• Korean Journal of Clinical Laboratory Science
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• v.53 no.1
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• pp.1-10
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• 2021

Radiopharmaceuticals are drugs that contain radioisotopes and are used in the diagnosis, treatment, or investigation of diseases. Radiopharmaceuticals must be manufactured in compliance with good manufacturing practice regulations and subjected to quality control before they are administered to patients to ensure the safety of the drug. Radiopharmaceuticals for administration to humans need to be sterile and pyrogen-free. Hence, sterility tests and membrane filter integrity tests are carried out to confirm the asepticity of the finished drug product, and a bacterial endotoxin test conducted to assess contamination, if any, by pyrogens. The physical appearance and the absence of foreign insoluble substances should be confirmed by a visual inspection. The chemical purity, residual solvents, and pH should be evaluated because residual by-products and impurities in the finished product can be harmful to patients. The half-life, radiochemical purity, radionuclidic purity, and strength need to be assessed by analyzing the radiation emitted from radiopharmaceuticals to verify that the radioisotope contents are properly labeled on pharmaceuticals. Radiopharmaceuticals always carry the risk of radiation exposure. Therefore, the time taken for quality control tests should be minimized and care should be taken to prevent radiation exposure during handling. This review discusses the quality control procedures and acceptance criteria for a diagnostic radiopharmaceutical.

• Neonatal Medicine
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• v.18 no.2
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• pp.301-309
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• 2011

Purpose: Point-of-care tests (POCTs) have the potential to significantly influence management of neonates. The aim of this study was to assess the clinical usefulness of the POCT chemistry analyzer in a neonatal intensive care unit (NICU). Methods: Blood samples of neonates admitted to the NICU were tested using a POCT chemistry analyzer (Piccolo Xpress Chemistry Analyzer, Abaxis, Union City, CA, USA) and a central laboratory chemical analyzer (Chemistry analyzer 7600-110, Hitachi Ltd., Tokyo, Japan) from March to September, 2010. Correlation of 15 analytes between the POCT and the central laboratory machine was evaluated. For consistency of the POCT, three consecutive samplings were performed. Differences among the three tests were recorded. The causes of performance errors were checked through log files. Results: One hundred of 112 pairs of tests for accuracy performed in 54 neonates showed a high correlation between the two machines. Twelve performance errors occurred during the 112 tests. The most common error was insufficient sample error. Eighteen triplet tests performed in 18 patients for consistency revealed a difference range of 3-10%, which was considered to be acceptable. No error occurred during the 54 tests. Conclusion: The POCT is capable of analyzing multiple analytes with a minimal amount of whole blood in a short time. The few performance errors noted presently are likely preventable. This POCT is concluded to be suitable for use as a simple and rapid diagnostic method in the NICU with a minimal amount of blood collected in a less invasive manner.

• Journal of Genetic Medicine
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• v.6 no.2
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• pp.146-154
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• 2009

Multiplex ligation dependent probe amplification (MLPA) is a PCR-based method to detect gene dosage. Since its introduction, MLPA has been used to test a large number of genes for major deletions or duplications. Genetic testing, as a diagnostic tool for genetic disease, has been used primarily to identify point mutations, including base substitutions and small insertions/deletions, using PCR and sequence analysis. However, it is difficult to identify large deletions or duplications using routine PCR- gel based assays, especially in heterozygotes. The MLPA is a more feasible method for identification of gene dosage than another routine PCR-based methods, and better able to detect deleterious deletions or duplications. In addition to detection of gene dosage, MLPA can be applied to identify methylation patterns of target genes, aneuploidy during prenatal diagnoses, and large deletions or duplications that may be associated with various cancers. The MLPA method offers numerous advantages, as it requires only a small amount of template DNA, is applicable to a wide variety of applications, and is high-throughput. On the other hand, this method suffers from disadvantages including the possibility of false positive results affected by template DNA quality, difficulties identifying SNPs located in probe sequences, and analytical complications in quantitative aspects.

• Journal of Veterinary Clinics
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• v.32 no.2
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• pp.191-195
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• 2015

A 7-year-old castrated male Korean Shorthair cat was referred with lethargy and anorexia. Laboratory examination revealed moderate degenerative changes of peripheral neutrophils on blood smear examination and decreased levels of free and total thyroxine ($T_4$) as well as bacterial growth on blood culture. Molecular analyses of the 16S ribosomal RNA gene and heat shock protein 60 gene confirmed the bacterium as Enterobacter cloacae. A minimal inhibitory concentration test showed multidrug resistance of the bacterium against 16 antibiotics. Polymerase chain reaction (PCR) and subsequent sequencing specifically for $bla_{TEM}$, $bla_{SHV}$, $bla_{CTX-M}$, and plasmid-mediated ampC genes revealed positive results to $bla_{TEM-1}$, $bla_{CTX-M-15}$, and plasmid-mediated $bla_{ACT-1}$ genes, indicating that the isolated bacterium contains plasmids containing genes encoding extended-spectrum beta-lactamase and plasmid-mediated ampC beta-lactamase. After 1 month of treatment with antibiotics and levothyroxine, the cat's condition improved; both the thyroid function test and the blood culture showed no abnormalities. This is the first report of community-acquired multidrug-resistant E. cloacae-induced euthyroid sick syndrome in a cat. By the prompt diagnostic procedures and properly selected antibiotic therapy, the cat was recovered from the multidrug-resistant bacterium-induced septicaemia.

• Tuberculosis and Respiratory Diseases
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• v.71 no.1
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• pp.30-36
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• 2011

Background: Pneumonia is commonly seen in outpatient clinics. it is widely known as the most common cause of death from infectious disease. Pneumonia has been diagnosed by its typical symptoms, chest X-ray and blood tests. However, both chest X-rays and blood tests have limitations in diagnosis. Thus primary care clinicians usually have been constrained due to a lack of adequate diagnostic tools. Vibration response imaging (VRI) is a newly emerging diagnostic modality, and its procedure is non-invasive, radiation-free, and easy to handle. This study was designed to evaluate the diagnostic usefulness of the VRI test among pneumonia patients and to consider its correlation with other conventional tests such as Chest X-ray, laboratory tests and clinical symptoms. Methods: VRI was performed in 46 patients diagnosed with pneumonia in Konkuk University Medical Center. VRI was assessed in a private and quiet room twice: before and after the treatment. Sensors for VRI were placed on a patient's back at regular intervals; they detected pulmonary vibration energy produced when respiration occurred and presented as specific images. Any modifications either in chest X-ray, C-reactive protein (CRP), white blood cell count (WBC) or body temperature were compared with changes in VRI image during a given time course. Results: VRI, chest X-ray and CRP scores were significantly improved after treatment. Correlation between VRI and other tests was not clearly indicated among all patients. But relatively severe pneumonia patients showed correlations between VRI and chest X-ray, as well as between VRI and CRP. Conclusion: This study demonstrates that VRI can be safely applied to patients with pneumonia.

• Korean Journal of Clinical Laboratory Science
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• v.53 no.3
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• pp.233-240
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• 2021

Evaluation of the resected margins of the frozen section during breast-conserving surgery can determine the presence of cancer cells in a short time and have a significant impact on the scope of surgery and the prognosis of the patient. However, breast tissue is composed of adipose tissue, which affects the accuracy of the test. In this study, a new method was applied to the resected surface of the frozen section in which wiping the surface of the frozen section block with alcohol was expected to expose the parenchyma to the surface as the adipose tissue would melt momentarily. Indeed, of the total of 98 cases, 37 cases showed a better exposure ratio of the parenchyma in the improved frozen section test than in the previous frozen section test. Of the 37 cases with increased visibility of parenchymal sections obtained by this method, two cases of ductal carcinoma in situ (DCIS) were detected. Although there are limitations such as turnaround time (TAT), the diagnostic accuracy of histopathologic examination of the frozen section may improve through this method and may have a direct impact on patient safety, and should therefore be researched further.

• Korean Journal of Clinical Laboratory Science
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• v.51 no.1
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• pp.26-33
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• 2019

Recently, the rapid growth of the companion animal market has led to the development of animal disease diagnosis kits. Therefore, the utility of the introduction of biomarkers for the development of animal molecular diagnostics is being reevaluated. A good biomarker should be precise and reliable, distinguish between normal and diseased states, and differentiate between different diseases. Recently reported genetic markers, tumor markers (cell free DNA, circulating tumor cells, granzyme, and skin tumors), and others (brucellosis, programmed death recovery-1, symmetric dimethylarginine, periostin, and cysteinyl leukotrien) have been developed. The biomarkers are used for risk prediction or for the screening, diagnosis, and monitoring of disease progression. The most important criteria for related biomarkers are disease specificity. Many potential biomarkers have emerged from laboratory and test studies, but they have not been validated in independent or large-scale clinical studies. Candidate biomarkers evaluate disease associations, verify the effectiveness of biomarkers for early detection and disease progression, and incorporate them into humans and animals. In the future, it will be necessary to reevaluate the utility of well-structured biomarker-based research and study the development of kits that can be used in on-site tests in accordance with the trends introduced in the diagnosis of animal diseases.

• Imaging Science in Dentistry
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• v.45 no.1
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• pp.1-5
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• 2015

Purpose: Lateral pterygoid muscle (LPM) plays an important role in jaw movement and has been implicated in Temporomandibular disorders (TMDs). Migraine has been described as a common symptom in patients with TMDs and may be related to muscle hyperactivity. This study aimed to compare LPM volume in individuals with and without migraine, using segmentation of the LPM in magnetic resonance (MR) imaging of the TMJ. Materials and Methods: Twenty patients with migraine and 20 volunteers without migraine underwent a clinical examination of the TMJ, according to the Research Diagnostic Criteria for TMDs. MR imaging was performed and the LPM was segmented using the ITK-SNAP 1.4.1 software, which calculates the volume of each segmented structure in voxels per cubic millimeter. The chi-squared test and the Fisher's exact test were used to relate the TMD variables obtained from the MR images and clinical examinations to the presence of migraine. Logistic binary regression was used to determine the importance of each factor for predicting the presence of a migraine headache. Results: Patients with TMDs and migraine tended to have hypertrophy of the LPM (58.7%). In addition, abnormal mandibular movements (61.2%) and disc displacement (70.0%) were found to be the most common signs in patients with TMDs and migraine. Conclusion: In patients with TMDs and simultaneous migraine, the LPM tends to be hypertrophic. LPM segmentation on MR imaging may be an alternative method to study this muscle in such patients because the hypertrophic LPM is not always palpable.

• Pediatric Infection and Vaccine
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• v.3 no.2
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• pp.123-127
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• 1996

Purpose : The most patients with acute streptococcal pharyngitis lack of classic clinical manifestations, therefore diagnostic laboratory test such as the throat culture or a rapid antigen detection test are frequently employed in primary practices of developed countries. We'd like to know the accuracy of the throat swab culture as gold standard for diagnosis of streptococcal infection with studying the discordant and concordant rate of duplicate culture. Methods : The study included 89 normal school children (boys:50, girls:39) who were attending Uljin primary school in Uljin, Kyong Sang Buk Do on March 1996. We obtained simultaneous 2 times of throat swab from each subject, and plating and streaking on 5-7% of sheep blood agar separately. We counted the characteristic beta-hemolytic colonies after overnight incubation. Results : 1) The carrier rate of beta-hemolytic streptococci at first culture is 25.1% and second one is 29.2%. 2) Ten out of 89(11.2%) is discordant in duplicate culture. 3) Culture containing less than 50 colonies of beta-hemolytic streptococci (+2) in first culture is 70.4%, second one is 85.7%. 4) Number of colonies is less than 50 in all ten discordant children. Conclusions : The discordant rate of duplicate throat swab cullture for beta-hemolytic streptococci is 11.2%, even if the subjects are normal school children. About 5% of individuals harboring beta-hemolytic streptococci in the pharynx may be missed by a single throat culture. If we are trying to examine the patients with pharyngitis, the discordant rate will be much lower than this results.

• Journal of Veterinary Clinics
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• v.24 no.2
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• pp.255-259
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• 2007

A 6-year-old, intact male, mongrel dog with yellowish urine, anorexia, depression was referred to the Veterinary Medical Teaching Hospital of the Chungnam National university. Immune mediated hemolytic anemia (IMHA) was diagnosed by clinical signs, physical examination, laboratory tests (CBC, serum chemistry, Coombs' test, autoagglutination test and urinalysis) and diagnostic imaging (X-ray and ultrasonography). Clinical signs were improved after combined immune-suppressive therapy (prednisolone and cyclosporine) and prophylactic heparin therapy. A thrombus ($4cm{\times}1cm$) was observed in the right ventricle by autopsy. Combined therapy and supportive care (antithrombolytic agent and acupuncture) were effective in a dog with IMHA.