기존의 외부정도관리 대상이 아닌 검사항목에 대한 소그룹 외부정도관리 프로그램 실시 경험

제갈동욱,이규형,김용구,송영선,장현식,박규호,윤순옥,조승진,박건희,임송,이명신 대한수혈학회 2011 大韓輸血學會誌 Vol.22 No.3

Background: Proficiency testing is part of a total quality management program that provides objective evidence of clinical laboratory testing competence for customers, accrediting bodies, and regulatory agencies. Performing alternative assessment procedures for clinical tests, without proficiency testing, is recommended by Clinical and Laboratory Standards Institute (CLSI) guideline. In our study, an alternative assessment procedure was performed for blood bank tests that do not have an external proficiency program. Methods: The laboratory for development and an evaluation center, supervised the program. Proficiency testing by seven institutions was performed 3 times at 6 month intervals by evaluating isoagglutinin and anti-D titers,and Weak D, Rh C and E typing, using ID-Internal Quality Control (Bio-Rad Laboratories) kits. Results: Isoagglutinin and anti-D titer results were within one fold dilution range for all seven participating institutions, and Weak D, Rh C and E typing results all demonstrated identical antigenic reference patterns. Conclusion: An alternative assessment procedure was successfully performed without a proficiency testing program. Commercially manufactured reference materials could be an alternative method to support commutable,external, proficiency testing program.

Glucose-6-Phosphate Dehydrogenase 결핍 환자에서 A형 간염 후발생한 용혈성 빈혈과 급성 신부전증 1예

제갈동욱,오은지,박연준,한경자,이승원,박종원 대한진단검사의학회 2007 Annals of Laboratory Medicine Vol.27 No.3

Glucose 6 phosphate dehydrogenase(G6PD)결핍은 효소결핍질환 중 가장 흔한 질환이지만, 한국에서는 드문 질환이다.환자는 평소에 건강하던 39세 남자로 급성 A형 간염에 이환된후, 고빌리루빈 혈증을 동반한 심한 용혈성 빈혈과 급성 신부전등의 합병증 소견을 보였다. 용혈성 빈혈의 감별을 위해 시행한G6PD 검사에서 중등도(moderate) 결핍이 확인되었다. G6PD결핍 환자에서 A형 간염이 동반된 경우 심한 간염 양상과 합병증을 동반할 수 있으므로, A형 간염과 같은 유발 인자가 있고, 고빌리루빈 혈증과 용혈 현상을 보이는 환자에서는 G6PD 검사가필요하다.

Impact of Genetic Abnormalities on the Prognoses and Clinical Parameters of Patients with Multiple Myeloma

제갈동욱,김명신,Ahlm Kwon,김현정,채효진,민창기,임지향,김용구,한경자 대한진단검사의학회 2013 Annals of Laboratory Medicine Vol.33 No.4

Background: We reviewed patients with multiple myeloma (MM) in order to assess the incidence of genetic abnormalities and their associations with clinical parameters, risk groups, and prognosis. Methods: A total of 130 patients with MM were enrolled. The incidences of genetic abnormalities were determined in all patients. The relationships of the genetic abnormalities and clinical parameters were investigated. In addition, a survival analysis was performed. Results: Abnormal karyotypes were detected in 42.3% (N=55) of the patients, and this was increased to 63.1% (N=82) after including the results determined with interphase FISH. Hypodiploidy was observed in 7.7% (N=10) of the patients, and all were included in the group with complex karyotypes (30.8%, N=40). The 14q32 rearrangements were detected in 29.2% (N=38) of the patients, and these most commonly included t(11;14),which was followed by t(4;14) and t(14;16) (16.2%, 11.5%, and 0.8%, respectively). Abnormal karyotypes and complex karyotypes were associated with disease progression markers, including low hemoglobin levels, low platelet counts, high plasma cell burden,high β2-microglobulin, and high international staging system stages. A high free light chain (FLC) ratio and FLC difference were associated with abnormal karyotypes, complex karyotypes, and higher plasma cell burden. Hypodiploidy and low platelet counts were significant independent prognostic factors and were more important in patient outcome than any single abnormality. Conclusions: Genetic abnormalities were associated with disease progression markers and prognosis of MM patients.

Performance Evaluation of a Point of Care SelexOnTM B-Type Natriuretic Peptide Immunoassay

제갈동욱,이승옥,최현유,조세운,박해일 대한진단검사의학회 2020 Laboratory Medicine Online Vol.10 No.3

Background: This study was conducted to evaluate the analytical performance of the SelexOnTM B-type natriuretic peptide (BNP) assay (Osang Healthcare Inc., Korea), a new rapid lateral flow immunoassay for point of care (POC) testing using whole blood. Methods: The imprecision, linearity, and method comparison of SelexOnTM BNP assay were evaluated. Two commercial BNP assays, the ADVIA Centaur® BNP (Siemens Health Care diagnostics Inc., USA) and the Triage® BNP assays (Alere, USA), were included for method comparison using 100 whole blood samples from patients. The reference interval was verified using 120 residual samples from health examination participants. Results: The SelexOn BNP had total CVs of 20.3%, 13.3%, and 10.3% in BNP concentrations of 89.44 pg/mL, 480.71 pg/mL, and 1,201.84 pg/mL of control materials, respectively. Linearity was observed from 56 pg/mL to 1544 pg/mL. The SelexOn BNP (y) regression equation was y=0.9706x-21.68 with Centaur BNP (x) (r=0.930) and y=0.7600x+0.0506 with Triage BNP (x) (r=0.845), respectively. The predicted mean difference (%) of the SelexOn BNP at the clinical decision levels (100 pg/mL) was up to 25% lower than the two comparative methods. The SelexOn BNP levels were below 50 pg/mL in 114 (95%) of the 120 samples. Conclusions: The SelexOn BNP using EDTA was developed as a POC test for differential diagnosis or treatment monitoring for acute heart failure. However, clinical decision values must be improved to be compatible with other BNP methods.

Analytical and Clinical Assessment of Prostate Specific Antigen Using an HISCL-5000 Chemiluminescence Immunoassay

한재호,제갈동욱,이승옥,김명신,김용구 대한진단검사의학회 2022 Laboratory Medicine Online Vol.12 No.1

Background: Prostate cancer (PCa) is the leading cause of cancer-related death worldwide. Prostate specific antigen (PSA) is a useful biomark- er that can be screened for the diagnosis and prognosis of PCa. We evaluated the analytical performance of the PSA test using an HISCL-5000 im- munoassay (Sysmex, Japan). Methods: The analytical and clinical evaluation of PSA was performed using an HISCL-5000 chemiluminescent enzyme immunoassay. For analyz- ing the precision, linearity, trueness, limit of detection (LOD), limit of blank (LOB) and for comparing the method with UniCel DxI-800 ACCESS (Beck- man Coulter, USA), 510 samples of PSA were collected. Clinical analyses were performed for benign prostate hyperplasia (BPH) and PCa. The area under the receiver operating characteristic curve (AUROC) was used for evaluating the diagnostic potential. Results: The within-laboratory coefficient of variation (CV) for low- (3.81 ng/mL) and high- (18.19 ng/mL) level PSA was 5.46% and 8.50%, re- spectively. Linearity was verified from 0.002 to 189.900 ng/mL for PSA. LOB and LOD were 0.007 and 0.020 ng/mL, respectively. Bias between the expected true and measured values was -9.70-11.16%. The regression equation by method comparison was y = -1.0605+0.9223x (R2 = 0.99). AUROC values for diagnosis of PCa and BPH compared to non-malignant disease were 0.52 and 0.75, respectively. When compared to healthy sub- jects, AUROC values were 0.96 and 0.97, respectively. Conclusions: PSA analysis using an HISCL-5000 immunoassay is reliable and can be used in clinical settings.

Correlation Between Fecal Toxin Enzyme Immunoassays and Disease Severity in Patients with Clostridioides difficile Infection in a Korean University Hospital

한은희,이승옥,제갈동욱,지정선 대한진단검사의학회 2021 Laboratory Medicine Online Vol.11 No.2

Background: The aim of this study was to evaluate the clinical usefulness of the Clostridioides difficile toxin enzyme immunoassay (EIA) and nucleic acid amplification test (NAAT) in determining the severity of C. difficile infection (CDI) according to three different severity criteria: the ATLAS score of Miller et al., the CDAD severity score of Zar FA et al., and the CDSS score of Na et al. Methods: From December 2015 to May 2018, 91 patients suspected of suffering from antibiotic-related diarrhea among those who tested positive (including equivocal) in either fecal C. difficile toxin EIA (VIDAS toxin A/B enzyme-linked fluorescent assay, BioMerieux SA, France) or NAAT (Seeplex Diarrhea ACE kit, Seegene, Korea), or both were tested to investigate the correlation between the results of each assay and the severity of CDI via retrospective medical record review and statistical testing. Results: For the 88 C. difficile tcdB NAAT positive cases, EIA positivity significantly correlated with the ATLAS score (P =0.005) but did not correlate with the CDAD severity (P =0.107) and CDSS scores (P =0.534). When EIA equivocal results were considered to be positive results, EIA positivity correlated with the CDAD severity (P =0.03) and ATLAS scores (P <0.001) but did not correlate with the CDSS score (P =0.169). Conclusions: The C. difficile toxin EIA assay may be clinically useful in assessing the severity of disease in CDI patients, especially in correlation with ATLAS severity scores.

포스터 4 : 분자유전학 검사로 확정된 항원력이 약한 A2형 1예

송영선,김지선,제갈동욱,김용구 대한임상병리사협회 2015 임상수혈검사학회 발표자료집 Vol.2015 No.-

배경(Background): ABO혈액형은 수혈이나 장기이식에서 임상적 의미가 가장 큰 혈액형이다. 안전한 수혈을 위해서는 먼저 정확한 혈액형 판정이 선행되어야 하며, 이를 위해서 혈구형검사와 혈청형 검사를 동시에 시행하고 두 결과의 일치가 중요하며 만약, 불일치할 경우 원인을 규명해야 한다. ABO혈액형 불일치현상을 일으키는 원인에는 한랭자가항체, 동종항체, ABO변이형, ABO혈액형 항원의 획득, 소실 및 약화연전현상 및 면역결핍증, 약제 등의 다양한 경우가 있다. 이를 해결하기 위하여 세척, 항온시간연장, 흡착 및 해리, A, B전이효소검사, 타액 검사 등의 방법을 이용하지만 이러한 혈청학적 검사로는 혈액형 확진에 어려움을 겪는예가 간혹 있다. 하지만 1990년대 초에 ABO유전자 구조가 규명된 이후 많은 분자유전학적연구가 이루어져 왔는데 ABO유전자형 검사가 혈액형판정이 어려운 검체들을 확진하는데 매우 도움이 되는 것으로 밝혀졌다. 이에 혈청학적 방법으로 ABO불일치를 보여 아형을 의심하는 환자의 검체를 분자유전학적 검사를 통하여 확진하였기에 보고하는 바이다. 방법(Methods): 환자 및 가족을 대상으로 ABO혈구형과 혈청형검사, Anti-A1과 Anti-H검사, 흡착 및 용출시험을 통해 표현형을 분석하였고 분자유전학적 검사로 염기서열분석을 통해ABO유전형 분석을 시행하였다. ABO유전형 분석은 exon 6과 exon 7을 증폭하여 염기서열분석을 하였다. 염기서열 중 261, 267, 467, 1059번째 염기 등을 살펴보았다. 결과(Results): 환자 및 가족을 대상으로 ABO혈구형과 혈청형검사, Anti-A1과 Anti-H검사, 흡착 및 용출시험을 통해 표현형을 분석하였고 분자유전학적 검사로 염기서열분석을 통해ABO유전형 분석을 시행하였다. ABO유전형 분석은 exon 6과 exon 7을 증폭하여 염기서열분석을 하였다. 염기서열 중 261, 267, 467, 1059번째 염기 등을 살펴보았다. 고찰(Discussion): ABO유전형 검사는 혈액은행 검사실에서 자주 접하는 ABO불일치 해결이나 각종 ABO아형의 확진 등에 사용될 수 있는 중요한 검사로 부각되고 있다. 특히 질병등의 이유로 항원력이 비정상적으로 약화되었을 경우 혈청학적 방법으로는 확진의 한계에이른다. A항원의 수에서 A2와 A weak와는 많은 차이가 있어 감별의 유용한 지표이나 이처럼 비정상적으로 약화된 경우에는 일반적으로 A weak를 의심할 수도 있었으나 분자유전학적 검사를 시행하여 A2로 확정되었다. 이와 같이 단순혈액형의 경우 혈액형으로 인한 오해로부터 수혈오류에 이르기까지 정상혈액형과 아형의 정확한 감별은 중요한 사항이라 할 수 있어 앞으로 ABO등의 혈액형검사에 분자유전학적 검사가 미치는 영향은 확대될 것으로 생각한다.

Clinical Presentation with High Penetrance in a Korean Family with Pulmonary Arterial Hypertension Associated with a BMPR2 Intron 3 Splice Site Pathogenic Variant

김미정,이승옥,제갈동욱,채효진,김명신,정해억,전두수 대한진단검사의학회 2018 Laboratory Medicine Online Vol.8 No.3

Pathogenic variants of bone morphogenic protein receptor type 2 gene (BMPR2) are related to the majority of cases of heritable pulmonary arterial hypertension (PAH). Over 400 pathogenic variants have been identified. However, clinical characterization of PAH is still incomplete. We present a case of heritable PAH in a Korean family showing serious clinical presentation with high penetrance. Genetic sequencing revealed a known heterozygous BMPR2 pathogenic variant, c.418+5G>A, at a splice site of intron 3. Serious clinical presentation with high penetrance suggested that the interplay of other factors with pathologic variants might be in genotype-phenotype correlation. Further studies are needed to clarify these issues for the development of personalized medicine approaches for PAH.

Clinical Significance of Inflammatory Biomarkers in Acute Pediatric Diarrhea

Yoonseon Park,Minji Son,제갈동욱,Hyun Yoo Choi,Sang Yong Kim,이승옥 대한소아소화기영양학회 2019 Pediatric gastroenterology, hepatology & nutrition Vol.22 No.4

Purpose: The aim of this study was to evaluate the clinical significance of inflammatory biomarkers in acute infectious diarrhea among children. Methods: Clinical parameters including fever, bacterial and viral etiology based on stool culture and multiplex polymerase chain reaction, and nine biomarkers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and leukocytes in blood and calprotectin, lactoferrin, myeloperoxidase, polymorphonuclear elastase, leukocytes, and occult blood in feces were evaluated in children who were hospitalized due to acute diarrhea without underlying disease. Results: A total of 62 patients were included. Among these patients, 33 had fever, 18 showed bacterial infections, and 40 patients were infected with 43 viruses. Of all the biomarkers, CRP was significantly correlated with fever ( p <0.001). CRP, ESR, calprotectin, lactoferrin, myeloperoxidase, fecal leukocytes, and occult blood were significantly associated with infection with bacterial pathogens ( p <0.001, p =0.04, p =0.03, p =0.003, p =0.02, p =0.03, p =0.002, respectively). The combination of CRP and fecal lactoferrin at their best cut-off values (13.7 mg/L and 22.8 µg/mL, respectively) yielded a sensitivity of 72.2%, and a specificityof 95.5% for bacterial etiology compared with their individual use. Conclusion: Blood CRP is a useful diagnostic marker for both fever and bacterial etiology in acute pediatric diarrhea. The combination of CRP and fecal lactoferrin yields better diagnostic capability for bacterial etiology than their use alone for acute diarrhea in children without underlying gastrointestinal disease.

Simultaneous Extracorporeal Membrane Oxygenation, Renal Replacement Therapy, and Plasma Exchange for Thrombocytopenia-Associated Multiple Organ Failure

이호원,유재은,이종민,제갈동욱,김명신,김용구 대한진단검사의학회 2021 Laboratory Medicine Online Vol.11 No.1

Thrombocytopenia-associated multiple organ failure (TAMOF) is a distinct type of sepsis related to thrombocytopenia, microangiopathic hemolysis, and multiple organ failure. TAMOF belongs to a spectrum of syndromes related to disseminated intravascular coagulopathy, thrombotic thrombocy topenic purpura, and hemolytic uremic syndrome. Treatment modalities for TAMOF include therapeutic plasma exchange along with other extracor poreal organ support. To the best of our knowledge, we report the first case of triple-modality treatment for TAMOF in Korea, which involved extra corporeal membrane oxygenation, continuous renal replacement therapy, and therapeutic plasma exchange in a patient with TAMOF.