4, A11 and A14, by the types of constitution. When the subjects' own criteria on their constitution were compared to the given constitutional criteria on each item, 4 items such as A6, A11, A13 and A14 were advisable to be excluded from the questionnaire or to be reunited to the other criteria. In the meanwhile, 3 items such as A7, A18 and A15 were desirable to be re-categorized to the other constitutional types and reconstructed to the QSCC II questionnaire. 3. In terms of 106 true-false questionnaire, there were statistically significant differences on the response rate of 46 items by the types of constitution. The 46 items include 15 items (32.6%) of the domain of 'handling something/strength and weakness', 4 items (8.7%) of the domain of 'interpersonal relationship', 9 items (19.6%) of the domain of 'state of mind at ordinary times', 2 items (4.3%) of the domain of 'distinctive emotional characteristics' area, 11 items (23.9%) of the domain of 'specific behavioral trait' and 5 items (10.9%) of the domain of 'physical characteristics'. Therefore, the areas of 'handling something/strength and weakness' and' specific behavioral trait' mainly contributed to the classification of constitutional type. 4. When the 106 true-false items were simplified to the 46 items, statistically significant differences were found on the rate of items allocated to the 3 types of constitution. The rate of selection assigned to the 3 constitutional types of the simplified 46-item questionnaire was higher than that of the original 106-item questionnaire. Conclusions; It was concluded that the rate of selection of each lay person about his own constitutional type would be still higher even though the simplified items of QSCC II questionnaire were applied. If more replicated studies are conducted on the diverse population using the simplifying QSCC II questionnaire in the future, a more simplified standardized Sasang Constitution Questionnaire that is available to the public rather than to medical staffs in the clinical settings could be developed. Moreover, the simplified scale will help nurses deliver more efficient nursing care by providing a more rapid way of health assessment.

• Tuberculosis and Respiratory Diseases
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• v.47 no.1
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• pp.50-56
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• 1999

Background : Pleural effusion is a common clinical problem and many clinical and laboratory evaluations, such as tumor marks, have been studied to discriminate malignant pleural fluid from benign pleural fluid. However their usefulness in the diagnosis of pleural effusion is still not established fully. We studied the diagnostic value of cyfra 21-1 in diagnosis of malignant pleural effusion. Methods: Pleural fluid was obtained from 45 patients with malignant diseases(32 lung cancer patients, 13 metastatic malignant diseases) and 47 patients with benign diseases. The level of cyfra 21-1 in the pleural fluid and serum were determined using a CYFRA 21-1 enzyme immunoassay kit(Cis-Bio International Co.). The t-test was used for comparison between two diseases groups and receiver operating characteristic(ROC) curves were constructed by calculating the sensitivities and specificities of the cyfra 21-1 at several points to determine the diagnostic accuracy of the cyfra 21-1. Results: In patients with primary lung cancer, the level of cyfra 21-1 in the pleural fluid was significantly higher than those of patients with benign diseases and had positive correlations between the level of cyfra 21-1 in the pleural fluid and serum levels. In the ROC curve analysis of the pleural fluid, the curve for primary lung cancer group was located closer to the left upper comer and the cut off value, sensitivity and specificity of the cyfra 21-1 of the primary lung cancer group was determined as 22.25ng/ml, 81.8% and 78.7% respectively. Conclusions: Our data indicates that the measurement of cyfra 21-1 level in pleural effusion has useful diagnostic value to discriminate malignant pleural effusion in primary lung cancer from benign pleural effusion.