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Objectives We conducted a nationwide external quality assessment (EQA) study of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification testing in Japan. Methods A total of 563 public health and private sector laboratories participated. The EQA samples comprised 6 RNA and full-process controls. Results The overall agreements were 99.3% and 97.9% for the RNA and full-process controls, respectively. A total of 530/563 (94.1%) laboratories reported correct results; public health laboratories had the highest accuracy. Thirty-three laboratories reported at least one incorrect result (26 laboratories of medical facilities, 5 commercial laboratories, 1 public health laboratory, and 1 other). Sixteen laboratories of medical facilities that used a fully automated assay system failed to detect the presence of the full-process control, due to inherent insufficiency in the limit of detection (LOD). Other causes of incorrect results included failure to ensure the LOD (n = 13), error in result judging or reporting (n = 3), and error in sample handling (n = 1). Conclusions Performance was mostly dependent on the laboratory category and assay evaluation, particularly the LOD. Guidance should be developed based on these results, particularly in the phase of new entry into laboratory services for SARS-CoV-2.

This study aimed to evaluate the usefulness of the LDN-PSA (LacdiNAc-glycosylated-prostate specific antigen) in detecting clinically significant prostate cancer in patients suspected of having clinically significant prostate cancer on multiparametric magnetic resonance imaging.Patients with prostate specific antigen levels ranging between 3.0 ng/mL and 20 ng/mL and suspicious lesions with PI-RADS (Prostate Imaging-Reporting and Data System) category ≥3 were included prospectively. The LDN-PSA was measured using an automated 2-step Wisteria floribunda agglutinin lectin-anti-prostate specific antigen antibody sandwich immunoassay.Two hundred four patients were included. Clinically significant prostate cancer was detected in 105 patients. On multivariable logistic regression analysis, prostate specific antigen density (OR 1.61,LDN-PSAD would be a biomarker for detecting clinically significant prostate cancer in patients with prostate specific antigen levels ≤20 ng/mL and suspicious lesions with PI-RADS category ≥3. The use of LDN-PSAD as an adjunct to the use of prostate specific antigen levels would avoid unnecessary biopsies in patients with the highest PI-RADS category 3. Multi-institutional studies with large population are recommended.

Various outcomes of mortality, medical costs, and antimicrobial usage result from antimicrobial stewardship (AS) programmes. Here, we clarified the effects of AS implementation by a well-trained pharmacist in an open intensive care unit (open ICU) through a retrospective, comparative study of 5123 open ICU patients of Tokai University Hospital. The 12 months before and after AS implementation were considered the control and study periods, respectively. After AS implementation, the number of AS cases increased significantly. The period until the implementation of therapeutic drug monitoring was significantly shortened, and antimicrobial drug usage increased significantly. The methicillin-resistant

Background Syphilis is a sexually transmitted disease caused by the spirochete Treponema pallidum. Recently, its incidence has been increasing worldwide. We encountered a young woman who presented with induration mimicking squamous cell carcinoma in the lower lip, without major medical conditions. Case presentation A 25-year-old Japanese woman presented with a 1-month history of a painless induration in her lower lip. Because squamous cell carcinoma was suspected, a preoperation work up was performed, including laboratory tests, an ultrasonographic examination, and a biopsy. The ultrasonography findings showed an oval-shaped 17 × 11 × 12 mm tumor-like lesion with heterogeneous internal echo and an indistinct border. A pressure test and color Doppler sonography revealed that the lesion was soft with a very abundant blood flow. These findings suggested the possibility of underlying inflammatory causes rather than a neoplastic tumor. Serology tests for syphilis, including the anti-Treponema pallidum antibody and reactive rapid plasma reagin tests, were positive. The biopsy revealed no malignancy. Finally, she was diagnosed as having primary syphilis and treated with amoxicillin for 28 days. The rapid plasma reagin value gradually decreased and the initial induration in her lower lip disappeared. Conclusion This case highlights the need for prompt examinations for possible underlying infective causes, such as syphilis, when seeing a painless induration with ulcer in the lip. Ultrasonography was helpful in the differential diagnosis of a tumor-like lesion and should be included in addition to syphilis serology tests, such as anti-Treponema pallidum antibody and rapid plasma reagin tests.

The crisis of the coronavirus disease (COVID-19) is causing damage to the social and medical community. However, extreme emergency neuro-interventions such as mechanical thrombectomy still require the healthcare workers to offer the appropriate treatment while preventing further spread of the infection. This article outlines the necessary steps in managing a possible COVID-19 patient starting from patient screening to personnel infection and environmental contamination measures.

Background Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is the causative agent of coronavirus disease 2019 (COVID‐19) and is capable of human‐to‐human transmission and rapid global spread. Thus, the establishment of high‐quality viral detection and quantification methods, and the development of anti‐SARS‐CoV‐2 agents are critical. Methods Here, we present the rapid detection of infectious SARS‐CoV‐2 particles using a plaque assay with 0.5% agarose‐ME (Medium Electroosmosis) as an overlay medium. Results The plaques were capable of detecting the virus within 36–40 h post‐infection. In addition, we showed that a monogalactosyl diacylglyceride isolated from a microalga (Coccomyxa sp. KJ) could inactivate the clinical isolates of SARS‐CoV‐2 in a time‐ and concentration‐dependent manner. Conclusions These results would allow rapid quantification of the infectious virus titers and help develop more potent virucidal agents against SARS‐CoV‐2., We presented the rapid detection of SARS‐CoV‐2 using a plaque assay within 36–40 h post‐infection. In addition, we showed that a compound from a microalga inactivated the virus.

Spread of drug-resistant bacteria is a serious problem worldwide. We thus designed a new sequence-based protocol that can quickly identify bacterial compositions of clinical samples and their drug-resistance profiles simultaneously. Here we utilized propidium monoazide (PMA) that prohibits DNA amplifications from dead bacteria, and subjected the original and antibiotics-treated samples to 16S rRNA metagenome sequencing. We tested our protocol on bacterial mixtures, and observed that sequencing reads derived from drug-resistant bacteria were significantly increased compared with those from drug-sensitive bacteria when samples were treated by antibiotics. Our protocol is scalable and will be useful for quickly profiling drug-resistant bacteria.

Ammonia is one of the members of odor gases and a possible source of odor in indoor environment. However, little has been known on the actual emission rate of ammonia from the human skin surface. Then, this study aimed to estimate the whole-body dermal emission rate of ammonia by simultaneous and multi-point measurement of emission fluxes of ammonia employing a passive flux sampler - ion chromatography system. Firstly, the emission fluxes of ammonia were non-invasively measured for ten volunteers at 13 sampling positions set in 13 anatomical regions classified by Kurazumi et al. The measured emission fluxes were then converted to partial emission rates using the surface body areas estimated by weights and heights of volunteers and partial rates of 13 body regions. Subsequent summation of the partial emission rates provided the whole body dermal emission rate of ammonia. The results ranged from 2.9 to 12mgh-1 with an average of 5.9±3.2mgh-1 per person for the ten healthy young volunteers. The values were much greater than those from human breath, and thus the dermal emission of ammonia was found more significant odor source than the breath exhalation in indoor environment.

We encountered a 45-year-old Japanese man who suffered from pulmonary thromboembolism and huge right ventricular thrombus after inferior vena cava (IVC) filter implantation without apparent thrombus in either the deep veins or inside the IVC filter. The biochemical data showed a discrepancy in the level of fibrinogen between the immunological and thrombin time methods, suggesting hypodysfibrinogenemia. The sequencing of the fibrinogen γ-chain gene (FGG) revealed a novel heterozygous missense mutation in exon 8 - a TGT to TCT transversion in codon 326 - resulting in an amino acid substitution of serine for cysteine (γCys326Ser). The characterization of the protein did not show known mechanisms for thrombosis in dysfibrinogenemia, such as dimer or albumin-binding complex formation. In summary, the current case with a life-threatening thrombotic event was found to have a novel heterozygous missense mutation resulting in γCys326Ser, which was suggested as a predisposing factor of the thrombosis. Known mechanisms responsible for thrombosis in the current case were not demonstrated, suggesting other mechanisms including superimposing inherited and/or acquired risk factors. When a patient presents with unusual thrombosis such as breakthrough pulmonary embolism and huge thrombus in the right ventricle, as in the current case, the laboratory process for heritable thrombophilia should be considered.

In the ongoing coronavirus disease 2019 (COVID-19) pandemic, PCR has been widely used for screening patients displaying relevant symptoms. The rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) enables prompt diagnosis and the implementation of proper precautionary and isolation measures for the patient. In the present study, we aimed to evaluate the basic assay performance of an innovative PCR system, GeneSoC® (Kyorin Pharmaceutical Co. Ltd., Tokyo, Japan). A total of 1,445 clinical samples were submitted to the clinical laboratory, including confirmed or suspected cases of COVID-19, from February 13 to August 31. Specimen types included nasopharyngeal swabs. The sampling was performed several times for each patient every 2–7 days. Using this system, sequences specific for SARS-CoV-2 RNA could be detected in a sample within 10–15 min using the microfluidic thermal cycling technology. Analytical sensitivity studies showed that GeneSoC® could detect the target sequence of the viral envelope and RNA-dependent RNA-polymerase (RdRp) genes at 5 and 10 copies/μL, respectively. The precision of the GeneSoC® measurements using clinical isolates of the virus at a concentration of 103 copies/μL was favorable for both the genes; within-run repeatability and between-run reproducibility coefficient of variation values were less than 3% and 2%, respectively; and the reproducibility of inter-detection units was less than 5%. Method comparison by LightCycler® 480 showed the positive and negative agreement to be 100% [(174/174) and (1271/1271), respectively]. GeneSoC® proved to be a rapid and reliable detection system for the prompt diagnosis of symptomatic COVID-19 patients and could help reduce the spread of infections and facilitate more rapid treatment of infected patients.

Background This study aimed to develop a simple and inexpensive method using the complete blood count (CBC) and differentials to screen for chronic myeloid leukemia (CML). Methods The receiver operating characteristic (ROC) curves of each CBC parameter, differential and the neutrophil alkaline phosphatase (NAP) score using CML and non-CML cases were generated to determine effective cut-off values. They were applied to the review of randomly-selected 45,608 samples for validation. Results The leukocyte count showed the highest area under the ROC curve (AUC) value (0.909) among the CBC parameters. In the absolute counts of differentials, the AUC was the highest in basophils (0.982), followed by immature granulocytes (IGs) (0.975), which had cut-off values of 0.43 × 109/L and 0.46 × 109/L, respectively. The AUC of the NAP score was 0.963 at a cut-off value 122. In the validation, the absolute basophil counts were elevated in 280 samples from 96 cases, including 22 CML cases. In contrast, the absolute IG counts were elevated in 1310 samples from 516 cases, including only 17 CML cases. Three newly-diagnosed CML cases whose data were analyzed sequentially at the CML onset consistently met the basophil criteria before the IG criteria. Conclusions The absolute basophil count is effective for screening for CML.

BACKGROUND AND OBJECTIVES Chronic obstructive pulmonary disease (COPD) mainly develops after long-term exposure to cigarette or biomass fuel smoke, but also occurs in non-smokers with or without a history of asthma. We investigated the proportion and clinical characteristics of non-smokers among middle-aged to elderly subjects with airflow obstruction. METHODS We retrospectively analyzed 1,892 subjects aged 40-89 years who underwent routine preoperative spirometry at a tertiary university hospital in Japan. Airflow obstruction was defined as a forced expiratory volume in 1 second (FEV1)/forced vital capacity < 0.7 or as the lower limit of the normal. RESULTS Among 323 patients presenting with FEV1/forced vital capacity < 0.7, 43 had asthma and 280 did not. Among the non-asthmatic patients with airflow obstruction, 94 (34%) were non-smokers. A larger number of women than men with airflow obstruction had asthma (26% vs. 7.6%, p < 0.001), or were non-smokers among non-asthmatics (72% vs. 20%, p < 0.001). Non-asthmatic non-smokers, rather than non-asthmatic smokers, asthmatic non-smokers, and asthmatic smokers, exhibited better pulmonary function (median FEV1: 79% of predicted FEV1 vs. 73%, 69%, and 66%, respectively, p = 0.005) and less dyspnea on exertion (1% vs. 12%, 12%, and 28%, respectively, p = 0.001). Pulmonary emphysema on thoracic computed tomography was less common in non-smokers (p < 0.001). Using the lower limit of the normal to define airflow obstruction yielded similar results. CONCLUSIONS There are a substantial number of non-smokers with airflow obstruction compatible with COPD in Japan. In this study, airflow obstruction in non-smokers was more common in women and likelier to result in mild functional and pathological abnormalities than in smokers. Further studies are warranted to investigate the long-term prognosis and appropriate management of this population in developed countries, especially in women.

In recent years, the diagnostic method of choice for Clostridium difficile infection (CDI) is a rapid enzyme immunoassay in which glutamate dehydrogenase (GDH) antigen and C. difficile toxin can be detected (C. diff Quik Chek Complete; Alere Inc.) (Quik Chek). However, the clinical significance remains unclear in cases that demonstrate a positive result for GDH antigen and are negative for toxin. In this study, we used the Quik Chek test kit on fecal samples, with an additional toxin detection step using a toxigenic culture assay for the aforementioned cases. CDI risk factors were assessed among the 3 groups divided by the Quik Chek test results. The study involved 1,565 fecal samples from patients suspected to have CDI who were hospitalized during the period of April 2012 to March 2014. The 3 groups were defined as follows: both GDH antigen positive and toxin positive (by Quik Chek test) (toxin-positive [TP] group, n = 109), both GDH antigen and toxin negative (toxin-negative [TN] group, n = 111), and positive only for GDH antigen but toxin positive with subsequent toxigenic culture (toxigenic culture [TC] group, n = 72). The gender, age, number of hospitalization days, white blood cell (WBC) counts, serum albumin levels, body mass index (BMI), fecal consistency, and use of antibacterials and proton pump inhibiters (PPIs) were analyzed. The positive rate for the fecal direct Quik Chek test was 7.0% (109/1,565 cases). However, toxigenic culture assays using the Quik Chek test for only the GDH-antigen-positive/toxin-negative samples were 35.3% positive (72/204 cases). As a result, the true positive rate for C. difficile toxin detection was estimated to be 11.6% (181/1,565 cases). Moreover, significant differences (P < 0.05) in the number of hospitalization days (>50 days), WBC counts (>10,000 WBCs/μl), and use of PPIs comparing the TN, TP, and TC groups, were observed. The odds ratios (ORs) for the development of CDI were 1.61 (95% confidence interval [CI], 0.94 to 2.74) and 2.98 (95% CI, 1.59 to 5.58) for numbers of hospitalization days, 2.16 (95% CI, 1.24 to 3.75) and 2.24 (95% CI, 1.21 to 4.14) for WBC counts, and 9.03 (95% CI, 4.9 to 16.6) and 9.15 (95% CI, 4.59 to 18.2) for use of PPIs in the TP and TC groups, respectively. These findings demonstrated that the use of PPIs was a significant risk factor for CDI development. Moreover, antibacterials such as carbapenems, cephalosporins, and fluoroquinolones were demonstrated to be risk factors. In conclusion, identification of the TC group of patients is thought to be important, as this study demonstrates that this group bears the same high risk of developing CDI as the TP group.

OBJECTIVES To evaluate the usefulness of sonography for monitoring the response to glucocorticoid treatment in patients with immunoglobulin G4 (IgG4)-related disease. METHODS We conducted a retrospective study using sonography in 12 patients with bilateral swollen submandibular glands who had a diagnosis of IgG4-related disease based on an elevated serum IgG4 level (>135 mg/dL) and histopathologic findings between January 2010 and December 2012. Among these patients, 6 were treated with prednisolone, and the other 6 were placed under observation. B-mode sonographic examinations of the submandibular glands were performed with or without color Doppler imaging at the initial examination and 6 months later. Findings were compared between the groups (treated and untreated), and their relationship with the treatment response of the primarily involved organs was investigated. RESULTS In the treated group, the submandibular glands of all 6 patients decreased in both size and volume after treatment (average volume ± SD, 27,449.7 ± 24,227.6 to 4609.7 ± 1911.4 mm(3); P = .004). The internal echo texture, characterized by multiple hypoechoic foci scattered against a heterogeneous hyperechoic background of submandibular tissue with demarcated hyperechoic lines, with or without hypoechoic tumor formation, disappeared or was obscured in all cases. In addition, the blood flow signals were reduced in all 3 patients who underwent color Doppler sonography, and the response observed on sonography was found to correlate with the IgG4 level and recovery of specific organ involvement. In contrast, in the untreated group, the submandibular glands showed a tendency to increase in both size and volume (average volume, 9326.3 ± 3054.8 to 12,217.4 ± 4605.5 mm(3); P= .2) without a decrease in the blood flow signals. CONCLUSIONS Sonography is considered useful for evaluating the response to glucocorticoid therapy in patients with IgG4-related disease of the submandibular glands.

A series of clinical isolates of drug-resistant (DR)Acinetobacter baumanniiwith diverse drug susceptibility was detected from eight patients in the emergency intensive care unit of Tokai University Hospital. The initial isolate was obtained in March 2010 (A. baumanniiTokai strain 1); subsequently, seven isolates were obtained from patients (A. baumanniiTokai strains 2–8) and one isolate was obtained from an air-fluidized bed used by five of the patients during the 3 months from August to November 2011. The isolates were classified into three types of antimicrobial drug resistance patterns (RRR, SRR and SSR) according to their susceptibility (S) or resistance (R) to imipenem, amikacin and ciprofloxacin, respectively. Genotyping of these isolates by multilocus sequence typing revealed one sequence type, ST208, whilst that by a DiversiLab analysis revealed two subtypes. All the isolates were positive forblaOXA-51-likeandblaOXA-66, as assessed by PCR and DNA sequencing.A. baumanniiTokai strains 1–8 and 10 (RRR, SRR and SSR) had quinolone resistance-associated mutations ingyrA/parC, as revealed by DNA sequencing. The ISAba1upstream ofblaOXA-51-likeand aminoglycoside resistance-associated gene,armA, were detected inA. baumanniiTokai strains 1–7 and 10 (RRR and SRR) as assessed by PCR. Among the genes encoding resistance–nodulation–division family pumps (adeB, adeGandadeJ) and outer-membrane porins (oprDandcarO), overexpression ofadeBandadeJand suppression ofoprDandcarOwere seen in isolates ofA. baumanniiTokai strain 2 (RRR), as assessed by real-time PCR. Thus, the molecular characterization of a series of isolates of DRA. baumanniirevealed the outbreak of ST208 and diverse antimicrobial drug susceptibilities, which almost correlated with differential gene alterations responsible for each type of drug resistance.

An outbreak of amikacin- and ciprofloxacin-resistant Acinetobacter baumannii ST219 in Tokai University hospital's emergency intensive care unit was caused by its colonization in water systems and subsequent spread through oral care using tap water. The outbreak was successfully controlled after replacement of the water system and implementation as of daily cleaning of water taps and oral care with a dry method. It is important to strictly manage the water system in critical care areas.

To control carbapenem-resistant Pseudomonas aeruginosa, we implemented a hospital-wide policy concerning the selective use of carbapenems based on the monitoring of P. aeruginosa isolates for susceptibility to five carbapenems using a customized dry plate method. In this study, we retrospectively investigated the outcome of our measures to control carbapenem-resistant P. aeruginosa.To select effective carbapenems, 100 clinical isolates were collected, and the minimum inhibitory concentration (MIC) to 5 carbapenems (IPM/CS, MEPM, DRPM, BIPM and PAPM/BP) was monitored using a customized dry plate method from 2006 to 2013. Carbapenems, which were associated with a high rate of drug resistance in P. aeruginosa, were restricted from use during our intervention study. The antimicrobial use density per 100 bed-days (AUDThe isolates consistently showed higher rates of drug-resistant P. aeruginosa in IPM/CS and PAPM/BP. Thus, DRPM, MEPM and BIPM were adopted for hospital-wide use. The detection rates of all IPM/Cs and MEPM-resistant P. aeruginosa significantly decreased. Meanwhile, the consumption of carbapenems showed an increasing trend.The outcome of the hospital-wide implementation of the selective use of carbapenems based on periodic monitoring of the susceptibility of P. aeruginosa isolates was retrospectively studied. Implementation of this measure might have contributed in part to the control of carbapenem-resistant P. aeruginosa in our hospital.

We encountered a 45-year-old Japanese man who suffered from pulmonary thromboembolism and huge right ventricular thrombus after inferior vena cava (IVC) filter implantation without apparent thrombus in either the deep veins or inside the IVC filter. The biochemical data showed a discrepancy in the level of fibrinogen between the immunological and thrombin time methods, suggesting hypodysfibrinogenemia. The sequencing of the fibrinogen γ-chain gene (FGG) revealed a novel heterozygous missense mutation in exon 8 - a TGT to TCT transversion in codon 326 - resulting in an amino acid substitution of serine for cysteine (γCys326Ser). The characterization of the protein did not show known mechanisms for thrombosis in dysfibrinogenemia, such as dimer or albumin-binding complex formation. In summary, the current case with a life-threatening thrombotic event was found to have a novel heterozygous missense mutation resulting in γCys326Ser, which was suggested as a predisposing factor of the thrombosis. Known mechanisms responsible for thrombosis in the current case were not demonstrated, suggesting other mechanisms including superimposing inherited and/or acquired risk factors. When a patient presents with unusual thrombosis such as breakthrough pulmonary embolism and huge thrombus in the right ventricle, as in the current case, the laboratory process for heritable thrombophilia should be considered.

The fractions and polysaccharides from Sasa veitchii were evaluated for their preventive effects on influenza A virus (IFV-A) infection. In IFV-A infected mice, the high-molecular portion (SH) of hot-water extract from S. veitchii significantly reduced virus yields in lung and bronchoalveolar lavage fluid (BALF) and increased in IFV-A-specific secretory IgA in BALF and intestine samples, and neutralizing antibody titers in BALFs and sera. Separation of SH by combination with ion-exchange column and gel filtration yielded six purified polysaccharides. Among them, SH2A1B1 with molecular weight of 29.7 kDa was found to reduce virus yields in lung as well as BALF in IFV-A-infected mice. A significant increase in the production of neutralizing antibody was also observed in BALFs on day 15 post-infection. Furthermore, significant enhancement of nitrite oxide production in RAW 264.7 cells was observed. These results suggest that the fractions from S. veitchii and SH2A1B1 could provide useful materials for prevention of IFV-A infection.

Background Conventional automated hematology analyzers have limitations in platelet measurements such as poor accuracy and precision in the low count range and interference by nonplatelet particles. In order to improve it, the newly developed XN-Series automated hematology analyzers (Sysmex Corporation, Kobe, Japan) have been installed with a new dedicated channel for platelet analysis (PLT-F), which is based on a fluorescence flow cytometry method with uses of a novel fluorescent dye specifically staining platelets. We evaluated the basic performance of this new PLT-F channel. Methods Basic performance of the PLT-F channel in within-run reproducibility and assay linearity was studied using standard methods. Correlation was studied between PLT-F and a conventional automated hematology analyzer (XE-2100) and immunoplatelet analysis using anti-CD61 monoclonal antibody (Cell-Dyn Sapphire; Abbott Laboratories). The assay interference by nonplatelet particles such as fragmented red and white blood cells was evaluated by using clinical samples, respectively, from burn injury and acute leukemia. Results Basic performance of the PLT-F platelet counting was satisfactory in within-run reproducibility, linearity and correlation with the conventional analyzer. The correlation was satisfactory also with the immunoplatelet analysis, even for samples from a patient with burn injury, and those with white blood cell fragments displayed, platelet abnormal flag and low platelet counts (

Visualization is a very fruitful technique for interpreting numerical data. However, when data change, the visualization also needs to change. Therefore, this study introduces two applications that interactively visualize changes to data items. Data examined in this study were from tests conducted on patients admitted to the Department of Emergency & Critical Care Medicine, Tokai University Hospital School of Medicine between 2006 and 2014.

The purpose of this study was to assess the relationship between the sonographic characteristics of the submandibular glands and organ involvement at the initial presentation in patients with immunoglobulin G4 (IgG4)-related disease.We conducted a retrospective study that included 15 patients who had bilateral swollen submandibular glands and elevated serum IgG4 levels between January 2005 and December 2010.In all 15 patients, sonography revealed the involvement of both sides of the submandibular glands. The sonographic appearance of each gland was classified into two types: localized tumor-forming and diffuse focal types. On the basis of this typing, all 15 patients were classified into two groups: a group with the localized tumor-forming type observed on one or both sides of the glands (n = 10) and a group with the diffuse focal type present on both sides (n = 5). All 10 patients in the former group had lesions in local exocrine organs, such as the lacrimal and parotid glands, with regional lymphadenopathy. In contrast, all 5 patients in the latter group had lesions in abdominal organs, such as autoimmune pancreatitis and sclerosing cholangitis.The sonographic patterns of the submandibular glands in patients with IgG4-related disease can be divided into two types: localized tumor-forming and diffuse focal. The distinctive patient groups defined by the sonographic patterns in both glands were associated with differential organ involvement and thus could be used as indicators of the disease extension and specific organ involvement.