• 핵의학기술
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• 제15권2호
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• pp.116-124
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• 2011

핵의학 검체검사 외부정도관리 숙련도시험을 평가 지표인 정밀도 및 회수율 측정을 학회에서 시행하고 있는 외부정도 관리혈청과 정확도 기반 WHO 인증표준물질을 사용하여 핵의학검사실에서 널리 사용하고 있는 방사면역측정법과 진단검사의학과에서 자동화장비를 이용하는 주된 방법인 화학발광면역측정법을 2009년, 2010년 각각 2회씩 총 4회를 시행하였다. 2009년도 종양 표지자 5종에서 측정 간 정밀도는 RIA는 평균 $14.8{\pm}4.2%$, EIA(CLIA)는 평균 $19.2{\pm}6.9%$ 이며, 두 방법 간 유의한 차이는 없었다(p>0.05). 2010년도 종양 표지자와 갑상선 기능검사 9종에서 RIA는 평균 $13.8{\pm}6.1%$, EIA(CLIA)는 평균 $15.5{\pm}7.7%$로 RIA 검사는 AFP, CEA, PSA, CA 125, $T_3$, $T_4$, TSH 종목에서 측정 간 정밀도 허용범위인 20% 이내로 양호한 결과를 보였고, 허용범위를 벗어난 CA 19-9는 p value 0.345로 유의한 차이는 없었다. 2010년도 WHO 인증표준물질을 사용한 RIA 검사 회수율 측정에서 AFP, PSA, $T_4$, TSH는 92~103%로 양호한 회수율을 보였다. CEA, CA 125, CA 19-9는 WHO 인증표준물질이 아닌 상품화된 정도관리물질을 사용하여 낮은 회수율을 보였으나, 유의한 차이는 없었다(p>0.05). $T_3$ 종목에서 RIA는 $118{\pm}21.1%$를 보였으나, EIA(CLIA)에서는 $145{\pm}22.9%$로 과대평가된 높은 회수율을 보였고, TSH 종목에서 RIA는 $103{\pm}9.6%$로 좋은 회수율을 보였지만, EIA(CLIA)는 $67{\pm}15.3%$로 낮은 회수율을 보였다. 방사면역측정법은 자동화장비를 이용한 화학발광면역측정법과의 숙련도 비교평가에서 측정 간 정밀도는 허용범위인 20% 이내 또는 두 방법 간 유의한 차이는 없었다(p>0.05). 회수율은 WHO 인증표준물질을 이용한 종목에서 90~110%로 양호한 결과를 보였고, 이외 종목에서도 두 방법 간 유의한 차이는 없었다(p>0.05). 따라서 방사면역측정법은 임상의에게 저렴한 비용으로 정확한 결과를 신속하게 보고할 수 있으며, 지속적으로 핵의학 체외진단키트에 대한 성능평가를 WHO 인증표준물질과 외부정도관리 숙련도 시험과 병행하여 수행함으로서 KOLAS 국제공인메디칼시험기관으로 인정받고 국제화와 검사실 표준화를 통하여 질 향상을 이루어야 한다.

• 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.

• 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.

• 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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• 제42권1호
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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.

• 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.

• 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.

• 적정기술학회지
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• 제7권2호
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• pp.206-210
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• 2021

고빌리루빈혈증은 신생아기에 가장 흔히 볼 수 있는 질환으로 전세계적으로 생후 일주일내 신생아 중 약 80%에서 관찰된다. 고빌리루빈혈증을 치료하지 않을 경우 핵황달 및 사망에 이르게 되므로 신속하고 정확하게 진단하는 것이 매우 중요하다. 본 연구에서는 상용 스마트폰을 사용하여 휴대가 편리하고 전처리 과정없이 사용이 간편한 총빌리루빈 측정시스템을 개발하였다. 본 시스템은 추가의 장치가 필요없이 스마트폰의 LED와 카메라를 이용하여 측정하며 전처리 없이 소량의 혈액을 주입하면 되므로 현장에서 누구나 쉽게 측정이 가능하다. Cobas c111의 측정값과 비교한 결과 3 mg/dL 이하 ±0.4 mg/dL 이내 94%(17/18), 3 mg/dL 이상 ±20% 이내 98%(276/282)로 CLIA 가이드라인의 정확도 기준을 만족함을 확인하였다. 이는 의료 시설 및 훈련된 인력 부족한 현장에서 신속하게 영유아의 황달 상태를 확인하는 방법으로 사용할 수 있을 것으로 보여진다.

• 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).