Utility of Serology in DeterminingHelicobacter pyloriEradication after Therapy

OBJECTIVE: To determine the usefulness of four serological tests in confirming cure ofH pyloriinfection before the previously reported six-month post-treatment delay.PATIENTS AND METHODS: As part of a prospective, blinded, controlled trial, in which patients with duodenal ulcers were randomized to receive different combinations of antibiotics, serum samples were obtained in 89 patients before treatment, as well as on several occasions after treatment. Antibody titres were determined by ELISA with Bio-Rad immunoglobulin (Ig) A, Bio-Rad IgG, Pyloriset EIA-A for IgA and Pyloriset EIA-G for IgG. Eradication was confirmed with antral biopsy three months after therapy.RESULTS: The percentage drop in titre following treatment was significantly larger for the group of patients who were treated successfully with all four kits. Optimal cut-offs for identifying successful therapy were determined, and accuracy improved as the interval between testing and therapy was prolonged. Six months after therapy, the IgG test from Bio-Rad achieved 100% sensitivity and 80% specificity, and that from Pyloriset achieved 88% sensitivity and 100% specificity. At three months, however, test performance was quite good, with 90% sensitivity and 80% specificity when using a Pyloriset IgA titre drop of 20% or greater to predict successful eradication.CONCLUSION: Serology is a simple, easily available, noninvasive method that exhibits good positive predictive value in the confirmation of successful cure ofH pyloriinfection three or six months after treatment.

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Test performance evaluation of SARS-CoV-2 serological assays

10.1101/2020.04.25.20074856 ◽

2020 ◽

Cited By ~ 52

Author(s):

Jeffrey D. Whitman ◽

Joseph Hiatt ◽

Cody T. Mowery ◽

Brian R. Shy ◽

Ruby Yu ◽

...

Keyword(s):

Test Performance ◽

Severe Disease ◽

Cross Reactivity ◽

Time Interval ◽

Rt Pcr ◽

Serum Samples ◽

Serological Tests ◽

Full Spectrum ◽

Assay Performance ◽

Lateral Flow Assays

ABSTRACTBackgroundSerological tests are crucial tools for assessments of SARS-CoV-2 exposure, infection and potential immunity. Their appropriate use and interpretation require accurate assay performance data.MethodWe conducted an evaluation of 10 lateral flow assays (LFAs) and two ELISAs to detect anti-SARS-CoV-2 antibodies. The specimen set comprised 130 plasma or serum samples from 80 symptomatic SARS-CoV-2 RT-PCR-positive individuals; 108 pre-COVID-19 negative controls; and 52 recent samples from individuals who underwent respiratory viral testing but were not diagnosed with Coronavirus Disease 2019 (COVID-19). Samples were blinded and LFA results were interpreted by two independent readers, using a standardized intensity scoring system.ResultsAmong specimens from SARS-CoV-2 RT-PCR-positive individuals, the percent seropositive increased with time interval, peaking at 81.8-100.0% in samples taken >20 days after symptom onset. Test specificity ranged from 84.3-100.0% in pre-COVID-19 specimens. Specificity was higher when weak LFA bands were considered negative, but this decreased sensitivity. IgM detection was more variable than IgG, and detection was highest when IgM and IgG results were combined. Agreement between ELISAs and LFAs ranged from 75.8-94.8%. No consistent cross-reactivity was observed.ConclusionOur evaluation showed heterogeneous assay performance. Reader training is key to reliable LFA performance, and can be tailored for survey goals. Informed use of serology will require evaluations covering the full spectrum of SARS-CoV-2 infections, from asymptomatic and mild infection to severe disease, and later convalescence. Well-designed studies to elucidate the mechanisms and serological correlates of protective immunity will be crucial to guide rational clinical and public health policies.

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Investigation of the Effects of Curcumin on Serum Cytokines in Obese Individuals: A Randomized Controlled Trial

The Scientific World JOURNAL ◽

10.1155/2014/898361 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 89

Author(s):

Shiva Ganjali ◽

Amirhossein Sahebkar ◽

Elahe Mahdipour ◽

Khadijeh Jamialahmadi ◽

Sepideh Torabi ◽

...

Keyword(s):

Controlled Trial ◽

Serum Levels ◽

Immunomodulatory Effects ◽

Serum Samples ◽

Randomized Controlled ◽

Array Technology ◽

Significant Difference ◽

Daily Dose ◽

Present Trial ◽

To Receive

Background. Obesity is a disorder often accompanied by a heightened state of systemic inflammation and immunoactivation. The present randomized crossover trial aimed to investigate the efficacy of curcumin, a bioactive polyphenol with established anti-inflammatory and immunomodulatory effects, on the serum levels of a panel of cytokines and mediators in obese individuals.Methods. Thirty obese individuals were randomized to receive curcumin at a daily dose of 1 g or a matched placebo for 4 weeks. Following a 2-week wash-out period, each group was assigned to the alternate treatment regimen for another 4 weeks. Serum samples were collected at the start and end of each study period. Serum levels of IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, VEGF, IFNγ, EGF, MCP-1, and TNFαwere measured using a multiplex Biochip Array Technology based method.Results. Mean serum IL-1β(P=0.042), IL-4 (P=0.008), and VEGF (P=0.01) were found to be significantly reduced by curcumin therapy. In contrast, no significant difference was observed in the concentrations of IL-2, IL-6, IL-8, IL-10, IFNγ, EGF, and MCP-1.Conclusions. The findings of the present trial suggested that curcumin may exert immunomodulatory effects via altering the circulating concentrations of IL-1β, IL-4, and VEGF.

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A Randomized Controlled Trial Shows that both 14-Day Hybrid and Bismuth Quadruple Therapies Cure Most Patients with Helicobacter pylori Infection in Populations with Moderate Antibiotic Resistance

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.00140-17 ◽

2017 ◽

Vol 61 (11) ◽

Cited By ~ 9

Author(s):

Feng-Woei Tsay ◽

Deng-Chyang Wu ◽

Hsien-Chung Yu ◽

Sung-Shuo Kao ◽

Kung-Hung Lin ◽

...

Keyword(s):

Helicobacter Pylori ◽

Antibiotic Resistance ◽

Eradication Rate ◽

Therapy Group ◽

Controlled Trial ◽

Hybrid Therapy ◽

Content Type ◽

Quadruple Therapy ◽

H Pylori ◽

To Receive

ABSTRACT Hybrid therapy is a novel two-step treatment achieving a high eradication rate for Helicobacter pylori infection. Currently, whether this new therapy achieves a higher eradication rate than bismuth quadruple therapy remains an unanswered question. The aim of this prospective, randomized comparative study was to investigate the efficacies of 14-day hybrid therapy and bismuth quadruple therapy in the treatment of H. pylori infection. From July 2013 to June 2015, eligible H. pylori-infected subjects were randomly assigned to receive either 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole for 14 days) or 14-day hybrid therapy (a 7-day dual therapy with pantoprazole plus amoxicillin, followed by a 7-day quadruple therapy with pantoprazole plus amoxicillin, clarithromycin, and metronidazole). H. pylori status was examined 6 weeks after the end of treatment. Three hundred thirty H. pylori-infected participants were randomized to receive 14-day bismuth quadruple therapy (n = 164) or 14-day hybrid therapy (n = 166). The eradication rates by intention-to-treat analysis were similar: 93.9% versus 92.8%, respectively (95% confidence interval [CI], −4.3% to 5.4%; P = 0.68). Per-protocol analysis yielded similar results (96.7% versus 94.9%, respectively; P = 0.44). However, bismuth quadruple therapy had a higher frequency of adverse events than hybrid therapy (55.5% versus 15.7%, respectively; 95% CI, 30.4% to 49.2%; P < 0.001). The two treatments exhibited comparable drug adherence (93.9% versus 97%, respectively). The resistance rates of antibiotics were: clarithromycin, 16.7% of patients; amoxicillin, 1.3%; metronidazole, 25%; and tetracycline, 0%. In the bismuth quadruple therapy group, the eradication rate of metronidazole-resistant strains was lower than that of metronidazole-susceptible strains (70.0% versus 96.4%, respectively; P = 0.04). In the hybrid therapy group, no significant impact of clarithromycin or metronidazole resistance on eradication rates was identified. Both 14-day hybrid and bismuth quadruple therapies cure most patients with H. pylori infection in populations with moderate antibiotic resistance. However, the 14-day hybrid therapy has fewer adverse effects than the bismuth quadruple therapy. (This study has been registered at ClinicalTrials.gov under identifier NCT02541864.)

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Serological survey of canine parvovirus 2 antibody titres in breeding kennels in northern Italy

BMC Veterinary Research ◽

10.1186/s12917-019-2085-4 ◽

2019 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Ada Rota ◽

Andrea Dogliero ◽

Elvira Muratore ◽

Paola Pregel ◽

Angela Del Carro ◽

...

Keyword(s):

Antibody Titre ◽

Herd Immunity ◽

Haemagglutination Inhibition ◽

Serum Antibody ◽

Significant Negative Correlation ◽

Northern Italy ◽

Canine Parvovirus ◽

Serum Samples ◽

Serological Tests ◽

Antibody Titres

Abstract Background Current guidelines recommend parvovirus revaccination of adult dogs no more frequently than every 3 years. The aim of this study was to determine the prevalence of dogs showing protective serum antibody titres against canine parvovirus 2 in breeding kennels in Northern Italy and to assess the effect of time from vaccination and the sex of the dog on antibody titres. The study was carried out on 370 animals of different breeds kept in 33 breeding kennels. Antibodies to canine parvovirus 2 in serum samples were measured with an indirect immunoenzymatic assay validated by the manufacturer in relation to the ‘gold standard’ haemagglutination inhibition test. The number of months that had elapsed since the last vaccination was calculated for each animal and categorized into the following classes: < 12 months; 13–24 months; 25–36 months; 37–48 months; and > 49 months. Results The prevalence of ‘unprotected’ dogs was 4.6%. A satisfactory solid herd immunity was present in the majority of breeding kennels, although some vaccination failures were detected. A significant negative correlation was found between antibody titre and months since last vaccination. Comparable antibody titres were found in the first 3 years after vaccination. Although the antibody titre over time was not affected by the sex of the dog, ‘unprotected’ females had been vaccinated more recently than males with analogous low titres. Conclusions Parvovirus revaccination of adult dogs every 3 years, as currently recommended, is also the appropriate recommendation for breeding kennels. Serological tests could be a useful tool to assess the effectiveness of vaccination.

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Detection of Helicobacter pylori Antibodies in a Pediatric Population: Comparison of Three Commercially Available Serological Tests and One In-House Enzyme Immunoassay

Journal of Clinical Microbiology ◽

10.1128/jcm.37.10.3328-3331.1999 ◽

1999 ◽

Vol 37 (10) ◽

pp. 3328-3331 ◽

Cited By ~ 18

Author(s):

Bengt Sunnerstam ◽

Torbjörn Kjerstadius ◽

Lillemor Jansson ◽

Johan Giesecke ◽

Mats Bergström ◽

...

Keyword(s):

Helicobacter Pylori ◽

Enzyme Immunoassay ◽

Reference Method ◽

False Positives ◽

Serological Response ◽

Serum Samples ◽

False Negatives ◽

Serological Tests ◽

Predictive Values ◽

H Pylori

A serum immunoglobulin G enzyme immunoassay (EIA) forHelicobacter pylori antibodies already in use in adults was evaluated with 99 pediatric serum samples to determine its usefulness for the study of H. pylori disease in children. The reference method used was either the 13C-urea breath test or a biopsy culture of gastric mucosa. In children, an EIA cutoff of 0.35 absorbancy unit yielded sensitivity, specificity, and positive and negative predictive values of 93, 97, 93, and 97%, respectively. The cutoff recommended when this EIA was published for use in adults was 0.70 absorbancy unit (H. Gnarpe, P. Unge, C. Blomqvist, and S. Mäkitalo, APMIS 96:128–132, 1988). Another subset of 169 serum samples taken from children was analyzed by four serological tests in order to compare the performance of the in-house EIA with the Pyloriset, HM-CAP, and Helico-G kits. For the 169 samples, 10 (5.9%) false-positives and no false-negatives occurred with the Helico-G, 3 (1.8%) false-positives and no false-negatives occurred with the Pyloriset, and 3 (1.8%) false-positives and 1 (0.6%) false-negative occurred with the HM-CAP. For the 169 samples, 1 (0.6%) false-positive and no false-negatives occurred with the in-house EIA. Serological detection of H. pylori antibodies with our EIA seems to be valuable in diagnosing H. pylori infection in children, but only if a lowered, specific pediatric cutoff is established. The commercial kits, particularly the Helico-G, seem to overdiagnose pediatric H. pylori infection. A positive serological test for H. pylori infection, particularly for children, needs to be confirmed by a reference method because of the possibility of spontaneous eradication of infection, with a lingering serological response.

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Helicobacter pylori and rosacea

Eastern Mediterranean Health Journal ◽

10.26719/2003.9.1-2.167 ◽

2003 ◽

Vol 9 (1-2) ◽

pp. 167-171

Author(s):

S. Zandi ◽

S. Shamsaddini ◽

M. J. Zahedi ◽

M. Hyatbaksh

Keyword(s):

Helicobacter Pylori ◽

Method Comparison ◽

Test Group ◽

Enzyme Linked Immunosorbent Assay ◽

Control Group ◽

Igg Antibody ◽

Serological Tests ◽

Serological Examination ◽

Antibody Titres ◽

H Pylori

Recent reports have suggested an increased prevalence of Helicobacter pylori infection in patients with rosacea, with some evidence of dermatological improvement in patients treated with antibiotics for this infection. Our study investigates the prevalence of H. pylori infection in rosacea patients in Kerman. Serological examination was done for 29 patients with classical identification of rosacea using the enzyme-linked immunosorbent assay IgG antibody method. Comparison of antibody titres with those of a control group revealed that the prevalence of positive serological tests for H. pylori was significantly higher in the test group. This supports the suggestion of some form of relationship between rosacea and H. pylori infection, though further investigations with larger sample sizes are required for a definite conclusion

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Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

SKIN The Journal of Cutaneous Medicine ◽

10.25251/skin.1.3.2 ◽

2017 ◽

Vol 1 (3) ◽

pp. 117-127

Author(s):

Yasaman Mansouri ◽

Yasmin Amir ◽

Michelle Min ◽

Raveena Khanna ◽

Ruiqi Huang ◽

...

Keyword(s):

Controlled Trial ◽

Subcutaneous Administration ◽

Open Label ◽

Post Dose ◽

Subcutaneous Injections ◽

Pain Scores ◽

Observational Cohort ◽

Vas Scores ◽

Pre Treatment ◽

To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

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Adenoma detection by Endocuff-assisted versus standard colonoscopy in an organized screening program: the “ItaVision” Randomized Controlled Trial

Endoscopy ◽

10.1055/a-1379-6868 ◽

2021 ◽

Author(s):

Manuel Zorzi ◽

Cesare Hassan ◽

Jessica Battagello ◽

Giulio Antonelli ◽

Maurizio Pantalena ◽

...

Keyword(s):

Screening Program ◽

Controlled Trial ◽

Withdrawal Time ◽

Adenoma Detection ◽

Organized Screening Program ◽

Immunochemical Test ◽

Medical Design ◽

Standard Colonoscopy ◽

To Receive ◽

Screening History

Objective Endocuff Vision (EV, Arc Medical Design Ltd., Leeds, England) has shown to increase mucosal exposure, and consequently adenoma detection rate (ADR), during colonoscopy. This nationwide multicentre study assessed possible benefits and harms of implementing EV in a Faecal Immunochemical Test (FIT)-based screening program. Design Patients undergoing colonoscopy after a FIT+ test were randomised 1:1 to receive colonoscopy with EV or standard colonoscopy, stratified by gender, age, and screening history. Primary outcome was ADR, Secondary outcomes were ADR stratified by endoscopists’ ADR, advanced ADR (AADR), adenoma per colonoscopy (APC), withdrawal time (WT), and adverse events (AE). Results Overall, 1,864 patients were enrolled in 13 centres. After exclusions, 1,813 (males: 53.7%; mean age: 60.1 years) were randomised, 908 in the EV arm and 905 in the control. ADR was significantly higher in the EV arm (47.8% vs 40.8%; RR 1.17, 95%CI 1.06-1.30) with no differences between arms regarding size or morphology. When stratifying for endoscopists’ ADR, only low detectors (ADR< 33.3%) showed a statistically significant ADR increase (EV = 41.1%, 95%CI 35.7-46.7 vs control = 26%, 95%CI 21.3-31.4 . AADR (24.8% vs 20.5%, RR 1.21; 95%CI 1.02-1.43) and APC (0.94 vs. 0.77, p=0.001) were higher in the EV arm. WT and AE were similar between arms. Conclusion EV increased ADR in a FIT-based screening program, supporting a complete exploration of colonic mucosa. Its utility was highest among endoscopists with a low ADR. ClinicalTrial.gov NCT03612674

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Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

Karger Kompass Pneumologie ◽

10.1159/000513487 ◽

2020 ◽

pp. 1-3

Author(s):

Maximilian Jorczyk

Keyword(s):

Very Low Birth Weight ◽

Controlled Trial ◽

Preterm Neonates ◽

Double Blind ◽

Mechanically Ventilated ◽

Before And After ◽

Anti Inflammatory ◽

To Receive ◽

Therapeutic Possibilities ◽

Inflammatory Effect

Introduction: Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. Objective: The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. Methods: This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for Ureaplasma. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). Results: Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood. Conclusions: Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O2 dependency at 28 days/death in mechanically ventilated preterm neonates.

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Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽

10.1177/17085381211010022 ◽

2021 ◽

pp. 170853812110100

Author(s):

Mohamed Shukri Abdelgawad ◽

Amr M El-Shafei ◽

Hesham A Sharaf El-Din ◽

Ehab M Saad ◽

Tamer A Khafagy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Radiofrequency Ablation ◽

Controlled Trial ◽

Compression Therapy ◽

Randomized Controlled ◽

Venous Ulcers ◽

Group A ◽

Group B ◽

To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

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