Malignant syphilis requiring differentiation from Kaposi's sarcoma.

Malignant syphilis (MS) is a rare variant of secondary syphilis. Also known as rupioid syphilis, MS is characterized by the presence of multiple papules, papulopustules, black lamellate crust that may resemble an oyster shell, or nodules with ulceration lacking central clearing. MS is often associated with immunodeficiency and frequently co-occurs with HIV infection. We here report a case of MS in a patient with HIV infection. HIV infection can cause atypical clinical symptoms of syphilis. In this case, unlike previous cases, cutaneous lesions of MS were limited to the face, making the diagnosis challenging based on clinical findings alone. However, his laboratory findings, appearance of the Jarisch-Herxheimer reaction, and a dramatic response to antibiotic therapy are characteristic of MS, making the diagnosis even more certain. Our case suggests the importance of physicians considering the possibility of MS when observing black-crusted lesions.

Multicenter Study of the Effectiveness of Antifungal Stewardship Team Intervention for Candidemia in Japan in 2008-2021.

Candidemia, linked to high mortality rates, requires prompt antifungal therapy for better outcomes. Treatment is structured as an action bundle, which is beneficial when followed closely. However, the Japanese action bundle lacks detailed guidance on severe complications like endocarditis or ocular issues. To address this, we adjusted the action bundle and assessed outcomes with and without AFT intervention. We strengthened protocols for blood cultures and organ assessments, and the AFT contacted the primary physician when yeast-like fungi were detected in the patient's blood culture bottles. Analyzing 204 candidemia cases from 2008-2021, we observed increased adherence and reduced mortality post-AFT intervention. Ophthalmology consultations rose significantly, but many patients had only one visit, suggesting inadequate follow-up. If endophthalmitis is diagnosed, a change in the treatment approach may be necessary. There is a possibility that abnormal ocular findings will be detected during subsequent visits, which highlights the need for improvement in ophthalmology follow-up rates as a future challenge for our AFT activities.

Acute tenosynovitis following an accidental injection of Bacille Calmette-Guérin (BCG) in a health care worker: A case report.

Case: A 36-year-old female healthcare worker with no past medical history, accidentally injected her flexed right middle finger with live attenuated Mycobacterium bovis bacillus Calmette-Guérin (BCG). Swelling and erythema around the injured area appeared two days after the needlestick injury. She was referred to the hospital and presented approximately nine days after self-inoculation. Surgical debridement was immediately performed. After 38 days, colonies were observed on cultures of the removed tissue on Ogawa's medium. This isolate was identified as M. bovis BCG by polymerase chain reaction (PCR) based on RD1 gene deletion. She had a history of BCG vaccination and her skin lesion appeared immediately after the accidental injection of M. bovis BCG. Therefore, in the differential diagnosis, the possibility that the lesion was an allergic reaction to BCG was considered. The subsequent culture results came back positive for M. bovis BCG and acute tenosynovitis caused by M. bovis BCG was diagnosed. The skin lesion was treated with anti-mycobacterial drugs and resolved. Discussion: The allergic reactions to BCG should be considered in the differential diagnosis of skin lesions following BCG vaccination. It is important to promptly submit a specimen for culture as delayed initiation of appropriate treatment can lead to a poor prognosis. In patients with accidental injection of M. bovis BCG, it is important to consider timely surgical excision and appropriate antimycobacterial therapy.

Vancomycin-resistant Enterococcus faecium in Japan, 2007-2015: a molecular epidemiology analysis focused on examining strain characteristics over time.

IMPORTANCE: Our study emphasizes the efficacy of whole-genome sequencing (WGS) in addressing outbreaks of vancomycin-resistant enterococci. WGS enables the identification and tracking of resistant bacterial strains, early detection and management of novel infectious disease outbreaks, and the appropriate selection and use of antibiotics. Furthermore, our approach deepens our understanding of how resistant bacteria transfer genes and adapt to their environments or hosts. For modern medicine, these insights have significant implications for controlling infections and effectively managing antibiotic use in the current era, where antibiotic resistance is progressing.

Public Health Centers' Training Session Programs to Develop Programs on Infection Control Practices for Multidrug-Resistant Organisms in Hospitals in Kawaguchi City, Japan.

Introduction The Kawaguchi City Public Health Center (PHC) conducted training sessions focusing on infection control practices on multidrug-resistant organisms (MDROs) for 19 hospitals and eight affiliated clinics (AFs) with beds in June 2022. Issues with infection control programs were identified via a survey implemented following the training sessions. These included providing feedback on infection control policies for MDROs, hand hygiene compliance programs (HHCPs), environmental cleaning (EC), and training sessions programs that hospitals or AFs with beds (hospitals) intended to implement in the future or develop (to be developed). We planned to examine whether the PHC training sessions programs have an effect on the development of hospital infection control programs designed to address these issues. The purpose of this study is to clarify the training session program provided by the Kawaguchi City PHC, which was effective in developing hospital infection control programs based on the results of the survey conducted after the training session. Methods In June 2023, a second training session that offered information on infection control practices was completed for 30 hospitals. This was followed by sending a questionnaire. We examined infection control programs to be developed and analyzed associations with the first learned information by training session (the first learned information). Results Twenty-four hospitals responded to the survey with a response rate of 80.0%. Half the respondents (12, 50.0%) had prepared for the infection control policy on carbapenem-resistant Enterobacteriaceae (CRE), 11 hospitals (45.8%) had provided feedback on HHC, and four (16.7%) planned to conduct feedback on HHC. HHCPs were planned to be developed by 19 hospitals (79.2%), EC by five hospitals (20.8%), training session by 12 hospitals (50.0%), and screening of MDROs upon hospital admission (AS) by nine hospitals (37.5%). The first learned information, "the prevention of healthcare-associated infections and cost savings by implementing cleaning bundles (the effects of cleaning bundles)," was identified by 10 hospitals (41.7%), and "specific programs on providing feedback effective for developing hand hygiene compliance (specific feedback)" was learned by eight hospitals (33.3%). The first learned information regarding specific feedback was significantly associated with HHCPs to be developed (p = 0.044). The first learned information on the effects of cleaning bundles was significantly associated with HHCPs and HHC feedback to be developed (p = 0.023, 0.034). The training session programs were not significantly connected to EC, training session, or AS to be developed. Conclusions Infection control programs to be developed were linked to the provision of information on numerical effects by implementing specific feedback and cleaning bundles. We suggest that the PHC should develop infection control programs for the hospitals and provide training sessions, including numerical effects.

Miliary Tuberculosis during R-MPV Therapy in an Elderly Patient with Primary Central Nerve System Lymphoma: A Case Report.

Most elderly patients with tuberculosis (TB) have previously been infected with Mycobacterium tuberculosis, which remains dormant in the body for decades and may reactivate when their immunity declines due to underlying diseases. Elderly cancer patients are at a high risk for TB, and the treatment of TB reactivation in these patients is challenging. Among cancer patients, the incidence of TB reactivation is the highest in lymphoma patients. However, the impact of chemotherapy on TB reactivation in lymphoma patients is unknown. We report the case of an immunocompetent elderly patient with primary central nervous system lymphoma (PCNSL) having no prior history of TB, who developed miliary TB during multiagent chemotherapy consisting of rituximab, high-dose methotrexate, procarbazine, and vincristine (R-MPV therapy). Retrospectively, the chest computed tomography showed calcification of the pleura, suggesting that the patient had a latent tuberculosis infection (LTBI) and developed miliary TB from the reactivation of TB triggered by the R-MPV therapy. Our case emphasizes that when chemotherapy is administered to patients with PCNSL, interferon-gamma release assay (IGRA) should be performed if there are findings on chest examination suggestive of LTBI, such as pleural calcification, and if IGRA is positive, chemotherapy should be given concurrently with LTBI treatment.

A New Method to Detect Variants of SARS-CoV-2 Using Reverse Transcription Loop-Mediated Isothermal Amplification Combined with a Bioluminescent Assay in Real Time (RT-LAMP-BART).

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), of which there are several variants. The three major variants (Alpha, Delta, and Omicron) carry the N501Y, L452R, and Q493R/Q498R mutations, respectively, in the S gene. Control of COVID-19 requires rapid and reliable detection of not only SARS-CoV-2 but also its variants. We previously developed a reverse transcription loop-mediated isothermal amplification assay combined with a bioluminescent assay in real time (RT-LAMP-BART) to detect the L452R mutation in the SARS-CoV-2 spike protein. In this study, we established LAMP primers and peptide nucleic acid probes to detect N501Y and Q493R/Q498R. The LAMP primer sets and PNA probes were designed for the N501Y and Q493R/Q498R mutations on the S gene of SARS-CoV-2. The specificities of RT-LAMP-BART assays were evaluated using five viral and four bacterial reference strains. The sensitivities of RT-LAMP-BART assays were evaluated using synthetic RNAs that included the target sequences, together with RNA-spiked clinical nasopharyngeal and salivary specimens. The results were compared with those of conventional real-time reverse transcription-polymerase chain reaction (RT-PCR) methods. The method correctly identified N501Y and Q493R/Q498R. Within 30 min, the RT-LAMP-BART assays detected up to 100-200 copies of the target genes; conventional real-time RT-PCR required 130 min and detected up to 500-3000 copies. Surprisingly, the real-time RT-PCR for N501Y did not detect the BA.1 and BA.2 variants (Omicron) that exhibited the N501Y mutation. The novel RT-LAMP-BART assay is highly specific and more sensitive than conventional real-time RT-PCR. The new assay is simple, inexpensive, and rapid; thus, it can be useful in efforts to identify SARS-CoV-2 variants of concern.

Clinical evaluation of anterior nasal cavity swab specimens by a rapid antigen test using a GLINE-2019-nCoV Ag Kit to diagnose COVID-19.

The promising diagnostic performance of rapid antigen tests (RATs) using non-invasive anterior nasal (AN) swab specimens to diagnose COVID-19 has been reported. A large number of RATs are commercially available; however, the careful assessment of RATs is essential prior to their implementation in clinical practice. We evaluated the clinical performance of the GLINE-2019-nCoV Ag Kit as a RAT using AN swabs in a prospective, blinded study. Adult patients who visited outpatient departments and received SARS-CoV-2 tests between August 16 and September 8, 2022, were eligible for this study. Patients who were aged under 18 years and patients without appropriate specimens were excluded. Two sets of AN and nasopharyngeal (NP) swabs were collected from all patients. Each set of specimens was tested by the RAT and quantitative reverse-transcription polymerase chain reaction (RT-qPCR). Of the 138 recruited patients, 84 were positive and 54 were negative by RT-qPCR using NP swabs. The positive agreement rate between RT-qPCR using NP swabs and RAT using AN swabs was 78.6% (95% confidence interval [CI], 68.3%-86.8%), the negative agreement rate was 98.1% (95% CI, 90.1%-99.9%), and the overall agreement rate was 86.2% (95% CI, 79.3%-91.5%), with a κ coefficient of 0.73. The positive agreement rate in the early phase (≤3 days from symptom onset) was >80%, but this fell to 50% in the late phase (≥4 days). This study demonstrates that the GLINE-2019-nCoV Ag Kit using AN swabs has good clinical performance and might be a reliable alternative method for diagnosing COVID-19.

A case of Talaromyces marneffei infection that required differentiation from Pneumocystis pneumonia.

We report a case of Talaromyces marneffei fungemia in a patient with HIV infection with a history of travelling to southern China. At first, Pneumocystis pneumonia was considered in this case because chest CT images showed typical ground-glass opacity and elevated ß-D-glucan levels. However, PCR testing of sputum for Pneumocystis jirovecii was negative and a filamentous fungus was isolated from blood cultures. The cultured fungus was subsequently identified as T. marneffei, and the patient was considered to have pneumonia caused by this organism. However, skin disease and lymphadenopathy, which are common in T. marneffei infections, were not observed during the disease course. This patient was successfully treated with voriconazole and consequently the chest CT shadow disappeared. In the present case, T. marneffei infection required differentiation from pneumonia with Pneumocystis jirovecii infection.

Evaluation of anti-severe acute respiratory syndrome coronavirus 2 antibody levels in coronavirus disease breakthrough infection during immunosuppressive therapy in a patient with connective tissue disease-related interstitial lung disease.

Herein, we report the case of a 67-year-old man with severe coronavirus disease (COVID-19) pneumonia and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine breakthrough infection during immunosuppressive therapy for connective tissue disease-related interstitial lung disease (CTD-ILD). The patient received glucocorticoids combined with tacrolimus as maintenance therapy. His serum anti-SARS-CoV-2-immunoglobulin G (IgG) antibody levels were extremely low at the onset of COVID-19 pneumonia, even after the second dose of SARS-CoV-2 mRNA vaccine (BNT162b2). After treatment for COVID-19 pneumonia, the levels of anti-SARS-CoV-2-IgG antibodies increased. These results indicated a lack of the ability to produce neutralising antibodies from immune cells despite the booster vaccination. Therefore, we suggest that advanced-age patients with CTD-ILD receiving immunosuppressive therapy with polypharmacy require consistent personal protection, vaccination of close caregivers, increased awareness, and booster vaccination. Moreover, we recommend that tacrolimus should be withdrawn for a while after vaccination under controlled conditions.

Bacterial Meningitis Caused by Bacillus subtilis var. natto.

A 67-year-old woman with a 2-day history of a fever, headache and disturbed consciousness was admitted to our hospital. Bacillus subtilis was isolated from both the cerebrospinal fluid and blood. She was cured by the administration of vancomycin. Next-generation sequencing identified the strain as B. subtilis var. natto, the same strain found in natto, which this patient ate daily. We suspected that some of the B. subtilis that caused the infection may have actually been B. subtilis var. natto.

Targeted Infection Control Practices in Japanese Hospitals for Multidrug-Resistant Organisms: Guidance From the Public Health Center.

Introduction The study conducted by the Kawaguchi City Public Health Center (PHC) in 2023 on hospital infection control (IC) programs revealed that hospitals can improve their IC programs if the PHC provides training sessions (TSs) that have numerical effects. In this study, we expected that we could help hospitals develop their IC practices by providing targeted guidance. This study aimed to clarify targeted guidance on IC practices and TS programs to develop hospitals'hospitals' IC programs on multidrug-resistant organisms (MDROs) by examining hospitals'hospitals' IC programs in reference to the study conducted in 2023 and other case reports. Methods In June 2022, the Kawaguchi City PHC conducted TSs for 19 hospitals and eight affiliated (AFs) clinics with beds, providing guidelines and practices on infection control (IC) for MDROs. After the TSs, we sent a questionnaire to these hospitals and affiliated clinics. The questionnaire inquired about current and planned IC policies, hand hygiene compliance programs (HHCPs), the usefulness of the TSs conducted by the PHC, and IC programs that the facilities intended to implement or develop in the future. This study examined the relationship between the perceived usefulness of the information provided and the IC programs planned for development, referencing a study conducted in 2023 and other case reports. Results Seventeen hospitals and six AFs with beds responded to the survey, yielding an 85.2% response rate. IC policies for methicillin-resistant Staphylococcus aureus (MRSA) were prepared by 21 hospitals (91.3%), whereas only five hospitals (21.7%) had prepared IC policies for carbapenem-resistant Enterobacteriaceae. Regarding HHCPs, an increase in the availability of alcohol-based hand sanitizer was identified by 17 hospitals (73.9%), while 13 hospitals (56.5%) reported using posters or symbols, 12 hospitals (52.2%) reported using TS and hand sanitizers, and nine hospitals (39.1%) assessed HH compliance and provided feedback. Furthermore, nine hospitals (39.1%) identified HHCPs and Environmental Cleaning (EC) for carbapenemase-producing Enterobacteriaceae (CPE) as useful information. There was a statistically significant association between TSs on HHCPs and the development of new HHCPs (p = 0.027). Additionally, information on EC for CPE was significantly associated with the development of staff cohorting strategies (p = 0.007). However, TS programs were not significantly connected to EC, nor were TSs to be developed. Conclusion The PHC should advise hospitals to assess if their HHCPs effectively contribute to improving HH compliance. It is essential for the PHC to furnish hospitals with resources and information that aid in the development of EC training. Additionally, the PHC should support the creation of specific and effective TS programs focused on EC or TS development. Conducting surveys to identify barriers to implementing staff cohorting strategies is also recommended. We propose that TS programs should include quantifiable data on HHCPs and EC, such as.

A new real-time quantitative polymerase chain reaction method using locked nucleic acids to detect Neisseria gonorrhoeae infection and point mutation on gyrA associated with quinolone susceptibility.

In Neisseria gonorrhoeae, fluoroquinolone resistance is caused by mutations on various genes, especially on gyrA. Locked nucleic acid DNA sequence was added to the forward primer for gyrA and subjected to real-time quantitative polymerase chain reaction, enabling simultaneous detection of N. gonorrhoeae and mutations associated with antimicrobial resistance.

Prevalence, molecular characterization, and drug susceptibility of extended-spectrum ß-lactamase-producing Klebsiella pneumoniae, K. quasipneumoniae, and K. variicola in Japan.

Klebsiella pneumoniae is an extended-spectrum ß-lactamase (ESBL)-producing bacterium (ESBL-KP). Recently, K. quasipneumoniae and K. variicola were reclassified from K. pneumoniae based on genome sequencing. However, the molecular characteristics and antimicrobial susceptibility patterns of ESBL-producing K. quasipneumoniae (ESBL-KQ) and ESBL-producing K. variicola (ESBL-KV) remain unclear. Here, we aimed to distinguish ESBL-KQ and ESBL-KV from ESBL-KP in terms of frequency, genomic characteristics, and antimicrobial susceptibility patterns. Of the 74 ESBL-KP isolates, 12 (16.2%) were reclassified as ESBL-KQ and 1 (1.4%) as ESBL-KV. Patients with ESBL-KP and ESBL-KQ infections were of similar age; ESBL-KQ infection was more frequent in men. Infection-associated mortality seemed to be similar in patients with ESBL-KQ and ESBL-KP infections, without a statistically significant difference (p = 0.99). Genetic analysis revealed that 19.1% of ESBL-producing Klebsiella isolates harbored AmpC. The prevalence of AmpC was higher with ESBL-KP (31.1%) than with ESBL-KQ (8.3%), although this difference was not statistically significant (p = 0.52). The frequency of ESBL-KQ with AmpC and quinolone-resistance-associated genes in clinical samples increased annually (p = 0.04). The prevalence of Klebsiella with fluoroquinolone-resistance genes did not differ significantly between species (p > 0.99). The gene profiles of ESBL-KQ and ESBL-KP differed, and the prevalence of antimicrobial resistance via AmpC and fluoroquinolone-resistance genes increased. Further studies are required to distinguish ESBL-KP and ESBL-KQ and determine the mechanism underlying the spread of AmpC and quinolone-resistance genes to prevent further spread of these genes.

Signaling via dopamine and adenosine receptors modulate viral peptide-specific and T-cell IL-8 response in COVID-19.

B-cell but not T-cell responses have been extensively studied using peripheral blood mononuclear cells (PBMCs) obtained from patients with coronavirus disease 2019 (COVID-19). Our recent study showed that not only T-helper (Th) 17 but also Th1 cells directly produce interleukin (IL)-8, a major source of neutrophilic inflammation, which is also known to induce disseminated intravascular coagulation (DIC) in COVID-19 patients. Neutrophilic inflammation caused by IL-17A or IL-8 can be fatal; thus, therapeutic intervention is highly expected. The present study aimed to investigate the T-cell responses in the Japanese patients. We synthesized spike protein-derived 15-mer peptides that are expected to bind to HLA class II allelic products frequently observed in the Japanese population, and checked the T-cell responses in Japanese patients with COVID-19. We have found that (i) patients show marked IL-8 but not IL-17A responses; (ii) these responses are restricted by HLA-DR; and (iii) IL-8 responses are abrogated by a dopamine D2 like receptor (D2R) agonist, ropinirole, and an adenosine A2a receptor (A2aR) antagonist, istradefylline. Compounds used for the treatment of Parkinson's disease may ease DIC in COVID-19. (183 words).

Point Prevalence Surveys of Antimicrobial Prescribing in a Non-Acute Care Hospital in Saitama Prefecture, Japan.

Background: The global point prevalence survey (Global-PPS) is the standard for the surveillance of prescribed antimicrobials among inpatients and provides data for the development of hospital antimicrobial stewardship programs. Aim: To evaluate the prevalence and quality of antimicrobial prescriptions using the universally standardized Global-PPS protocol in a non-acute care hospital in Saitama Prefecture, Japan. Methods: Antimicrobial prescriptions for inpatients, staying at the hospital overnight, were surveyed on three separate week days in November 2018, January 2019, and May 2019. Information on the prescribed antimicrobials on the survey target day was obtained from the in-hospital pharmacy. Survey data were collected by physicians, based on the extracted information. Patient information was anonymized and entered in the Global-PPS Web application by physicians. We report the antimicrobial use prevalence, the indication for prescription, diagnosis, the most prescribed antimicrobials, and a set of quality indicators related to antimicrobial prescribing. Results: In total, 6.7% of the surveyed inpatients (120/1796) were prescribed antimicrobials on the survey day. Sulfamethoxazole/trimethoprim was the most commonly prescribed, with 20.0% of systemic antibiotic prescriptions (ATC J01). Of all antibiotics for systemic use, up to 58.4% were Watch antibiotics, as defined by the World Health Organization AWaRe classification. The most prescribed group of systemic antibiotics was non-penicillin beta-lactam antibiotics (34.4%), followed by penicillin antibiotics in combination with beta-lactamase inhibitors (25.6%), and sulfonamides with trimethoprim (20.8%). Healthcare-associated infections and medical prophylaxis were the most common indications reported in 69.3% and 26.3% of prescriptions, respectively. The most common diagnosis for systemic antibiotic prescriptions was pneumonia (49.6%). Reasons for antimicrobial prescriptions were indicated in the medical records for 67.1% of prescriptions, and the stop/review date was documented to be 50.3%. Compliance with local guidelines reached 66.7%. Conclusions: This study highlights important challenges related to antimicrobial prescription in a highly specific, non-acute care patient population.

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.

HbA1c level may be a risk factor for oxygen therapy requirement in patients with coronavirus disease 2019.

INTRODUCTION: Many clinical studies have identified significant predictors or risk factors for the severity or mortality of coronavirus disease 2019 (COVID-19) cases. However, there are very limited reports on the risk factors for requiring oxygen therapy during hospitalization. In particular, we sought to investigate whether plasma glucose and HbA1c levels could be risk factors for oxygen therapy requirement. MATERIALS AND METHODS: A single-center, retrospective study was conducted of 131 COVID-19 patients hospitalized at Saitama Medical University Hospital between March 2020 and November 2020. To identify the risk factors for oxygen therapy requirement during hospitalization, a stepwise multivariate binary logistic regression analysis was performed using several clinical parameters commonly obtained on admission, including plasma glucose and HbA1c levels. RESULTS: Of the 131 patients with COVID-19, 33.6% (44/131) received oxygen therapy during hospitalization. According to the logistic regression analysis, male sex (odds ratio [OR]: 8.76, 95% confidence interval [CI]: 1.65-46.5, P < 0.05), age (OR: 1.07, 95% CI: 1.02-1.12, P < 0.01), HbA1c levels (OR: 1.94, 95% CI: 1.09-3.44, P < 0.05), and serum C-reactive protein (CRP) levels (OR: 2.22, 95% CI: 1.54-3.20, P < 0.01) emerged as independent variables associated with oxygen therapy requirement during hospitalization. CONCLUSIONS: In addition to male sex, age, and serum CRP levels, HbA1c levels on admission may serve as a risk factor for oxygen therapy requirement during the clinical course of COVID-19, irrespective of diabetes history and status. This may contribute to the efficient delegation of limited numbers of hospital beds to patients at risk for oxygen therapy requirement.

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.