scholarly journals Bean extract-based gargle for efficient diagnosing COVID-19 at early-stage using rapid antigen tests: a clinical, prospective, diagnostic study

Author(s):  
Joseph Kwon ◽  
Euna Ko ◽  
Se-Young Cho ◽  
Young-Ho Lee ◽  
Sangmi Jun ◽  
...  

Importance: The antigen-based rapid diagnostic test (Ag-RDT), using saliva specimens, is fast, non-invasive and suitable for SARS-CoV-2 self-testing, unlike nasopharyngeal swab (NPS) testing. Objective: To assess the diagnostic sensitivity of a novel Beanguard gargleTM (BG)-based virus detection method for early diagnosis of COVID-19. Design: This clinical trial was conducted at Gunsan Medical Center, Namwon Medical Center, and Jeonbuk National University Hospital, between May 7 and July 7, 2021. Setting: Paired NPS and BG-based saliva specimens collected from COVID-19 patients and healthy individuals were analyzed using NPS-RT-PCR, BG-RT-PCR, and BG-Ag-RDTs. Participants: The study comprised 102 COVID-19-positive patients hospitalized after governmental screening process and 100 healthy individuals. Forty-five COVID-19 patients were sampled within 6 days of illness and 57 within 7–15 days; 27 were categorized as asymptomatic and 75, as symptomatic. Eight and 2 patients carried the SARS-CoV-2 Alpha and Delta variants, respectively. Intervention: The diagnostic performances of BG-Ag-RDT, BG-RT-PCR, and NPS-RT-PCR for detecting SARS-CoV-2 were compared. Main outcomes: The sensitivities of BG-Ag-RDT and BG-RT-PCR towards salivary viral detection were highly concordant, with no discrimination between symptomatic, asymptomatic, or SARS-CoV-2 variant cases. Results: Among total participants (mean age, 43.7 years), 51% were women. BG-Ag-RDTs showed high sensitivity (97.8%, [95% CI, 88.4% to 99.6%]) and specificity (100%, [95% CI, 96.3% to 100%) in 45 patients within 6 days of illness and could detect all cases of SARS-CoV-2 Alpha and Delta variants. In 11 asymptomatic early-stage cases, both BG-Ag-RDTs and BG-RT-PCR showed excellent sensitivity and specificity of 100% (95% CI, 74.1% to 100% and 95% CI, 20.7% to 100%, respectively). The interaction between SARS-CoV-2 spike proteins and truncated canavalin, an active ingredient from bean extract (BE) and the ultrastructural features of SARS-CoV-2 particles coated with BE were observed. 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. Conclusions and Relevance: Using BG-based saliva remarkably enhances the Ag-RDT diagnostic performance as an alternative to NPS and enables rapid and accurate COVID-19 self-testing and mass screening, supporting efficient COVID-19 management. Trial Registration: KCT0006438 Design: This clinical trial was conducted at Gunsan Medical Center, Namwon Medical Center, and Jeonbuk National University Hospital, between May 7 and July 7, 2021. Setting: Paired NPS and BG-based saliva specimens collected from COVID-19 patients and healthy individuals were analyzed using NPS-RT-PCR, BG-RT-PCR, and BG-Ag-RDTs. Participants: The study comprised 102 COVID-19-positive patients hospitalized after government screening and 100 healthy individuals. Forty-five COVID-19 patients were sampled within 6 days of illness and 57 within 7–15 days; 27 were categorized as asymptomatic and 75, as symptomatic. Eight and 2 patients carried the SARS-CoV-2 Alpha and Delta variants, respectively. Intervention: The diagnostic performances of BG-Ag-RDT, BG-RT-PCR, and NPS-RT-PCR for detecting SARS-CoV-2 were compared. Main outcomes: The sensitivities of BG-Ag-RDT and BG-RT-PCR towards salivary viral detection were highly concordant, with no discrimination between symptomatic, asymptomatic, or SARS-CoV-2 variant cases. Results: Among total participants (mean age, 43.7 years), 51% were women. BG-Ag-RDTs showed high sensitivity (97.8%, [95% CI, 88.4% to 99.6%]) and specificity (100%, [95% CI, 96.3% to 100%) in 45 patients within 6 days of illness and could detect all cases of SARS-CoV-2 Alpha and Delta variants. In 11 asymptomatic early-stage cases, both BG-Ag-RDTs and BG-RT-PCR showed excellent sensitivity and specificity of 100% (95% CI, 74.1% to 100% and 95% CI, 20.7% to 100%, respectively). The interaction between SARS-CoV-2 spike proteins and truncated canavalin, an active ingredient from bean extract (BE) and the ultrastructural features of SARS-CoV-2 particles coated with BE were observed. 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. Conclusions and Relevance: Using BG-based saliva remarkably enhances the Ag-RDT diagnostic performance as an alternative to NPS and enables rapid and accurate COVID-19 self-testing and mass screening, supporting efficient COVID-19 management.

2021 ◽  
Vol 10 (12) ◽  
pp. 2627
Author(s):  
Pierre-Edouard Fournier ◽  
Sophie Edouard ◽  
Nathalie Wurtz ◽  
Justine Raclot ◽  
Marion Bechet ◽  
...  

The Méditerranée Infection University Hospital Institute (IHU) is located in a recent building, which includes experts on a wide range of infectious disease. The IHU strategy is to develop innovative tools, including epidemiological monitoring, point-of-care laboratories, and the ability to mass screen the population. In this study, we review the strategy and guidelines proposed by the IHU and its application to the COVID-19 pandemic and summarise the various challenges it raises. Early diagnosis enables contagious patients to be isolated and treatment to be initiated at an early stage to reduce the microbial load and contagiousness. In the context of the COVID-19 pandemic, we had to deal with a shortage of personal protective equipment and reagents and a massive influx of patients. Between 27 January 2020 and 5 January 2021, 434,925 nasopharyngeal samples were tested for the presence of SARS-CoV-2. Of them, 12,055 patients with COVID-19 were followed up in our out-patient clinic, and 1888 patients were hospitalised in the Institute. By constantly adapting our strategy to the ongoing situation, the IHU has succeeded in expanding and upgrading its equipment and improving circuits and flows to better manage infected patients.


2021 ◽  
Vol 94 (1117) ◽  
pp. 20200574
Author(s):  
Alexander Gross ◽  
Georg Heine ◽  
Martin Schwarz ◽  
Dorina Thiemig ◽  
Sven Gläser ◽  
...  

Objectives: Although chest CT has been widely used in patients with COVID-19, its role for early diagnosis of COVID-19 is unclear. We report the diagnostic performance of chest CT using structured reporting in a routine clinical setting during the early phase of the epidemic in Germany. Methods: Patients with clinical suspicion of COVID-19 and moderate-to-severe symptoms were included in this retrospective study. CTs were performed and reported before RT-PCR results (reference standard) became available. A structured reporting system was used that concluded in a recently described five-grade score (“CO-RADS”), indicating the level of suspicion for pulmonary involvement of COVID-19 from 1 = very low to 5 = very high. Structured reporting was performed by three Radiologists in consensus. Results: In 96 consecutive patients (50 male, mean age 64), RT-PCR was positive in 20 (21%) cases. CT features significantly more common in RT-PCR-positive patients were ground-glass opacities as dominant feature, crazy paving, hazy margins of opacities, and multifocal bilateral distribution (p < 0.05). Using a cut-off point between CO-RADS 3 and 4, sensitivity was 90%, specificity 91%, positive predictive value 72%, negative predictive value 97%, and accuracy 91%. ROC analysis showed an AUC of 0.938. Conclusions: Structured reporting of chest CT with a five-grade scale provided accurate diagnosis of COVID-19. Its use was feasible and helpful in clinical routine. Advances in knowledge: Chest CT with structured reporting may be a provisional diagnostic alternative to RT-PCR testing for early diagnosis of COVID-19, especially when RT-PCR results are delayed or test capacities are limited.


2009 ◽  
Vol 36 (8) ◽  
pp. 1800-1802 ◽  
Author(s):  
BARRY BRESNIHAN ◽  
ELIZA PONTIFEX ◽  
ROGIER M. THURLINGS ◽  
MARJOLEIN VINKENOOG ◽  
HANI EL-GABALAWY ◽  
...  

Objective.To determine whether the correlation between the mean change in disease activity and the mean change in synovial sublining (sl) CD68 expression could be demonstrated across different academic centers.Methods.Synovial biopsies obtained at arthroscopy from patients with rheumatoid arthritis before and 160 days after rituximab therapy were selected and coded. Paired sections were processed independently at Amsterdam Medical Center (AMC) and at St. Vincent’s University Hospital (SVUH), Dublin. Digital image analysis (DIA) was employed at both centers to quantify sublining CD68 expression.Results.After analysis of CD68sl expression at centers in 2 different countries, high levels of intracenter and intercenter agreement were observed. For the pooled sections stained at AMC, the correlation between 2 investigators was R = 0.942, p = 0.000, and for sections stained at SVUH, R = 0.899, p = 0.001. Similarly, the intracenter correlations for ΔCD68sl expression after treatment were R = 0.998, p = 0.000, for sections stained at AMC and R = 0.880, p = 0.000, for sections stained at SVUH. The intercenter correlation for the pooled scores of sections stained at AMC was R = 0.85, p = 0.000, and for the sections stained at SVUH, R = 0.62, p = 0.001. The consistent correlation between ΔDAS (Disease Activity Score) and ΔCD68sl expression across different studies (Pearson correlation = 0.895, p < 0.001) was confirmed. The standardized response mean values for ΔCD68sl, calculated from analyses at both AMC and SVUH, were consistently 0.5 or greater, indicating a moderate to high potential to detect change.Conclusion.The correlation between mean ΔDAS and mean ΔCD68sl expression was confirmed across 2 centers. Examination of serial biopsy samples can be used reliably to screen for interesting biological effects at the site of inflammation at an early stage of drug development.


Author(s):  
Julie Toubiana ◽  
Clement Poirault ◽  
Alice Corsia ◽  
Fanny Bajolle ◽  
Jacques Fourgeaud ◽  
...  

Background: Acute clinical manifestations of SARS-CoV-2 infection are less frequent and less severe in children than in adults. However, recent observations raised concerns about potential post-viral severe inflammatory reactions in children infected with SARS-CoV-2. Methods: We describe an outbreak of cases of Kawasaki disease (KD) admitted between April 27 and May 7, 2020, in the general paediatrics department of a university hospital in Paris, France. All children prospectively underwent nasopharyngeal swabs for SARS-CoV-2 RT-PCR, SARS-CoV-2 IgG serology testing, and echocardiography. The number of admissions for KD during the study period was compared to that observed since January 1, 2018, based on discharge codes, using Poisson regression. Results: A total of 17 children were admitted for KD over an 11-day period, in contrast with a mean of 1.0 case per 2-week period over 2018-2019 (Poisson incidence rate ratio: 13.2 [95% confidence interval: 7.3-24.1], p <0.001). Their median age was 7.5 (range, 3.7-16.6) years, and 59% of patients originated from sub-Saharan Africa or Caribbean islands. Eleven patients presented with KD shock syndrome (KDSS) requiring intensive care support, and 12 had myocarditis. All children had marked gastrointestinal symptoms at the early stage of illness and high levels of inflammatory markers. Fourteen patients (82%) had evidence of recent SARS-CoV-2 infection (positive RT-PCR 7/17, positive IgG antibody detection 14/16). All patients received immunoglobulins and some received corticosteroids (5/17). The clinical outcome was favourable in all patients. Moderate coronary artery dilations were detected in 5 cases (29%) during hospitalisation. Conclusions: The ongoing outbreak of KD in the Paris might be related to SARS-CoV2, and shows an unusually high proportion of children with gastrointestinal involvement, KDSS and African ancestry.


2021 ◽  
Vol 10 (4) ◽  
pp. 3474-3478
Author(s):  
Swati Garg

In India, vaginal tuberculosis (FGTB) is a common cause of infertility, but diagnosis is difficult because of the form of the disease of people in need. Traditional diagnostic methods include the detection of rapid bacilli acid in endometrial or peritoneal biopsy, epithelioid granuloma biopsy, or a positive Expert type in biopsy, although this is only available in a small percentage of cases, leaving patients many are not available. Diagnosis of GTB by PCR along with histopathological findings leads to high sensitivity and specificity. So, both diagnostic and operative laparoscopy and hysteroscopy are the modalities essential for management of genital TB in infertile women. This review discusses various diagnostic modalities including endometrial or peritoneal biopsy to detect epithelioid granuloma on microscopy, role of PCR for GTB and correlation of two for early diagnosis of genital tuberculosis so that management will be started at early stage which can prevent patient from getting permanent damage to organs. Tuberculosis being endemic in counties likes India; it is often a leading cause of infertility. Early diagnosis is crucial because, by the time patient reports with infertility, already the damage has started and reverting tubal patency is almost impossible. Early diagnosis typically fails in developing countries, primarily because there are no pathognomonic signs of the disease and either poor sensitivity or procedurally invasive diagnostic methods are in use.


2004 ◽  
Vol 25 (8) ◽  
pp. 634-640 ◽  
Author(s):  
Jong Hee Shin ◽  
Mi-Na Kim ◽  
Dong Hyeon Shin ◽  
Sook-In Jung ◽  
Kwang Jin Kim ◽  
...  

AbstractObjective:To compare the epidemiology and genetic relatedness ofCandida tropicalisisolates causing bloodstream infection (BSI) in two hospitals.Setting:Two tertiary-care hospitals in Korea.Methods:A retrospective molecular epidemiologic analysis using pulsed-field gel electrophoresis (PFGE) was performed with 49C. tropicalisisolates from sporadic cases of BSI. The isolates were collected from 27 patients at Chonnam National University Hospital (CUH) during a 6-year period and 22 patients at Asan Medical Center (AMC) during a 2-year period.Results:Based on the PFGE patterns, the average similarity value (SAB) for the 27 isolates from CUH was 0.84 ± 0.08, which was significantly higher than that for the 22 isolates from AMC (0.78 ± 0.06;P< .001). Of the 49 strains from patients at the 2 hospitals, 9 isolates were placed into 3 subtypes with SABvalues of 1.0, which indicated that they were identical. All 9 of these strains were isolated from CUH patients, and each type strain was isolated sporadically during a period ranging from 4 months to 3 years. On comparison of the clinical characteristics of the patients of the 2 hospitals, the CUH strains were isolated more frequently from non-neutropenic patients and patients with central venous catheter–related fungemia; cases from CUH had a better outcome than those from AMC (P< .05).Conclusions:These data show that the clinical and epidemiologic characteristics ofC. tropicalisfungemia may differ markedly among hospitals and that some cases ofC. tropicalisfungemia may be caused by endemic strains within a hospital.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4431-4431
Author(s):  
Sun Young Kim ◽  
Hee Jin Kim ◽  
Keun Wook Bae ◽  
Ho Joon Im ◽  
Ji Yoon Kim ◽  
...  

Abstract Abstract 4431 Background Langerhans cell histiocytosis (LCH) pathogenesis is hypothesized a genetic change may have a significant effect on the cellular mechanisms controlling proliferation and apoptosis of LCs. In LCH, the expression of MMP12 was observed most abundantly in multi-system disease, which has the poor prognosis, and high expression of GSN was reported but the clinical significance of GSN was unveiled until now. We will investigate the association between these proteins and clinical outcomes in patients diagnosed with LCH. Methods Archival paraffin block were retrieved from children diagnosed with LCH and followed up at Asan medical center and Chungnam National University Hospital between 1998 and 2008. Available formalin-fixed, paraffin-embedded specimens from these patients will be used for GSN, MMP12 immunohistochemistry. We will analyze the correlations between protein expression states and clinical features. Results The medical records of the patients with LCH was analyzed for the factors that affect relapse and overall survival. The specimens from 49 patients were available for immunohistochemistry. Of these, 2 slides were not suitable because the quality of staining was not good for evaluation or the tumor cells are too difficult to be differentiated. The median age of 49 patients was 9.5 years, range 5 months to 22 years with a definite diagnosis of LCH based on CD1a positivity. The gelsolin and MMP12 were expressed in various degrees except eight specimens and overexpression had a tendency of correlation with multisystem and risk organ involvement. Conclusion Gelsoin and MMP12 might be associated with the pathogenesis of LCH and the high expressions in LCH have a possibility of playing a role in the progression of LCH. Disclosures: No relevant conflicts of interest to declare.


Author(s):  
Zhiqing Zhan ◽  
Jie Li ◽  
Zhangkai J. Cheng

AbstractThe coronavirus disease 2019 (COVID-19) pandemic has imposed an enormous disease burden worldwide, and the Delta variant now has become dominant in 53 countries. Recently published studies have shown that during periods of high viral load, rapid antigen tests (RAT) yield similar results to reverse transcriptase-polymerase chain reaction (RT-PCR) tests, and when used in serial screening (e.g., every three days), it has a high sensitivity. In this perspective, we recommend RT-PCR combined with RAT at points of entry: (i) RAT can be added to the detection phase at ports of entry to detect asymptomatic infections as early as possible; (ii) RAT can be added to post-entry quarantine every three days or less to reduce the rate of missed detection in later quarantine; (iii) Adding regular RAT to regular PCR testing for key airport personnel to prevent cross-infection and conduct closed-off management. In the face of sporadic Delta variant outbreaks, the combination of the two could help rapid triage and management of suspected populations at an early stage and thus contain the outbreak more quickly and effectively. We also discuss the issue whether the current antigen detection reagents can cope with various SARS-CoV-2 variants.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5084-5084
Author(s):  
Hee Won Moon ◽  
Tae Young Kim ◽  
Seong- Ho Kang ◽  
Hyun-Sook Chi ◽  
Eul Zu Seo ◽  
...  

Abstract Recent studies proposed the classification of multiple myeloma (MM) by the pathways involved in the early pathogenesis; nonhyperdiploid variants with a high incidence of IgH translocations and hyperdiploid variants associated with no IgH translocation. Most studies applied cytogenetic study or flow cytometry to define the ploidy. In this study, we combined the cytogenetic results and fluorescent in situ hybridization results to define the ploidy and investigated IgH tranlocation and 13q deletion in relation to the ploidy level on Korean patients with MM. A total of 135 cases diagnosed as MM between 1997 and 2003 from Seoul National University Hospital and the Asan Medical center were enrolled in this study. Conventional cytogenetic studies and FISH studies with different probes specific for the regions containing the genes or chromosomes (RB1, D13S319, D13S25, IgH/FGFR3, IgH/BCL2, IGH dual color, break apart rearrangement probe, IgH/CCND1, 1q, p53, p16, MLL, CEP 7, 11, 12) were performed. Of 135 patients with MM, 62 (45.9%) patients had hyperdiploid karyotype by cytogenetics and FISH. IgH translocations were observed in 37.4% of Korean patients with MM and were more frequent (54.7%) in hyperdiploid variants than in nonhyperdiploid variants (17.4%). Incidence of deletion 13q was 34.7% and also more frequent in hyperdiploid variants (54.2%) than in nonhyperdiploid variants (16.1%). In conclusion, IgH translocations and 13q deletions were not associated with nonhyperdiploid MM and appeared more frequently in hyperdiploid variant in Korean patients with MM.


2019 ◽  
Vol 47 (7) ◽  
pp. 3234-3242 ◽  
Author(s):  
Li Jiang ◽  
Yuning Li ◽  
Zhi Zhang ◽  
Lixing Lin ◽  
Xiaoli Liu

Objective Low-cost diagnostic and prognostic biomarkers could help guide clinical management of neonates with myocardial injury after asphyxia. This study aimed to assess the utility of creatine kinase (CK)-MB, high-sensitivity cardiac troponin I (hs-cTnI), brain natriuretic peptide (BNP), and myoglobin in the early diagnosis of myocardial injury following neonatal asphyxia. Methods Eighteen neonates with asphyxia and myocardial injury, 22 neonates with asphyxia and no myocardial injury, and 19 neonates without asphyxia (controls) were enrolled consecutively at the Neonatology Department, First Hospital of Lanzhou University (August 2013 to December 2014). Serum CK-MB, hs-cTnI, BNP, and myoglobin levels were evaluated at 12 hours and 7 days after birth. Their diagnostic value for myocardial injury was assessed by receiver operating characteristic (ROC) curve analysis. Results Levels of all four markers were higher in neonates with asphyxia and myocardial injury than in neonates with asphyxia and no myocardial injury or controls 12 hours after birth. The marker hs-cTnI had the highest diagnostic value. Using a cutoff value of 0.087 µg/L for hs-cTnI, the sensitivity, specificity, and diagnostic accuracy for asphyxia-induced myocardial injury were 55.6%, 95.5%, and 77.5%, respectively. Conclusions Serum hs-cTnI levels can predict myocardial injury caused by neonatal asphyxia at an early stage.


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