A Retrospective Clinical Audit of the ImmunoCAP ISAC 112 for Multiplex Allergen Testing

2020 ◽  
Vol 182 (1) ◽  
pp. 14-20
Author(s):  
Jamie Erskine ◽  
Elspeth Brooker ◽  
Susan Leech ◽  
Anastasia Chalkidou ◽  
Stephen Keevil ◽  
...  

<b><i>Introduction:</i></b> Complex cases of multiple allergies can be particularly difficult to diagnose using standard methods such as skin prick tests and assessment of a patient’s allergic history. Multiplex allergy testing may improve outcomes for allergy patients by avoiding misdiagnosis and providing reassurance. The ImmunoCAP Immuno Solid-Phase Allergen Chip (ISAC) 112 is a CE-marked, molecular, multiplex, allergy test that can test for IgE antibodies to 112 components from 51 allergen sources. However, its clinical utility is unknown and is difficult to estimate due to the complexity of the diagnostic pathway in which it is used. <b><i>Objective:</i></b> To assess how the ImmunoCAP ISAC 112 is currently being used in UK practice. The patient populations in which it may have the most benefit were examined, and the sequence of other tests implemented alongside ISAC was determined. <b><i>Methods:</i></b> A retrospective audit of 100 patient cases from 2 UK tertiary allergy clinics was performed. Fifty paediatric and fifty adult cases were selected for audit. The indications for ordering an ISAC test, the other tests used alongside ISAC, and changes in management actioned by the ISAC test were investigated. <b><i>Results:</i></b> 73.6% of paediatric and 78% of adult patients referred for an ISAC test were suspected to have multiple sensitizations. The sequence of testing varied greatly between cases, but 70% of adult and 98% of paediatric patients had at least one other investigation prior to an ISAC test. In most cases, ISAC testing confirmed clinical suspicion. <b><i>Conclusions:</i></b> A prospective research study is necessary to further investigate the clinical utility and cost-effectiveness of the ISAC. A UK national registry would be of great benefit but will require a large resource base.

1984 ◽  
Vol 30 (4) ◽  
pp. 538-541 ◽  
Author(s):  
G J Barnard ◽  
J B Kim ◽  
J L Brockelbank ◽  
W P Collins ◽  
B Gaier ◽  
...  

Abstract We have developed immunoassays, monitored by the detection of chemiluminescence, for measuring choriogonadotropin in human urine. These methods involve the use of derivatives of isoluminol and include: (a) a labeled antigen with a second antibody covalently linked to polyacrylamide beads as the solid-phase reagent (i.e., solid-phase chemiluminescence immunoassay); and (b) an excess concentration of a specific antibody passively adsorbed onto the walls of polystyrene tubes and a labeled antibody of different specificity (i.e., two-site immunochemiluminometric assay). After the respective binding reactions, the solutions are aspirated, the antigen- or antibody-bound fractions are washed twice with 500 microL of buffer, sodium hydroxide (2 mol/L; 200 microL) is added, and the mixture is incubated for 60 min at 60 degrees C. After cooling, the label is oxidized with microperoxidase/hydrogen peroxide and the resulting chemiluminescence signal is measured for 10 s. We have evaluated the methods in terms of their sensitivity, precision, and clinical utility, and we compare results with values obtained by radioimmunoassay.


1994 ◽  
Vol 40 (9) ◽  
pp. 1761-1765 ◽  
Author(s):  
J Hedström ◽  
J Leinonen ◽  
V Sainio ◽  
U H Stenman

Abstract We developed a sensitive time-resolved immunofluorometric assay (IFMA) for trypsin-2 complexed with alpha 1-antitrypsin (AAT). We used a trypsin-2-specific monoclonal antibody on the solid phase and a europium-labeled polyclonal antibody to AAT as tracer. The detection limit is 0.05 microgram/L and the range of linearity extends to 100 micrograms/L. We compared the clinical utility of the trypsin-2-AAT assay with that of free trypsinogen-2 and amylase in serum by studying 120 healthy subjects, 29 patients with acute pancreatitis, 11 with extrahepatic biliary obstruction, and 34 with acute abdominal disorders of extrapancreatic origin. In patients with acute pancreatitis the median concentration of trypsin-2-AAT in serum was 59-fold that in healthy controls, 42-fold that in patients with biliary obstruction, and 33-fold that in patients with acute abdominal disorders of extrapancreatic origin. These differences are greater than those for trypsinogen-2 (19-, 20-, and 28-fold, respectively) and amylase (5.4-, 6.5-, and 5.4-fold, respectively). Compared with the assays of free trypsinogen-2 and amylase, our assay of trypsin-2-AAT improved the clinical specificity for acute pancreatitis by eliminating false-positive results in our control groups. Increased concentrations of trypsin-2-AAT and trypsinogen-2 were also observed in patients with chronic renal failure undergoing dialysis.


1988 ◽  
Vol 34 (1) ◽  
pp. 118-122 ◽  
Author(s):  
J A Rugg ◽  
C W Flaa ◽  
S R Dawson ◽  
C T Rigl ◽  
K S Leung ◽  
...  

Abstract We describe a radial partition enzyme immunoassay in which fully automated quantification of human thyrotropin (hTSH) takes less than 11 min. This "sandwich"-type assay involves two monoclonal antibodies, both specific for the intact hTSH molecule. The solid phase consists of tabs of glass-fiber filter paper containing a pre-immobilized monoclonal anti-hTSH antibody complexed with a goat antibody specific for the Fc region of mouse IgG. The patient's sample is first applied to the central "reaction zone" of the tab, wherein hTSH binds to the immobilized antibody. Application of a buffered solution containing enzyme-labeled Fab' fragments of the second monoclonal anti-hTSH antibody initiates "sandwich" formation. A wash buffer containing a fluorogenic substrate elutes unbound conjugate to the tab periphery. The bound enzyme conjugate is quantified by measuring the rate of increase in fluorescence in the reaction zone of the tab, then converting the rate to clinical units by comparison with a stored calibration curve. The clinical utility and performance of the present assay compare favorably with those of other sensitive assays for hTSH.


Author(s):  
Sofia Farkona ◽  
Antoninus Soosaipillai ◽  
Panagiota Filippou ◽  
Christos Liaskos ◽  
Dimitrios P. Bogdanos ◽  
...  

AbstractBackground:Pancreatic autoantibodies (PABs) are detected in patients with inflammatory bowel disease (IBD). Their prevalence is higher in Crohn’s disease (CrD) than in ulcerative colitis (UC). Glycoprotein 2 (GP2) and, more recently, CUB and zona pellucida-like domain-containing protein 1 (CUZD1) have been identified as target autoantigens of PAB. The clinical utility of CUZD1 autoantibodies has only recently been assessed by indirect immunofluorescence (IIF) assays. In this study, we developed and validated novel immunoassays for the detection of CUZD1 autoantibodies.Methods:Recombinant CUZD1 protein was utilized as a solid-phase antigen for the development of two immunoassays for the detection of IgG and IgA CUZD1 autoantibodies. Serum samples from 100 patients with CrD, 100 patients with UC, 129 patients assessed for various autoimmune diseases (vADs) and 50 control individuals were analyzed.Results:Two immunofluorometric assays for the detection of IgG and IgA CUZD1-specific antibodies were developed. CUZD1 autoantibodies were detected in 12.5% (25/200) IBD patients, including 16% of patients with CrD and in 9% of patients with UC (CrD vs. UC, p<0.05), compared with 3.1% (4/129) patients suspected of having vADs (CrD vs. ADs, p<0.05; UC vs. ADs, p=0.08). CUZD1 autoantibody positivity was not found to be related to disease location, age of disease onset or disease phenotype.Conclusions:This is the first study to describe novel IgA and IgG CUZD1 autoantibody enzyme-linked immunosorbent assay. These immunoassays agree well with standard IIF techniques and can be utilized in multicenter studies to investigate the diagnostic and clinical utility of CUZD1 autoantibodies.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Omar Suhail Alsaed ◽  
Laith Ishaq Alamlih ◽  
Omar Al-Radideh ◽  
Prem Chandra ◽  
Samar Alemadi ◽  
...  

AbstractWe investigated the performance of ANA-ELISA for CTDs screening and diagnosis and comparing it to the conventional ANA-IIF. ANA-ELISA is a solid-phase immune assay includes 17 ANA-targeted recombinant antigens; dsDNA, Sm-D, Rib-P, PCNA, U1-RNP (70, A, C), SS-A/Ro (52 and 60), SS-B/La, Centromere B, Scl-70, Fibrillarin, RNA Polymerase III, Jo-1, Mi-2, and PM-Scl. During the period between March till December 2016 all requests for ANA from primary, secondary, and tertiary care centers were processed with both techniques; ANA-IIF and ANA-ELISA. The electronic medical record of these patients was reviewed looking for CTD diagnosis documented by the Senior rheumatologist. SPSS 22 is used for analysis. Between March and December 2016, a total of 12,439 ANA tests were requested. 1457 patients were assessed by the rheumatologist and included in the analysis. At a cut-off ratio ≥ 1.0 for ANA-ELISA and a dilutional titre ≥ 1:80 for ANA-IIF, the sensitivity of ANA-IIF and ANA-ELISA for all CTDs were 63.3% vs 74.8% respectively. For the SLE it was 64.3% vs 76.9%, Sjogren’s Syndrome was 50% vs 76.9% respectively. The overall specificity of ANA-ELISA was 89.05%, which was slightly better than ANA-IIF 86.72%. The clinical performance of ANA-ELISA for CTDs screening showed better sensitivity and specificity as compared to the conventional ANA-IIF in our cohort.


1996 ◽  
Vol 4 (1) ◽  
pp. 1-10
Author(s):  
Joy A Bliss ◽  
Gregory G Caputy

Business and economic aspects of a medical practice are rapidly becoming more complex. Physicians are at a crossroads in the manner by which medical and surgical care will be delivered in Canada, at the very base of which are the business aspects and management of health care. The purpose of this research study was to determine the business acumen of plastic surgeons in active practice. The resource base was Canadian plastic surgeons who are members of the Canadian Society of Plastic Surgeons. The intent of the questionnaire research study was to evaluate whether these surgeons perceive this area as necessary and whether they feel adequately prepared to manage this aspect of their practice. The findings of the research indicate that the plastic surgeons surveyed did perceive a need for business acumen in the practice of medicine. The majority felt they were not prepared adequately to deal with the business side of operating a medical practice and perceived a need for basic knowledge in the area of business. The implications of this research are that medical education has ignored this important aspect of preparing a physician to practise medicine in the present economic environment. Educational materials to structure and systematically disseminate business resource information need to be developed so that this group would be able to deal adequately with business-related problems when faced with them in medical practice. Due to the specialty-specific nature of the business needs, this education should likely occur during residency or fellowship training.


Author(s):  
D J Newman ◽  
J P Ashby

The analytical performance and clinical utility of a direct immunoradiometric assay (IRMA) for intact 1–84 human parathyroid hormone (PTH) was evaluated. The assay is available commercially (Allégro intact PTH, Nichols Institute) and utilises two affinity purified region-specific antisera against either 1–34 (radiolabelled antibody) or 39–84 (solid phase antibody) human PTH. High assay sensitivity (detection limit, 1·4 pg 1·84 PTH/mL) permitted the measurement of PTH in all normocalcaemic individuals studied. Elevated results were obtained in all patients (21 studied) with histologically proven primary hyperparathyroidism (PHPT) and 34 out of 35 patients with presumptive PHPT. Thirteen out of 24 patients with non-parathyroid hypercalcaemia had suppressed results, but the remainder had concentrations within the reference range.


2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110065
Author(s):  
Natalia Ukleja-Sokołowska ◽  
Kinga Lis ◽  
Magdalena Żbikowska-Gotz ◽  
Rafał Adamczak ◽  
Andrzej Kuźmiński ◽  
...  

Background Levels of specific IgE (sIgE) against allergen components can be assessed using multiplex assays or with highly sensitive, quantitative methods. The aim of this study was to compare the sensitivity and specificity of different immunological methods for diagnosis of shrimp allergy. Methods Twenty patients with positive skin prick tests for frozen tiger shrimp were selected for further examination. Blood samples were taken to assess concentrations of sIgE against the house dust mites Dermatophagoides pteronyssinus and D. farinae, shrimp allergen extract, allergen components Der p 1, Der p 2 and Pan a 1 (ImmunoCap), and the ImmunoCap ISAC 112 panel. Results All patients had elevated levels of sIgE against shrimp and D pteronyssinus. Eight patients were sensitized to Pen m 1, three patients were sensitized to Pen m 2, and two patients were sensitized to Pen m 4 (ISAC). ImmunoCap ISAC detected shrimp sensitization in 50% of patients. There was a strong correlation between concentrations of sIgE against Pen m1 and Der p 10 detected by ImmunoCap. Conclusions The singleplex ImmunoCap system remains the reference diagnostic method, but in the case of shrimp allergy ImmunoCap ISAC provided better insight into patient allergen profiles.


Author(s):  
K. Pegg-Feige ◽  
F. W. Doane

Immunoelectron microscopy (IEM) applied to rapid virus diagnosis offers a more sensitive detection method than direct electron microscopy (DEM), and can also be used to serotype viruses. One of several IEM techniques is that introduced by Derrick in 1972, in which antiviral antibody is attached to the support film of an EM specimen grid. Originally developed for plant viruses, it has recently been applied to several animal viruses, especially rotaviruses. We have investigated the use of this solid phase IEM technique (SPIEM) in detecting and identifying enteroviruses (in the form of crude cell culture isolates), and have compared it with a modified “SPIEM-SPA” method in which grids are coated with protein A from Staphylococcus aureus prior to exposure to antiserum.


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