Japanese Journal of Medical Technology
Online ISSN : 2188-5346
Print ISSN : 0915-8669
ISSN-L : 0915-8669
Volume 73, Issue 4
Displaying 1-32 of 32 articles from this issue
Original Article
  • Yukinori SAKATA, Chiho MIZOHATA, Toshitaka OKUMURA, Aiko SHINTANI, Ryu ...
    Article type: Original Article
    2024 Volume 73 Issue 4 Pages 631-637
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Pleural effusion CEA (hereinafter referred to as PF-CEA) is widely used to aid in the diagnosis of cancerous pleuritis, and pleural effusion cytology (hereinafter referred to as cytology) is widely used in the diagnosis of cancers. In this study, we examined the determination of 202 cases of malignant pleural effusions that were previously reported to be malignant by cytology and histopathological confirmation and diagnosed as cancerous pleuritis. We confirmed that re-examination improves grades. When redetermining cytology, we confirmed the accuracy of the PF-CEA test for cancerous pleuritis (cutoff value of 5.1 ng/mL, sensitivity of 70.8%, and specificity of 94.2%) in 192 cases at our hospital. After that, we considered the findings obtained by examining the PF-CEA results of the 202 cases of malignant pleural effusions by histopathological diagnosis. Among the 202 cases, five cases of malignant mesothelioma and six cases of malignant lymphoma were all negative in PF-CEA. Although many adenocarcinomas and squamous cell carcinomas were positive in PF-CEA, the positivity rate was low at approximately 27% in ovarian serous carcinomas. As a result of rediagnosing the cytology considering these factors, the number of cases diagnosed as adenocarcinomas, malignant mesothelioma, and malignant lymphoma increased, and the difficulty in differentiation was eliminated. The above showed that PF-CEA is useful for determining cytology.

  • Mitsuru KURATA, Junji NOMURA, Kazuhiro ANDOU
    Article type: Original Article
    2024 Volume 73 Issue 4 Pages 638-643
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The infection caused by the new coronavirus (SARS-CoV-2) (COVID-19) has long been suggested to have many asymptomatic infections (including mild symptoms), and the infection continues. It has also been pointed out as a contributing factor. Although there have been reports on seroepidemiological studies using local residents and donated blood specimens, there are few reports on changes in the natural infection antibody prevalence rate or its relationship with lifestyle, which is thought to be due to subclinical infection in health check-ups. This study targeted 44,493 patients who underwent a SARS-CoV-2-N (Nucleocapsid) antibody test during the period from July 2020 to October 2023, based on their age and gender. , SARS-CoV-2-N antibody test results were analyzed in three periods according to the predominant period of the variant strain. Additionally, since this infection is mainly transmitted through droplets, we also gained some knowledge regarding its relationship with drinking habits.

  • Kaho KURASHIMA, Tomoe YAMASHITA, Itsuko SATO, Ruri KONO, Tomoya FUKUOK ...
    Article type: Original Article
    2024 Volume 73 Issue 4 Pages 644-651
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Blood coagulation tests are essential for accurate diagnosis and treatment, including assessment of preoperative hemostasis, identification of bleeding or thrombophilia, and monitoring the efficacy of anticoagulant therapy. In our laboratory, blood sample re-collection for coagulation tests is requested if any of the following three criteria are met: (1) Coagulation is suspected in a concurrently collected CBC. (2) Abnormal test values are detected (deviation from the previous APTT, PT values, etc., shortening of APTT, or measurement errors). (3) Clot formation is observed in the erythrocyte layer post-measurement. In this study, we evaluated to verify whether the suspected coagulation specimens increased coagulation or fibrinolysis in each of the three criteria. We analyzed 101 pairs of suspected coagulation and re-collected specimens and performed the following tests on another day: APTT, PT, fibrinogen, FDP, D-dimer, FM, TAT, PIC, and tPAI·C. The proportions of the initial criteria were as follows: (1) suspected CBC coagulation in 57 cases (56%), (2) abnormal test values in 34 cases (34%), and (3) confirmation of coagulum post-measurement in 10 cases (10%). Criteria (1) and (2) showed significant differences for all items, whereas criterion (3) showed significant differences except for APTT, D-dimer, and PIC. Our results support the effectiveness of a multi-step procedure for excluding unsuitable samples. The test values of coagulation-suspected specimens confirmed by the operational procedure showed significant fluctuations compared to re-collected specimens. Therefore, re-collecting revealed elevated levels of coagulation or fibrinolysis in the coagulation-suspect specimen.

  • Eiichiro SATO
    Article type: Original Article
    2024 Volume 73 Issue 4 Pages 652-660
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Supplementary material

    This study aimed to identify essential factors for the early detection of asymptomatic hepatitis C virus (HCV) infection among patients visiting university hospitals. This initiative seeks to enhance the testing rates and efficacy of HCV antibody tests for individuals who have yet to undergo the same. This research employed a single-center cross-sectional design. After excluding patients based on the exclusion criteria, the final analysis included 6,945 patients. Data on sex, age, inpatient–outpatient classification, blood test results and medical history were extracted from the electronic medical records from Osaka University Hospital. Blood tests served as routine admission and pre-surgery test for patients. Basic statistics were used to analyze the data collected from patients with asymptomatic HCV infection and those with negative HCV antibody tests after which statistical comparisons between the groups were conducted. Uni- and multivariable binary logistic regression models were used to identify variables independently associated with HCV ribonucleic acid (HCVRNA) detection. Explanatory variables included sex, age, inpatient–outpatient classification, blood test data, and medical history. Significant differences were found between the parameters of the two groups, except for sex, inpatient–outpatient classification, chloride, creatinine, and C-reactive protein. Factors associated with asymptomatic HCV infection included older age, outpatient, the decrease in platelet counts and albumin, as well as the increase in total protein based on blood test results. Therefore, older age, outpatient, the decrease in platelet counts and albumin and the increase in total protein may be associated with asymptomatic HCV infection among patients attending the university hospital.

  • Ayu HIDAKA, Yuki OSHIMA, Seika NAKAMURA, Saya FUJIWARA, Risa KANESHIGE ...
    Article type: Original Article
    2024 Volume 73 Issue 4 Pages 661-666
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Antiphospholipid syndrome (APS) is an autoimmune disease characterized by the appearance of antiphospholipid antibodies (aPLs) and clinical findings such as arterial and/or venous thrombosis and obstetric complications. As per the revised criteria of the International Classification Criteria for APS, the items required for testing of aPL include anti-cardiolipin antibodies (aCL) and anti-β2-glycoprotein I antibodies (aβ2GPI), lupus anticoagulant (LA) activity. Recent clinical studies suggest that direct oral anticoagulant (DOACs) therapy affects coagulation assays for determining LA activity. In the present study, we investigated the effects of DOAC type and plasma concentration on dilute Russell’s viper venom time (dRVVT), which is recommended as the first-line test for determining LA activity. We prepared DOAC-containing plasma so that the DOAC concentrations equivalent to the peek and trough values in the patient’s blood by adding each of the four types of DOAC to pooled plasma from healthy individuals. We performed LA activity determination on these samples using three types of commercially available dRVVT reagents. In measurements using LA test-Gradypore and LA reagent DRVVT, which are widely used in Japan, all cases of plasma containing various DOACs were determined to be LA false positive. On the other hand, the recently developed Coagpia LA reagent correctly determined that all plasma containing various DOACs were LA negative. The present suggested that patients who received DOAC therapy may be diagnosed as LA false-positive in the dRVVT-LA test depending on the measurement reagent used. Therefore, we recommend using Coagpia LA reagent to determine LA activity in patients treated with DOACs.

  • Shuhei KIDOGUCHI, Hidenori ONISHI, Hiromasa TSUBOUCHI, Fumie MAEDA, Yu ...
    Article type: Original Article
    2024 Volume 73 Issue 4 Pages 667-673
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Objectives: The incidence of deep vein thrombosis (DVT) has been reported to increase after large-scale disasters. Shelter environments, decreased activity, and overnight stays in cars have been reported as causes of DVT after disasters, while aging is a common risk factor for DVT. There are few reports on DVT detection rates in evacuees compared to those in the general population. In this study, we screened DVT in the elderly general population and compared the DVT detection rate and its background factors to those of elderly evacuees (Kumamoto earthquakes, April 2016). Methods: We conducted DVT screening in the elderly general population at a health event in Tsuruga City, Fukui Prefecture, Japan. The number of subjects in the general population was 81 (69.4 ± 8.0 years old) and in the earthquake evacuees was 207 (68.2 ± 16.1 years old). Medical interviews and lower limb venous ultrasounds were performed in all cases. Results: The DVT detection rate in earthquake evacuees was 11.1% (23/207) and that in the general population was 2.5% (2/81). DVT, insomnia, difficulty standing up from the floor or bed, dehydration, staying in a car, and dyslipidemia were significantly higher in earthquake evacuees than in the general population. Although the prevalence of DVT was low in the general population, soleus vein dilatation and hypertension were observed in DVT-positive individuals. Conclusion: The DVT detection rate in elderly earthquake evacuees was over 4 times higher than that in the elderly general population, and various background factors directly related to large-scale disasters were involved.

Technical Article
  • Hidemi CHIKAZAWA, Tomokazu KUCHIBIRO, Hirofumi OHTAKI, Makoto NIKI, Hi ...
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 674-683
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Antimicrobial susceptibility testing is an important test for determining appropriate antimicrobial therapy. This study, based on the Clinical Laboratory Standards Institute (CLSI), measures the antimicrobial susceptibility of various bacterial species including Corynebacterium, Nocardia, Rapidly Growing Mycobacteria (RGM), and sophisticated anaerobes . We fabricated a custom panel dry plate DP1R (Eiken Chemical Co., Ltd.) which allows concentration measurement, and conducted performance evaluations in collaboration with other institutions. The ATCC strain was used as the evaluation method, and a total of 10 measurements, 5 simultaneous measurements over 5 days, were conducted at 7 facilities to investigate the convergence of MIC values. In addition, 38 Corynebacterium isolates, 34 Nocardia isolates, 67 RGM isolates, and 33 anaerobic isolates were tested for MIC values using clinical isolates. As a result, the DP1R tested this time was considered to be within the acceptable range. Simultaneous reproducibility and inter-day reproducibility across multiple facilities are also good, and it can be seen that the plate performance is sufficient for use. It is also useful from an accuracy assurance standpoint because it can test multiple bacterial species using a CLSI-compliant method. The results of antimicrobial susceptibility testing using a new testing method with DP1R are expected to greatly contribute greatly to the selection of appropriate antimicrobial a treatment.

  • Misato KAMIYA, Eiji ITO, Aya SATO, Takeshi OHSHIMA
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 684-690
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Heparin-induced thrombocytopenia (HIT) is a serious adverse reaction associated with heparin use. While rapid antibody testing is crucial, it’s mainly outsourced. In our hospital, we have been performing in-house testing using the ELISA method. However, the procedure has been cumbersome and results took several hours to be reported. Recently, an immunochromatographic (IC) assay with a response time of 15 minutes was developed and became eligible for insurance coverage from May of the 5th year of Reiwa era. Therefore, we conducted an assessment of its utility. The concordance rate was 86%, indicating good results. Analysis of discordant cases and cases allowing longitudinal evaluation revealed factors such as differences in specificity due to variations in measurement principles and antigen usage, as well as differences in sensitivity. Furthermore, a positive result for HIT antibodies through immunological measurements does not necessarily indicate the onset of HIT. Diagnosing HIT based solely on HIT antibody positivity may lead to overdiagnosis. However, the functionally-based measurement methods, considered the gold standard in Europe and the United States, are challenging to implement outside of research facilities. Therefore, diagnosing HIT requires a combination of serological and clinical findings for confirmation. This study demonstrated that HIT antibody testing, which previously required significant time, can now be determined and reported within 15 minutes, facilitating easy retesting in accordance with symptom improvements. This is expected to contribute to the rapid diagnosis and appropriate management of HIT.

  • Mariko KOBAYASHI, Tatsuya IWASAKI, Kiyoshi KAMIYAMA, Susumu OOSAWA, Hi ...
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 691-698
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The Biuret method is the mainstay of serum total protein assay, with a prevalence of almost 100%. Therefore, it is difficult to verify abnormal data due to pitfalls such as lipoprotein-X or amino acid infusions by other methods. On the other hand, the pyrogallol red (PR) method, which is used for the urinary protein assay, has less nonspecific reactions to non-protein components such as amino acids and carbohydrates, but is not used for the serum total protein assay because of its high sensitivity. We investigated whether the JEOL JCA-BM6070, which has a sample pre-dilution function, can be used to confirm the serum protein assay obtained by the biuret method by setting appropriate parameters and adapting it to the PR method, which has fewer nonspecific reactions than the biuret method. The correlation between the PR-BM method (y) and the Biuret method (x) in 163 patient sera samples was r = 0.977, y = 1.00x + 0.07, and the measured values of both methods generally agreed. From these results, we conclude that the PR-BM method can be used as a confirmatory method for serum total protein measurement.

  • Misa WAKAIDA, Takeo SAWADA, Hideto KONDO, Yuma TAKADA, Naomi YANASE, Y ...
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 699-707
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Deep mycosis is an opportunistic infection occured mainly in patients with immune dysfunction. In clinical practice, the detection of (1→3)-β-D-glucan is used as an auxiliary diagnosis. In this study, we examined the test reagents available in Japan by two companies for the purpose of introducing this test into hospital laboratory. We compared the outsourced tests currently performed at our hospital with each reagent company. The basic performance of within-run and between-day precision, dilution linearity, and correlation between methods were similar to the previous reports. In addition, the comparison of the difference between double measurements of the same sample suggested that measurement errors were likely to occur in the low concentration range in both method A and method B. In this result, 45/69 (65.2%) of results in low concentration range were positive for one method and negative for the other method. This discrepancy in determination is considered to be due to the difference in proportionality between measured values and cut-off value. The medical record review revealed that β-D-glucan value fluctuated in relation to symptoms that suggested infections including deep mycosis. When selecting a β-D-glucan test reagent, we should select a reagent that is appropriate for the actual situation of the facility, including the operability of the measurement. The introduction of this test in the hospital is expected to lead to early diagnosis and appropriate treatment of deep mycosis.

  • Chiyo INOKUCHI, Hisaki IGARASHI, Kazuya HATTORI, Yasuhiko KITAYAMA
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 708-718
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    At our hospital, 2 to 4 people perform fluorescence observation to determine HER2 FISH (human epidermal growth factor receptor type 2 fluorescence in situ hybridization). However, in the case of equivocal or difficult-to-diagnose cases, observation takes a long time, and the fluorescence fades due to excitation light irradiation, making it difficult to confirm the signal under direct vision. Therefore, we investigated visualization using the CISH (chromogenic in situ hybridization) method after HER2 FISH. As a result of the study, (1) cocktail antibodies (anti-Rhodamine monoclonal antibody <×2,000>), anti-Fluorescein antibody <×200>) were incubated at room temperature for 30 minutes, (2) AP-labeled anti-IgG polyclonal antibody (Histofine Simple Stain AP <R>) was incubated at room temperature. 30 minutes, (3) BCIP/NBT 1–3 minutes at room temperature, after washing (4) PO-labeled monoclonal anti-IgG antibody (Histofine Simple Stain MAX PO <M>) 30 minutes at room temperature, (5) AEC 10 minutes at room temperature, after drying (6) Visualization became possible with the protocol of water-soluble Aquatex encapsulation. We believe it will be highly useful, including reducing problems with fading and storage space at −20°C, providing virtualization to clinicians, and using it for internal quality control and education.

  • Daisuke HACHISUKA, Toyofumi NAKANISHI, Takashi IWASAKI, Yuto JINNO, Ak ...
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 719-725
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Crystal-induced arthritis arises from variety of crystal formations, with gout (sodium urate crystals) and pseudogout (calcium pyrophosphate crystals) being the most common forms of crystal-induced arthritis in rheumatic diseases, although hydroxyapatite (HA) crystals are a rare contributor to this condition. HA crystals, lacking characteristic birefringence under a simple polarizing microscope, pose challenges in accurate assessment. Electron microscopy or Alizarin Red S staining is conventionally employed for identification; however, accessibility to these methods is limited in many healthcare institutions. In this study, Von Kossa’s method, Hematoxylin-Eosin stain (HE) and Giemsa stain were investigated as the most useful staining techniques for the diagnosis of hydroxyapatite deposition in joint fluid. Results indicated positive staining for HA crystals in all four methods, with Von Kossa’s method and HE stain exhibiting notably high positivity rates. Image analysis, utilizing RGB histogram, revealed that Von Kossa’s method offered distinct contrast among HA crystals, leukocytes, and the background. The findings suggest that Von Kossa’s method holds promise as a viable alternative to Alizarin Red S staining for the identification of HA crystals. This underscores its potential utility as a practical diagnostic tool for crystal-induced arthritis in scenarios where conventional methods are unavailable.

  • Yuya MAKI, Shingo SUGAWARA, Aya SATO, Noriyuki OKUBO, Shizue ISHIZUKA, ...
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 726-732
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Sysmex XN has different detection performance of platelet aggregation depending on the platelet measurement mode. In this study, we utilized this difference to examine whether the presence or absence of the PLT-Clumps flags in each mode can differentiate fibrin strands from platelet aggregation when the same specimen is measured with PLT-I and PLT-F. Of the 18,540 specimens for which blood counts were requested, 757 were included in the study if they met the following criteria. (i) PLT decreased by more than 30% from the previous value; (ii) PLT-Clumps-flag was displayed; (iii) fibrin precipitation or platelet aggregation was observed, although the above conditions were not met. Then, sensitivity, specificity, and AUC were determined based on the Q-Flag value, which is the trigger for flagging, and specimen findings, and compared in each mode. Criteria were also developed to classify specimen characteristics as “negative,” “platelet aggregation,” or “fibrin strands” according to the presence or absence of the PLT-Clumps flag in each mode, and concordance with specimen findings was evaluated. The AUC for fibrin strands was significantly higher for PLT-F. Sensitivity and specificity for platelet aggregation were clearly lower for PLT-I (0.06, 0.65) than for PLT-F (0.87, 0.91). The concordance rate of the criteria was 98.7% for PLT-Clumps flags not in both modes (= negative), 99.5% for PLT-I only (= negative), 67.9% for PLT-F only (= platelet aggregation), and 92.0% for both modes (= fibrin strands). The results suggest that the combination of PLT-Clumps flags may be able to differentiate the cause of false low platelets.

  • Kota MAEYAMA, Reiko OYAMADA, Fua SHIRAYAMA, Hajime MIURA
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 733-740
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    In the past, most prothrombin time (PT) reagents were required to add special dissolving solution or purified water. Recently, several companies have released liquid-type PT kits that are easy to prepare. This time, we report on the basic performance evaluation of a liquid-type PT kit, “HemosIL ReadiPlasTin” (I.L.Japan Co., Ltd.), using ACL TOP 550 CTS (I.L.Japan Co., Ltd). Two concentrations of control plasma and post-test residual patient plasma were used as samples. The repeatability was less than 1.5% CV after 10 times measurements, and the onboard stability was less than 3.0% CV after 14 days of measurements twice a day. The dilution linearity was confirmed up to 144.3% for PT activity and the limit of detection was 5.7%. The effect of comorbidities was less than 5% change in each case. The effect of heparin was less than 10% up to 1.25 U/mL. The correlation with the conventional reagent was y = 0.987x − 0.0138, r = 0.9978 for PT-INR. The preparation time was less than 1 minute for the study reagent, whereas the conventional reagent was about 34 minutes. The basic performance of the HemosIL ReadiPlasTin was very good and correlated well with the conventional reagent. The conventional reagent was taken more than 30 minutes to prepare, and there was a risk of solvent dispensing errors, whereas the study reagent could be used immediately by simply mixing two liquid vials, which was considered to have very high usability and significantly reduce the burden on medical technologist.

  • Masaya TACHIKAWA, Hidekazu ISHIDA, Yohei KATO, Kohei OSHIMA, Tomo NISH ...
    Article type: Technical Article
    2024 Volume 73 Issue 4 Pages 741-748
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The measurement of C-reactive protein (CRP) in serum is based on an immunological assay, and its standardization has been largely achieved by the serum protein reference material CRM470 (ERM-DA470) through the World Health Organization and the Japanese National Reference Material. Most of the reagents used for CRP measurement in Japan have been ERM-DA470 or ERM-DA472/IFCC as the primary reference material. However, the currently released lot is ERM-DA474/IFCC (DA474), and there are few reports of measuring reagents in accordance with DA474 in the laboratory. Here, we evaluated the basic performance of “LZ Test ‘Eiken’ CRP-RV”, a reagent for measuring CRP based on DA474. Accuracy, precision, analytical range, specificity, and reagent stability were assessed, and good results were obtained for all items. Compared with the control reagent, the correlation coefficient and regression equation showed good results, but a concentration-dependent sigmoidal error distribution was observed. This error was considered due to the difference of the linearity tendency of the calibration curve, including the precision in the low-concentration range, between the test reagent and the control. The high sensitivity of the test reagent is expected to contribute to the early detection of inflammatory reactions and latent diseases in clinical testing and to prompt therapeutic intervention.

Material
  • Kohei OSHIMA, Hidekazu ISHIDA, Yohei KATO, Masaya TACHIKAWA, Aki OKA, ...
    Article type: Material
    2024 Volume 73 Issue 4 Pages 749-756
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Red cell distribution width coefficient of variation (RDW-CV) has traditionally been used as an indicator of microcytic anemia, but its association with cardiovascular diseases has recently garnered attention. In this study, we investigated the potential of RDW-CV as a marker for kidney function screening. We analyzed 11,921 blood test records of individuals aged 18 and over that included cystatin C (CysC) measurements. Estimated glomerular filtration rates (eGFR) were derived from the blood test data and categorized based on the chronic kidney disease (CKD) guideline’s GFR classification. No clear trend was observed in the RDW-CV values when categorized by eGFR derived from serum creatinine. There was a trend of increasing RDW-CV values with declining kidney function in categories based on eGFRcys from CysC. The identification ability between the eGFRcys G1 + G2 group and G4 + G5 group yielded an area under the receiver operating characteristic curve of 0.681, with an odds ratio (95% confidence interval) of 1.27 (1.23–1.31). This odds ratio remained significant after adjusting for sex, age, serum creatinine, red blood cell count, hemoglobin concentration, and hematocrit values. These results conjection that RDW-CV is an independent factor for GFR classification progression. Our findings suggest the potential of RDW-CV as a renal function screening marker.

  • Miho YOSHIDA, Ryuko TSUKAMOTO, Naoko IMAGAWA, Yusuke SUMA, Tomoya HACH ...
    Article type: Material
    2024 Volume 73 Issue 4 Pages 757-763
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The quality control of the color was carried out by the subjective confirmation of the person conducting the pathological examination; furthermore, a trial of the digitizing of the Hematoxylin-Eosin stain (H&E stain) by Red-Green-Blue (RGB) and ΔC has not been conducted to date. In this study, we used a control specimen for the stainability check of the H&E stain every morning. We digitized the specimen after the staining and further digitized the color for the optical density using the image analysis software HALO® and compared it. As a result of having digitized the specimen, unevenness was larger in the first year compared to that in the 5 year. Visual evaluation of H&E staining was relatively uniform and no differences were observed. The numerical results showed periodic fluctuations in eosin. In addition, when we set the limit control in the Xbar control chart with ±2SD and ±3SD, the results were within the control limits. We could successfully evaluate an irregularity in the stainability objectively by digitizing the color for the optical density using HALO® analysis. It is an objective means of internal quality control and a useful tool to visualize changes in the stainability.

  • Tatsuya KATAFUCHI, Saori TAJIRI, Keisuke HASHIMUKAI, Hirokuni KAKINUMA ...
    Article type: Material
    2024 Volume 73 Issue 4 Pages 764-769
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The 2016 World Health Organization Classification of Tumors of the Central Nervous System explicitly describes the importance of noting 1p and 19q co-deletion status in the pathological diagnosis of oligodendrogliomas. Although 1p/19q co-deletion can be detected using fluorescence in situ hybridization (FISH), this approach has complex sample preparation requirements, and there are challenges in long-term FISH sample storage. In the present study, we therefore developed a semi-automated chromogenic in situ hybridization (saCISH) method, which can be observed under an optical microscope. We used a sample set of 20 cases in which 1p/19q co-deletion analysis had already been performed using FISH. For the saCISH method, we first automated the pre-treatment process using an immunostainer; this was followed by the hybridization of labeled probes. Subsequently, automated immunostaining of the labeled probes was conducted, with missing chromosomes colored in red and reference chromosomes colored in brown. In the prepared samples, we then counted each signal and calculated the ratios of 1p/1q and 19q/19p. The saCISH method had a reduced handling time compared with FISH, from approximately 100 minutes to 35 minutes, and improved the complexity of specimen preparation by automating the pre-processing steps. However, challenges were identified with the saCISH method, including a tendency for red signals to appear brown when signals overlapped, and the potential interference of non-specific pigment deposition when identifying signals. Further improvements in the color development method for labeled probes are therefore necessary.

  • Fumihiko KITAGAWA, Ryosuke KIKUCHI, Takashi FUJITA
    Article type: Material
    2024 Volume 73 Issue 4 Pages 770-779
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    In 2018, the “Basic Plan for the Promotion of Cardiovascular Disease Measures” was formulated. The Japanese Association of Medical Technologists is considering an accuracy control survey for cardiovascular disease-related laboratory test items with the aim of expanding the accuracy control system for clinical laboratories in accordance with national policy. The Cardiovascular Disease-Related Laboratory Test Item Accuracy Control Survey Working Group has begun preparing samples for the accuracy control surveys and discussing a time schedule for conducting pre-surveys. In the process, a “Questionnaire Survey on Cardiovascular Disease-related Laboratory Test Item Accuracy Management” was conducted during the 2023 Japan Society of Clinical Hygiene Technologists Clinical Laboratory Accuracy Management Survey to ascertain the status of operation of cardiovascular disease-related laboratory test items at each medical institution. The questionnaire received responses from 1,811 institutions. As a result, 1,251 (88.4%) institutions, including institutions currently under consideration, willing to undergo an external accuracy control survey for cardiovascular disease-related laboratory test items. We also investigated whether reference intervals, pathology identification values, and panic values were set for each item, but the values differed greatly between institutions, and 36 (14.8%) institutions that set pathology identification values, even for items with a high setting rate. In addition, most of the institutions used recommended blood collection tubes for BNP measurement in the reagent package inserts, but some institutions used EDTA-2Na aprotinin-added blood collection tubes. The results of this survey revealed issues such as not only establish a system for accuracy control surveys, but also unifying units, setting reference intervals, and panic values.

  • Yumika YOSHIDA, Makoto KAWACHI, Tatuya KAWASAKI, Yasuo HARADA, Mina IN ...
    Article type: Material
    2024 Volume 73 Issue 4 Pages 780-786
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Improving medical safety requires the submission of as many incident reports as possible. In our examination room, since the fiscal year 2018, we have adopted the slogan “one report, platinum report” and started efforts to increase the number of reports. As clear objectives, we set out to increase the number of level 0a and 1 reports by 50% compared to the previous year, conduct medical safety rounds, and ensure thorough barcode labeling on specimen containers. To improve the reporting process, the committee streamlined report submission, significantly reducing the workload for incident discoverers and lowering the psychological barrier to reporting incidents. For sharing reports with the nursing department, we discussed incident classification and prioritized thorough labeling of specimen containers, sharing the reports accordingly. Before and after these efforts, the total number of reports increased from 326 to 1,471, approximately 4.5 times higher. Particularly, level 0a reports increased from 41 to 465, about 11.3 times higher. The number of reports related to labeling errors increased from 78 to 649, about 8.3 times higher. This significant increase was attributed to clearly stating the need for reporting labeling errors and the committee’s streamlined report submission process, which reduced the workload for incident discoverers, making it easier to report incidents. In the future, we would like to utilize the abundant reports to identify root causes, develop effective countermeasures, and improve medical safety.

  • Ryuichi MAENOSONO, Shiori MATSUKI, Sonoko UCHINO, Fuminori NAMINO, Shi ...
    Article type: Material
    2024 Volume 73 Issue 4 Pages 787-793
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The Kagoshima University Hospital’s Epilepsy Center was established in March 2013 and has been engaged in the comprehensive treatment of epilepsy with the cooperation of the neurosurgery, pediatric, and neuropsychiatry departments, as well as the nursing, laboratory, and social worker departments. The number of electroencephalography examinations has continued to increase since 2013. Clinical technologists have also been responsible for the electrode placement and management of long-term video electroencephalography monitoring since 2015. However, there were problematic differences in the performance of the electroencephalography machines, different methods of examination among the departments, and a lack of a hospital system. We aimed to establish a system for efficient operation and centralized management of the electroencephalography in the hospital during the machine upgrades in March 2022. As a result, we purchased three electroencephalography machines dedicated for electroencephalography and two dedicated for long-term video electroencephalography that could record videos and to standardize their performance. In addition, all the electroencephalography machines were integrated into the physiological function examination department system, and all electroencephalography data and reports could be viewed in the electronic medical records. Furthermore, the number of rooms equipped with LAN terminals in the hospital was increased for the workload required by long-term video electroencephalography, which reduced the laboratory staff’s workload. Unifying the electroencephalography management system and improving the environment of the hospital’s system, were carried out to achieve an efficient operation. In the future, we would like to further improve the present status of the Department of Clinical Laboratory with the medical departments’ cooperation.

  • Takumi ITABASHI, Keiji FUKASAWA, Masahiko KATSUYAMA, Hideo MARUTA
    Article type: Material
    2024 Volume 73 Issue 4 Pages 794-799
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    In Japan, the issue of overwork among doctors is a serious concern. To address this, from April 2024, new regulations will cap doctors’ overtime and holiday work hours. As a result, each medical facility must develop a plan to reduce doctors’ working hours. One proposed solution is task-shifting and task-sharing with clinical laboratory technicians. The Japan Association of Medical Technologists (JAMT) conducted surveys to understand the current situation of clinical laboratory technicians. The 2023 survey results indicated that 70% of facilities did not include their clinical laboratories in the internal meetings for developing these plans. To improve this trend, the analysis aimed to identify easy-to-implement strategies for facilities. It was found that facilities with good attendance at task-shifting and task-sharing training sessions had higher participation of clinical laboratory technicians in internal planning meetings. Therefore, it is urgent for those in management positions in clinical laboratories to emphasize the importance of task-shifting and task-sharing to facility administrators and to promote attendance at training sessions. Specifically, strategies to encourage younger technicians to attend and organizing training sessions at the facility’s expense are considered effective. This will likely lead to more proactive involvement of clinical laboratories in the planning process.

Case Report
  • Takahiro KIDO, Kayoko NOZAKI, Ryoko OSAKO, Yuki OKAMURA, Yuko KUBO, Yu ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 800-806
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    A 60-year-old man resented to our hospital with jaundice, ocular conjunctival hyperemia, liver dysfunction, kidney dysfunction, and low platelet counts. Abdominal ultrasonography (AUS) findings showed suggestion of acute hepatitis, including decreased brightness of the liver parenchyma, relative clarity of the internal vasculature, a collapsed gallbladder lumen, and marked thickening of the gallbladder wall. The blood test showed elevated levels of total bilirubin (T-Bil) and biliary enzymes, with only slight elevations in hepatic transaminases such as AST and ALT. The CT scan showed significant edematous thickening of the gallbladder wall, but no stones were detected in the common bile duct. On the 4th day of admission, AUS findings showed a normal morphology of the gallbladder. In contrast to the decreased biliary enzymes in the laboratory findings, T-Bil levels had risen to 13.96 mg/dL on the 11th day of admission. Leptospirosis was suspected based on his varied clinical symptoms, elevated biliary enzymes, markedly elevated T-Bil, and behavioral history. On the 15th day of admission, the patient was diagnosed with Weil’s disease (severe form of leptospirosis) based on positive antibodies and clinical symptoms such as ocular conjunctival hyperemia, jaundice, and acute kidney dysfunction. In addition to the elevated levels of bilirubin concentration and biliary enzymes activity, the discrepancy between acute hepatitis-like in AUS findings and nonsignificant elevated hepatic enzyme activity in the blood test is important for suspecting leptospirosis, leading to early diagnosis and treatment.

  • Saori SUZUKI, Masakazu OSADA, Mayu KAWAI, Wakana SUZUKI
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 807-813
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Burkholderia pseudomallei (B. pseudomallei) is an environmental bacterium distributed in soil and water. Common mode of infections include inhalation of dust or water droplets from contaminated soil and contact between skin wounds and soil. We encountered a case of B. pseudomallei infection that was detected in a pleural effusion. The patient was a Thai male. He was admitted to our hospital with fever, chills, pleural effusion, cardiomegaly, renal dysfunction, and elevated inflammatory response. Gram-negative bacilli were observed in a pleural fluid culture collected on admission. These bacilli formed smooth colonies on sheep blood agar and Drigalsky agar fractionated medium. Gram staining showed a characteristic clip-like appearance, and continued incubation on agar mediumresulted in mucoid colonies, that contracted and wrinkled after one week. Identification tests, including growth at 42°C, negative reaction on acetamide medium, and motility, confirmed that the pathogen was B. pseudomallei. Positive oxidase test and clavulanic (CVA/AMPC) and resistant to gentamycin (GM) and colistin (CL), which were consistent with the characteristics of B. pseudomallei. Furthermore, B. pseudomallei was identified by LAMP and Multiplex PCR. we review the literature and report on this rare case.

  • Yuya IWAKIRI, Noriaki KAWANO, Akira SATA, Shoji AWANO, Hiroko KUGIMIYA ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 814-821
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    To date, I. indica is a resident bacterium in the intestinal tract of flies, and can be detected in wounds with moths and ulcers on the feet of patients living in poor environment. Based on the Fear T’s case report and the summary of previously published 13 cases of Ignatzschineria infection, there were no previous case report in Japan. Herin, we first reported two cases of Ignatzschineria indica bacteremia in Japan. Due severe economic problems, two 70 year-male case and 80 year-female case lives in cars and hoarding house, respectively. Two cases had the ulcer of lower limbs. I. indica in two cases were identified in the culture of blood stream by mass spectrometry method. Thus, two cases successfully treated with antibiotics haboring the sensitivity for I. indica. To the best our knowledge, we first reported two cases of Ignatzschineria indica bacteremia in Japan. Thus, the clinicians should be considered the possibilities of I. indica infection for the cases with moths and ulcers on the feet of patients living in poor environment.

  • Mutsuko MORINAGA, Misao OKAMOTO, Satoko FURUKAWA, Hisaharu MITEKURA, S ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 822-830
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Blood gas analyzers can simultaneously measure not only gas analysis but also many other test items such as electrolytes, glucose, creatinine, and hemoglobin. Therefore, essential tests can be quickly obtained for initial medical treatment at the emergency scene or to assess the patient’s general condition in the event of a sudden change in medical condition. In the present case, we experienced a discrepancy between sodium (Na) levels measured by a blood gas analyzer (direct electrode method) and a general-purpose automatic analyzer (ion selective electrode dilution method) in a patient transported to our Advanced Emergency Medical Center for suspected drug poisoning. The results of the time series analysis of electrolyte parameters and blood drug detection after the patient’s arrival and the results of the addition test also suggested that the phenomenon of high Na deviation in the direct method was caused by atomoxetine. We searched for similar cases of sodium level deviation in past drug intoxication cases analyzed in our toxicology laboratory, and found no cases of high sodium level deviation, including drugs similar to the present case. The accompanying documentation for the blood gas analyzer listed several substances as interfering with sodium measurement, but did not list Atomoxetine, which was obtained in the present case. It is important to recognize that blood gas analyzers, which play an important role in initial medical care, are subject to a variety of interferences from a wide range of measurement items, and any discrepancies in measurements should be accurately reported to the clinical side.

  • Etsuko INOUE, Hitomi SHIBUYA, Yuko IKEMOTO, Ami HAYASHI, Hideaki INOUE
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 831-841
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Ordinarily, reaction time course in measurement of alanine aminotransferase (ALT) after adding a second reagent is decrease gradually in 340 nm, but we experienced a case in which an increase in absorbance was observed. Increasing an absorbance occurred at all 14 wavelengths used for the measurement. Immunoglobulin levels (IgG, IgA, and IgM) were within the standard range and no M protein was detected, but the results of immunoglobulin absorption test and reduction treatment indicated that IgM caused an abnormal reaction. To improve performance, some commercially available reagents contain ingredients other than the main ones. Considering the possibility that abnormal reactions may arose from there reagents, we measured the sample with the reagent prepared ourself, but the reaction time course was the same. When a surfactant was added to the first reagent of both the self-prepared reagent and the current reagent, the reaction time courses after adding a second reagent were not increased, and became common. These results suggest that the presence of strongly hydrophobic IgM may affected the ALT measurement.

  • Seiya SUZUKI, Hiroki UCHIDA, Takayoshi KOYASU, Kyota HANAMI, Sumiyo AD ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 842-849
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Background: Glomerular endotheliosis is the pathognomonic glomerular lesion in pre-eclampsia and has also been described in cancer patients treated with tyrosine kinase inhibitors. We report a case of glomerular endotheliosis revealed by kidney biopsy in a cancer patient receiving lenvatinib monotherapy followed by intermittent combination therapy with bevacizumab and atezolizumab. Case: The patient, a male in his sixties with advanced hepatocellular carcinoma, developed proteinuria and hypoalbuminemia, and therefore lenvatinib was discontinued 15 weeks after initiation. As improvement was evident 5 weeks after drug withdrawal, intermittent combination therapy with bevacizumab and atezolizumab was started, but as the urine protein and serum albumin levels again decreased, the medication was discontinued after 41 weeks. A renal biopsy demonstrated pre-eclampsia-like lesions on light and electron microscopy, including occlusion of glomerular peripheral capillary lumina by swollen reactive endothelial cells and diffuse thickening of the glomerular capillary basement membrane, resembling glomerular endotheliosis. Capillary endothelial damage caused by tyrosine kinase inhibitors on a background of diabetic nephropathy was diagnosed, and the patient was started on an angiotensin II receptor antagonist, resulting in a decrease of urinary protein to the pre-treatment level 3 months later. Conclusion: Administration of tyrosine kinase inhibitors to patients with renal impairment is associated with a high risk of severe proteinuria, and the initiation and continuation of medication requires careful consideration.

  • Hiroki UCHIDA, Kyota HANAMI, Takayoshi KOYASU, Seiya SUZUKI, Seiji KOB ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 850-856
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Scleroderma renal crisis (SRC) is a life-threatening complication of systemic sclerosis (SSc), characterized by new-onset progressive acute renal failure, often with associated microangiopathic hemolytic anemia (MAHA). Here, we report a patient who developed SRC prior to being diagnosed with SSc. A 78-year-old man consulted a family doctor with complaints of general fatigue and epigastralgia. Medical examination revealed progressive renal damage and thoracic esophageal cancer, and he was referred to our hospital. On admission, hypertension, bilateral pleural effusion, anemia, thrombocytopenia, and acute kidney damage were evident. A peripheral blood smear showed schistocytes with evidence of MAHA. Renal biopsy to clarify the diagnosis revealed marked edematous intimal expansion of the interlobular arteries and ischemic change with endothelial damage of the glomeruli, suggesting SRC. Subsequent systemic examination revealed a modified Rodman total skin thickness score (mRSS) of 27 points and positivity for anti-RNA polymerase III (RNAP 3) antibody. On this basis, a diagnosis of anti-RNAP-positive diffuse cutaneous SSc accompanied by SRC was made. Patients with anti-RNAP 3-positive SSc frequently develop SRC and are complicated by malignancies prior to diagnosis of SSc. Prompt diagnosis and appropriate treatment intervention are essential for this disease.

  • Akihiro ITO, Kentaro NAKAMOTO, Yasuaki GAMASAWA, Hisako SAKAMAKI, Taku ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 857-862
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    The patient was a Brazilian woman in her 40s. She consulted the department of general medicine at our hospital after a white, motile, and several centimeters long worm was found in her stool. The genus and species of the worm could not be identified. Therefore, we consulted an expert through Aichi Association of Medical Technologists. The worm was presumed to be a proglottid of the genus Taenia based on its morphological characteristics. We then performed a genetic test for identifying the species and estimating the origin of infection. Morphological observation revealed a genital pore located laterally. Injecting with India ink into the pore demonstrated uterine branches in the worm body. Next, Taenia eggs, which had a brown and radial embryophore, were detected by microscopic examination of liquid containing worm cut into small pieces. Furthermore, DNA was extracted from the worm, amplified by PCR and subjected to sequencing analysis, which confirmed the worm to be Taenia saginata. Next, the extracted DNA was compared with worldwide data by performing phylogenetic tree analysis; however, since the extracted DNA sequence was short, we could not estimate the origin of infection. Experience and knowledge have been limited about parasites because of decreasing the number of infections with parasites and examination. It is often the case that Identifying the genus and species is difficult based on morphological features. In this scenario, genetic testing is an extremely useful tool for species identification.

  • Yusuke SOTA, Tomoharu KONO, Nahoko TOCHIGI, Tatsuya TOCHIGI, Tomoko YA ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 863-868
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    Popliteal venous aneurysm (VA) can cause fatal pulmonary thromboembolism (PTE) and therefore, surgical treatment is indicated. A 40-year-old man developed PTE and visited a hospital where venous ultrasonography and a computed tomography (CT) scan were performed, but no source of embolism was found. PTE recurred after 3 months, whereupon we administered thrombolytic and anticoagulation therapy at our hospital. However, PTE recurred one month later. We performed venous ultrasonography that revealed a cavity associated with the popliteal vein, which was diagnosed as a popliteal VA. We performed surgery and there has been no recurrence of PTE.

  • Megumi TAKAGI, Shota YONETANI, Yoko IDA, Koji ARAKI, Hiroyuki MIYAGI, ...
    Article type: Case Report
    2024 Volume 73 Issue 4 Pages 869-874
    Published: October 25, 2024
    Released on J-STAGE: October 25, 2024
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    We encountered a suspected case of allergic bronchopulmonary mycosis (ABPM) caused by Schizophyllum commune. The patient, a woman in her 50s with a history of chronic cough, underwent a chest X-ray, which revealed infiltration in the right upper and middle lung fields. She was referred to our hospital for further assessment and treatment. Blood analysis indicated elevated eosinophil counts and serum total IgE levels. A chest CT scan revealed central bronchiectasis and a hyperabsorbable mucus plug, leading to the suspicion of ABPM. Consequently, the patient was admitted for a bronchoscopy. Gram-stained images of bronchoalveolar lavage fluid showed characteristic features of S. commune, including clamp connections and hyphal spicules at the septum of the fungus. Subsequent cultures of Sabouraud Dextrose CG agar medium showed the formation of white, cotton-wool-like colonies after 72 h of incubation. The cellophane tape method confirmed the presence of clamp connections and spicules. Additionally, the basidiocarp was observed after 10 days of incubation. The findings from the mass spectrometry and genetic analysis revealed the presence of S. commune. Treatment with itraconazole and prednisolone resulted in no recurrence. The results of genetic analysis and mass spectrometry were consistent, and identification by mass spectrometry was useful. When assessing specimens from patients suspected of ABPM, consideration should be given to S. commune in addition Aspergillus spp. Morphological characteristics of the mycelium should be meticulously observed under low magnification of the microscope when examining Gram-stained specimens.

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