• 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.20 no.2
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• pp.75-79
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• 2016

Purpose The ASAN Medical Center, Nuclear Medicine performs TSH (Thyroid stimulating hormone) and FT4 (Free Thyroxine) tests 8 times per day. Accordingly, 70 ~ 80 kit tubes are consumed every day for the measurements and the time consumed for reagent dispensing averages over 170 seconds, where the TAT (turnaround time) may be effected when the number of test samples is larger than expected. Therefore, the following test was conducted with the purpose to reduce the number of kit tubes consumed, and reduce the time for reagent dispensing. Materials and Methods The test is based on applying the same reagent for tests where the number of samples is 30 or less. The test for TSH was conducted 9 times from July $1^{st}$ 2015 to July $10^{th}$ 2015. The test for FT4 was conducted 4 times from June $18^{th}$ 2015 to June $22^{nd}$, 2015. Standard Solution No.2 (0.153 uU/mL) and No.5 (4.96 uU/mL) was selected as the two-point standards for the TSH test, and Standard Solution No.3 (0.777 ng/dL) and No.4 (2.044 ng/dL) was selected as the two-point standards for the FT4 test. 38 test samples were subject to correlation analysis. Results For TSH, the result of the normal test shows ranges of 0.20 ~ 0.37 uU/mL for Control1, 0.53 ~ 0.71 uU/mL for Control2, and 6.77 ~ 7.94uU/mL for Control3, while the result of two-point calibration curve test shows ranges of 0.18 ~ 0.27 uU/mL for Control1, 0.53 ~ 0.71 uU/mL for Control2, and 7.30 ~ 8.52 uU/mL for Control3. For FT4, the result of the normal test shows ranges of 0.85 ~ 0.94 ng/dL for Control1 and 4.23 ~ 4.57 ng/dL for Control2, while the result of two-point calibration curve test shows ranges of 0.61 ~ 0.75 ng/dL for Control1 and 3.88 ~ 5.71 ng/dL for Control2. For TSH, the CV% of the normal test for Control1, Control2 and Control3 are 10.5, 3.3 and 3.6 respectively, while the CV% of the two-point calibration curve test for Control1 and Control1 are 12.4, 8.2 and 5.1 respectively. The result shows an outstanding correlation of TSH: y = 0.9985x - 0.0459 $R^2=0.9986$. For FT4, the CV% of the normal test for Control1 and Control2 are 0.70 and 0.71 respectively, while the CV% of the two-point calibration curve test for Control1 and Control1 are 8.7 and 16.2 respectively. The result shows an outstanding correlation of FT4: y = 1.2674x - 0.1133 $R^2=0.9824$. Conclusion The two-point calibration curve can be efficiently applied for TSH in cases where the number of test samples is not large, since the number of samples to be re-tested increases when the result is abnormal from the calibration curve. The two-point calibration curve test should not be applied for FT4 where the results do not consistently comply with the quality assessment range. Depending on how the two-point calibration curve is applied, up to 5 test tubes can be conserved per test, and the reduced time for reagent dispensing is anticipated to have a positive effect on the TAT (turnaround time).

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.24
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• pp.10905-10909
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• 2015

Purpose: The aim of this study was to evaluate the diagnostic value of FNA-Tg for detecting lymph node metastases in patients with a history of differentiated thyroid cancer (DTC). Materials and Methods: A total of 58 patients with DTC diagnosis and evidence of single or multiple suspicious cervical lymph nodes were assessed. All underwent total or near-total thyroidectomy with (35 cases) or without (23 cases) radioiodine (RAI) ablation, followed by thyroid stimulating hormone (TSH) suppression therapy. A total of 68 lymph nodes were examined by ultrasound-guided fine needle aspiration (US-FNA) for both cytological examination and FNA-Tg measurement. Serum Tg and anti-thyroglobulin antibody (TgAb) levels were also measured. Diagnostic performance including sensitivity, specificity, accuracy, positive (PPV) and negative predictive value (NPV) of FNAC and FNA-Tg were calculated and compared. The Spearman's rank correlation coefficient was used to estimate the relationship between FNA-Tg and serum TgAb. Results: The FNA-Tg levels were significantly higher with DTC metastatic lymph nodes (median 927.7 ng/mL, interquartile range 602.9 ng/mL) than non-metastatic lymph nodes (median 0.1 ng/mL, interquartile range 0.4 ng/mL) (p<0.01). Considering 1.0 ng/mL as a threshold value for FNA-Tg, the sensitivity, specificity, accuracy, PPV and NPV of FNA-Tg were 95.7%, 95.5%, 95.6%, 97.8% and 91.3%, respectively. The sensitivity and accuracy of the combination of FNAC and FNA-Tg were significantly higher than that of FNAC alone (p<0.05). The diagnostic performance of FNA-Tg was not significantly different between cases with or without RAI ablation, and the serum TgAb levels did not interfere with FNA-Tg measurements. Conclusions: Measurement of FNA-Tg is useful. The combination of FNAC and FNA-Tg is more sensitive and accurate for detecting lymph node metastases in patients with a history of DTC than FNAC alone. Serum TgAbs appear to be irrelevant for measurement of FNA-Tg.

• Sleep Medicine and Psychophysiology
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• v.18 no.1
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• pp.40-44
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• 2011

Narcolepsy is a sleep disorder, which is characterized by excessive daytime sleepiness (EDS) that is typically associated with cataplexy, sleep fragmentation and other REM sleep-related phenomenon such as sleep paralysis and hypnagogic hallucination. Narcoleptic symptoms can be developed from various medical or neurological disorders. A 17-year-old male patient admitted for the evaluation of EDS which started three-month ago. He slept more than 18 hours a day with cataplexy and hypnagogic hallucination. He was obese with body mass index (BMI) of 30.4 kg/$m^2$. After admission he was newly diagnosed to the thyrotoxicosis. T3 391.2 ng/dL (60-181), free T4 4.38 ng/dL (0.89-1.76), TSH <0.01 ${\mu}IU$/mL (0.35-5.5) were measured. His pulse rate ranged 70-90 beats per minute and blood pressure ranged 150/100-120/70 mmHg. Polysomnography revealed many fragmentations in sleep with many positional changes (81 times/h). Sleep onset latency was 33.5 min, sleep efficiency was 47.9%, and REM latency from sleep onset was delayed to 153.6 min. REM sleep percent was increased to 27.1%. Periodic limb movement index was 13.4/h. In the multiple sleep latency test (MSLT), average sleep latency was 0.4 min and there were noted 3 SOREMPs (Sleep Onset REM sleep period) on 5 trials. We couldn't discriminate the obvious sleep-wake pattern in the actigraph and his HLA DQB1 $^*0602$ type was negative. His thyroid function improved following treatment with methimazole and propranolol. Vital sign maintained within normal range. Cataplexy was controlled with venlafaxine 75 mg. Subjective night sleep continuity and PLMS were improved with clonazepam 0.5 mg, but the EDS were partially improved with modafinil 200-400 mg. Thyrotoxicosis might give confounding role when we were evaluating the EDS, though sleep fragmentation was one of the major symptoms of narcolepsy, but enormous amount of it made us think of the influence of thyroid hormone. The loss of sleep-wake cycle, limited improvement of EDS to the stimulant treatmen, and the cataplexy not supported by HLA DQB1 $^*0602$ should be answered further. We still should rule out idiopathic hypersomnia and measuring CSF hypocretin level would be helpful.

• Radiation Oncology Journal
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• v.9 no.2
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• pp.185-195
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• 1991

Seventy four patients with pituitary adenoma received radiation therapy (RT) on the pituitary area using 6 MV linear accelerator during the past 7 years at the Division of Radiation Therapy, Kangnam St. Mary's Hospital, Catholic University Medical College. Thirty nine were men and 35 were women. The age ranged from 7 to 65 years with the mean being 37 years. Sixty five ($88\%$) patients were treated postoperatively and 9 ($12\%$) primary RT, To evaluate the effects of RT, we analyzed the series of endocrinologic studies with prolactin (PRL), growth hormone (GH), adrenocorticotrophic hormone (ACTH), leuteinizing hormone (LH), follicular stimulating hormone (FSH) and thyroid stimulating hormone (TSH) etc after RT. All but one with Nelson's syndrome showed abnormal neuroradiologic changes in the sella turcica with invasive tumor mass around supra- and/or parasella area. The patients were classified as 23 ($29\%$) prolactinomas and 20 ($26\%$) growth hormone (GH) secreting tumors, and 6 ($8\%$ ACTH secreting ones consisting of 4 Cushing's disease and 2 Nelson's syndrome. Twentynine ($37\%$) had nonfunctioning tumor and four ($5\%$) of those secreting pituitary tumors were mixed PRL-GH secreting tumors. The hormonal level in 15 ($65\%$) of 23 PRL and 3 ($15\%$) of 20 GH secreting tumors returned to normal by 2 to 3 years after RT, but five PRL and five GH secreting tumors showed high hormonal level requiring bromocriptine medication. Endocrinologic insufficiency developed by 3 years after RT in 5 of 7 panhypopituitarisms, 4 of seven hypothyroidisms and one of two hypogonadisms, respectively. Fifteen ($20\%$) patients were lost to follow up after RT.

• 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.

• Tuberculosis and Respiratory Diseases
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• v.54 no.3
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• pp.304-310
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• 2003

Background : Recent discoveries on the physiology of an erection have demonstrated that the organic causes of impotence are more common, and psychogenic impotence is correspondingly less common than was formally believed. The incidence of sexual dysfunctions in chronic obstructive pulmonary disease (COPD) patients is largely unknown or may be perfunctorily attributed to the associated illness or to aging. This study investigated whether or not the impotence was related to the COPD itself as well as whether or not it nay stem from organic causes in a notable proportion of such patients. Methods : The sexual function was evaluated in 10 COPD patients and 10 normal control subjects. A nocturnal Rigi Scan was performed to evaluate the erectile function of each group. The level of hormones such as the free testosterone, prolactin and thyroid stimulating hormone (TSH) was measured, and a pulmonary function test and arterial blood gas analysis was performed. Results : The time duration and frequency of a penile erection were significantly lower in COPD patients than the controls (p<0.05). In addition, the $PaO_2$ levels correlated with the time duration of the penile erection. Conclusion : These results suggest that COPD is one of the causes of organic erectile dysfunction.