• 핵의학기술
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• 제19권2호
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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.

• 대한임상검사과학회지
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• 제40권2호
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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.

• 대한임상검사과학회지
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• 제36권1호
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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.

• 핵의학기술
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• 제15권1호
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• pp.121-125
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• 2011

배경 : B형간염표면항원(HBsAg)은 B형간염의 진단에 있어 가장 중요한 혈청학적 지표 중 하나이다. HBsAg 검사에 대한임상검사실의 수요에 맞추어 자동화 장비 및 검사법이 계속 개발되어 왔다. 본 연구는 국내에 보급된 RIAKEY, BNIBT, RIAKEY Ultra Sensitive HBsAg, ROCHE 키트의 민감도 및 변이형 검출능과 CLIA법의 CENTAUR 장비와 RIAKEY Ultra Sensitive HBsAg의 상관계수를 알아보고자 하였다. 방법 : WHO $1^{st}$ International Standard 1985(80/549), WHO $2^{nd}$ International Standard 2003 (00/588) 표준물질 2개를 이용하여 농도별 0.08, 0.04, 0.02, 0.01, 0.005 IU/ml 까지 계단희석을 시행하였으며, Subtype ad 9종, Subtype ay 변이시료 1종을 이용하여 RIAKEY, BNIBT, RIAKEY Ultra Sensitive HBsAg, ROCHE 키트를 이용하여 시행하였다. 그리고, 아형 검출에 사용된 변이시료 10종에 대한 IRMA법의 RIAKEY Ultra Sensitive HBsAg와 CLIA법의 CENTAUR 장비를 이용한 상관계수를 비교하였다. 결과 : 표준물질의 농도별 측정 시 WHO 0.01 PANEL 에서 Index 1.0 이상의 결과 값을 얻었으며, 그 결과 민감도는 0.01 IU/ml로 측정되었다. RIAKEY Ultra sensitve HBsAg 키트가 민감도측면에서 우수함을 알 수 있었다. RIAKEY Ultra sensitve HBsAg IRMA 키트에서는 adw2 9종과 ayw1 1종의 변이형 형태에 따라 모두 Index 1.0 이상으로 혈청중의 HBsAg을 100% 측정할수 있었다. RIAKEY Ultra sensitive HBsAg와 CLIA의 결과가 Y=1.0075 X + 1.2434, $R^2$=0.9982으로 우수한 상관성을 보였다. 결론 : 4세대인 IRMA법의 Ultra Sensitive HBsAg 키트로 혈청중의 HBsAg과 여러 가지 아형을 신속하고 정확히 측정하여 질병을 진단 할 수 있을 것으로 여겨진다.

• Journal of Genetic Medicine
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• 제12권2호
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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.

• 대한임상검사과학회지
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• 제37권2호
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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.

• 대한임상검사과학회지
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• 제39권1호
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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).

• Journal of Chest Surgery
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• 제43권6호
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• pp.588-595
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• 2010

배경: 종양의 종류에 따라 발현되는 종양 항원의 종류도 다양하며 그 발현률의 차이는 더욱 다양하다. 이와 같은 이유로 폐암의 치료연구를 위해서는 인체를 대신할 만한 동물 모형이 절대 필요하다. 저자는 편평상피세포암의 세포주를 배양하여 Nude mice의 흉강 내에 주입하는 방법으로 종양형성을 시도하여 종양형성의 성공 유무와 조직학적 변화와 함께 폐암과 관련 있는 EGFR (epidermal growth factor receptor)의 수용기 중 하나인 HER2/neu 종양 유전자와 세포 성장 억제 작용과 악성화 과정에서의 저항성으로 작용하는 TGF-${\beta}_1$을 각각 정량 하도록 하여 인공적인 동소 폐암의 경우 암유전자의 발현에 관하여 조사해보고자 하였다. 대상 및 방법: 면역성이 없는 20마리의 수컷생쥐 (Male BALB/c nude mice)로 5마리를 대조군으로 하였으며, 나머지 15마리는 실험군으로 하고 체중은 20~25 gm (Orient, Japan)의 범위에 있었다. HER2/neu는 채혈하여 보관된 혈액의 혈청을 분리하여 CLIA (chemiluminiscent immunoassay) 법으로 정량적으로 측정하였으며 TGF-${\beta}_1$은 immunosandwitch법을 이용하여 정량 분석하였다. 통계학적 분석을 위하여 SPSS통계(SPSS Version10.0, USA)프로그램을 이용하였으며 Student T test를 하였으며 p값이 0.05 미만인 경우를 유의성이 있는 것으로 간주하였다. 결과: 정상 대조군에서나 인위적으로 주입한 폐암 세포주에 의한 폐암이 만들어진 이후에도 HER2/neu 유전자의 증폭은 전혀 반응을 나타내지 못하였다. 하지만 TGF-${\beta}_1$ 대조군의 정량치는 $28,490{\pm}8,549pg/mL$이었고 폐암 세포 주입군은 $42,362{\pm}14,449pg/mL$로 유의하게 1.48배 높게 나왔다(p<0.483). HER2/neu 유전자와 TGF-${\beta}_1$은 유의한 상관관계가 없는 것으로 나타났다. 결론: TGF-${\beta}_1$유전자는 대조군에 비하여 1.48배 정도의 증폭이 발현되었다. TGF-${\beta}_1$의 증폭은 Nude mice에서 발암에 의한 생체 치유 억제 기전이 확실히 작동하고 있다는 것을 의미하며, 인체의 조기 폐암의 발견에 역할을 가능케 하는 정량 검사법으로 이용할 수도 있을 것이다.

• 대한임상검사과학회지
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• 제38권3호
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• pp.184-188
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• 2006

The purpose of the recovery experiment in clinical chemistry is performed to estimate proportional systematic error. We must know all measurements have some error margin in measuring analytical performance. Proportional systematic error is the type of error whose magnitude increases as the concentration of analyte increases. This error is often caused by a substance in the sample matrix that reacts with the sought for analyte and therefore competes with the analytical reagent. Recovery experiments, therefore, are used rather selectively and do not have a high priority when another analytical method is available for comparison purposes. They may still be useful to help understand the nature of any bias revealed in the comparison of kit experiments. Recovery should be expressed as a percentage because the experimental objective is to estimate proportional systematic error, which is a percentage type of error. Good recovery is 100.0%. The difference between 100 and the observed recovery(in percent) is the proportional systematic error. We calculated the amount of analyte added by multiplying the concentration of the analyte added solution by the dilution factor(mL standard)/(mL standard + mL specimen) and took the difference between the sample with addition and the sample with dilution. When making judgments on method performance, the observed that the errors should be compared to the defined allowable error. The average recovery needs to be converted to proportional error(100%/Recovery) and then compared to an analytical quality requirement expressed in percent. The results of recovery experiments were total protein(101.4%), albumin(97.4%), total bilirubin(104%), alkaline phosphatase(89.1%), aspartate aminotransferase(102.8), alanine aminotransferase(103.2), gamma glutamyl transpeptidase(97.6%), creatine kinase(105.4%), lactate dehydrogenase(95.9%), creatinine(103.1%), blood urea nitrogen(102.9%), uric acid(106.4%), total cholesterol(108.5), triglycerides(89.6%), glucose(93%), amylase(109.8), calcium(102.8), inorganic phosphorus(106.3%). We then compared the observed error to the amount of error allowable for the test. There were no items beyond the CLIA criterion for acceptable performance.