• 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.

• 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).

• 대한임상검사과학회지
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• 제36권2호
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• pp.98-109
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• 2004

The lower limit of detection, precision, setting method of target value, reportable range determination, recovery, linearity, and comparison study with another equipment was evaluated for the Toshiba-120FR chemistry autoanalyzer which was newly introduced at the Daejeon Veteran Hospital in Dec. 2003. Nineteen kinds of test for AST, ALT, ALP, LDH, GGT, TP, ALB, GLU, T-cho, T-bil, TG, UA, CAL, IP, AMY, HDL-C, LDL-C, Cre and BUN were performed to evaluate the lower limit of detection, precision, setting method of target value, reportable range determination, recovery, linearity, and comparison study with other equipment according to the NCCLS guidelines(EP5-A, EP6-P, EP9-A). The Toshiba-120FR autochemical analyzer showed good precision for all tested items. The data concerning the lower limit of detection, precision(total CV 0.47%~3.65%), setting method of target value, reportable range determination, recovery(93%~111%), linearity($R^2=0.997{\sim}0.999$), and comparison study(r=0.977~0.999) with other equipment was acceptable for all tested items. The results of evaluation for the Toshiba-120FR autochemical analyzer showed that this equipment could be used as an alternative to other equipment.

• 핵의학기술
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• 제26권1호
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• pp.42-46
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• 2022

핵의학과 검체검사에서 시행되는 모든 정량 검사는 정확도와 정밀도를 고려하여 측정가능범위 및 임상보고 가능범위가 설정되어 있다. 측정가능범위를 벗어난 검체는 희석 실험을 시행하여 최종 검사 결과를 보고해야 한다. 그동안 희석을 진행하는 검체의 수가 많지 않았고, 검사 종목별 희석액이 시약 마다 달라 검사자가 실험 종목마다 적절한 희석배수를 정하여 결과를 보고하는 데 어려움이 있었다. 이에 따라 RIA 검사별 최대 희석배수의 설정 및 임상보고가능범위의 상한치 검증이 필요하다고 판단되었다. 본 연구에서는 KOLAS를 바탕으로 설정된 임상보고 가능범위의 상한치를 검증하였고 그에 따른 각 종목의 최대희석배수를 설정하였다. 서울아산병원에서 시행하고 있는 모든 RIA 검사 중 희석하는 30종의 검사종목을 대상으로 연구를 진행하였다. 2021년 3월부터 7월까지 총 4개월간의 자료를 종목별로 취합하여 분석하였다. 각 검체는 검사 항목별 Kit 내 기재된 희석방법에 따라 D.W, Kit 내 전용 Diluent 혹은 0 Standard로 희석하였으며 2배, 4배 및 10, 10², 10³, 10⁴ 등의 계단희석을 진행한 검체를 대상으로 하였다. 실험 결과의 유효성을 확인할 수 있는 지표로 실측값을 기댓값으로 나눈 백분율을 사용하였다. 본 연구에서는 백분율 허용범위를 80~120%로 설정하였으며 이를 만족한 실험 결과를 연구의 표본이 되는 N값으로 설정하였다. 총 30종의 검사항목 중 백분율 허용범위에 속하는 N값의 수가 5개 이상인 종목은 19종목이었다. 희석배수의 검증 결과 10⁴로 설정된 검사는 𝛼-fetoprotein, Thyroglobulin으로 2종목이며, 10³으로 설정된 검사는 CA-125, CEA, 𝛽-hCG로 3종목, 10²으로 설정된 검사는 Free PSA, PSA, CA15-3, SCC, Ferritin, PTH, Cortisol, Calcitonin, Aldosterone 으로 9종목이다. 10으로 설정된 검사는 𝛽2-Microglobulin, C-peptide, Testosterone 3종목이 있다. 남은 2종목인 Renin Activity와 Follicle Stimulation Hormone은 각각 2배, 4배로 설정하였다. 그 외 특이사항이 있는 항목은 11종목으로 허용범위를 벗어난 결과가 섞여 있어 표본이 부족하거나 희석검체 수가 부족하여 값을 설정하기 어려웠다. 이러한 종목들은 기존 자료를 토대로 희석배수를 설정하였고, 추후 자료를 수집하여 허용범위 내에 속하는 N값의 수가 충족된다면 희석배수를 재설정할 계획이다. 본 연구를 통해 임상보고 가능범위를 실증적 방식으로 검토하고, RIA 검사별 적절한 희석배수를 표준화함으로써 핵의학 검사의 경제성을 높이고, 연구를 통해 검증된 임상보고 가능범위 내에서 더욱 정확한 희석검사결과를 도출하는 데 도움이 되고자 하였다. 이를 통해 핵의학 혈액검사의 전반적인 질 향상을 기대해 볼 수 있으리라 사료된다.