• The Korean Journal of Nuclear Medicine Technology
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• v.15 no.2
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• pp.116-124
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• 2011

Purpose: To establish accurate external quality assurance (EQA) test, cross institutional and modality tests were performed using WHO certificated reference material (CRM) and same pooled patients serum. Materials and Methods: Accuracy and precision were evaluated using CRM and pooled patients' serum for AFP, CEA, PSA, CA 125, CA 19-9, T3, T4, Tg, TSH. To evaluate the accuracy and precision, recover test and coefficient variation were measured. RIA test were performed in major 5 RIA laboratory and EIA (CLIA) test were done in 5 major EIA laboratory. same sample of CRM and pooled serum were delivered to each laboratory. Results: In 2009, mean precision of total tumor marker of RIA was $14.8{\pm}4.2%$ and that of EIA(CLIA) was $19.2{\pm}6.9%$. In 2010, mean precision of 5 tumor marker and T3, T4, Tg, TSH was $13.8{\pm}6.1%$ in RIA and $15.5{\pm}7.7%$ in EIA (CLIA). There was no significant difference between RIA and EIA. In RIA, the coefficient variations (CV) of AFP, CEA, PSA, CA 125, T3, T4, TSH were within 20%. The CV of CA 19-9 was over 20% but there was no significant difference with EIA (CLIA) (p=0.345). In recovery test using CRM, AFP, PSA, T4, TSH showed 92~103% of recovery in RIA. In recovery test using commercial material, CEA, CA 125, CA 19-9 showed relatively lower recovery than CRM but there was no significant difference between RIA and EIA (CLIA). Conclusion: By evaluating the precision and accuracy of each test, EQA test could more accurately measured the quality of each test and performance of laboratory.

• The Korean Journal of Nuclear Medicine Technology
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• v.19 no.2
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• pp.112-114
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• 2015

Purpose Vitamin D to Anti- Rickets both steroid compounds showing activity, By acting on bone tissue secretary and the key to maintain serum Ca homeostasis. The blood level of vitamin D is the largest in D3 that the concentration of the metabolite is reflected in the holding state of vitamin D in vivo. Sunlight to change the 7-dehydrocholesterol in the skin and through the skin to D3, In the liver in combination with the D2 and D3 D4 changes. The Radioimmunoassay(RIA) method is measuring the D 3, the sensitivity can be measured also difficult trace substance to measure the normal test because it is very sensitive, but recently, a check is possible, for the Total D3 in Chemimicroparticle immunoassay(CMIA) or Chemiluminescent immunoassay(CLIA) measuring using microparticle RIA and CMIA(Architect i2000SR) / use the CLIA(DXI-800) method to compare and evaluate the correlation between the tests in the same test items. Materials and Methods Commissioned from January 2014 to March 2015 patients were enrolled in a total of 273 people. 29 out of 273 people conducted by RIA were compared with CMIA, 244 patients were compared with CLIA. Using reagents and equipment were used RIA(Diasource), CMIA(Architect i2000SR, Abbott Diagnostics) / CLIA( Unicel DXi-800, Beckman coulter). Results Correlation of the RIA and CLIA was a R2 = 0.1844 (y = 0.7303x + 3.9005), and the correlation of RIA CMIA is R2 = 0.2762 (y = 0.8862x + 4.56) respectively. (According to statistics, during the same period RIA is Deficiency 4.31%, Insufficiency 90.53%, Sufficiency 5.16%, was Excess 0%, CLIA / CMIA is Deficiency 17.02%, Insufficiency 75.91%, Sufficiency 7.03%, indicating the distribution of 0.03 % Excess) Conclusion Serum vitamin D and parathyroid hormone that show an inverse relationship, the level above which are not parathyroid hormone and vitamin D reduced the increase. The density is different for each study, at most 20 is reported to be the maximum between 30 ng / ml. In Korea it requires a proposed standard of vitamin D deficiency, reference to the WHO lack the case more than 10ng/ml, 20ng/ml and defined by the lack of, if not more than, the IOM, but looking at 12ng/ml or less to the normal to lack, at least 20ng/ml, the reference do not match the deficit under 20ng/ml, 21-29ng/ml relative lack between, was also defined as a sufficient condition for more than 30ng/ml. Although not statistically is between RIA and CLIA two ways to vitamin D levels change according to season match, when seasonally seen in summer as commonly known (April to September), winter (October to March) relative to the increase measured than it was found. Finally, the study on the correlation between the two methods have been expected to result in a consistent and apply the same view high reference value on the graph is difficult. However, there may be differences between the test equipment and methods, and could be especially the case of RIA method using an organic solvent is difficult to compare different methods and correlated view similar trend in vitamin D deficiency and quarterly aspect ratio.

• The Korean Journal of Nuclear Medicine Technology
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• v.15 no.1
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• pp.121-125
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• 2011

Purpose: The DNA-type virus HBV, discovered by D. Dane and others in 1976, is approximately 42nm big and known as the main cause of liver-related diseases around the world. HBsAg has 4 kinds of subtypes including adw, adr, ayw and ayr and besides common antigen factor a, there are d, y, r, w. From the methods of serologically testing HBV, IRMA, EIA and CLIa were developed for testing HBsAg and are being used in examining the surface antigen of HBV. In this study, among the methods for testing HBV, the recently developed RIAKEY Ultrasensitive HBsAg IRMA kit's sensitivity level and performance in detection of mutant forms were measured and compared with CLIA. Materials and methods: Two certified reference materials, which are WHO 1st International Standard 1985(80/549) and WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA), were used in the examination and the sensitivity level was measured by diluting these materials from 0.08 IU/ml to 0.005 IU/ml. The materials for examining the detection of mutant forms included 9 kinds of subtype 'ad' and one kind of subtype 'ay' purchased from DSI company. Also, with the use of positive and negative samples, they was compared with CLIA. Result: Ultrasensitive HBsAg kit based on IRMA method showed the detection of up to 0.01 IU/ml not only for WHO 1st International Standard 1985(80/549) but also for WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA) and the sensitivity level was measured as 0.01 IU/ml by WHO standard. In testing the performance for detection of mutant forms, the 9 kinds of subtype 'ad' and one kind of subtype 'ay' mutant materials were detected, demonstrating the capacity of detecting various types of mutant forms. Conclusions: With the clinical importance of sensitivity level and performance in detection of mutant forms increasing in the field of HBsAg diagnosis, the examination of IRMA's effectiveness using RIA method in the aspects of the sensitivity level and performance in detection of mutant forms was carried out and its result is as follows. The sensitivity level was measured as 0.01 IU/ml by WHO standard and it was possible to measure various types of mutant forms with high sensitivity. Thus it is suggested that more speedy and accurate reports could be produced from a nuclear medicine laboratory for clinical practitioners requiring results of various situations.

• Korean Journal of Clinical Laboratory Science
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• v.40 no.2
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• pp.86-93
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• 2008

This study was performed to investigation of the serum alpha-fetoprotein (AFP) levels in healthy adults. A total of 2,160 (male 1,415, female 745) health checkup adults were examined for AFP levels by chemiluminescence immunoassay (CLIA) method, during the period from September, 2007 to August, 2008. The mean serum AFP level was 2.168 (0.605~20.35) ng/mL, and it was 2.309 (0.605~20.35) ng/mL in male, 1.906 (0.605~10.36) ng/mL in female, respectively. 1,816 (male 1,109, female 709) healthy adults were screened for the absence of viral hepatitis and normal alanine amino transferase (ALT) levels. The mean serum AFP level of healthy adult was 2.041 (0.605~7.83) ng/mL, and it was 2.181 (0.605~7.83) ng/mL in male, 1.822 (0.605~6.55) ng/mL in female, respectively. Serum AFP increased with age group, there was a higher level in male compared to female. These results suggests that the use of reference value of AFP in healthy adults in the Jeonbuk. With the reference value now defined, it becomes possible to compare levels in different populations.

• Korean Journal of Clinical Laboratory Science
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• v.42 no.1
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• pp.32-37
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• 2010

The author was performed to investigation of current status of prevalence for anti-hepatitis C virus (HCV) among the health-checkup adults in Jeonbuk province. A toal of 1,553 (male 1,046, female 507) serum samples were diagnosed by 3rd generation enzyme immunoassay (EIA) for anti-HCV. Total prevalence of anti-HCV was 0.9%, and prevalence of male and female were 0.8% and 1.2%, respectively. The prevalence of female was higher than male. According to ages group, prevalence of anti-HCV was highest in 60 age group, but it was not found in 20 age group. 14 samples with anti-HCV positive were diagnosed by EIA for hepatitis B virus surface antigen (HBs Ag), by chemiluminescence immunoassay (CLIA) for serum albumin, alanine transaminase (ALT) and asparagine transaminase (AST). Positive for HBs Ag was not found. The mean of serum albumin levels was 4.5 g/dL, and mean of ALT and AST were 34.3 IU and 31.9 IU, respectively. Through this study, I know that the prevalence of anti-HCV among adults in Jeonbuk, and suggest that the positive of anti-HCV persons who have lower serum albumin, normal to mild elevations in serum enzymes are chronic hepatitis.

• Korean Journal of Clinical Laboratory Science
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• v.36 no.1
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• pp.13-18
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• 2004

This study was designed to establish working range for reoportable range in own laboratory in order to cover the upper and lower limits of the range in test method. We experimented ten times during 10 days for setting of reportable range with between run for method evaluation. It is generally assumed that the analytical method produces a linear response and that the test results between those upper and lower limits are then reportable. CLIA recommends that laboratories verify the reportable range of all moderate and high complexity tests. The Clinical Laboratory Improvement Amendments(CLIA) and Laboratory Accreditation Program of the Korean Society for Laboratory Medicine states reportable range is only required for "modified" moderately complex tests. Linearity requirements have been eliminated from the CLIA regulations and from others accreditation agencies, many inspectors continue to feel that linearity studies are a part of good lab practice and should be encouraged. It is important to assess the useful reportable range of a laboratory method, i.e., the lowest and highest test results that are reliable and can be reported. Manufacturers make claims for the reportable range of their methods by stating the upper and lower limits of the range. Instrument manufacturers state an operating range and a reportable range. The commercial linearity material can be used to verify this range, if it adequately covers the stated linear interval. CLIA requirements for quality control, must demonstrate that, prior to reporting patient test results, it can obtain the performance specifications for accuracy, precision, and reportable range of patient test results, comparable to those established by the manufacturer. If applicable, the laboratory must also verify the reportable range of patient test results. The reportable range of patient test results is the range of test result values over which the laboratory can establish or verify the accuracy of the instrument, kit or test system measurement response. We need to define the usable reportable range of the method so that the experiments can be properly planned and valid data can be collected. The reportable range is usually defined as the range where the analytical response of the method is linear with respect to the concentration of the analyte being measured. In conclusion, experimental results on reportable range using concentrated control sample and zero calibrators covering from highest to lowest range were salicylate $8.8{\mu}g/dL$, phenytoin $0.67{\mu}g/dL$, phenobarbital $1.53{\mu}g/dL$, primidone $0.16{\mu}g/dL$, theophylline $0.2{\mu}g/dL$, vancomycine $1.3{\mu}g/dL$, valproic acid $3.2{\mu}g/dL$, digitoxin 0.17ng/dL, carbamazepine $0.36{\mu}g/dL$ and acetaminophen $0.7{\mu}g/dL$ at minimum level and salicylate $969.9{\mu}g/dL$, phenytoin $38.1{\mu}g/dL$, phenobarbital $60.4{\mu}g/dL$, primidone $24.57{\mu}g/dL$, theophylline $39.2{\mu}g/dL$, vancomycine $83.65{\mu}g/dL$, valproic acid $147.96{\mu}g/dL$, digitoxin 5.04ng/dL, carbamazepine $19.76{\mu}g/dL$, acetaminophen $300.92{\mu}g/dL$ at maximum level.

• Journal of Genetic Medicine
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• v.12 no.2
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• pp.79-84
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• 2015

Purpose: We developed and validated a fetal trisomy detection method for use as a noninvasive prenatal test (NIPT) including a Clinical Laboratory Improvement Amendments (CLIA)-certified bioinformatics pipeline on a cloud-based computing system using both Illumina and Life Technology sequencing platforms for 221 Korean clinical samples. We determined the necessary proportions of the fetal fraction in the cell-free DNA (cfDNA) sample for NIPT of trisomies 13, 18, and 21 through a limit of quantification (LOQ) test. Materials and Methods: Next-generation sequencing libraries from 221 clinical samples and three positive controls were generated using Illumina and Life Technology chemistries. Sequencing results were uploaded to a cloud and mapped on the human reference genome (GRCh37/hg19) using bioinformatics tools. Based on Z-scores calculated by normalization of the mapped read counts, final aneuploidy reports were automatically generated for fetal aneuploidy determination. Results: We identified in total 29 aneuploid samples, and additional analytical methods performed to confirm the results showed that one of these was a false-positive. The LOQ test showed that the proportion of fetal fraction in the cfDNA sample would affect the interpretation of the aneuploidy results. Conclusion: Noninvasive chromosome examination (NICE), a CLIA-certified NIPT with a cloud-based bioinformatics platform, showed unambiguous success in fetus aneuploidy detection.

• Journal of Appropriate Technology
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• v.7 no.2
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• pp.206-210
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• 2021

Hyperbilirubinemia is the most common neonatal disease and is observed in about 80% of newborns worldwide in neonatal period within a week after birth. Untreated infant hyperbilirubinemia may lead to brain damage and even death, so it is very important to diagnose it quickly and accurately. In this study, a total bilirubin measurement system was developed that is portable and easy to use without pre-processing using a commercial smartphone. This system measures using the LED and camera of the smartphone without the need for additional devices, and because a small amount of blood is injected without pre-treatment, anyone can easily measure it in the field. In a comparative study with Cobas c111 results, accuracy meets CLIA guidelines with 94% (17/18) within ±0.4 mg/dL below 3 mg/dL and 98% within ±20% above 3 mg/dL (276/282). This system offers a simple, fast and accurate diagnosis for jaundice in infants and young children in low-resource settings.

• 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.

• Korean Journal of Clinical Laboratory Science
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• v.39 no.1
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• pp.31-36
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• 2007

The purpose of the clinically reportable range (CRR) in clinical chemistry is to estimate linearity in working range. The reportable range includes all results that may be reliably reported, and embraces two types of ranges: the analytical measurement range (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. CAP and JCAHO require linearity on analyzers every six months. The clinically reportable range is the range of analyte values that a method can measure, allowing for specimen dilution, concentration, or other pretreatment used to extend the direct analytical measurement range. The AMR cannot exceed the manufacturer's limits. Establishing AMR is easily accomplished with Calibration Verification Assessment and experimental Linearity. For example: The manufacturer states that the limits of the AST on their instrument are 0-1100. The lowest level that could be verified is 2. The upper level is 1241. The verified AMR of the instrument is 2-1241. The lower limit of the range is 2, because that is the lowest level that could be verified by the laboratory. The laboratory could not use the manufacturer's lower limit of 2 because they have not proven that the instrument values below 2 are valid. The upper limit of the range is 1241, because although the lab has shown that the instrument is linear to 1241, the manufacturer does not make that claim. The laboratory needs to demonstrate the accuracy and precision of the analyzer, as well the validation of the patient AMR. Linearity requirements have been eliminated from the CLIA regulations and from the CAP inspection criteria, however, many inspectors continue to feel that linearity studies are a part of good lab practice and should be encouraged. If a lab chooses to continue linearity studies, these studies must fully comply with the calibration/calibration verification requirements of CLIA and/or CAP. The results of lower limit and upper limit of clinically reportable range were total protein (2.1 - 79.9), albumin (1.3 - 39), total bilirubin (0.2 - 106.2), alkaline phosphatase (13 - 6928.2), aspartate aminotransferase (24 - 7446), alanine aminotransferase (13 - 6724.2), gamma glutamyl transpeptidase (16.64 - 9904.2), creatine kinase (15.26 - 4723.8), lactate dehydrogenase (127.66 - 13231.8), creatinine (0.4 - 129.6), blood urea nitrogen (8.67 - 925.8), uric acid (1.6 - 151.2), total cholesterol (48.52 - 3162), triglycerides (36.91 - 3367.8), glucose (31 - 4218), amylase (21 - 6694.2), calcium (3.1 - 118.2), inorganic phosphorus (1.11 - 108), HDL (11.74 - 666), NA (58.3 - 1800), K (1.0 - 69.6), CL (38 - 1230).