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INTRODUCTION: Currently, there are two types of percutaneous arteriovenous fistula (pAVF) formation systems approved by the FDA: Ellipsys and WavelinQ. Although these systems are already in use in Europe or the United States, they have not been approved for use in Korea yet. For this reason, this study aimed to check anatomical feasibility of these systems for Korean population prior to their actual use. METHODS: Consecutive patients who received ultrasound vein mapping for arteriovenous fistula formation from June 2021 to June 2022 were included. The anatomical feasibility of each system was confirmed according to the manufacturer's instructions for use (IFU). RESULTS: Upper extremity ultrasonography was performed for a total of 83 patients to determine their feasibility for pAVF formation. Of these patients, 65.1% were feasible for pAVF formation with appropriate deep communicating vein (DCV) and outflow. Among them, 57.8% were feasible for the Ellipsys system and 54.2% were feasible for the WavelinQ system. Most patients who were infeasible for pAVF formation had a DCV of small size. Ulnar vessels were more suitable than radial vessel for WavelinQ (54.2% vs 33.7%, P-value = .012). The most common reason for not meeting the criteria was a small vein size at the access site. CONCLUSIONS: More than half of all patients were feasible for pAVF formation in this study. Ellipsys had a higher feasibility than WavelinQ, although they showed no significant difference in the feasibility. If these devices are imported into Korea, it will be a good opportunity for many patients to reduce the surgical burden and create AVFs more easily through these procedures.
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Background: Living donor kidney transplantation (LDKT) is a crucial treatment for end-stage renal disease, with pre-emptive LDKT (transplantation before dialysis initiation) offering significant benefits in graft function and patient survival. The selection of a vasopressor during LDKT, particularly between norepinephrine and dopamine, and its impact on renal arterial hemodynamics measured using the renal arterial resistive index (RARI) is poorly understood. Methods: This retrospective observational cohort study enrolled 347 eligible pre-emptive LDKT recipients from the Seoul St. Mary's Hospital between January 2019 and June 2023. Utilizing propensity score matching (PSM), the patients were categorized into dopamine and norepinephrine groups to compare the effects of these vasopressors on the intraoperative RARI, postoperative estimated glomerular filtration rate (eGFR), and hourly urine output. The RARI was measured via the Doppler ultrasonography of the renal hilum and parenchyma post-graft vascular and ureteral anastomoses. Results: The preoperative differences in the recipients' and donors' characteristics were mitigated following PSM. The dopamine group exhibited higher intraoperative RARI values at the renal hilum (0.77 ± 0.11 vs. 0.66 ± 0.13, p < 0.001) and parenchyma (0.71 ± 0.1 vs. 0.6 ± 0.1, p < 0.001) compared to those of the norepinephrine group. However, these differences were not statistically significant on postoperative day 7. The norepinephrine infusion adjusted for the propensity scores was associated with significantly lower odds of an RARI > 0.8 (hilum: OR = 0.214, 95% CI = 0.12-0.382, p < 0.001; parenchyma: OR = 0.1, 95% CI = 0.029-0.348, p < 0.001). The early postoperative outcomes showed a higher eGFR (day 1: 30.0 ± 13.3 vs. 25.1 ± 17.4 mL/min/1.73 m2, p = 0.004) and hourly urine output (day 1: 41.8 ± 16.9 vs. 36.5 ± 14.4 mL/kg/h, p = 0.002) in the norepinephrine group. Furthermore, the long-term outcomes were comparable between the groups. Conclusions: Norepinephrine infusion during pre-emptive LDKT is associated with more favorable intraoperative renal arterial hemodynamics, as evidenced by a lower RARI and improved early postoperative renal function compared to those of dopamine. These findings suggest a potential preferential role for norepinephrine in optimizing perioperative management and early graft functions in LDKT recipients. Given the retrospective nature of this study, further prospective studies are needed to confirm these observations. Additionally, the study limitations include the potential for unmeasured confounding factors and the inability to determine causality due to its observational design.
Subject(s)
Dopamine , Kidney Transplantation , Living Donors , Norepinephrine , Propensity Score , Renal Artery , Humans , Kidney Transplantation/methods , Male , Female , Dopamine/therapeutic use , Dopamine/administration & dosage , Retrospective Studies , Middle Aged , Norepinephrine/therapeutic use , Norepinephrine/administration & dosage , Adult , Renal Artery/drug effects , Vasoconstrictor Agents/therapeutic use , Vasoconstrictor Agents/administration & dosage , Cohort Studies , Vascular Resistance/drug effects , Hemodynamics/drug effects , Hemodynamics/physiologyABSTRACT
BACKGROUND: The current study aimed to determine the optimal tacrolimus trough levels for balancing graft survival and patient safety following kidney transplantation. MATERIALS AND METHODS: We conducted a retrospective cohort study involving 11,868 kidney transplant recipients from five medical centers. The association between tacrolimus exposures (periodic mean trough level, coefficient of variability, time in therapeutic range) and composite allograft outcome (de novo donor specific antibody, biopsy-proven rejection, kidney dysfunction, and graft failure), as well as safety outcomes (severe infection, cardiovascular events, malignancy, and mortality) were assessed. Data were sourced from Clinical Data Warehouses and analyzed using advanced statistical methods, including Cox marginal structural models with inverse probability treatment weighting. RESULTS: Tacrolimus levels of 5.0-7.9 ng/mL and 5.0-6.9 ng/mL during the 2-12 month and 12-72 month post-transplantation periods, respectively, were associated with reduced risks of composite allograft outcomes. During the first post-transplant year, the adjusted hazard ratios (aHR) for composite allograft outcomes were: 0.69 (95% CI 0.55-0.85, P<0.001) for 5.0-5.9 ng/mL; 0.81 (95% CI 0.67-0.98, P=0.033) for 6.0-6.9 ng/mL; and 0.73 (95% CI 0.60-0.89, P=0.002) for 7.0-7.9 ng/mL (compared to levels ≥8.0 ng/mL). For the 6-year composite outcomes, aHRs were 0.68 (95% CI 0.53-0.87, P=0.002) for 5.0-5.9 ng/mL and 0.65 (95% CI 0.50-0.85, P=0.001) for 6.0-6.9 ng/mL. These optimal ranges showed reduced rates of severe infection (6 y), malignancy (6 y), and mortality (1 y). CONCLUSION: This multicenter study provides robust evidence for optimal tacrolimus trough levels during the periods 2-12 and 12-72 months following kidney transplantation.
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BACKGROUND: Peripherally inserted central catheter (PICC) has become a common procedure. Although ultrasound (US)-guidance has improved success rates, a small percentage of malposition is inevitable. The purpose of our study is to evaluate malposition rates of US-guided bedside PICC catheter insertion, and the clinical factors associated with malposition. METHODS: This is a retrospective cohort study evaluating 5981 patients who had undergone ultrasound-guided bedside PICC placement from January 2017 to December 2021 at a single tertiary center. Final tip location was confirmed on chest radiograph. RESULTS: Patients were categorized into optimal, suboptimal, and malposition groups according to final tip location. 4866 cases (81.7%) showed optimal tip position, 790 (13.3%) were suboptimal, and 299 (5.0%) were malpositioned. Logistic regression analysis identified six variables associated with tip malposition; height (odds ratio (OR) 1.044; 95% confidence interval (CI), 1.028-1.061; p < 0.001), body mass index (BMI) (OR 1.051; 95% CI, 1.017-1.087; p = 0.003), prior failure at accessing peripheral intravenous (IV) access (OR 1.718; 95% CI, 1.215-2.428; p = 0.002), side of the arm (OR 3.467; 95% CI, 2.457-4.891; p < 0.001), length of the catheter (OR 0.763; 95% CI, 0.734-0.794; p < 0.001), and number of previous central catheter insertions (OR 1.069; 95% CI, 1.004-1.140; p = 0.038). Malpositioned catheters were corrected by either bedside repositioning, bedside reinsertion, fluoroscopic reinsertion, switching to jugular catheters or catheter removal. No patient related factors were significantly associated with malposition or success of reposition. CONCLUSION: US-guidance can help reduce catheter malposition during bedside PICC insertion. Patients with risk factors such as multiple previous central vein insertions, failed peripheral line insertions, left arm insertion, or high BMI should undergo thorough sonographic evaluation of the arm vessels to prevent malposition.
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Hemodialysis (HD) using an HD catheter is performed widely on renal failure patients. The catheter was evaluated using the recirculation ratio in pre-clinical status, which is a crucial index indicating its performance. However, pre-clinical in-vivo experiments have limitations: high cost, and ethical issues. Hence, computational and in-vitro methods have been developed as alternatives. However, computational methods require fluid dynamic knowledge, whereas in-vitro experiments are complicated and expensive. In this study, we developed a pulsatile flow generator to mimic blood flow achieving cost effectiveness and user convenience. The device used iterative learning control, achieving blood flow in the superior and inferior vena cava within a 3.3% error. Furthermore, the recirculation ratios were measured based on two insertion directions and two different external pipe materials to evaluate the catheter regarding patients' posture and blood vessel stiffness. The results provide a better understanding of cardiovascular device performance without complicated and costly pre-clinical tests.
Subject(s)
Catheterization, Central Venous , Humans , Catheterization, Central Venous/methods , Pulsatile Flow , Renal Dialysis/methods , CathetersABSTRACT
Purpose: This study aims to investigate the feasibility of Zenith Fenestrated AAA Endovascular Graft (Z-FEN, Cook Medical) from a single Korean institution database by evaluating the vascular anatomy of Korean abdominal aortic aneurysm (AAA) patients with hostile aortic neck. Methods: This is a retrospective study on patients with AAA who underwent endovascular aortic repair (EVAR) and open surgery repair between January 2012 and December 2021 (n = 211). The anatomic characteristics of the aortic neck were evaluated using 3-dimensional reconstructed computed tomographic scans. For the juxtarenal AAA patients (n = 39), feasibility of fenestrated stent graft was evaluated under the protocol of fenestrated EVAR. For those who were not suitable for the application of Z-FEN, the reasons for unsuitability were analyzed. Results: Among 211 AAA patients, 108 patients (51.2%) had complex aortic neck, and 39 (18.5%) had insufficient aortic neck length (<15 mm) for conventional EVAR. Of the 39 patients with juxtarenal AAAs, 13 (33.3%) were determined feasible for Z-FEN. Twenty-six patients (66.7%) were noncandidate for Z-FEN due to severe neck angulation, short aortic neck length, inadequate iliac artery anatomy, large aortic neck diameter, and severe calcification and thrombosis. Proximal aortic neck length of the non-feasible group was significantly shorter than that of the feasible group (P = 0.002). Conclusion: Z-FEN was applicable to 33.3% of the juxtarenal AAA patients. As recent studies confirm, the effectiveness and safety of fenestrated EVAR, Z-FEN can be an option for AAA patients with short aortic neck.
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BACKGROUND: As a population, living kidney donors have a longer life expectancy than the general population. This is generally thought to be an artifact of selection, as only healthy individuals are allowed to donate, and the operative mortality and risk of subsequent renal failure are very low. However, there may also be an additional benefit to the process, as the donor evaluation may uncover an early occult cancer or a potentially serious medical problem. While these problems may preclude donation, they may be lifesaving, as they are likely to be diagnosed and treated before the donor develops symptoms. PATIENTS AND METHODS: We looked at the incidence of occult cancer and other previously undiagnosed medical problems including renal disease, diabetes, hypertension, cardiac disease, and hepatitis C, in individuals volunteering to become a kidney donor at our center who proceeded with the evaluation between January 1, 1996 and May 31, 2011. RESULTS: Of 4088 potential donors, 19 (.46%) were discovered to have an unsuspected cancer, and 286 (7%) were found to have a previously undiagnosed medical problem. CONCLUSIONS: The living donor evaluation may lead to the early diagnosis of a life-threatening illness. This should be considered as one of the potential benefits of living donation.
Subject(s)
Hepatitis C , Hypertension , Kidney Transplantation , Neoplasms , Humans , Living Donors , Neoplasms/diagnosisABSTRACT
BACKGROUND: Transcutaneous oxygen pressure (TcPO2) is a noninvasive, nonradiological test to measure local oxygen released from capillaries through the skin. Since it reflects the metabolic state of the lower limb, it can predict wound healing in patients with critical limb threatening ischemia (CLTI). The purpose of this study was to determine the effectiveness of TcPO2 test in evaluating wound healing potential of patients with CLTI. METHODS: This was a retrospective, single-center, nonrandomized, and observational study. A prospectively registered database of patients who visited Vascular Surgery Department of St. Mary's Hospital for CLTI and underwent TcPO2 tests from October 1, 2015 to July 1, 2021 was reviewed. Patients were divided into 2 groups: (1) those who had amputation only; and (2) those who underwent revascularization procedures. Patients whose wound healing status could not be determined were excluded. The clinical characteristics of patients, patient characteristics related to lower TcPO2 value, treatment success rate, and time for the wound to be healed were analyzed. RESULTS: A total of 84 patients were included in this study. There was no difference in background patient characteristics between the 2 groups despite better survival within 12 months and shorter healing time in the revascularization group. A total of 76 patients survived 12 months after surgery, and 63 patients were healed. Higher HbA1c, higher serum creatinine, history of stroke, and history of coronary artery disease were related to lower TcPO2 value on multiple linear regression. The cutoff value of TcPO2 was determined to be 40 mm Hg for predicting wound healing. This value was similar to those of previous studies. In addition, there was a negative correlation between TcPO2 and wound healing time. Correlations among the anklebrachial index (ABI), toe-brachial index (TBI), and TcPO2 were not determined because ABI and TBI for some patients could not be obtained due to wound condition. CONCLUSIONS: The TcPO2 value can predict the wound healing process of ischemic lower extremity injury.
Subject(s)
Oxygen , Wound Healing , Humans , Treatment Outcome , Retrospective Studies , Predictive Value of Tests , Chronic Limb-Threatening Ischemia , Ischemia/diagnostic imaging , Ischemia/surgery , Blood Gas Monitoring, TranscutaneousABSTRACT
OBJECTIVES: Current guidelines recommend initial postoperative follow-up with computed tomography angiography (CTA) after endovascular aneurysm repair (EVAR). However, CTA has risks associated with ionizing radiations and nephrotoxic contrast agents. We investigated possibilities to replace the initial postoperative CTA with contrast enhanced duplex ultrasound (CE-DUS) in selected patients. METHODS: Out of the 273 consecutive patients who underwent EVAR, 173 were excluded and the 100 patients who underwent CTA and CE-DUS imaging concurrently (≤1 month interval between CTA and CE-DUS imaging) within 60 days after EVAR were analyzed. Patients who underwent EVAR outside the manufacturer's instructions for use or who had endoleaks discovered on intraoperative angiography were classified as the high-risk group, otherwise, they were classified as the low-risk group. Measurements of diagnostic values of CE-DUS âârelated to the detection of complications were calculated using CTA as the gold standard. McNemar's test was performed to compare these values and Pearson correlation coefficient was derived to compare CE-DUS measurements of sac diameters with CTA. RESULTS: In the low-risk group, no difference was observed between CE-DUS and CTA in the detection of EVAR-related complications (sensitivity = 0.95, specificity = 0.93). In the high-risk group, CE-DUS was not as accurate as CTA for the detection of overall EVAR-related complications (sensitivity = 0.57, specificity = 0.86, p = 0.04) and for the detection of complications other than endoleaks (p = 0.02). Regarding sac diameter measurement, there was good agreement between CE-DUS and CTA (r = 0.92, p < 0.001). CONCLUSIONS: First postoperative CE-DUS was reliable for the evaluation of EVAR-related complications compared to CTA in selected patients. Individualized EVAR follow-up strategy using CE-DUS based on the initial risk of EVAR-related complications should be considered.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Endoleak/etiology , Aortic Aneurysm, Abdominal/surgery , Endovascular Aneurysm Repair , Blood Vessel Prosthesis Implantation/adverse effects , Aortography/methods , Follow-Up Studies , Predictive Value of Tests , Endovascular Procedures/adverse effects , Contrast Media , Treatment OutcomeSubject(s)
Femoral Artery , Vascular System Injuries , Humans , Femoral Artery/diagnostic imaging , Vascular System Injuries/diagnostic imaging , Vascular System Injuries/etiology , Vascular System Injuries/surgery , Iatrogenic Disease , Treatment Outcome , Retrospective Studies , Popliteal Artery/diagnostic imaging , Popliteal Artery/surgeryABSTRACT
INTRODUCTION: Hemodialysis vascular access parameters of intraoperative Color flow Doppler ultrasound remain controversial. This study aimed to evaluate the optimal cut-off value and efficacy of intraoperative arteriovenous fistula parameters identified by Color flow Doppler ultrasound for arteriovenous fistula maturation success. METHODS: This retrospective study consisted of a review of the medical records of 137 consecutive patients who underwent their first autologous arteriovenous fistula formation under local anesthesia for end-stage renal disease from April 9, 2020 to March 19, 2021. RESULTS: The receiver operating characteristic curve analysis revealed that the optimal cut-off for intraoperative cephalic vein flow volume for brachiocephalic arteriovenous fistula maturation at the 4-week follow-up was 349.53 ml/min (area under the curve, 0.792; p, 0.036; Youden index, 0.514). CONCLUSION: Intraoperative color Doppler ultrasound outflow cephalic vein flow volume is a useful factor in predicting arteriovenous fistula maturation. Intraoperative Color flow Doppler ultrasound should be performed.
Subject(s)
Arteriovenous Shunt, Surgical , Humans , Radial Artery , Retrospective Studies , Treatment Outcome , Blood Flow Velocity , Vascular Patency , Renal Dialysis , Ultrasonography, DopplerABSTRACT
BACKGROUND: To evaluate early outcomes of aortoiliac or isolated iliac artery aneurysm repair using the Zenith® Bifurcated Iliac Side (ZBIS) stent graft combined with the LifeStream™ Balloon Expandable Vascular Covered Stent as a bridging stentgraft. METHODS: Between August 2018 and February 2020, 38 patients (37 male, mean age 72.7 years) received 46 LifeStream stents in conjunction with 38 ZBIS stent grafts to bridge hypogastric arteries for aneurysm repair in six university hospitals in Korea. The primary outcomes were technical success rate and procedure-related complications. Secondary outcomes were bridging stent graft patency and re-intervention. RESULTS: All procedures were performed as elective standard endovascular aortic aneurysm repair (EVAR) and unilateral iliac branch device (IBD). Mean follow-up was 13.1 months, and patient overall survival rate was 96.7%. Technical success rate was 76.3% (n = 29). Causes of failure included seven total endoleaks; six type Ic and one type IIIc from the IBD junction, one unintentional IIA coverage, and one failure to deploy the IIA stent graft. Procedure-related complications occurred in two patients: one LifeStream migration and one ZBIS stent graft migration. Overall patency rates for the LifeStream and ZBIS stents were 97.4% and 97.2%, respectively. CONCLUSION: This multicenter preliminary experience with the LifeStream™ Balloon Expandable Vascular Covered Stent in IBD demonstrated good patency; however, an unexpectedly high rate of type Ic endoleaks was observed. Combined use of the LifeStream stent with the ZBIS stent graft is safe and feasible to preserve pelvic circulation with good patency and a low rate of device-related reintervention.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Male , Aged , Endoleak/etiology , Endoleak/prevention & control , Blood Vessel Prosthesis/adverse effects , Prosthesis Design , Treatment Outcome , Retrospective Studies , Stents/adverse effects , Republic of Korea , Aortic Aneurysm, Abdominal/surgery , Risk FactorsABSTRACT
Purpose: This study aimed to compare the characteristics of venous thromboembolic disease (VTE) in Korean to Caucasian population. Materials and Methods: XALIA-LEA and XALIA were phase IV non-interventional prospective studies with identical designs that investigated the effect of rivaroxaban versus standard anticoagulation for VTE. Koreans accounted for the largest proportion of the overall enrolled population of XALIA-LEA. However, in the XALIA study, most patients were Caucasian. Therefore, Korean data from XALIA-LEA and Caucasian data from XALIA were used in this study. This study compared the clinical characteristics and primary outcomes of the XALIA program, including major bleeding, recurrent VTE, and all-cause mortality. Results: The Korean population was older, was less obese, and had more active cancer at baseline than the Caucasian population. Provoked VTE was more common in the Korean population. Interestingly, Koreans showed less accompanying thrombophilia than Caucasians, and factor V Leiden mutations were not detected. Korean analyses comparing the effects of rivaroxaban and standard anticoagulation with primary outcomes showed a lower incidence of major bleeding, recurrent VTE, and all-cause mortality with rivaroxaban. Similar results were obtained in the propensity score matching analysis. Conclusion: Characteristic differences were found between Korean and Caucasian VTE patients. Despite these ethnic differences, the effectiveness and safety of rivaroxaban therapy in these patients were consistent.
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Spermidine is a cationic polyamine that plays key roles in diverse biological processes, including biofilm formation and cell viability in bacteria. In some human gastrointestinal bacteria, such as Helicobacter pylori and Campylobacter jejuni, spermidine is biosynthesized using carboxyspermidine dehydrogenase (CASDH) and carboxyspermidine decarboxylase through an alternative pathway rather than the classical pathway found in most bacteria and eukaryotes. CASDH condenses putrescine and aspartate ß-semialdehyde into carboxyspermidine in an NADPH-dependent manner. Because structural information on CASDH is not available, the exact enzymatic mechanism of CASDH has not been elucidated. To reveal the structural features of CASDH required for cofactor and substrate recruitment, we determined the crystal structures of the H. pylori CASDH protein alone and in complex with NADP. CASDH consists of three domains (D1, D2, and D3) and assembles into a homodimer exclusively using the D3 domain. The CASDH structure harbors a dent between the D1 and D3 domains. The NADP cofactor is inserted into the interdomain dent and induces structural rearrangements in CASDH, including dent closure and local structural changes in the D1 and D3 domains. A comparative analysis suggests that the substrate of CASDH binds in a cavity near the nicotinamide moiety of NADPH for the condensation reaction.
Subject(s)
Helicobacter pylori , Spermidine , Helicobacter pylori/metabolism , NADP/metabolism , Oxidoreductases/metabolism , Spermidine/metabolismABSTRACT
The pathogenic Listeria monocytogenes bacterium produces the flagellum as a locomotive organelle at or below 30°C outside the host, but it halts flagellar expression at 37°C inside the human host to evade the flagellum-induced immune response. Listeria monocytogenes GmaR is a thermosensor protein that coordinates flagellar expression by binding the master transcriptional repressor of flagellar genes (MogR) in a temperature-responsive manner. To understand the regulatory mechanism whereby GmaR exerts the antirepression activity on flagellar expression, we performed structural and mutational analyses of the GmaR-MogR system. At or below 30°C, GmaR exists as a functional monomer and forms a circularly enclosed multidomain structure via an interdomain interaction. GmaR in this conformation recognizes MogR using the C-terminal antirepressor domain in a unique dual binding mode and mediates the antirepressor function through direct competition and spatial restraint mechanisms. Surprisingly, at 37°C, GmaR rapidly forms autologous aggregates that are deficient in MogR neutralization capabilities.
Subject(s)
Listeria monocytogenes , Humans , Listeria monocytogenes/genetics , Bacterial Proteins/metabolism , Flagella/genetics , Flagella/metabolism , Gene Expression Regulation, BacterialABSTRACT
The effects of COVID-19 vaccination on alloimmunization and clinical impact in transplant candidates remain largely unknown. In a 61-year-old man who had no donor-specific antibodies (DSA) and was planned to undergo ABO-incompatible kidney transplantation (ABOi KT), DSAs (anti-A24, anti-B51, and anti-Cw14) developed after COVID-19 vaccination. After desensitization therapy, antibody level was further increased, leading to flow cytometric crossmatch-positive status. Donor-specific T cell immunity using interferon-gamma ELISPOT was continuously negative, whereas SARS-CoV-2 specific T cell immunity was intact. After confirming the C1q-negative status of DSA, the patient received ABOi KT. The patient had stable graft function and suppressed alloimmunity up to 2 months after KT. COVID-19 vaccination might relate to alloimmunization in transplant candidates, and desensitization through immune monitoring can help guide transplantation.
Subject(s)
COVID-19 , Kidney Transplantation , Alleles , Antibodies , COVID-19 Vaccines , Flow Cytometry , Graft Rejection , Graft Survival , HLA Antigens , Humans , Living Donors , Male , Middle Aged , SARS-CoV-2 , VaccinationABSTRACT
The antigen-based rapid diagnostic test (Ag-RDT) using saliva specimens is fast, noninvasive, and suitable for SARS-CoV-2 self-testing, unlike nasopharyngeal swab (NPS) testing. We evaluated a novel Beanguard gargle (BG)-based virus collection method that can be applied to Ag-RDT as an alternative to the current RT-PCR with an NPS for early diagnosis of COVID-19. This clinical trial comprised 102 COVID-19-positive patients hospitalized after a governmental screening process and 100 healthy individuals. Paired NPS and BG-based saliva specimens from COVID-19 patients and healthy individuals were analyzed using NPS-RT-PCR, BG-RT-PCR, and BG-Ag-RDTs, whose diagnostic performance for detecting SARS-CoV-2 was compared. BG-Ag-RDTs showed high sensitivity (97.8%) and specificity (100%) in 45 patients within 6 days of illness and detected all cases of SARS-CoV-2 Alpha and Delta variants. In 11 asymptomatic active COVID-19 cases, both BG-Ag-RDTs and BG-RT-PCR showed sensitivities and specificities of 100%. Sensitivities of BG-Ag-RDT and BG-RT-PCR toward salivary viral detection were highly concordant, with no discrimination between symptomatic (97.0%), asymptomatic (100%), or SARS-CoV-2 variant (100%) cases. The intermolecular interactions between SARS-CoV-2 spike proteins and truncated canavalin, an active ingredient from the bean extract (BE), were observed in terms of physicochemical properties. The detachment of the SARS-CoV-2 receptor-binding domain from hACE2 increased as the BE concentration increased, allowing the release of the virus from hACE2 for early diagnosis. Using BG-based saliva specimens remarkably enhances the Ag-RDT diagnostic performance as an alternative to NPS and enables noninvasive, rapid, and accurate COVID-19 self-testing and mass screening, supporting efficient COVID-19 management. IMPORTANCE An Ag-RDT is less likely to be accepted as an initial test method for early diagnosis owing to its low sensitivity. However, our self-collection method, Ag-RDT using BG-based saliva specimens, showed significantly enhanced detection sensitivity and specificity toward SARS-CoV-2 including the Alpha and Delta variants in all patients tested within 6 days of illness. The method represents an attractive alternative to nasopharyngeal swabs for the early diagnosis of symptomatic and asymptomatic COVID-19 cases. The evidence suggests that the method could have a potential for mass screening and monitoring of COVID-19 cases.