Effect of Novel Stratified Lipid Risk by "LDL-Window" and Flow-Mediated Dilation on the Prognosis of Coronary Artery Disease Using the FMD-J Study A Data.

BACKGROUND: Elevated levels of triglyceride (TG) and non-high-density lipoprotein cholesterol (non-HDL-C) are regarded as a residual lipid risk in low-density lipoprotein cholesterol (LDL-C)-lowering therapy. This study investigated the association between lipid risk stratified by TG and non-HDL-C and the prognosis of patients with coronary artery disease (CAD), and the association between stratified lipid risk and flow-mediated dilatation (FMD) index.Methods and Results: The 624 CAD patients enrolled in flow-mediated dilation (FMD)-J study A were divided into 4 groups: low-risk group (n=413) with TG <150 mg/dL and non-HDL-C <170 mg/dL; hyper-TG group (n=180) with TG ≥150 mg/dL and non-HDL-C <170 mg/dL; hyper-non-HDL group (n=12) with TG <150 mg/dL and non-HDL-C ≥170 mg/dL; and high-risk group (n=19) with TG ≥150 mg/dL and non-HDL-C ≥170 mg/dL. Comparison of the groups showed the cumulative incidence of a 3-point major adverse cardiovascular event (MACE) was different and highest in the high-risk group in all the patients (P=0.009), and in patients with a FMD index ≥7.0% (P=0.021), but not in those with a FMD index <7.0%. Multivariable regression analysis showed that high lipid risk (P=0.019) and FMD <7.0% (P=0.040) were independently correlated with the incidence of a 3-point MACE. CONCLUSIONS: Novel stratification of lipid risk, simply using TG and non-HDL-C levels, combined with FMD measurement, is useful for predicting cardiovascular outcomes in patients with CAD.

First case of necrotizing fasciitis and bacteremia caused by Bifidobacteriumbreve.

We report the first case of necrotizing fasciitis and bacteremia caused by Bifidobacterium breve. Some Bifidobacterium breve strains are known as probiotic bacterium. However, it causes bacteremia in infants and immunocompromised patients. Our patient developed necrotizing fasciitis which was thought to have been infected from chronic diabetic foot ulcers. Bifidobacterium breve was isolated from the patient's blood and soft tissue sample. The patient underwent amputation and intravenous antibiotics administration.

A novel I551F variant of the Na+/HCO3- cotransporter NBCe1-A shows reduced cell surface expression, resulting in diminished transport activity.

Homozygous mutations in SLC4A4, which encodes the electrogenic Na+/[Formula: see text] cotransporter (NBCe1), cause proximal renal tubular acidosis associated with extrarenal symptoms. Although 17` mutated sites in SLC4A4 have thus far been identified among patients with proximal renal tubular acidosis, the physiological significance of other nonsynonymous single-nucleotide variants (SNVs) remains largely undetermined. Here, we investigated the functional properties of SNVs in NBCe1. From the National Center for Biotechnology Information dbSNP database, we identified 13 SNVs that have not previously been characterized in the highly conserved, transmembrane domains of NBCe1-A. Immunocytochemical analysis revealed that the I551F variant was present predominantly in the cytoplasm in human embryonic kidney (HEK)-293 cells, whereas all other SNVs did not show as dramatic a change in subcellular distribution. Western blot analysis in HEK-293 cells demonstrated that the I551F variant showed impaired glycosylation and a 69% reduction in cell surface levels. To determine the role of I551 in more detail, we examined the significance of various artificial mutants in both nonpolarized HEK-293 cells and polarized Madin-Darby canine kidney cells, which indicated that only I551F substitution resulted in cytoplasmic retention. Moreover, functional analysis using Xenopus oocytes demonstrated that the I551F variant had a significantly reduced activity corresponding to 39% of that of the wild-type, whereas any other SNVs and artificial I551 mutants did not show significant changes in activity. Finally, immunofluorescence experiments in HEK-293 cells indicated that the I551F variant retained wild-type NBCe1-A in the cytoplasm. These data demonstrate that the I551F variant of NBCe1-A shows impaired transport activity predominantly through cytoplasmic retention and suggest that the variant can have a dominant negative effect by forming complexes with wild-type NBCe1-A.NEW & NOTEWORTHY Electrogenic Na+/[Formula: see text] cotransporter 1-A (NBCe1-A) in the proximal tubule regulates the acid/base balance and fluid volume homeostasis. From the National Center for Biotechnology Information dbSNP database, we identified the I551F variant of NBCe1-A, which showed reduced glycosylation, cell surface expression, and transport activity. We also found that the I551F variant can exert a dominant negative effect on wild-type NBCe1-A, suggesting its physiological significance.

Effect of position therapy and oral devices on sleep parameters in patients with obstructive sleep apnea.

PURPOSE: The purpose of this study was to elucidate the effect of a neck-worn position therapy device (PTD) and oral appliance (OA) on sleep parameters in patients with obstructive sleep apnea (OSA). METHODS: Patients with an apnea hypopnea index (AHI) of 5/h or more at baseline polysomnography were divided into a PTD group and an OA group randomly. All participants underwent a type 1 polysomnography for diagnosis and device-set outcome measurements. RESULTS: The PTD decreased the AHI from a mean of 24.2/h to 16.7/h, and the OA decreased the AHI from 20.8/h to 10.3/h. Snoring duration decreased from 31.1% to 16.9% in the PTD group, and from 41.2% to 30.7% in the OA group. There were no significant differences in these decreases between the two groups. The PTD decreased sleep-time percentage in the supine position from a mean of 67.4% to 4.5%, despite five patients who were unable to avoid the supine position. There were no significant differences in improvement in sleep efficiency, percentage of stage wake, stage N1, stage N2, and stage REM, and overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups. CONCLUSION: PTDs are a potential treatment modality that does not disturb sleep in patients with OSA.

Target of Triglycerides as Residual Risk for Cardiovascular Events in Patients With Coronary Artery Disease　- Post Hoc Analysis of the FMD-J Study A.

BACKGROUND: Circulating triglyceride (TG) levels are a current focus as a residual risk for cardiovascular (CV) events. We evaluated the relationship between circulating TG levels and future CV events in patients with coronary artery disease (CAD) who were treated with conventional therapy. Methods and Results: We analyzed data for 652 patients who were enrolled in the FMD-J Study A. We investigated the associations between serum TG levels and first major CV events (death from CV cause, nonfatal acute coronary syndrome (ACS), nonfatal stroke, and CAD) for a 3-year follow-up period. Patients were divided into 4 groups based on serum TG level: low-normal (<100 mg/dL), high-normal (100-149 mg/dL), borderline hypertriglyceridemia (150-199 mg/dL), and moderate hypertriglyceridemia (≥200 mg/dL). During a median follow-up period of 46.6 months, 14 patients died (9 from CV causes), 16 had nonfatal ACS, 6 had nonfatal stroke, and 54 had CAD. The Kaplan-Meier curves for first major CV event among the 4 groups were significantly different (P=0.04). After adjustment for various confounders, serum TG level ≥100 mg/dL were significantly associated with an increased risk of first major CV events compared with serum TG level <100 mg/dL. CONCLUSIONS: Serum TG level may be a surrogate marker for predicting CV events in patients with CAD.

Association Between Waist-to-Height Ratio and Endothelial Dysfunction in Patients With Morbidity　- A Report From the FMD-J Study.

BACKGROUND: Waist circumference (WC), waist-to-height ratio (WHtR) and body mass index (BMI) are known as easy anthropometric markers of abnormal obesity and screening tools for predicting cardiovascular outcomes, but which indices are best is unclear. We therefore investigated the superiority and association between each index and low flow-mediated dilatation (FMD) as a surrogate marker for cardiovascular outcomes in patients with morbidity in a large Japanese prospective cohort.Methods and Results:A total of 1,645 Japanese patients who had coronary artery disease and hypertension or diabetes mellitus were enrolled, and 1,087 of them were analyzed. The high-WHtR group (≥0.5) showed greater morbidity and increased inflammation in association with atherosclerosis compared with the low-WHtR group. High WHtR and advanced age were identified as predictors of low FMD (odds ratio (OR) 1.39, 95% confidence interval (CI) 1.02-1.88, P=0.037 and OR 1.55, 95% CI 1.19-2.01, P=0.001, respectively). However, WC was not associated with that risk in either sex (male: OR 1.37, 95% CI 0.97-1.93, P=0.076; female: OR 1.08, 95% CI 0.68-1.73, P=0.74), and no association was evident between high BMI and low FMD (OR 0.92, 95% CI 0.71-1.19, P=0.54). CONCLUSIONS: WHtR offers a superior predictor of decreased FMD than other anthropometric indices, and progression of arteriosclerosis might be detected more sensitively. Further study is needed to investigate the relationship between cardiovascular mortality and WHtR.

[Catch-Up Seminar for Laboratory Medicine: Now and in the Future Overview of the Guidelines from the Japanese Society of Laboratory Medicine (JSLM 2015) -For Post 2017-].

We published a guideline for clinical laboratory tests (JSLM 2015) in November 2015. This guideline is unique regarding its multi-disciplinary character, compared with most guidelines from scientific groups that were developed to answer specific clinical questions or overcome problems that were not easily solved by reviewing standard references or textbooks. On the other hand, the JSLM guideline and committee of this publication were developed in response to the introduction of the prospective payment system (DRG/PPS or DPC: diagnosis procedure complex) in Japanese healthcare insurance. We needed a resource explaining the "selection of laboratory tests in a clinically effective and also economically reasonable way". The committee was founded in 1988, and the guideline was provided in 1989 as a draft. "JSLM 2015" is the seventh version of this laboratory test guideline, and the contents have been updated to be consistent with the latest concept in the wide area of clinical medicine. Because laboratory medicine has to cover a very wide clinical area, it is often difficult for laboratory physi- cians, or those with a similar profession, to have specific subspecialty knowledge to be able to deal with all specific problems raised in clinical laboratory facilities. We developed the guideline under the concept of providing "a resource to meet the least minimum requirement in everyday performance of laboratory medi- cine", and we believe that this guideline will compensate for the lack of knowledge required for the resolution of all problems in the clinical laboratory. [Review].

[Multidrug-Resistant Acinetobacter baumannii].

Teikyo University Hospital reported an outbreak of multidrug-resistant Acinetobacter baumannii (MDRAB) to the local public health department in 2010. The number of inpatients with MDRAB including asympto- matic carriers was 58 between August 2009 and September 2010. The way to tackle infection control issues has been comprehensively revised since this event in our hospital. The change could not have been achieved by a single department, such as the Department of Infection Control and Prevention or the Central Laboratory alone. Rather, collaboration among every department in the hospital was necessary. Although the impact of the outbreak on our hospital was enormous, it elucidated various clues to improve hospital man- agement regarding not only infection control but also safety management. [Review].

Genotyping of Acinetobacter baumannii strains isolated at a Japanese hospital over five years using targeted next-generation sequencing.

Acinetobacter baumannii is a Gram-negative bacterial agent involved in nosocomial infections. In this five-year retrospective study, phylogenetic relationships among carbapenem-resistant A. baumannii strains that were isolated at Teikyo University Hospital in Tokyo metropolis, Japan, were explored. A panel of 72 carbapenem-resistant A. baumannii strains that isolated from January 2006 until August 2010 was studied. Next-Generation sequencing (NGS) was employed to perform large-scale genotyping of these isolates. They were separated, according to the time of isolation, into two genetically distinct groups, one correspondent to strains of the outbreak reported to local public health department in 2010 and the other contained strains from earlier isolations, suggesting different origins of the isolates. Moreover, taxa in each group showed two main clustering patterns. Multilocus sequence typing (MLST) study on 8 isolates from the last outbreak showed that they were from one sequence type, 92, displaying less discriminatory power comparing to large-sequence typing. The clonal lineage profiles produced in this retrospective study will be used as a reference database to compare future isolations of A. baumannii. This study demonstrates the power of NGS in conducting epidemiological researches, allowing a high resolution genotyping.

[Changes in PT and APTT When Administrating Rivaroxaban, a Direct Inhibitor of Activated Factor X].

The effects of oral rivaroxaban (RX), a direct inhibitor of activated factor X (Xa), on prothrombin time (PT) and activated partial thromboplastin time (APTT) were examined. PT and APTT before and after administration of 15 mg RX in 10 healthy subjects were measured by using various reagents. In addition, the blood Xa inhibitor concentration was measured and its correlation with PT and APTT, as measured by each reagent, was examined. Furthermore, the relationship (sensitivity) between the prolongation ratio and FX activity was evaluated. Prolongation of both PT and APTT was observed after RX administration, and maximal prolongation was observed four hours after administration for each reagent. The prolongation ratio was different among the reagents used for examination, and the reagent with the highest sensitivity to FX and factor VII showed the largest prolongation ratio. PT and APTT were positively correlated with RX concentration when measured by any reagent. In this study, neither PT, APTT, nor RX concentration returned to the values measured prior to dosing even at 24 hours after administration of RX. Our results suggest that approximate concentration of remaining RX may be estimated by PT (second) when using a reagent showing a larger prolongation ratio.

Role of Small Dense Low-density Lipoprotein Cholesterol in Cardiovascular Events in Patients with Coronary Artery Disease and Type 2 Diabetes Mellitus Receiving Statin Treatment.

AIM: There is little information on the relationships of serum small dense low-density lipoprotein cholesterol (sdLDL-C) levels and serum triglyceride (TG) levels with cardiovascular events in patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM) who are receiving statins. The aim of this study was to evaluate the relationships of serum TG levels and sdLDL-C levels as residual risks for cardiovascular events in patients with CAD and type 2 DM who were being treated with statins. METHODS: The subjects were divided into four groups based on TG levels and sdLDL-C levels: sdLDL-C of ＜40.0 mg/dL and TG of ＜150 mg/dL, sdLDL-C of ≥ 40.0 mg/dL and TG of ＜150 mg/dL, sdLDL-C of ＜40.0 mg/dL and TG of ≥ 150 mg/dL, and sdLDL-C of ≥ 40.0 mg/dL and TG of ≥ 150 mg/dL. During a median follow-up period of 1419 days, cardiovascular events occurred in 34 patients. RESULTS: The incidences of cardiovascular events were significantly higher in patients with sdLDL-C of ≥ 40.0 mg/dL and TG of ＜150 mg/dL and in patients with sdLDL-C of ≥ 40.0 mg/dL and TG of ≥ 150 mg/dL, but not in patients with sdLDL-C of ＜40.0 mg/dL and TG of ≥ 150 mg/dL, than in patients with sdLDL-C of ＜40.0 mg/dL and TG of ＜150 mg/dL. CONCLUSIONS: Under the condition of treatment with statins, patients with CAD and type 2 DM who had sdLDL-C levels of ≥ 40.0 mg/dL had a high risk for cardiovascular events even though serum TG levels were controlled at ＜150 mg/dL.

[The values of physiological function testing accepted in new Japanese medical insurance policy 2012].

Physiological function tests are managed by the clinical laboratory medicine section in most hospitals in Japan. Appropriate usage and refunds for the tests are important for both medical benefits and economically sustainable medical insurance management. The Japanese medical insurance policy was revised this year, and many physiological function tests, mainly respiratory and cardiovascular function testing, were accepted for refunding. These tests are common in each field, but evidence for their medical benefits should be re-evaluated in Japanese people.

[Measures to prevent patient identification errors in blood collection/physiological function testing utilizing a laboratory information system].

We constructed an integrated personal identification workflow chart using both bar code reading and an all in-one laboratory information system. The information system not only handles test data but also the information needed for patient guidance in the laboratory department. The reception terminals at the entrance, displays for patient guidance and patient identification tools at blood-sampling booths are all controlled by the information system. The number of patient identification errors was greatly reduced by the system. However, identification errors have not been abolished in the ultrasound department. After re-evaluation of the patient identification process in this department, we recognized that the major reason for the errors came from excessive identification workflow. Ordinarily, an ultrasound test requires patient identification 3 times, because 3 different systems are required during the entire test process, i.e. ultrasound modality system, laboratory information system and a system for producing reports. We are trying to connect the 3 different systems to develop a one-time identification workflow, but it is not a simple task and has not been completed yet. Utilization of the laboratory information system is effective, but is not yet perfect for patient identification. The most fundamental procedure for patient identification is to ask a person's name even today. Everyday checks in the ordinary workflow and everyone's participation in safety-management activity are important for the prevention of patient identification errors.

Reduced reactive hyperemia of the brachial artery in diabetic patients assessed by repeated measurements: The FMD-J B study.

Type 2 diabetes mellitus (T2DM) is a major cause of microvascular dysfunction. However, its effect on blood flow patterns during ischemic demand has not been adequately elucidated. In this study, we investigated the hypothesis that microvascular dysfunction in patients with T2DM manifests as brachial reactive hyperemia (BRH), defined as the ratio of peak blood flow velocities in a brachial artery before and after forearm cuff occlusion. The study enrolled 943 subjects (men, n = 152 [T2DM] and n = 371 [non-T2DM]; women, n = 107 [T2DM] and n = 313 [non-T2DM], respectively) with no history of cardiovascular disease. Semiautomatic measurements were obtained three times at 1.5-year intervals to confirm the reproducibility of factors involved in BRH for each sex. An age-adjusted mixed model demonstrated attenuated BRH in the presence of T2DM in both men (p = 0.022) and women (p = 0.031) throughout the study period. Post hoc analysis showed that the estimated BRH was significantly attenuated in patients with T2DM regardless of sex, except at baseline in women. In multivariate regression analysis, T2DM was a negative predictor of BRH at every measurement in men. For women, BRH was more strongly associated with alcohol consumption. Repeated measurements analysis revealed that T2DM was associated with attenuated postocclusion reactive hyperemia.

A multicenter study design to assess the clinical usefulness of semi-automatic measurement of flow-mediated vasodilatation of the brachial artery.

Flow-mediated vasodilatation of the brachial artery (FMD) is a marker which is related to endothelial nitric oxide bioavailability. Commercially available ultrasound machines equipped with online computer-assisted semi-automatic analysis software to measure FMD have recently become available in Japan. These devices enable more convenient examination, enhanced reproducibility of FMD measurement, and a shortened examination time. Using such devices, in the present multicenter prospective study we propose to: 1) establish standardized FMD values and determine the annual rates of FMD change in healthy subjects; 2) confirm the predictive value of FMD for future cardiovascular events in Japanese subjects; 3) evaluate the potential usefulness of a multimarker strategy, including measurements of FMD, pulse-wave velocity (PWV), ankle-brachial pressure index, biochemical markers, and proteomic biomarkers obtained by mass spectroscopic analysis to assess the prognosis of subjects with coronary artery disease; and 4) clarify the usefulness of FMD measurement to predict the rate of progression of carotid atherosclerosis, arterial stiffness and microalbuminuria in subjects with hypertension or diabetes mellitus. In total, we estimate that approximately 4000 Japanese subjects in 3 different study groups will eventually be enrolled in this prospective observational investigation. We anticipate that the present study will provide important evidence for the usefulness of FMD measurement in the risk stratification for cardiovascular disease.

Preoperative apnea-hypopnea index predicts increased postoperative intrathoracic pressure during sleep in patients who underwent endoscopic nasal surgery.

OBJECTIVE: Respiratory condition could worsen during sleep in patients with nasal packing following endoscopic nasal and sinus surgery (ESS) under general anesthesia. Recently, a noninvasive intrathoracic pressure estimation sensor was developed that uses photoplethysmographic pulse wave technology. The purpose of this study was to noninvasively evaluate the effect of bilateral nasal packing on respiration during sleep, using a photoplethysmographic pulse wave sensor in perioperative patients who underwent ESS under general anesthesia. METHODS: In this observational cross-sectional case-control study, estimated intrathoracic pressure and SpO2 were noninvasively measured during sleep with a wristband-type photoplethysmographic pulse wave sensor and a pulse oximeter in 43 patients with chronic sinusitis, nasal allergy, or septal deviation who underwent bilateral ESS under general anesthesia. Measurements were taken preoperatively, at postoperative day 1 (POD1) with bilateral nasal packing in place, and at POD5 after the nasal packing was removed. Based on the preoperative obstructive apnea-hypopnea index (AHI) score determined by overnight polysomnography, patients were classified into those with moderate to severe obstructive sleep apnea (OSA) (AHI ≥ 15/h) and those with mild or non-OSA (AHI ≤ 15/h). RESULTS: Significant changes were noted in estimated intrathoracic pressure, but not in SpO2 nadir, between time points. Estimated intrathoracic pressure decreased the most at POD1 with bilateral nasal packing in place in patients with OSA after ESS. Multivariate stepwise regression revealed the relative incidence of increased estimated intrathoracic pressure on POD1 was independently predicted by preoperative AHI, but not by age, body mass index, total nasal resistance, or preoperative SpO2 nadir. CONCLUSION: Use of the photoplethysmographic pulse wave sensor to noninvasively measure intrathoracic pressure detected changes in perioperative respiratory effort that pulse oximetry did not. Attention should be paid to the use of postoperative bilateral nasal packing in patients with moderate to severe OSA who undergo ESS under general anesthesia. Our results support the concept of using less, short-term, or no nasal packing after ESS.

The T wave inversion score is useful for evaluating the time-course of acute pulmonary embolism.

BACKGROUND: The 12-lead electrocardiogram (ECG) has relatively poor specificity for identifying acute pulmonary embolism (APE). The aim of this study was to investigate ECG abnormalities according to 2 different criteria and their usefulness for assessing changes in APE. METHODS AND RESULTS: Fifty-two APE patients underwent ECG examinations in the acute and chronic phases. ECG abnormalities were assessed according to Stein's criteria (QRS complex abnormalities and T wave inversion in any lead except aV(L), III, aV(R), or V1) and Kosuge's criteria (T wave inversion in any lead except aV(R) or aV(L)). Many patients had electrocardiographic abnormalities in the acute phase, but no specific abnormalities were found. According to Kosuge's criteria, the frequency of T wave inversion was higher than that of abnormal QRS complexes and T wave inversion according to Stein's criteria (P < 0.01). In 20 cases with preclinical ECG records, the time-course of changes in the T wave inversion score (total numbers of T wave inversions per patient) was examined. The peak T wave inversion score was noted at 3 days after onset (P < 0.01). CONCLUSIONS: These results suggest that the T wave inversion score, calculated according to Kosuge's criteria, is useful for predicting the time-course of APE.

[Comparison of portable apnea monitors in the detection of apnea episode during daytime rest].

Although polysomnography (PSG) is the golden standard for the diagnosis of sleep apnea syndrome (SAS), access to this procedure is limited because it requires special institution and trained technicians. Therefore, many portable recording devices have been developed for detection of SAS including home monitoring. The present study evaluated the usefulness of four portable devices in detecting apneic events. The four devices are, (1) FM-500 thermister sensor type III device, (2) LS-300 pressure sensor type III device, (3) Morpheus pressure sensor type III device, and (4) SD-101, a sheet-type type IV device that detects chest wall movement. This study included 1,114 patients who underwent a daytime rest session during a routine clinic visit. The subjects were asked to remain quiet and in a supine position in a dark room. We compared the respiratory disturbance index (RDI) and number of oxygen desaturation events (OD) measured by the four portable devices in each patient. The RDI and number of OD measured by the device using the thermister sensor were significantly lower than those measured by the three other devices. These findings suggest that when using a portable recording device to screen for SAS, the characteristics of the device should be taken into account.

Gender Differences in the Circadian and Seasonal Variations in Patients with Takotsubo Syndrome: A Multicenter Registry at Eight University Hospitals in East Japan.

Objective The aim of this study was to clarify the circadian and seasonal variations in addition to identify sex-based differences in Japanese patients with Takotsubo syndrome (TTS). Methods The authors conducted a retrospective observational study to analyse the differences between the groups based on sex. Patients The patients were registered out of each institute registry of the acute coronary syndrome (ACS) which contains a total of 10,622 cases in eight academic hospitals in east Japan. Results Data for 344 consecutive TTS (73 male and 271 female) were extracted from each hospital registry. In-hospital mortality was higher in the male group than in the female group (18% vs. 7%; p=0.005). With regard to the circadian variations in all study patients, TTS events occurred most often in the afternoon and least often during the night. Moreover, the patterns of circadian variations in the female and male groups were the same as that of all study patients. TTS events occurred most frequently in the autumn and least often in the spring in the whole study cohort. Moreover, the seasonal variation in the female group showed the same pattern as that of the whole cohort. However, there were no significant seasonal differences in the incidence of TTS in the male group. Conclusion In a multicenter study in Japan, seasonal variation was observed in the female group but not in the male group. Circadian variation was observed in both groups. These results suggested that the pathogenesis and clinical features of TTS might therefore differ according to sex.

A rabbit monoclonal antibody-mediated lateral flow immunoassay for rapid detection of CTX-M extended-spectrum ß-lactamase-producing Enterobacterales.

Infections of CTX-M extended-spectrum ß-lactamase-producing Enterobacterales are a severe threat in clinical settings. CTX-M genes on plasmids have been transferred to many Enterobacterales species, and these species have spread, leading to the global problem of antimicrobial resistance. Here, we developed a lateral flow immunoassay (LFIA) based on an anti-CTX-M rabbit monoclonal antibody. This antibody detected CTX-M variants from the CTX-M-9, CTX-M-2, and CTX-M-1 groups expressed in clinical isolates. The LFIA showed 100% sensitivity and specificity with clinical isolates on agar plates, and its limit of detection was 0.8 ng/mL recombinant CTX-M-14. The rabbit monoclonal antibody did not cross-react with bacteria producing other class A ß-lactamases, including SHV. In conclusion, we developed a highly sensitive and specific LFIA capable of detecting CTX-M enzyme production in Enterobacterales. We anticipate that our LFIA will become a point-of-care test enabling rapid detection of CTX-M in hospital and community settings as well as a rapid environmental test.