Evaluation of an immunochromatography-based rapid antigen test, Inspecter Kowa® SARS-CoV-2, using saliva specimens for the detection of SARS-CoV-2.

BACKGROUND: In the context of the coronavirus disease 2019 (COVID-19) pandemic, a rapid and reliable point-of-care test is an essential tool for controlling the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In particular, an immunochromatography test (ICT) that uses saliva specimens for rapid antigen detection not only reduces the risk of secondary infections but also reduces the burden on medical personnel. METHODS: The newly developed salivary antigen test kit "Inspecter Kowa® SARS-CoV-2" is an ICT to which saliva specimens can be directly applied. We evaluated its usefulness in comparison with reverse transcription quantitative PCR (RT-qPCR) and the Espline® SARS-CoV-2 Kit for the detection of SARS-CoV-2 using nasopharyngeal swab specimens. In this study, 140 patients with suspected symptomatic COVID-19 who visited our hospital were enrolled, and nasopharyngeal swab and saliva specimens were collected after they consented to participate in the study. RESULTS: Inspector Kowa SARS-CoV-2 was positive in 45 of 61 (73.8%) saliva that were positive by RT-qPCR and the Espline® SARS-CoV-2 Kit was also positive in 56 of 60 (93.3%) Np swabs that were positive by RT-qPCR. Good antigen detection was achieved by ICT with saliva and nasopharyngeal swab specimens when viral load was ≥105 copies/mL, whereas detection sensitivity was low when viral load was <105 copies/mL, especially in saliva specimens. CONCLUSION: This ICT for the detection of SARS-CoV-2 salivary antigen is an attractive tool that does not require specialized equipment and allows patients to perform the entire process from sample collection to self-diagnose and to reduce the burden on medical care during a pandemic.

Utility and safety of robot-assisted radical cystectomy in older patients with bladder cancer.

Introduction: This study aimed to investigate the efficacy and safety of robot-assisted radical cystectomy (RARC) in older patients with bladder cancer (BCa).Material and methods: We reviewed the clinical and pathological records of 110 patients with BCa who underwent RARC at Gifu University Hospital between February 2019 and January 2023. Older patients were defined as those with BCa aged ≥ 75 years. The enrolled patients were divided into two groups: those aged < 75 years (Group I) and those aged ≥ 75 years (Group II). Oncological outcomes, including overall survival (OS) and recurrence-free survival (RFS), were the primary endpoints of the study; the secondary endpoints were the surgical and pathological outcomes.Results: A shorter console time, less blood loss, and reduced time to postoperative fluid and food intake in Group II may be attributed to the fact that more patients opted for ureterocutaneostomy in Group II than in Group I. In all patients, the three-year OS and RFS rates were 84.7% and 88.5%, respectively. There were no significant differences in OS or RFS between the two groups. (p = .403, p = .963, respectively).Conclusions: RARC appears to be a safe and useful treatment option for older patients with BCa.

Evaluation of the correlation between the access SARS-CoV-2 IgM and IgG II antibody tests with the SARS-CoV-2 surrogate virus neutralization test.

Fully automated immunoassays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies that are strongly correlated with neutralization antibodies (nAbs) are clinically important because they enable the assessment of humoral immunity after infection and vaccination. Access SARS-CoV-2 immunoglobulin M (IgM) and immunoglobulin G (IgG) II antibody tests are semi-quantitative, fully automated immunoassays that detect anti-receptor-binding domain (RBD) antibodies and might reflect nAb levels in coronavirus disease 2019 (COVID-19). However, no studies have investigated the clinical utility of these tests in association with nAbs to date. To evaluate the clinical utility of Access SARS-CoV-2 IgM and IgG II antibody tests and their correlation with the SARS-CoV-2 surrogate virus neutralization test (sVNT) that measures nAbs in patients with COVID-19, we analyzed 54 convalescent serum samples from COVID-19 patients and 89 serum samples from non-COVID-19 patients. The presence of anti-RBD antibodies was detected using Access SARS-CoV-2 IgM and IgG II antibody tests, while nAbs were measured by sVNT. The sensitivity and specificity of sVNT were 94.4% and 98.9%, respectively. There were strong positive correlations between the inhibition values of sVNT and the results of the Access SARS-CoV-2 IgM (R = 0.95, R2 = 0.90, p < 0.001) and IgG II antibody tests (R = 0.96, R2 = 0.92, p < 0.001). In terms of the presence of nAbs, the sensitivity and specificity were 98.1% and 98.9% in the IgM assay and 100.0% and 100.0% in the IgG II assay, respectively. The Access SARS-CoV-2 IgM and IgG II antibody tests showed high sensitivity and specificity for the detection of nAbs in COVID-19 patients and might be alternatives for measuring nAbs.

Diabetes Mellitus as a Predictive Factor for Urinary Tract Infection for Patients Treated with Kidney Transplantation.

Background and Objectives: We aimed to investigate the rate of incidence and risk factors of post-transplant urinary tract infection (UTI) in patients receiving kidney transplantation (KT) at our institution. Materials and Methods: A retrospective cohort study was carried out on patients who underwent KT for end-stage kidney disease (ESKD) from January 2008 to December 2021 at Gifu University Hospital. UTI was defined as the existence of bacterial and/or fungal infection in urine with ≥105 colony-forming units/mL, with or without urinary and/or systemic symptoms of UTI. Patients were divided into two groups: those with UTI after KT (UTI group) and those without UTI (non-UTI group). The primary endpoint of this study was the relationship between covariates and UTI after KT. Results: Two hundred and forty patients with ESKD received KT at Gifu University Hospital. Thirty-four participants developed UTI after surgery, and the most common pathogen was Escherichia coli. At the end of the follow-up, graft loss was observed in six patients (2.5%), independent of UTI episodes. In the multivariate analysis, diabetes mellitus (DM) was statistically associated with post-transplant UTI in kidney transplant recipients. Conclusions: Preoperative serum glucose control in patients with DM may have a crucial role in preventing UTI and preserving renal function after KT.

Validation of standardized training system for robot-assisted radical prostatectomy: comparison of perioperative and surgical outcomes between experienced surgeons and novice surgeons at a low-volume institute in Japan.

INTRODUCTION: Although robot-assisted radical prostatectomy (RARP) has become a standard treatment modality in patients with prostate cancer (PCa), RARP is a complicated and difficult surgical procedure due to the risk of serious surgery-related complications. This study aimed to evaluate the validation of a standardized training system for RARP in patients with PCa at a single institute. MATERIAL AND METHODS: We retrospectively reviewed the clinical and pathological records of 155 patients with PCa who underwent RARP at Gifu University between August 2018 and April 2021. We developed an institutional program for new surgeons based on the separation of the RARP procedure into six checkpoints. The primary endpoints were surgical outcomes and perioperative complications among three groups (expert, trainer, and novice surgeon groups). RESULTS: The console time was significantly longer in the novice surgeon group than in the other groups. Regarding bladder neck dissection, ligation of lateral pedicles, and vesicourethral anastomosis, the operative time was significantly shorter in the expert group than in the other groups. Surgery-related complications occurred in 15 patients (9.7%). CONCLUSIONS: Our training system for RARP might help reduce the influence of the learning curve on surgical outcomes and ensure that the surgeries performed at low-volume institutions are safe and effective.

[A Case of Penile Strangulation Due to Metal Rings Released with the Cooperation of a Rescue Team].

In this report, we describe a case of penile strangulation via metal rings. A 65-year-old Japanese man was transferred to the emergency room of our hospital for, dysuria and penile pain following penile incarceration with metal rings. Five metal rings approximately 30 mm in diameter were incarcerated to the penile root. Physical examination, revealed marked penile swelling distal to the rings. Various methods including the use of a ring cutter, were attempted to relieve the penial strangulation. However, these techniques failed, prompting referral to a rescue team. We started cutting the rings with an air cutter. After, 90 minutes, the rings were successfully removed. This study highlights the benefit of early cooperation with the rescue team in managing patients with mechanical penile strangulation.

[A Case Report of a Patient with Metastatic Adrenocortical Carcinoma who Received the Combination Etoposide, Doxorubicin, Cisplatin, and Mitotane Therapy and Achieved Remission].

A 40-year-old Japanese female was referred to our institution with a high serum lactate dehydrogenase level. Computed tomography (CT) showed a large right adrenal tumor, 14 cm in size without distant metastases. The patient was clinically diagnosed with T2N0M0 adrenocortical carcinoma and underwent right adrenalectomy. The pathological diagnosis was adrenocortical carcinoma with negative surgical margin. The patient was administered mitotane for 2 years as adjuvant therapy. Subsequently, CT revealed asynchronous multiple metastases, including liver, lung, left kidney, and right acetabulum. The patient received 15 courses of EDP (a combination of etoposide, doxorubicin, and cisplatin) plus mitotane therapy, and had stable disease without new lesions.

Evaluation of a chemiluminescent enzyme immunoassay-based high-throughput SARS-CoV-2 antigen assay for the diagnosis of COVID-19: The VITROS® SARS-CoV-2 Antigen Test.

A high-throughput, fully automated antigen detection test for SARS-CoV-2 is a viable alternative to reverse-transcription polymerase chain reaction (RT-qPCR) for mass screening during outbreaks. In this study, we compared RT-qPCR for viral load and the VITROS® SARS-CoV-2 Antigen Test with reference to the results of the LUMIPULSE® SARS-CoV-2 Ag Test. Of 128 nasopharyngeal swab specimens taken from patients suspected of being infected with SARS-CoV-2, 49 were positive and 79 were negative according to RT-qPCR. Consistent dose-dependent detection with VITROS® assay was successfully achieved when using nasopharyngeal swab specimens with Ct values of 32.0 or lesser, whereas the CLEIA-based LUMIPULSE® assay was able to detect lower viral loads compared with the VITROS® assay. Our results show that the performance of the VITROS® assay was satisfactory for the diagnosis of contagious COVID-19 patients in the clinical setting. Highlights The performance of the VITROS® SARS-CoV-2 Antigen Test was sufficient for the diagnosis of contagious COVID-19. This test showed high sensitivity and specificity in the detection of SARS-CoV-2 in samples with a Ct value of 32 or less.

Antibody response patterns in COVID-19 patients with different levels of disease severity in Japan.

We analyzed antibody response patterns according to the level of disease severity in patients with novel coronavirus disease 2019 (COVID-19) in Japan. We analyzed 611 serum specimens from 231 patients with COVID-19 (mild, 170; severe, 31; critical, 30). Immunoglobulin M (IgM) and IgG antibodies against nucleocapsid protein (N) and spike 1 protein (S1) were detected by enzyme-linked immunosorbent assays. The peaks of fitting curves for the optical density (OD) values of IgM and IgG antibodies against N appeared simultaneously, while those against S1 were delayed compared with N. The OD values of IgM against N and IgG against both N and S1 were significantly higher in the severe and critical cases than in the mild cases at 11 days after symptom onset. The seroconversion rates of IgG were higher than those of IgM against both N and S1 during the clinical course based on the optimal cut-off values defined in this study. The seroconversion rates of IgG and IgM against N and S1 were higher in the severe and critical cases than in the mild cases. Our findings show that a stronger antibody response occurred in COVID-19 patients with greater disease severity and there were low seroconversion rates of antibodies against N and S1 in the mild cases.

[A Case of Pyonephrosis Due to Urethral Stent Forgotten for 4 Years].

A 53-year-old woman had left pyonephrosis and bladder stone. A double-J ureteral stent was placed for left ureterostenosis and she was lost to followup. Five years later, she had back pain. Computed tomography revealed left hydronephrosis, pyonephrosis and bladder stone. After drainage by percutaneous nephrostomy and antibiotic treatment, left nephroureterectomy was performed. She has been free from recurrence of infection for 3 months after the surgery.

[A Case of Mucinous Adenocarcinoma Extending to Bladder Neck and Prostate].

A 56-year-old man visited a clinic with the chief complaint of frequent micturition and residual sensation of urine. He was referred to our hospital for close examination. Cystoscopy showed a tumor protruding toward the bladder neck from the prostate with stones and debris on the surface. Magnetic resonance imaging showed an encapsulated tumor of iso-intensity in the prostate in T2-weighed images. Prostate specific antigen was 0.88 mg/dl. Transurethral resection of prostate was performed under the diagnosis of benign prostate hyperplasia. During the operation, a solid tumor with mucus deposit was observed. Intraoperative rapid pathological diagnosis was mucinous adenocarcinoma. A radical cystectomy was performed. Pathologically, mucinous adenocarcinoma was distributed in the bladder neck, the prostate and surrounding tissue, but the prostatic urethra was intact. The surgery was assessed to be curative. Neither neoadjuvant nor adjuvant chemotherapy was performed, since the effectiveness of chemotherapy for mucinous adenocarcinoma arising from urothelial epithelium has not been established.

Antimicrobial susceptibility and prevalence of resistance genes in Bacteroides fragilis isolated from blood culture bottles in two tertiary care hospitals in Japan.

The in vitro susceptibilities of Bacteroides fragilis to antimicrobial agents, especially to carbapenem, are a major concern in the treatment of patients with bloodstream infections. In this study, 50 isolates of B. fragilis were obtained from positive blood bottles from 2014 to 2019 in Saitama, Japan. Their susceptibility to ampicillin/sulbactam was reduced to 70.0% compared with a previous report, whereas they were still sufficiently susceptible to piperacillin/tazobactam (94.0%). Five cfiA-positive isolates (5/50, 10.0%) were identified that were resistant to doripenem and meropenem, and two of them carried an insertion sequence located upstream of the cfiA-coding region. In particular, imipenem should be considered as a first-line carbapenem for the empirical treatment of B. fragilis infection because only insertion sequence and cfiA double-positive strains showed resistance to imipenem. Thirty-six percent of the isolates had a reduced minimum inhibitory concentration for moxifloxacin. In addition, metronidazole should still be considered as an active agent for B. fragilis because all isolates were susceptible to this antibiotic and the prevalence of the nim gene was low in Japan.

[A Case of Squamous Cell Carcinoma of the Renal Pelvis that Disseminated to the Nephrostomy Tract after Percutaneous Nephrolithotripsy].

A 50-year-old man was diagnosed with right staghorn calculus. Urine cytology showed atypical cells, and he was followed for suspicion of urothelial carcinoma. However, there was no evidence of tumor six months later, and percutaneous nephrolithotripsy (PNL) was performed for right staghorn calculus. Eight months later, renal pelvic squamous cell carcinoma extending to the abdominal wall through the nephrostomy tract was identified. After neoadjuvant chemotherapy, radical nephroureterectomy and enbloc resection of the nephrostomy tract tumor was performed. The renal pelvic squamous cell carcinoma did not recur. However he died of small cell lung cancer 3 years postoperatively. Planning of treatment strategy was difficult in the present case. Even though PNL was performed after sufficient follow up and examination, renal pelvic cancer could not be diagnosed and extended to the PNL tract. Fortunately, radical en-bloc resection was possible. We herein, report a case of renal pelvic squamous cell carcinoma after PNL.

Clinical characteristics in blood stream infections caused by Klebsiella pneumoniae, Klebsiella variicola, and Klebsiella quasipneumoniae: a comparative study, Japan, 2014-2017.

BACKGROUND: Klebsiella variicola and K. quasipneumoniae are new species distinguishable from K. pneumoniae but they are often misidentified as K. pneumoniae in clinical settings. Several reports have demonstrated the possibility that the virulence factors and clinical features differ among these three phylogroups. In this study, we aimed to clarify whether there were differences in clinical and bacterial features between the three phylogroups isolated from patients with bloodstream infections (BSIs) in Japan. METHODS: Isolates from all patients with BSIs caused by K. pneumoniae admitted to two hospitals between 2014 and 2017 (n = 119) were included in the study. Bacterial species were identified via sequence analysis, and their virulence factors and serotypes were analyzed via multiplex PCR results. Clinical data were retrieved from medical records. RESULTS: Of the 119 isolates, 21 (17.7%) were identified as K. variicola and 11 (9.2%) as K. quasipneumoniae; K1 serotype was found in 16 (13.4%), and K2 serotype in 13 (10.9%). Significant differences in the prevalence of rmpA, iutA, ybtS, entB and kfu (p < 0.001), and allS genes (p < 0.05) were found between the three phylogroups. However, there were no significant differences in clinical features, including the 30-day mortality rate, between the three organisms, although K. variicola was more frequently detected in patients over 80 years old compared with other Klebsiella species (p < 0.005), and K. quasipneumoniae more frequently occurred in patients with malignancy (p < 0.05). CONCLUSIONS: Our findings demonstrated the differences in bacterial pathogenicity and clinical features among these three phylogroups. Further epidemiological studies into BSI caused by Klebsiella species are warranted.

[Cardiac Metastasis in a Patient with Clear Cell Renal Cell Carcinoma who Underwent Multimodality Therapy for Multiple Metastases after Radical Nephrectomy].

The patient underwent laparoscopic left radical nephrectomy for clear cell renal cell carcinoma (ccRCC). After surgery, the patient had multiple lung metastases and underwent the combination therapy of radiofrequency ablation, interferon-alpha, and inteleukin-2. Thereafter, computed tomography showed multiple lymph node and brain metastases. The patient was administered targeted therapy and radiation. Eventually, the patient suddenly complained of dyspnea. An echocardiogram, coronary angiography and magnetic resonance imaging suggested acute heart failure and pericardial effusion due to a metastatic tumor in the cardiac anteroseptal and posterior wall. Nivolumab was administered for cardiac metastases. The patient has been in stable condition with no progression of cardiac metastases after the administration of nivolumab for 22 months.

Combination approach using neoadjuvant therapy with radical prostatectomy for improving oncological outcomes of high-risk prostate cancer: a narrative review.

Background and Objective: Prostate cancer (PCa) is the most common cancer in men. High-risk PCa is associated with an increased risk of PCa-related death. The combined use of androgen deprivation therapy (ADT) is essential to improve oncological outcomes in patients with high-risk PCa, and relatively long-term ADT administration is preferred when radiotherapy is performed. Meanwhile, whether neoadjuvant therapy for radical prostatectomy (RP) improves oncological outcomes remains controversial. This study aimed to review the oncological outcomes of RP in high-risk PCa and emphasize the significance of neoadjuvant therapy including neoadjuvant hormonal therapy (NHT) and neoadjuvant chemohormonal therapy (NCHT) followed by RP for managing high-risk PCa. Methods: We searched for articles published in the PubMed and Scopus databases from January 1, 2005 to March 30, 2023 using the medical subject headings (MeSH) terms: prostate cancer, prostatectomy, radiation therapy, neoadjuvant therapy, and treatment outcome. Key Content and Findings: The study on NHT before RP for high-risk PCa found that NHT was associated with reduced adverse pathological features, such as pT3, positive surgical margins (PSM), and lymph node involvement. However, despite shorter operative times and improved surgical outcomes, NHT did not significantly enhance biochemical recurrence (BCR) or other oncological outcomes. The combination therapy using ADT and androgen receptor signaling inhibitors (ARSI) showed varying results. Another investigation explored NCHT with taxane-based agents, indicating acceptable treatment benefits and improved BCR-free survival rates in high-risk PCa patients, demonstrating potential feasibility for this approach. Ongoing trials, like the PROTEUS trial, aim to further evaluate the therapeutic efficacy of neoadjuvant therapy in high-risk PCa. Conclusions: NHT for high-risk PCa does not contribute to improved oncological outcome and should not be administered easily for downstaging or PSM reduction. NHT in combination with ARSI has the potential advantage of improving the oncological outcome of high-risk PCa compared to RP alone, but the results are currently unsatisfactory, and the development of individualized treatment strategies using several different therapeutic approaches is needed.

Impact of Cytoreductive Nephrectomy in the Management of Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Study.

In this study, we aimed to determine the utility of cytoreductive nephrectomy (CN) in real-world clinical practice and investigate whether CN contributes to improved oncological outcomes in patients with metastatic renal cell carcinoma (mRCC). This retrospective multicenter cohort study enrolled patients with mRCC who received systemic therapy at six institutions between May 2005 and May 2023. The patients were divided into those who did not undergo CN (Group I) and those who underwent CN (Group II). The primary endpoints were oncological outcomes, including cancer-specific survival (CSS) and progression-free survival (PFS). Altogether, 137 patients with mRCC were included in this study. The median CSS was 14 months in Group I and 32 months in Group II (p < 0.001). Additionally, the median PFS in Groups I and II was 5 and 13 months, respectively (p = 0.006). A multivariate analysis showed that CN was an independent prognostic factor for CSS and PFS. Hence, CN is a potential treatment modality that can improve oncological outcomes in patients with mRCC.

Direct Comparison of Two Different Definitions with Biochemical Recurrence after Low-Dose-Rate Brachytherapy for Prostate Cancer.

We aimed to determine whether biochemical recurrence-free survival (BRFS) of patients with prostate cancer (PCa) who received low-dose-rate brachytherapy (LDR-BT) differed according to the definition of biochemical recurrence (BCR) after radical prostatectomy (RP) and the definition given by the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS). We reviewed the clinical records of 476 consecutive patients with PCa who received LDR-BT at the Gifu University Hospital. The primary endpoint of this study was the difference in BRFS between the two aforementioned definitions. When the follow-up period ended, 74 (15.5%) and 20 (4.2%) patients had BCR according to the RP and J-POPS definitions, respectively. The 5-year BRFS rates were 85.0% and 96.9% for the RP and J-POPS definitions, respectively (p < 0.005). According to the RP definition, the 5-year BRFS rates were 80.6% in the group aged <63 years and 86.6% in those aged ≥63 years (p = 0.050). According to the J-POPS definition, the 5-year BRFS rates were 94.1% and 97.8% in the groups aged <63 years and ≥63 years, respectively (p = 0.005). The definition of recurrence in LDR-BT may need to be reconsidered.