Clozapine Blood Level Testing by Immunoassay Clozapine Blood Level Testing by Immunoassay English summary Une production de l’Institut national d’excellence en santé et en services sociaux (INESSS) DECEMBER 2024 1 SUMMARY Clozapine Blood Level Testing by Immunoassay Introduction A request to introduce a new test into the Répertoire québécois et système de mesure des procédures de biologie of clozapine immunoassay. A budgetary impact analysis considering the costs associated with the introduction of this assay to the Répertoire was conducted. Costs were projected over a 3-year timeframe from a healthcare system perspective. All scientific, contextual and experiential data were interpreted and synthesized in findings to guide the analysis process for the development of the recommendation
Impact of high temperatures on enzyme-linked immunoassay (ELISA) performance for leptin measurements in human milk stored under varied freeze/thaw conditions. Ambient temperature conditions are a common concern during laboratory analysis. Due to unexpected shipping conditions, leptin ELISA kits (Leptin Ultrasensitive, ALPCO USA; Catalog #22-LEPHUU-E01) arrived from the manufacturer at our
Validation of two immunoassays for oxytocin measurements in human saliva. The objective of this research was to develop and validate two immunoassays for oxytocin measurement in human saliva, one using a monoclonal and the other a polyclonal antibody against oxytocin, whose affinity for oxytocin was tested by an antibody mapping epitope analysis. These assays were analytically validated and used
Development of nucleic acid lateral flow immunoassay for duplex detection of Leishmania martiniquensis and Leishmania orientalis in asymptomatic patients with HIV. Leishmaniasis, a neglected tropical disease caused by parasitic protozoa of the Leishmania genus, remains a global health concern with significant morbidity and mortality. In Thailand, the rising incidence of autochthonous leishmaniasis cases involving Leishmania (Mundinia) martiniquensis and novel Leishmania (Mundinia) orientalis underscores the critical need for accurate diagnosis and effective control strategies. This study presents a sensitive and specific nucleic acid lateral flow immunoassay (NALFIA) that integrates a duplex PCR assay with a lateral flow device (LFD) strip format. Targeting the internal transcribed spacer
A comparative study evaluating three line immunoassays available for serodiagnosis of equine Lyme borreliosis: Detection of Borrelia burgdorferi sensu lato-specific antibodies in serum samples of vaccinated and non-vaccinated horses. Diagnosis of equine Lyme borreliosis (LB), an infection caused by members of the Borrelia burgdorferi sensu lato complex (Bbsl), is challenging due antibody test (IFA) for antibody screening combined with a qualitative, highly specific immunoassay (e. g. line immunoassay (LIA)) for confirmation. In this study, three LIAs available for detection of antibodies in equine serum samples were evaluated and compared. A total of 393 serum samples of 131 horses with known serostatus were used. It included groups of non-vaccinated horses, immunized horses
Comparison of anti-HCV combined with HCVcAg (Elecsys HCV Duo immunoassay) and anti-HCV rapid test followed by HCV RNA analysis using qRT-PCR to identify active infection for treatment. Hepatitis C virus (HCV) infection can cause acute and chronic hepatitis, leading to liver cirrhosis and hepatocellular carcinoma. The World Health Organization aims to eliminate viral hepatitis by 2030 through extensive screening and treatment. To achieve this goal, comprehensive and widespread screening is essential for diagnosis and treatment. This study aims to evaluate the diagnostic sensitivity and specificity of the Elecsys® HCV Duo immunoassay (Duo-assay), which simultaneously detects anti-HCV antibodies (Duo/anti-HCV) and HCV core antigen (Duo/HCVcAg) in a single sample, compared with initially antibody
Modified TPPA combined with western blotting facilitates syphilis diagnosis in isolated reactive treponemal chemiluminescence immunoassay sera: a prospective cohort study. The challenge of dealing with isolated reactive treponemal chemiluminescence immunoassay (CIA) results in clinical practice has prompted the development of a more efficient algorithm for distinguishing true infection from
Development and validation of a quantitative Orthopoxvirus immunoassay to evaluate and differentiate serological responses to Mpox infection and vaccination. The Mpox outbreak, caused by Monkeypox virus (MPXV), underscores the need for a serological assay to assess Mpox immunity. Modified Vaccinia Ankara (MVA) vaccine, an attenuated vaccinia virus (VACV), is authorised for Mpox prevention. We aimed to develop a quantitative immunoassay to differentiate infection- and vaccination-induced immunity and explore serological responses to Mpox infection and vaccination. We evaluated an electrochemiluminescence assay targeting IgG to 10 MPXV and 3 VACV antigens in plasma from adults in a cohort study with previous Mpox, MVA-vaccination, or historical controls. Sensitivity and specificity
Lipoprotein(a) immunoassays and their associations with coronary artery calcification and aortic valve calcification. Lp(a) causes atherosclerosis and degenerative aortic valve disease, but concerns have risen that mass-based assays may be affected by isoform sizes and provide inaccurate estimates of Lp(a) exposure. We compared contemporary immunoturbidimetric assays reporting either mass-based (Randox) or molar-based (Roche) using data from 5129 unselected participants from the prospective population-based Rotterdam Study. We demonstrate that these immunoassays provide interchangeable Lp(a) measurements, and that associations with CT coronary artery calcium and aortic valve calcification were near-identical.
Rapid, High Sensitivity Detection of Antibodies to Trypanosoma cruzi using a Recombinant Tc24 Antigen-based Magneto-Immunoassay: A Pilot Study. The diagnosis of chronic Chagas disease (CD) is challenging due to the wide genetic diversity of Trypanosoma cruzi (T. cruzi), the causative agent of CD, and low levels of parasitemia, resulting in low sensitivity and accuracy using existing diagnostics . We report a magneto-immunoassay that employs dually-labeled magnetic beads (DMBs) incorporating a recombinant Tc24 antigen, which is homologous across multiple discrete typing units (DTUs) of T. cruzi. In this pilot study, 102 serum samples from seven endemic countries were tested using this magneto-immunoassay, revealing its ability to distinguish Chagas-positive from Chagas-negative cases more
Comparative study on the utility of automated chemiluminescence immunoassay for NS1 antigen-based dengue diagnosis. With newer dengue outbreaks extending to regions that were previously unaffected, about half of the world's population is now at risk of dengue infection. This scale of dengue spread and its undistinguishing primary fever symptom demands embracing automated high-throughput diagnostic techniques for quicker confirmatory diagnosis which otherwise requires time, cost and skill intensive reverse transcription-polymerase chain reaction (RT-PCR). Magnetic bead-based automated chemiluminescence immunoassay (CLIA) is one potential platform that has proven its diagnostic potential for different diseases. However, adoption of CLIA for dengue diagnosis demands extensive validation
Multiplex bead immunoassay in ABO-A2-incompatible kidney transplantation. Kidney transplantation from ABO-A2 donors into ABO-O and -B recipients can alleviate inequitable transplant access created by ABO demographics. ABO-A2-incompatible eligibility is determined by anti-A hemagglutination titres. However, titres do not distinguish antibodies specific for A-II glycans, the sole A-antigen subtype in vascular endothelium, from other anti-A antibodies. We examined whether reliance on anti-A titres unnecessarily limited ABO-A2-incompatible transplants for candidates with low anti-A-II levels. We created a single-antigen-bead immunoassay for ABO antibodies, confirmed the specificity and reproducibility, and demonstrated the ability to detect anti-A and -B glycan-subtype-specific antibodies in healthy
Analytical validation, sample stability, and clinical evaluation of a new high-sensitivity cardiac troponin I immunoassay for use in dogs, with comparison to a previous ultrasensitive assay. Cardiac troponin I (cTnI) is considered the gold standard biomarker for myocardial injury and shows a high degree of homology between humans and dogs. The ADVIA Centaur XP High-Sensitivity Troponin I (AC-cTnI
Clinical sensitivity and specificity of a high-throughput microfluidic nano-immunoassay combined with capillary blood microsampling for the identification of anti-SARS-CoV-2 Spike IgG serostatus. We evaluate the diagnostic performance of dried blood microsampling combined with a high-throughput microfluidic nano-immunoassay (NIA) for the identification of anti-SARS-CoV-2 Spike IgG seropositivity
Identification of New Mycobacterium bovis antigens and development of a multiplexed serological bead-immunoassay for the diagnosis of bovine tuberculosis in cattle. Serological assays for bovine tuberculosis diagnosis require the use of multiple Mycobacterium bovis specific antigens to ensure the detection of infected animals. In the present study, identification and selection process of antigens , and PE25/PPE41)] were constructed and thenused to develop a new multiplexed serological assay based on Luminex technology. The performance of the Luminex-bTB immunoassay was evaluated using sera from cattle with known tuberculosis status. Among the proteins whose ability to detect bovine tuberculosis was evaluated for the first time, PE25/PPE41 and Mb1403, but not Mb3871, showed good detection capacity
Clinical value of plasma ALZpath pTau217 immunoassay for assessing mild cognitive impairment. Among plasma biomarkers for Alzheimer's disease (AD), pTau181 and pTau217 are the most promising. However, transition from research to routine clinical use will require confirmation of clinical performance in prospective cohorts and evaluation of cofounding factors. pTau181 and pTau217 were quantified
Novel ultrasensitive immunoassay for the selective quantification of tau oligomers and related soluble aggregates. Tau aggregation into paired helical filaments and neurofibrillary tangles is characteristic of Alzheimer's disease (AD) and related disorders. However, biochemical assays for the quantification of soluble, earlier-stage tau aggregates are lacking. We describe an immunoassay that is selective for tau oligomers and related soluble aggregates over monomers. A homogeneous (single-antibody) immunoassay was developed using a novel anti-tau monoclonal antibody and validated with recombinant and brain tissue-derived tau. The assay signals were concentration dependent for recombinant tau aggregates in solution but not monomers, and recognized peptides within, but not outside, the aggregation
Discovery of Two Novel Immunoepitopes and Development of Peptide-based Sarcoidosis Immunoassay. Sarcoidosis is a systemic granulomatous disorder associated with hypergammaglobulinemia and the presence of autoantibodies. The specific antigens initiating granulomatous inflammation in sarcoidosis are unknown and there is no specific test available to diagnose sarcoidosis. To discover novel -based immunoassay specific for sarcoidosis. We chemically synthesized both immunoepitopes (Cofilinμ and Chain A), and generated rabbit polyclonal antibodies against both neoantigens. After extensive standardization, we developed a direct peptide ELISA and measured epitope-specific IgG in sera of 386 subjects including, healthy controls (n=100), three sarcoidosis cohorts (n=186), pulmonary tuberculosis
Establishment of fluorescence multi-flow cytometric immunoassay for the simultaneous quantitative detection of six allergen-sIgE antibodies. The in vitro specific IgE (sIgE) assays now commonly used in clinical laboratories are not only time-consuming and expensive, but also require a large number of serum samples. To address these limitations, a novel fluorescent microsphere-based multiplex flow cytometric immunoassay was developed. This innovative assay enables rapid and simultaneous quantitative detection of multiple allergen-sIgE antibodies. The aim of this study was to establish a new method for the simultaneous quantitative detection of six allergen-sIgE antibodies based on fluorescence multiplex flow cytometry. Six different encoded fluorescent microspheres were selected