• 대한임상검사과학회지
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• 제37권3호
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• pp.178-184
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• 2005

Carry over contamination has been reduced in some systems by flushing the internal and external surfaces of the sample probe with copious amount of diluent. It between specimens should be kept as small as possible. A built-in, continuous-flow wash reservoir, which allows the simultaneous washing of the interior and exterior of the syringe needles, addresses this issue. In addition, residual contamination can further be prevented through the use of efficient needle rinsing procedures. In discrete systems with disposable reaction vessels and measuring cuvets, any carry over is entirely caused by the pipetting system. In analyzers with reuseable cuvets or flow cells, carry over may arise at every point through which high samples pass sequentially. Therefore, disposable sample probe tips can eliminate both the contamination of one sample by another inside the probe and the carry over of in specimen into the specimen in the cup. The results of the applicative carry over experiment studied on 21 items for total protein (TP), albumin (ALB), total bilirubin (TB), alkaline phosphatase (ALP), aspratate aminotranferase (AST), alanine aminotranferase (ALT), gamma glutamyl transferase (GGT), creatinine kinase (CK), lactic dehydrogenase (LD), creatnine (CRE), blood urea nitrogen (BUN), uric acid (UA), total cholesterol (TC), triglyceride (TG), glucose (GLU), amylase (AMY), calcium (CA), inorganic phosphorus (IP), sodium (Na), potassium (K), chloride (CL) tests in chematology were as follows. Evaluation of process performance less than 1% in all tests was very good, but a percentage of ALB, TP, TB, ALP, CRE, UA, TC, GLU, AMY, IP, K, Na, and CL was 0%, implying no carry over. Other tests were ALT(-0.08%), GGT(-0.09%), CK(0.08%), LD(0.06%), BUN(0.12%), TG (-0.06%), and CA(0.89%).

• 대한임상검사과학회지
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• 제38권2호
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• pp.117-124
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• 2006

The analytical measurement range (AMR) is the range of analyte values that a method can directly measure on a specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. The linearity of the AMR is its ability to obtain test results which are directly proportional to the concentration of analyte in the sample from the upper and lower limit of the AMR. The AMR validation is the process of confirming that the assay system will correctly recover the concentration or activity of the analyte over the AMR. The test specimen must have analyte values which, at a minimum, are near the low, midpoint, and high values of the AMR. The AMR must be revalidated at least every six months, at changes in major system components, and when a complete change in reagents for a procesure is introduced; unless the laboratory can demonstrate that changing the reagent lot number does not affect the range used to report patient test results. The AMR linearity was total protein (0-16.6), albumin (0-8.1), total bilirubin (0-18.1), alkaline phosphatase (0-1244.3), aspartate aminotransferase (0-1527.9), alanine aminotransferase (0-1107.9), gamma glutamyl transpeptidase (0-1527.7), creatine kinase (0-1666.6), lactate dehydrogenase (0-1342), high density lipoprotein cholesterol (0.3-154.3), sodium (35.4-309), creatinine (0-19.2), blood urea nitrogen (0.5-206.2), uric acid (0-23.9), total cholesterol (-0.3-510), triglycerides (0.7-539.6), glucose (0-672.7), amylase (0-1595.3), calcium (0-23.9), inorganic phosphorus (0.03-17.0), potassium (0.1-116.5), chloride (3.3-278.7). We are sure that materials for the AMR affect the evaluation of the upper limit of the AMR in the process system.