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1.
Am J Med ; 135(1): 76-81, 2022 01.
Article En | MEDLINE | ID: mdl-34508698

BACKGROUND: Fecal immunochemical testing (FIT) is widely used for colorectal cancer screening, its only indication. Its effect on clinical decision-making beyond screening is unknown. We studied the use of FIT in emergency and inpatient settings and its impact on patient care. METHODS: Using electronic medical records, we reviewed all non-ambulatory FITs performed from November 2017 to October 2019 at a tertiary care community hospital. We collected data on demographics, indications, gastroenterology consultations, and endoscopic procedures. Multivariate logistic regression was performed to determine the effect of FIT on gastroenterology consultation and endoscopy. RESULTS: We identified 550 patients with at least 1 FIT test. Only 3 FITs (0.5%) were performed for colorectal cancer screening. FITs were primarily ordered from the emergency department (45.3%) or inpatient hospital floor (42.2%). Anemia (44.0%), followed by gastrointestinal bleeding (40.9%), were the most common indications. FIT was positive in 253 patients (46.0%), and gastroenterology consultation was obtained for 47.4% (n = 120), compared with 14.5% (n = 43) of the 297 FIT-negative patients (odds ratio 3.28; 95% confidence interval, 2.23-4.82, P < .0001). A potential bleeding source was identified in 80% of patients with reported or witnessed overt gastrointestinal bleeding, a similar proportion (80.7%; P = .92) to patients who were FIT positive with overt gastrointestinal bleeding. Multivariate analysis showed that melena, hematemesis, and a positive FIT were associated with gastroenterology consultation (all P < .05), while only melena (odds ratio 3.34; 95% confidence interval, 1.48-7.54) was associated with endoscopy. CONCLUSIONS: Nearly all emergency department and inpatient FIT use was inappropriate. FIT resulted in more gastroenterology consultation but was not independently associated with inpatient endoscopy.


Emergency Service, Hospital/statistics & numerical data , Feces , Immunologic Tests/statistics & numerical data , Adult , Aged , Female , Humans , Inpatients , Male , Middle Aged , Retrospective Studies
2.
Allergol Immunopathol (Madr) ; 49(3): 120-130, 2021.
Article En | MEDLINE | ID: mdl-33938197

INTRODUCTION AND OBJECTIVE: The oral food challenge (OFC) is the gold standard to diagnose food allergy (FA); however, it is not a procedure free from the risk of having significant allergic reactions, even life-threatening.The aims of our study were to evaluate the frequency of positive OFCs performed in children with a suspected diagnosis of IgE- and non-IgE-mediated (food protein-induced enterocolitis syndrome (FPIES)) FA and how the failed challenges were managed. MATERIALS AND METHODS: A retrospective chart review was done on all children who have had OFCs in a tertiary-care pediatric allergy unit from 2017 to 2019. RESULTS: 682 patients were enrolled and 2206 challenges were performed: 2058 (93%) for IgE-mediated FA and 148 (7%) for FPIES. There were 262 (11.8%) challenge failures. The transfer to the emergency department was required 3 times (1.1%). None of the failed challenges resulted in death or hospitalization and 13.3% challenges did not require any treatment. CONCLUSIONS: Our findings confirm that food challenges can be performed safely in a specialized setting by well-trained personnel; all food challenge reactions, even the most serious, were reversible, thanks to a prompt recognition and treatment that generally did not worsen over time.


Enterocolitis/diagnosis , Food Hypersensitivity/diagnosis , Immunoglobulin E , Adolescent , Child , Child, Preschool , Enterocolitis/immunology , Female , Food Hypersensitivity/immunology , Hospitals, Pediatric , Humans , Immunologic Tests/methods , Immunologic Tests/statistics & numerical data , Infant , Male , Skin Tests/methods , Skin Tests/statistics & numerical data , Syndrome , Tertiary Care Centers
3.
Sci Rep ; 11(1): 4348, 2021 02 23.
Article En | MEDLINE | ID: mdl-33623065

Fecal immunochemical test (FIT) is widely used as a colorectal cancer screening tool. Antithrombotic drugs may affect the screening performance of FIT for colorectal tumors. The aim of this study was to clarify the effect of antithrombotic agents on FIT accuracy in screening for colorectal neoplasms. This retrospective study enrolled a total of 758 patients who underwent both FIT and total colonoscopy. The effect of antithrombotic drugs on FIT accuracy in detecting colorectal neoplasms (CN), including colorectal cancer (CRC), advanced adenoma (AA), and non-advanced adenoma (NAA), was examined. Of the 758 patients, 144 (19%) received antithrombotic drugs (administration group). In administration group, 61/144 (42%) cases had CN [CRC:14, AA:15, NAA:32] and 217/614 (35%) cases had CN (CRC:43, AA:56, NAA:118) in non-administration group. The prevalence of CN was not significantly different between the two groups (p = 0.1157). There was no significant difference in sensitivity or specificity of the detection of all types of CN with or without taking antithrombotic drugs. Neither the positive predictive value nor negative predictive value of FIT was affected by antithrombotic drug administration. Taking antithrombotic drugs may not have a large impact on sensitivity, specificity, positive predictive value, or negative predictive value of FIT in screening for CN.


Adenoma/prevention & control , Colorectal Neoplasms/prevention & control , Fibrinolytic Agents/administration & dosage , Occult Blood , Adenoma/epidemiology , Aged , Aged, 80 and over , Colorectal Neoplasms/epidemiology , Female , Humans , Immunologic Tests/standards , Immunologic Tests/statistics & numerical data , Male , Mass Screening/standards , Mass Screening/statistics & numerical data , Middle Aged , Prevalence , Sensitivity and Specificity
4.
Pediatr Res ; 89(3): 549-553, 2021 02.
Article En | MEDLINE | ID: mdl-32268342

BACKGROUND: Prematurity presents a diagnostic challenge in interpreting primary immunodeficiency (PID) testing. METHODS: We retrospectively reviewed the charts of all infants in our level IV referral neonatal intensive care unit (NICU) in Massachusetts, with immunologic testing performed from 2006 to 2018. RESULTS: The overall rate of PID testing was enriched in our population, with 1% of admitted patients having extended immunologic testing. The addition of TREC (T cell receptor excision circle) newborn screening in Massachusetts in 2009 increased the proportion of infants tested for PID in our NICU by 3-fold (1.21% post-newborn screening (NBS) vs. 0.46% pre-NBS). A majority of the term and late preterm (≥34 weeks) infants (31 of 41, 76%), as well as very premature (29-33 weeks) infants (12 of 17, 71%), who had immune testing, had a genetic diagnosis associated with secondary immunodeficiency or a PID. Most infants who were born extremely premature (EP, <29 weeks) (25 of 29, 86%) had no identifiable cause of immunodeficiency besides prematurity, despite a mean postmenstrual age of 40.1 weeks at the time of testing. CONCLUSIONS: Persistent immune derangements were present within a subgroup of the EP population through term postmenstrual age. EP infants with significant infectious history and abnormal immune testing at term-corrected age should be considered for genetic testing. IMPACT: The role of immunologic testing in the premature population is unclear, we therefore reviewed the records of all infants in our NICU who had immunologic testing, to rule out immunodeficiency, done from 2006 to 2018. The addition of newborn screening for SCID in 2009 doubled the number of infants who had immune investigations. The extremely premature cohort included many infants with persistent immune derangements through term-corrected gestational age, suggesting a persistent effect of prematurity on immune development and potential function. We propose that former premature infants with clinical evidence of immunodeficiency and sustained immune abnormalities by term-corrected age undergo genetic testing for immunodeficiency.


Hospitals, Pediatric/statistics & numerical data , Immunologic Tests/statistics & numerical data , Infant, Extremely Premature/immunology , Infant, Newborn/immunology , Infant, Premature, Diseases/epidemiology , Intensive Care Units, Neonatal/statistics & numerical data , Neonatal Screening , Primary Immunodeficiency Diseases/epidemiology , Tertiary Healthcare/statistics & numerical data , Adrenal Cortex Hormones/adverse effects , DiGeorge Syndrome/diagnosis , DiGeorge Syndrome/epidemiology , Early Diagnosis , Female , Gestational Age , Humans , Immunologic Memory , Infant, Premature, Diseases/diagnosis , Lymphocyte Count , Lymphopenia/epidemiology , Male , Massachusetts/epidemiology , Primary Immunodeficiency Diseases/diagnosis , Primary Immunodeficiency Diseases/genetics , Procedures and Techniques Utilization , Retrospective Studies , Severe Combined Immunodeficiency/diagnosis , Severe Combined Immunodeficiency/epidemiology , T-Lymphocyte Subsets/immunology
5.
Clin Chem Lab Med ; 59(1): 101-106, 2020 07 21.
Article En | MEDLINE | ID: mdl-32692695

Objectives: The new European In Vitro Diagnostic (IVD) Regulation 2017/746 (IVDR) restricts the use of lab-developed tests (LDT) after 26th May 2022. There are no data on the impact of the IVDR on laboratories in the European Union. Methods: Laboratory tests performed in UZ Leuven were divided in four groups: core laboratory, immunology, special chemistry, and molecular microbiology testing. Each test was classified as Conformité Européenne (CE)-IVD, modified/off-label CE-IVD, commercial Research Use Only (RUO) or LDT. Each matrix was considered a separate test. Results: We found that 97.6% of the more than 11.5 million results/year were generated with a CE-IVD method. Of the 922 different laboratory tests, however, only 41.8% were CE-IVD, 10.8% modified/off-label CE-IVD, 0.3% RUO, and 47.1% LDT. Off-label CE-IVD was mainly used to test alternative matrices not covered by the claim of the manufacturer (e.g., pleural or peritoneal fluid). LDTs were mainly used for special chemistry, flow cytometry, and molecular testing. Excluding flow cytometry, the main reasons for the use of 377 LDTs were lack of a CE-IVD method (71.9%), analytical requirements (14.3%), and the fact the LDT was in use before CE-IVD available (11.9%). Conclusions: While the large majority of results (97.6%) were generated with a CE-IVD method, only 41.8% of laboratory tests were CE-IVD. There is currently no alternative on the market for 71.5% of the 537 LDTs performed in our laboratory which do not fall within the scope of the current IVD directive (IVDD). Compliance with the IVDR will require a major investment of time and effort.


Hospitals, University/standards , Laboratories, Hospital/standards , Reagent Kits, Diagnostic/standards , Belgium , Chemistry Techniques, Analytical/standards , Chemistry Techniques, Analytical/statistics & numerical data , Hospitals, University/legislation & jurisprudence , Hospitals, University/statistics & numerical data , Humans , Immunologic Tests/standards , Immunologic Tests/statistics & numerical data , Laboratories, Hospital/legislation & jurisprudence , Laboratories, Hospital/statistics & numerical data , Microbiological Techniques/standards , Microbiological Techniques/statistics & numerical data , Reagent Kits, Diagnostic/statistics & numerical data
6.
Dan Med J ; 66(10)2019 Oct.
Article En | MEDLINE | ID: mdl-31571572

INTRODUCTION: In Denmark, diagnosing and treating allergy is mainly performed by general practitioners (GPs), but precise expectations of the GPs are not described in guidelines. Furthermore, very little is known about GPs' use of allergen-specific immunoglobulin E (sIgE) tests. The aim of this study was to describe the use of these tests in the Central Denmark Region. METHODS: We performed analyses on data from all sIgE tests ordered by GPs in the Central Denmark Region in 2015. A test was considered positive if the serum level of IgE was ≥ 0.35 kU/l. RESULTS: Serum levels of sIgE were determined in 26,129 patients, equivalent to 2% of the Danish population. A total of 106,237 tests were performed, the majority as part of screening algorithms for inhalant and food allergens. Screening was ordered 20,697 times for inhalation allergens and 12,999 times for food allergens. Additionally, a considerable number of tests for antibiotics (n = 4,407), insect venom (n = 748) and other allergens were performed (n = 824). Positive rates were determined for various allergens in relation to gender and age. The rates were generally higher than rates known to be present in the background population. A higher percentage of females than males was tested. However, positive rates were generally lower in females than in males. CONCLUSIONS: This is the first descriptive analysis of the use of testing for sIgE in general practice. Results from this study may be used to optimise how GPs order and interpret sIgE tests in the future. FUNDING: none. TRIAL REGISTRATION: not relevant.


Allergens/analysis , General Practice/statistics & numerical data , Hypersensitivity, Immediate/diagnosis , Immunoglobulin E/analysis , Immunologic Tests/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Adult , Allergens/immunology , Denmark , Female , Humans , Hypersensitivity, Immediate/immunology , Immunoglobulin E/immunology , Immunologic Tests/methods , Male , Middle Aged
7.
Medicine (Baltimore) ; 98(23): e15977, 2019 Jun.
Article En | MEDLINE | ID: mdl-31169732

BACKGROUND: Tuberculosis (TB) is a highly contagious and chronic disease. The microbiological examination to confirm children TB disease are limited due to paucibacillary Mycobacterium, specimens and detecting facilities. Considering these limitations in diagnosing children TB, new and reliable methods that detect children TB should be developed. Recently, Interferon gamma-induced protein 10 (IP-10) has been identified as a sensitive parameter in detecting children TB. The present study aims to synthesis and analysis the diagnostic value of IP-10 for children TB. METHODS: We will search PubMed, Embase, the Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure, and Chinese Biological Medical Databases. We will search relevant citations up to May 2019. The quality of individual study will be assessed using the Quality Assessment of Diagnostic Accuracy Studies tool-2 (QUADAS-2). Stata 14.0 software will be used to calculate the pooled sensitivity, pooled specificity, pooled positive likelihood ratio (PLR), pooled negative likelihood ratio (NLR), pooled diagnostic odds ratio (DOR), pre-test probability, post-test probability and the hierarchical summary receiver operating characteristic (HSROC) curve. RESULTS: The results of this study will be published in a peer-reviewed journal. DISCUSSION: The evidence will indicate that IP-10 test is an alternative immunological test in detecting children TB. This is a protocol of systematic review and meta-analysis, so the ethical approval and patient consent are not required. PROTOCOL REGISTRATION NUMBER: CRD42019129743.


Chemokine CXCL10/analysis , Immunologic Tests/statistics & numerical data , Mycobacterium/immunology , Tuberculosis, Pulmonary/diagnosis , Adolescent , Case-Control Studies , Child , Child, Preschool , Cohort Studies , Female , Humans , Immunologic Tests/methods , Infant , Likelihood Functions , Male , Meta-Analysis as Topic , Research Design , Sensitivity and Specificity , Systematic Reviews as Topic , Tuberculosis, Pulmonary/immunology
8.
J Infect Chemother ; 25(4): 267-272, 2019 Apr.
Article En | MEDLINE | ID: mdl-30642770

The application and clinical impact of rapid antigen detection test (RADT) in the treatment of acute pharyngitis is unknown in Japan. We aimed to examine the proportions of RADT usage to identify Group A ß-hemolytic Streptococcus (GAS) in outpatients with acute pharyngitis and evaluate the association between RADT and antibiotic treatment. We analyzed health insurance claims data from 2013 to 2015. Logistic regression models were used to analyze associated factors with RADT, overall antibiotic prescription, or penicillin use. We analyzed 1.27 million outpatient visits with acute pharyngitis, in which antibiotics were prescribed in 59.3% of visits. Of the total visits, 5.6% of patients received RADT, and 10.8% of the antibiotics were penicillin. Penicillin selection rates were higher in cases with RADT (25.4%) than those without RADT (9.7%). Compared to large-scale facilities, antibiotic prescription rates were higher in physicians' offices. For factor analysis, age (3-15 years), diagnosis code (streptococcal pharyngitis), size of the medical facility (large-scale hospitals), and physician's specialty (pediatrics) were associated with RADT use. Penicillin selection rate increased with RADT implementation (25.4% vs. 9.7%: adjusted odds ratio 1.55; 95% CI, 1.50-1.60). At 63% of the facilities, the RADT implementation rate was <5% of acute pharyngitis visits prescribed antibiotics. In conclusion, the proportion of RADT usage for outpatients with acute pharyngitis was low in Japan. With appropriate indication and evaluation, we expect that more utilization of RADT can help promote antimicrobial stewardship for outpatients with acute pharyngitis by prompting penicillin therapy. Further investigation with detailed clinical data are warranted.


Anti-Bacterial Agents/therapeutic use , Antigens, Bacterial/isolation & purification , Immunologic Tests/statistics & numerical data , Pharyngitis/drug therapy , Streptococcal Infections/drug therapy , Acute Disease/therapy , Adolescent , Adult , Aged , Anti-Bacterial Agents/pharmacology , Antimicrobial Stewardship/standards , Antimicrobial Stewardship/statistics & numerical data , Child , Child, Preschool , Humans , Immunologic Tests/instrumentation , Infant , Infant, Newborn , Japan , Middle Aged , Penicillins/pharmacology , Penicillins/therapeutic use , Pharyngitis/immunology , Pharyngitis/microbiology , Practice Guidelines as Topic , Reagent Kits, Diagnostic/statistics & numerical data , Retrospective Studies , Streptococcal Infections/immunology , Streptococcal Infections/microbiology , Streptococcus pyogenes/immunology , Streptococcus pyogenes/isolation & purification , Young Adult
9.
Medicine (Baltimore) ; 98(1): e13731, 2019 Jan.
Article En | MEDLINE | ID: mdl-30608385

This study aims to evaluate the clinic value of ultrasound, computed tomography (CT) and serological testing in the differentiation between hepatic Cystic Echinococcosis (CE) types 1 and simple hepatic cysts.Totally 50 patients with CE Types 1 and 50 patients with simple hepatic cysts were included. All patients examined by ultrasound, CT and serological testing respectively. The receiver operating characteristic (ROC) curve of diagnosis methods was drawn and their sensitivity, specificity, Youden index, positive likelihood ratio, negative likelihood ratio, positive predictive value and negative predictive value were compared. Pathology result was used as golden standard.The area under ROC curve of ultrasound was 0.97 and of CT and serological testing was 0.79 and 0.71 respectively. The sensitivity of ultrasound in the diagnosis of CE Types 1 was 96.00%, specificity was 98.00%, the positive likelihood ratio was 48.00, and negative likelihood ratio was 0.04. Disease prevalence was 50%, positive predictive value was 97.96%, and negative predictive value was 96.08%. The sensitivity of CT was 80.00%, specificity was 62.00%, positive likelihood ratio was 2.11, and negative likelihood ratio was 0.32. Disease prevalence was 50%, positive predictive value was 67.80%, and negative predictive value was 75.61%. The sensitivity of immunological test was 86.00%, specificity was 72.00%, positive likelihood ratio was 3.07, and negative likelihood ratio was 0.19. Disease prevalence was 50%, positive predictive value was 75.44%, and negative predictive value was 83.72%. Combined ultrasound and immunological test, the sensitivity and the specificity was 82% and 100% respectively. Combined CT and immunological test, the sensitivity the specificity was 70% and 82% respectively.In the differentiate diagnosis of CE Types 1 and simple hepatic cyst, ultrasound is better than CT with high sensitivity and specificity, therefore recommended. Immunological examination is an important complement to the imaging examination.


Cysts/diagnosis , Echinococcosis, Hepatic/diagnosis , Immunologic Tests/statistics & numerical data , Liver Diseases/diagnosis , Ultrasonography/statistics & numerical data , Adolescent , Area Under Curve , Child , Child, Preschool , Cysts/epidemiology , Diagnosis, Differential , Echinococcosis, Hepatic/epidemiology , Female , Humans , Liver/diagnostic imaging , Liver/pathology , Liver Diseases/epidemiology , Male , Predictive Value of Tests , Prevalence , ROC Curve , Retrospective Studies , Sensitivity and Specificity , Tomography, X-Ray Computed
11.
Am J Gastroenterol ; 113(12): 1891-1899, 2018 12.
Article En | MEDLINE | ID: mdl-30337703

OBJECTIVE: To estimate the change in the participation rate and the change in neoplasia incidence before and after the change of the Fecal Occult Blood Test (FOBT) in the cohort included in the Colorectal Cancer Screening Program (CRCSP). METHODS: Cohort of 279,210 people, aged 50-74 years, invited at least once before 2009, to participate in a CRCSP campaign. The participation rate and the cumulative neoplasia incidence were described on 4 campaigns (≤2008, 2009-2010, 2011-2012 and 2013-2014) with a Guaiac FOBT (gFOBT) and a first campaign (2015-2016) with a Fecal Immunochemical Test (FIT). The cumulative incidence was estimated by the actuarial method and its confidence interval by the Greenwood method. RESULTS: The participation rate decreased from 32.7% (first gFOBT-campaign) to 24.4% (fourth gFOBT-campaign) then, made a significant bound in the FIT-campaign (28.4%; p < 0.001). 35.4% of the 965 high-risk-polyps screened in this cohort were detected in the FIT-campaign. CRC incidence gradually decreased from 0.4 to 0.1/1000 person-years from the first to the fourth gFOBT-campaign before reaching a bound to 0.4/1000 person-years in the FIT-campaign. CONCLUSION: Although it was still below the minimum European target (45%), the participation rate has increased between the last gFOBT-campaign and FIT-campaign, justifying the impact of promotional campaigns and the acceptance of the new test by people and GPs. A decline in the neoplasia incidence was observed between the initial and the fourth gFOBT-campaign. The change from gFOBT to FIT between the fourth and fifth campaigns, was associated with a significant increase in detection of neoplasia.


Colorectal Neoplasms/epidemiology , Early Detection of Cancer/statistics & numerical data , Immunologic Tests/instrumentation , Mass Screening/statistics & numerical data , Occult Blood , Patient Acceptance of Health Care/statistics & numerical data , Aged , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/methods , Early Detection of Cancer/trends , Female , Follow-Up Studies , France/epidemiology , Guaiac/chemistry , Humans , Immunologic Tests/statistics & numerical data , Immunologic Tests/trends , Incidence , Indicators and Reagents/chemistry , Male , Mass Screening/methods , Mass Screening/trends , Middle Aged , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity
12.
Eur J Clin Microbiol Infect Dis ; 37(9): 1637-1645, 2018 Sep.
Article En | MEDLINE | ID: mdl-29876774

Despite group A streptococci being an infrequent cause of pharyngitis in adult outpatients, sore throat remains a common indication for antibiotic prescription. This prospective multicentre non-randomised study describes a community pharmacy-based antimicrobial stewardship intervention consisting in the implementation of rapid antigen testing (RAT) for the management of adults with sore throat. Trained pharmacists triaged patients presenting with symptoms of pharyngitis using the modified Centor score. Those at risk for streptococcal infection were tested with RAT. Patients with a positive RAT were invited to consult a physician, whereas others were offered a symptomatic treatment. All patients received educational leaflets and were asked to fill in a follow-up form 7 days later. Ninety-eight pharmacies in one French region participated, and 559 patients were included over 6 months. RAT was proposed in 367 (65.7%) cases, and it was positive in 28 (8.3%). The follow-up form was returned by 140 (38.5%) participants. Of these, 10/10 patients with positive RAT further consulted a physician and were prescribed an antibiotic treatment, whereas 96.5% (110/114) of patients with negative results and not having any other reason to seek for doctor's advice did not consult. All participants found the intervention useful. Pharmacists spent 6-15 min to perform the intervention, and 98.6% (73/74) of pharmacists giving a feedback declared to be ready to implement this intervention in daily practice, if endorsed and reimbursed. Our results suggest that a pharmacy-based programme for the management of sore throat is feasible and could increase adherence to guidelines.


Immunologic Tests/statistics & numerical data , Pharmacies/statistics & numerical data , Pharyngitis/diagnosis , Streptococcal Infections/diagnosis , Streptococcus pyogenes/isolation & purification , Anti-Bacterial Agents/therapeutic use , Female , Follow-Up Studies , France , Guideline Adherence , Humans , Male , Pharmacies/standards , Pharmacists , Pharyngitis/drug therapy , Prospective Studies , Referral and Consultation/statistics & numerical data , Streptococcal Infections/drug therapy
13.
Am J Gastroenterol ; 113(12): 1848-1854, 2018 12.
Article En | MEDLINE | ID: mdl-29925915

OBJECTIVES: METHODS:: RESULTS:: Patients randomized to opt-in agreed to participate 23.1% of the time, and only 2.5% of those in opt-out chose not to participate. FIT kits were mailed to 22.4% and 93% of patients in opt-in and opt-out arms, respectively. In intention-to-screen analysis, patients in the opt-out arm had a higher FIT completion rate (29.1%) than in the opt-in arm (9.6%) (absolute difference 19.5%; 95% confidence interval, 10.9-27.9%; P < .001). Results were similar in subgroup analysis of those sent initial messaging through the EHR portal (9.5% opt-in versus 37.5% in opt-out). CONCLUSIONS: .


Colorectal Neoplasms/diagnosis , Early Detection of Cancer/statistics & numerical data , Mass Screening/organization & administration , Patient Acceptance of Health Care/psychology , Refusal to Participate/statistics & numerical data , Aged , Early Detection of Cancer/methods , Early Detection of Cancer/psychology , Female , Humans , Immunologic Tests/methods , Immunologic Tests/psychology , Immunologic Tests/statistics & numerical data , Male , Mass Screening/methods , Mass Screening/psychology , Mass Screening/statistics & numerical data , Middle Aged , Occult Blood , Patient Acceptance of Health Care/statistics & numerical data
14.
PLoS One ; 13(4): e0195308, 2018.
Article En | MEDLINE | ID: mdl-29630613

The CDC Tier 1 select agent Francisella tularensis is a small, Gram-negative bacterium and the causative agent of tularemia, a potentially life-threatening infection endemic in the United States, Europe and Asia. Currently, there is no licensed vaccine or rapid point-of-care diagnostic test for tularemia. The purpose of this research was to develop monoclonal antibodies (mAbs) specific to the F. tularensis surface-expressed lipopolysaccharide (LPS) for a potential use in a rapid diagnostic test. Our initial antigen capture ELISA was developed using murine IgG3 mAb 1A4. Due to the low sensitivity of the initial assay, IgG subclass switching, which is known to have an effect on the functional affinity of a mAb, was exploited for the purpose of enhancing assay sensitivity. The ELISA developed using the IgG1 or IgG2b mAbs from the subclass-switch family of 1A4 IgG3 yielded improved assay sensitivity. However, surface plasmon resonance (SPR) demonstrated that the functional affinity was decreased as a result of subclass switching. Further investigation using direct ELISA revealed the potential self-association of 1A4 IgG3, which could explain the higher functional affinity and higher assay background seen with this mAb. Additionally, the higher assay background was found to negatively affect assay sensitivity. Thus, enhancement of the assay sensitivity by subclass switching is likely due to the decrease in assay background, simply by avoiding the self-association of IgG3.


Francisella tularensis/immunology , Immunoassay/methods , Immunoglobulin Class Switching/immunology , Immunoglobulin G/classification , Immunoglobulin G/immunology , Lipopolysaccharides/immunology , Tularemia/diagnosis , Amino Acid Sequence , Animals , Antibodies, Bacterial/classification , Antibodies, Bacterial/genetics , Antibodies, Bacterial/immunology , Antibodies, Monoclonal/classification , Antibodies, Monoclonal/genetics , Antibodies, Monoclonal/immunology , Antibody Affinity , Antigen-Antibody Reactions , Enzyme-Linked Immunosorbent Assay/methods , Enzyme-Linked Immunosorbent Assay/statistics & numerical data , Female , Francisella tularensis/pathogenicity , Humans , Immunoassay/statistics & numerical data , Immunoglobulin Class Switching/genetics , Immunoglobulin G/genetics , Immunologic Tests/methods , Immunologic Tests/statistics & numerical data , Limit of Detection , Lipopolysaccharides/analysis , Mice , Mice, Inbred BALB C , Sensitivity and Specificity , Surface Plasmon Resonance , Tularemia/immunology , Tularemia/microbiology
15.
J Pediatr Gastroenterol Nutr ; 66(4): 598-602, 2018 04.
Article En | MEDLINE | ID: mdl-28922259

OBJECTIVES: The aim of this study was to evaluate the current well-being and dietary restrictions in children 6 years after food challenge-confirmed diagnosis of non-IgE cow's milk protein allergy, compared to peers with gastrointestinal symptoms but negative food challenge. This study aimed to evaluate the diagnostic process retrospectively. METHODS: This is an Internet-based survey for mothers whose children underwent 6 years ago the double-blind, placebo-controlled food challenge for cow's milk (CM) because of gastrointestinal symptoms causing suspicion of non-IgE CM protein allergy. Concurrent dietary restrictions, overall well-being, medical history, and retrospective views on the food challenge were queried using a study-specific questionnaire, the Quality of life using PedsQL general score and parental stress with the Parenting Stress Index questionnaire. RESULT: Mothers of 42 children (23 girls), median age of 6.7 years (range 5.7-8.6), participated in the survey, the response rate was 70%. All children now consumed cow's milk protein. The only food restrictions reported were empirical lactose-free diets in 7 children (17%). One-third of the children in both groups were presently reported to have eating-related issues such as picky eating. Quality of life was good and present parenting stress was average in both groups. The majority of the mothers (87%) felt positive or neutral about the food challenge performed in infancy. CONCLUSIONS: The non-IgE CM allergy with gastrointestinal symptoms diagnosed in infancy was a transient condition with good outcome. At an early school age, nearly all children have a good quality of life and a regular diet. The use of the double-blind, placebo-controlled food challenge was well-endorsed.


Gastrointestinal Diseases/epidemiology , Immunologic Tests/statistics & numerical data , Milk Hypersensitivity/diagnosis , Quality of Life , Adaptation, Psychological , Animals , Child , Child, Preschool , Double-Blind Method , Female , Follow-Up Studies , Gastrointestinal Diseases/etiology , Humans , Immunoglobulin E , Male , Milk/immunology , Milk Hypersensitivity/complications , Milk Hypersensitivity/psychology , Mothers/psychology , Retrospective Studies , Surveys and Questionnaires
16.
J. investig. allergol. clin. immunol ; 28(5): 321-329, 2018. tab, graf
Article En | IBECS | ID: ibc-174533

Background: Allergic diseases are highly prevalent in industrialized populations. In Spain, children suspected of having an allergic disease are usually referred by their primary care pediatrician to an allergy unit at a general hospital or a children’s hospital. We report data from a subanalysis of the pediatric population in Alergológica 2015. Methods: Data were collected from pediatric patients (age, ≤14 years) consulting an allergist for the first time in 2014 and the first quarter of 2015 in order to determine variations compared with data reported in Alergólogica 2005. Results: Alergológica 2015 included fewer pediatric patients than Alergológica 2005. The study population comprised 481 patients aged ≤14 years from more than 200 centers throughout Spain. Males accounted for 56.5%. Rhinoconjunctivitis was the main reason for consulting an allergist (53.8% vs 46.3% in 2005), followed by asthma (30.2% vs 34.6%), and food allergy (20.0% vs 14.5%). Conclusions: The findings of Alergológica 2015 show a notable increased frequency of allergic rhinitis, drug allergy, and food allergy. The frequency of other allergic conditions remained unchanged, except for asthma, whose frequency decreased, as in adult patients


Antecedentes: Las enfermedades alérgicas son muy prevalentes en las poblaciones industrializadas. En España, los niños con sospecha de enfermedad alérgica son habitualmente derivados por su médico de atención primaria a una unidad de alergia de un hospital general o de un hospital infantil. Se notifican los datos del subanálisis de la población pediátrica de Alergológica 2015. Métodos: Se recogieron los datos de los pacientes pediátricos (edad ≤ 14 años) que acudieron al alergólogo por primera vez en 2014 y el primer trimestre de 2015 con el objetivo de determinar las variaciones con respecto a los datos de Alergológica 2005. Resultados: Alergológica 2015 incluyó menos pacientes pediátricos que Alergológica 2005. La población estudiada comprendía 481 pacientes de edad ≤14 años, de más de 200 centros españoles. Los varones representaron el 56,5%. La rinoconjuntivitis fue el principal motivo de consulta al alergólogo (53,8% frente a 46,3% en 2005), seguida del asma (30,2% frente a 34,6%) y la alergia alimentaria (20,0% frente a 14,5%). Conclusiones: Los hallazgos de Alergológica 2015 muestran un aumento notable de la frecuencia de la rinitis alérgica, la alergia a fármacos y la alergia alimentaria. La frecuencia de otras afecciones alérgicas permaneció inalterada, excepto para el asma, cuya frecuencia disminuyó, al igual que en los pacientes adultos


Humans , Child , Adolescent , Hypersensitivity/epidemiology , Immunologic Tests/statistics & numerical data , Morbidity Surveys , Respiratory Hypersensitivity/epidemiology , Dermatitis, Contact/epidemiology , Drug Hypersensitivity/epidemiology , Food Hypersensitivity/epidemiology , Hypersensitivity, Immediate/epidemiology , Spain/epidemiology , Urticaria/epidemiology , Angioedema/epidemiology
18.
Eur J Pediatr ; 175(8): 1099-105, 2016 Aug.
Article En | MEDLINE | ID: mdl-27357411

UNLABELLED: The study presents an overview on current situation of primary immunodeficiency (PID) patients in Poland and the 2014 annual report of the Polish Working Group for Immunodeficiency (PWGID). The group was set up in 2005 to improve diagnosis, treatment, and care of patients with immunodeficiencies and currently includes 15 pediatric and 13 adult centers. According to PWGID report 4099, PID patients are recognized in Poland, with the prevalence 10.6/100,000. The majority of them (54.2 %) have predominantly antibody deficiency (PAD). In 2014 alone, a total number of 731 newly diagnosed individuals are reported. As predicted, the vast majority (70 %) of them have PAD. Approximately one third of PAD patients require immunoglobulin replacement therapy. Within the entire cohort, an intravenous route of immunoglobulin therapy dominates (67.3 %). However, within the age groups, distribution of immunoglobulin therapy varies and seems to be age related. Among children, 36 % receive subcutaneous immunoglobulin, while with adults 26 %. CONCLUSION: Analysis of numbers of either newly recognized or treated patients indicates its dynamic increase in recent years. This is the result of comprehensive activities by PWGID supported by governmental institutions, outstanding foundations, and patient's organization. WHAT IS KNOWN: • Immunoglobulins' treatment has substantially changed the life of individuals with PAD. Patients with common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA) can live and lead a near normal life. Early diagnosis of the disease followed by earlier implementation of appropriate treatment, including gammaglobulin replacement therapy, improves the quality of life. • Targeted efforts of health care professionals and government are required to optimize diagnostic and therapeutic approach for PAD. What is New: • Comprehensive activities of PWGID lead to better recognition of PID individuals and should improve reporting Polish PIDs to the ESID database. • Following the joint efforts of immunologists, patient's, and governmental organizations in the end of 2014, the Therapeutic Program for Treatment Adults with PID was introduced, leading to universal access to currently available treatment options and to improve the quality of life.


Immunization, Passive/statistics & numerical data , Immunologic Deficiency Syndromes/epidemiology , Adolescent , Adult , Age Distribution , Child , Child, Preschool , Health Services Accessibility/statistics & numerical data , Humans , Immunoglobulins/therapeutic use , Immunologic Deficiency Syndromes/drug therapy , Immunologic Tests/statistics & numerical data , Incidence , Infant , International Cooperation , Poland/epidemiology , Prevalence , Young Adult
19.
Hosp Pediatr ; 6(8): 496-500, 2016 Aug.
Article En | MEDLINE | ID: mdl-27390368

BACKGROUND: Diffuse alveolar hemorrhage (DAH) is a devastating clinical syndrome characterized by a falling hematocrit, respiratory insufficiency, and radiographic evidence of pulmonary infiltrates. Literature regarding management of DAH in childhood-onset SLE (cSLE) is limited. METHODS: We reviewed the presentation, management, and outcome of DAH in a pediatric tertiary medical center with one of the largest cSLE cohorts in North America. During a 10 year period 7 of 410 children with cSLE had DAH. RESULTS: The majority of cSLE patients with DAH were male (71%) and Hispanic (57%). The median age at the time of DAH diagnosis was 14 years (range 3 -15 years). DAH was the presenting manifestation of cSLE in 29% of children; 71% presented with DAH within 3 months of their diagnosis. All patients had cough, 86% had dyspnea, and 29% had hemoptysis. All patients had anemia and 71% had thrombocytopenia. Eighty-six percent had hematuria/proteinuria, and a positive anti-double stranded DNA antibody. Chest imaging showed diffuse ground glass opacities in all events. All patients developed respiratory insufficiency (29% supplemental oxygenation and 71% mechanical ventilation). Transfusions were required in 57% of cases. All patients received corticosteroids and additional immunomodulation to achieve disease control. Eighty-six percent of our DAH/cSLE cohort survived their initial event (median follow-up 2.5 years). No survivor required supplemental oxygen or had a DAH recurrence. CONCLUSIONS: SLE should be in the hospitalist's differential diagnosis for any child with respiratory insufficiency, cytopenias, and/or urinary abnormalities. Once cSLE is identified, initiation of aggressive immune suppression with multiple agents may enhance outcomes.


Hemorrhage , Immunologic Factors/therapeutic use , Lung Diseases , Lupus Erythematosus, Systemic , Radiography, Thoracic , Adolescent , Aftercare/methods , Aftercare/statistics & numerical data , Age of Onset , Blood Transfusion/methods , Female , Hemorrhage/diagnosis , Hemorrhage/ethnology , Hemorrhage/physiopathology , Hemorrhage/therapy , Humans , Immunologic Tests/statistics & numerical data , Lung Diseases/diagnosis , Lung Diseases/ethnology , Lung Diseases/physiopathology , Lung Diseases/therapy , Lupus Erythematosus, Systemic/diagnosis , Lupus Erythematosus, Systemic/epidemiology , Lupus Erythematosus, Systemic/physiopathology , Male , Medical Records, Problem-Oriented , Radiography, Thoracic/methods , Radiography, Thoracic/statistics & numerical data , Symptom Assessment/statistics & numerical data , United States/epidemiology
20.
J. investig. allergol. clin. immunol ; 26(1): 31-39, 2016. tab, ilus, graf
Article En | IBECS | ID: ibc-150187

Background: Component-based diagnosis on multiplex platforms is widely used in food allergy but its clinical performance has not been evaluated in nut allergy. Objective: To assess the diagnostic performance of a commercial protein microarray in the determination of specific IgE (sIgE) in peanut, hazelnut, and walnut allergy. Methods: sIgE was measured in 36 peanut-allergic, 36 hazelnut-allergic, and 44 walnut-allergic patients by ISAC 112, and subsequently, sIgE against available components was determined by ImmunoCAP in patients with negative ISAC results. ImmunoCAP was also used to measure sIgE to Ara h 9, Cor a 8, and Jug r 3 in a subgroup of lipid transfer protein (LTP)-sensitized nut-allergic patients (positive skin prick test to LTP-enriched extract). sIgE levels by ImmunoCAP were compared with ISAC ranges. Results: Most peanut-, hazelnut-, and walnut-allergic patients were sensitized to the corresponding nut LTP (Ara h 9, 66.7%; Cor a 8, 80.5%; Jug r 3, 84% respectively). However, ISAC did not detect sIgE in 33.3% of peanut-allergic patients, 13.9% of hazelnut-allergic patients, or 13.6% of walnut-allergic patients. sIgE determination by ImmunoCAP detected sensitization to Ara h 9, Cor a 8, and Jug r 3 in, respectively, 61.5% of peanut-allergic patients, 60% of hazelnut-allergic patients, and 88.3% of walnut-allergic patients with negative ISAC results. In the subgroup of peach LTP-sensitized patients, Ara h 9 sIgE was detected in more cases by ImmunoCAP than by ISAC (94.4% vs 72.2%, P<.05). Similar rates of Cor a 8 and Jug r 3 sensitization were detected by both techniques. Conclusions: The diagnostic performance of ISAC was adequate for hazelnut and walnut allergy but not for peanut allergy. sIgE sensitivity against Ara h 9 in ISAC needs to be improved (AU)


Introducción: La utilidad clínica del diagnóstico por componentes no ha sido evaluada en el estudio de la alergia a frutos secos (FS). Objetivo: Evaluar la capacidad diagnóstica de una micromatriz comercial de proteínas alergénicas en la alergia a cacahuete, avellana y nuez. Métodos: Se determinó la sIgE en pacientes alérgicos a FS mediante la micromatriz ISAC 112, e ImmunoCAP en los pacientes con sIgE negativa frente a los componentes de ISAC. Además, se realizó ImmunoCAP frente a Ara h 9, Cor a 8 y Jug r 3 en un subgrupo de pacientes sensibilizados a LTP. La sIgE detectada por ImmunoCAP fue comparada con los rangos de ISAC. Resultados: La mayoría de los alérgicos a cacahuete (66,7%), avellana (80,5%) y nuez (84%) estaba sensibilizados a su LTP. Sin embargo, no se detectó sIgE frente a los componentes de ISAC en el 33,3% de alérgicos a cacahuete, 13,9% de alérgicos a avellana y 13,6% de los alérgicos a nuez. El ImmunoCAP permitió detectar sIgE a Ara h 9 en 61,5%, Cor a 8 en 60% y Jug r 3 en 83,3% de los ISAC negativo. En el subgrupo LTP, ImmunoCAP (94,4%) fue superior a ISAC (72,2%) en la detección de sIgE a Ara h 9 (p<0,05). La sIgE frente a Cor a 8 y Jug r 3 fue detectada de forma similar por ambas técnicas. Conclusiones: La micromatriz ISAC es adecuada para el diagnóstico de alergia a avellana y nuez. La sensibilidad del componente Ara h 9 de ISAC debe ser mejorada (AU)


Humans , Male , Female , Adolescent , Nut Hypersensitivity/immunology , Arachis/immunology , Peanut Hypersensitivity/immunology , Corylus/immunology , Hypersensitivity/diagnosis , Hypersensitivity/immunology , Immunologic Tests/instrumentation , Immunologic Tests/methods , Immunologic Tests , Immunologic Techniques/methods , Immunologic Tests/classification , Immunologic Tests/statistics & numerical data , Immunologic Tests/standards , Immunologic Techniques/instrumentation , Immunologic Techniques/standards , Immunologic Techniques
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