• The Korean Journal of Nuclear Medicine Technology
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• v.25 no.1
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• pp.34-40
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• 2021

Purpose If a new test is introduced or reagents are changed in the laboratory of a medical institution, the characteristics of the test should be analyzed according to the procedure and the assessment of reagents should be made. However, several necessary conditions must be met to perform all required comparative evaluations, first enough samples should be prepared for each test, and secondly, various reagents applicable to the comparative evaluations must be supplied. Even if enough comparative evaluations have been done, there is a limit to the fact that the data variation for the new reagent represents the overall patient data variation, The fact puts a burden on the laboratory to the change the reagent. Due to these various difficulties, reagent changes in the laboratory are limited. In order to introduce a competitive bid, the institute conducted a full investigation of Radioimmunoassay(RIA) reagents for each test and established the range of reagents available in the laboratory through comparative evaluations. We wanted to share this process. Materials and Methods There are 20 items of tests conducted in our laboratory except for consignment tests. For each test, RIA reagents that can be used were fully investigated with the reference to external quality control report. and the manuals for each reagent were obtained. Each reagent was checked for the manual to check the test method, Incubation time, sample volume needed for the test. After that, the primary selection was made according to whether it was available in this laboratory. The primary selected reagents were supplied with 2kits based on 100tests, and the data correlation test, sensitivity measurement, recovery rate measurement, and dilution test were conducted. The secondary selection was performed according to the results of the comparative evaluation. The reagents that passed the primary and secondary selections were submitted to the competitive bidding list. In the case of reagent is designated as a singular, we submitted a explanatory statement with the data obtained during the primary and secondary selection processes. Results Excluded from the primary selection was the case where TAT was expected to be delayed at the moment, and it was impossible to apply to our equipment due to the large volume of reagents used during the test. In the primary selection, there were five items which only one reagent was available.(squamous cell carcinoma Ag(SCC Ag), β-human chorionic gonadotropin(β-HCG), vitamin B12, folate, free testosterone), two reagents were available(CA19-9, CA125, CA72-4, ferritin, thyroglobulin antibody(TG Ab), microsomal antibody(Mic Ab), thyroid stimulating hormone-receptor-antibody(TSH-R-Ab), calcitonin), three reagents were available (triiodothyronine(T3), Tree T3, Free T4, TSH, intact parathyroid hormone(intact PTH)) and four reagents were available are carcinoembryonic antigen(CEA), TG. In the secondary selection, there were eight items which only one reagent was available.(ferritin, TG, CA19-9, SCC, β-HCG, vitaminB12, folate, free testosterone), two reagents were available(TG Ab, Mic Ab, TSH-R-Ab, CA125, CA72-4, intact PTH, calcitonin), three reagents were available(T3, Tree T3, Free T4, TSH, CEA). Reasons excluded from the secondary selection were the lack of reagent supply for comparative evaluations, the problems with data reproducibility, and the inability to accept data variations. The most problematic part of comparative evaluations was sample collection. It didn't matter if the number of samples requested was large and the capacity needed for the test was small. It was difficult to collect various concentration samples in the case of a small number of tests(100 cases per month or less), and it was difficult to conduct a recovery rate test in the case of a relatively large volume of samples required for a single test(more than 100 uL). In addition, the lack of dilution solution or standard zero material for sensitivity measurement or dilution tests was one of the problems. Conclusion Comparative evaluation for changing test reagents require appropriate preparation time to collect diverse and sufficient samples. In addition, setting the total sample volume and reagent volume range required for comparative evaluations, depending on the sample volume and reagent volume required for one test, will reduce the burden of sample collection and planning for each comparative evaluation.

• The Korean Journal of Nuclear Medicine Technology
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• v.23 no.2
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• pp.51-58
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• 2019

Purpose In in-vitro laboratories of nuclear medicine department, when the reagent lot or reagent lot changes Comparability test or parallel test is performed to determine whether the results between lots are reliable. The most commonly used standard domestic laboratories is to obtain %difference from the difference in results between two lots of reagents, and then many laboratories are set the standard to less than 20% at low concentrations and less than 10% at medium and high concentrations. If the range is deviated from the standard, the test is considered failed and it is repeated until the result falls within the standard range. In this study, several tests are selected that are performed in nuclear medicine in-vitro laboratories to analyze parallel test results and to establish criteria for customized percent difference for each test. Materials and Methods From January to November 2018, the result of parallel test for reagent lot change is analyzed for 7 items including thyroid-stimulating hormone (TSH), free thyroxine (FT4), carcinoembryonic antigen (CEA), CA-125, prostate-specific antigen (PSA), HBs-Ab and Insulin. The RIA-MAT 280 system which adopted the principle of IRMA is used for TSH, FT4, CEA, CA-125 and PSA. TECAN automated dispensing equipment and GAMMA-10 is used to measure insulin test. For the test of HBs-Ab, HAMILTON automated dispensing equipment and Cobra Gamma ray measuring instrument are used. Separate reagent, customized calibrator and quality control materials are used in this experiment. Results 1. TSH [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(low concentration) [14.8 / 4.4 / 3.7 / 0.0 ] C-2(middle concentration) [10.1 / 4.2 / 3.7 / 0.0] 2. FT4 [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(low concentration) [10.0 / 4.2 / 3.9 / 0.0] C-2(high concentration) [9.6 / 3.3 / 3.1 / 0.0 ] 3. CA-125 [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(middle concentration) [9.6 / 4.3 / 4.3 / 0.3] C-2(high concentration) [6.5 / 3.5 / 4.3 / 0.4] 4. CEA [%diffrence Max / Mean / median] (P-value by t-test > 0.05) C-1(low concentration) [9.8 / 4.2 / 3.0 / 0.0] C-2(middle concentration) [8.7 / 3.7 / 2.3 / 0.3] 5. PSA [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(low concentration) [15.4 / 7.6 / 8.2 / 0.0] C-2(middle concentration) [8.8 / 4.5 / 4.8 / 0.9] 6. HBs-Ab [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(middle concentration) [9.6 / 3.7 / 2.7 / 0.2] C-2(high concentration) [8.9 / 4.1 / 3.6 / 0.3] 7. Insulin [%diffrence Max / Mean / Median] (P-value by t-test > 0.05) C-1(middle concentration) [8.7 / 3.1 / 2.4 / 0.9] C-2(high concentration) [8.3 / 3.2 / 1.5 / 0.1] In some low concentration measurements, the percent difference is found above 10 to nearly 15 percent in result of target value calculated at a lower concentration. In addition, when the value is measured after Standard level 6, which is the highest value of reagents in the dispensing sequence, the result would have been affected by a hook effect. Overall, there was no significant difference in lot change of quality control material (p-value>0.05). Conclusion Variations between reagent lots are not large in immunoradiometric assays. It is likely that this is due to the selection of items that have relatively high detection rate in the immunoradiometric method and several remeasurements. In most test results, the difference was less than 10 percent, which was within the standard range. TSH control level 1 and PSA control level 1, which have low concentration target value, exceeded 10 percent more than twice, but it did not result in a value that was near 20 percent. As a result, it is required to perform a longer period of observation for more homogenized average results and to obtain laboratory-specific acceptance criteria for each item. Also, it is advised to study observations considering various variables.

• The Korean Journal of Physiology
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• v.5 no.1
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• pp.23-42
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• 1971

I. Chemical analysis A study was planned to see if administration of ginseng extract has any influence upon the adrenal, the hepatic, the splenic, and the pancreatic nucleic acid contents of rats, and to estimate the effect of ACTH administration as a substitute for stress reaction upon these nucleic acid contents of rats previously primed with ginseng. Ninety male rats$(body\;weight:\;150{\sim}200gm)$ were divided into the ginseng, the saline, and the normal control groups, which received for 5 days 0.5ml/100 gm body weight of ginseng extract solution (4 mg of ginseng alcohol extract in 1 ml of saline), same amount of saline, or no medication, respectively. On the 5th experimental day, each of the 3 groups was further divided into 2 subgroups yielding the ginseng, the ginseng-ACTIT, the saline, the saline-ACTH, the normal control, and the normal-ACTH subgroups. The ginseng, the saline, and the normal control subgroups were sacrificed 3 hours after the last medication, while the ginseng-ACTH, the saline·ACTH, and the normal-ACTH subgroups received ACTH(0.1 unit/subject) 1 hour after the last medication and were sacrificed after 1 more hour. The adrenal gland, the liver, the spleen and the pancreas of each rat were measured for RNA and DNA contents using the chemical method of Schmidt-Thannhauser-Schneider. Following results were obtained: 1. Adrenal RNA and DNA contents and RNA/DNA ratio were all significantly higher in the ginseng group compared with the values obtained from the normal control and the saline groups. Generally administration of ACTH reduced nucleic acid contents of the viscera examined. However, in the ginseng group the rate of decrease [(value of ginseng-ACTH subgroup-value of ginseng subgroup) x100/value of ginseng subgroup)] in adrenal RNA and DNA contents and in RNA/DNA ratio were more conspicuous than they were in the normal control and the saline groups. 2. Hepatic RNA and DNA contents and RNA/DNA ratio were all significantly less in the ginseng group than in the normal control and the saline groups. After ACTH, the rate of decrease in hepatic RNA, DNA, and RNA/DNA ratio of the ginseng· group was less conspicuous than those of the other 2 groups. 3. With regard to the splenic nucleic acid contents, the RNA and the RNA/DNA values of the ginseng group were higher than those of the normal control group but lower than those of the saline group, while the DNA value of the ginseng group was lower than that of the normal control group but higher than that of the saline group. Following administration of ACTH, the rate of decrease in RNA and DNA contents and in RNA/DNA ratio of the ginseng group was more conspicuous than that of the normal control group but less remarkable than that of the saline group. 4. Pancreatic RNA and DNA contents were notably lower in the ginseng group than in the normal control and the saline groups. However, the RNA/DNA ratio of the ginseng group was higher than that of the normal control and the saline groups.'After ACTH, the rate of decrease in pancreatic RNA and RNA/DNA ratio of the ginseng group was less than that of the normal. control group but more than that of the saline group, while the DNA content was actually increased in the ginseng group though it decreased in the normal control and the saline groups. Although the results are not clear enough for an accurate interpretation, they seem to indicate that ginseng exerts notable influence upon the RNA and DNA contents and the RNA/DNA ratio of the viscera stodied. On the whole the drug tends to increase the RNA and DNA contents and RNA/DNA ratio of the adrenal gland but seems to diminish the values of the other 3 viscera. In the early period following ACTH, ginseng facilitates the fall in RNA and DNA contents and RNA/DNA ratio of the adrenal gland, while it tends to reduce the fall in the values of the other viscera studied. II. Autoradiographic and histochemical analysis It was planned autoradiographically and histochemically to affirm and extend the results obtained in part I with regard to the chemically assessed change in the adrenal, the pancreatic, the hepatic and the splenic DNA and RNA contents under the influence of ginseng and ACTH. Fourty male mice (body weight: $18{\sim}20gm$) and 20 male rats were used. Each animal species was divided into the saline, the ginseng, the saline-ACTH, and the ginseng-ACTH groups according to the administered drugs. In the mice, the adrenal, the pancreatic, the splenic and the hepatic DNA-synthetic activity was assessed autoradiographically after administration of $^3H$-thymidine. In the rats, the RNA content of the above 4 organs was assessed histochemically after staining them with methylgreen pyronine. Following results were obtained: 1. Labeled cells were significantly more numerous in the adrenal cortex, the spleen and the liver of the ginseng group than in those of the saline group, although they were less numerous in the pancreas of the ginseng group than in the pancreas of the saline group. The adrenocortical, the pancreatic, the splenic and the hepatic tissues were stained with methylgreen pyronine more deeply in the ginseng group than in the saline group. 2. The adrenocortical, the pancreatic, the splenic and the hepatic tissues contained labeled cells less numerously in the saline-ACTH and the ginseng-ACTH group than in the saline and the ginseng groups. All these tissues were also stained with methylgreen pyronine less deeply in the saline-ACTH and the ginseng-ACTH groups than in the saline and the ginseng groups. 3. However, the adrenal cortex, the spleen, the pancreas, and the liver contained labeled cells more numerously in the ginseng-ACTH group than in the saline-ACTH group. the 4 tissues were stained with methylgreen pyronine more deeply in the ginseng-ACTH group than in the saline-ACTH group. It is inferred from the above results that though with exception, the ginseng mostly facilitates cellular synthesis of nucleic acids and mitigates reduction in nucleic acid content of tissues after administration of ACTH.