scholarly journals Accuracy of the new rapid test for monitoring adalimumab levels

2019 ◽  
Vol 12 ◽  
pp. 175628481982823 ◽  
Author(s):  
Cátia Rocha ◽  
Joana Afonso ◽  
Paula Lago ◽  
Bruno Arroja ◽  
Ana I. Vieira ◽  
...  
Keyword(s):  
Trough Level ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Rapid Test ◽  
Turnaround Time ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Kappa Statistics ◽  
Serum Samples ◽  
Wide Range

Background: The loss of response to adalimumab (ADL) has been related to low serum concentrations at trough. Currently, most methods commercially available for the quantification of ADL are enzyme-linked immunosorbent assay (ELISA) based, with a turnaround time of approximately 8 h, delaying the target dosage adjustment to the subsequent infusion. In this study, we aimed to evaluate the performance of the newly available rapid-test ADL quantification assay by comparing it with three established ELISA methods, using spiked samples and a set of clinical samples. Methods: Spiked samples from control donors and 120 serum samples from inflammatory bowel disease (IBD) patients undergoing ADL therapy were quantified using lateral flow Quantum Blue® Adalimumab and, the ELISA formats from Immundiagnostik, R-Biopharm and an in-house assay. Results: The rapid-test assay had intraclass correlation coefficients of 0.590, 0.864 and 0.761 when comparing with the Immundiagnostik, R-Biopharm and in-house assays, respectively. For the five therapeutic windows, the accuracy was high: ADL rapid test compared with the Immundiagnostik (58–88%); R-Biopharm, 68–89%; and in house, 60–88%; and kappa statistics revealed 0.492–0.602, 0.531–0.659 and 0.545–0.682, respectively. Conclusions: The Quantum Blue® Adalimumab assay can replace the commonly used ELISA-based ADL quantification kits and it is a reliable alternative to these methods. This rapid-test assay enables the quantitative determination of ADL serum trough level in only 15 min. The developed assay allows measurement of ADL over a wide range. Hence, it represents a valuable tool for the clinician to assess the ADL trough level.

scholarly journals A Rapid Immunochromatography Test Based on Hcp1 Is a Potential Point-of-Care Test for Serological Diagnosis of Melioidosis

2018 ◽  
Vol 56 (8) ◽  
Author(s):  
Phornpun Phokrai ◽  
Wisansanee Karoonboonyanan ◽  
Nida Thanapattarapairoj ◽  
Chidchanok Promkong ◽  
Adul Dulsuk ◽  
...  
Keyword(s):  
Point Of Care ◽  
Clinical Manifestations ◽  
Antibody Detection ◽  
Enzyme Linked Immunosorbent Assay ◽  
Target Antigen ◽  
Northeast Thailand ◽  
Serum Samples ◽  
Serological Method ◽  
Healthy Donors ◽  
Wide Range

ABSTRACTMelioidosis is a fatal infectious disease caused by the environmental bacteriumBurkholderia pseudomallei. It is highly endemic in Asia and northern Australia but neglected in many other tropical countries. Melioidosis patients have a wide range of clinical manifestations, and definitive diagnosis requires bacterial culture, which can be time-consuming. A reliable rapid serological tool is greatly needed for disease surveillance and diagnosis. We previously demonstrated by enzyme-linked immunosorbent assay (ELISA) that a hemolysin-coregulated protein (Hcp1) is a promising target for serodiagnosis of melioidosis. In this study, we developed a rapid immunochromatography test (ICT) using Hcp1 as the target antigen (Hcp1-ICT). We evaluated this test for specific antibody detection using serum samples obtained from 4 groups of human subjects, including the following: (i) 487 culture-confirmed melioidosis patients from four hospitals in northeast Thailand; (ii) 202 healthy donors from northeast Thailand; (iii) 90 U.S. healthy donors; and (iv) 207 patients infected with other organisms. Compared to culture results as a gold standard, the sensitivity of ICT for all hospitals was 88.3%. The specificities for Thai donors and U.S. donors were 86.1% and 100%, respectively, and the specificity for other infections was 91.8%. The results of the Hcp1-ICT demonstrated 92.4% agreement with the Hcp1-ELISA results with a kappa value of 0.829, indicating that the method is much improved compared with the current serological method, the indirect hemagglutination assay (IHA) (69.5% sensitivity and 67.6% specificity for Thais). The Hcp1-ICT represents a potential point-of-care (POC) test and may be used to replace the IHA for screening of melioidosis in hospitals as well as in resource-limited areas.

scholarly journals Development of a Novel Cocktail Enzyme-Linked Immunosorbent Assay and a Field-Applicable Lateral-Flow Rapid Test for Diagnosis of Contagious Bovine Pleuropneumonia

2016 ◽  
Vol 54 (6) ◽  
pp. 1557-1565 ◽  
Author(s):  
Martin Heller ◽  
Nimmo Gicheru ◽  
Georgina Tjipura-Zaire ◽  
Cecilia Muriuki ◽  
Mingyan Yu ◽  
...  
Keyword(s):  
Immunosorbent Assay ◽  
Rapid Test ◽  
Lateral Flow ◽  
Sub Saharan Africa ◽  
Enzyme Linked Immunosorbent Assay ◽  
Contagious Bovine Pleuropneumonia ◽  
Serum Samples ◽  
Content Type ◽  
Mycoplasma Mycoides ◽  
Sub Saharan

Contagious bovine pleuropneumonia (CBPP) is a severe respiratory disease that is widespread in sub-Saharan Africa. It is caused byMycoplasma mycoidessubsp.mycoides, a bacterium belonging to theMycoplasma mycoidescluster. In the absence of an efficient CBPP vaccine, improved and easy-to-use diagnostic assays for recurrent testing combined with isolation and treatment of positive animals represent an option for CBPP control in Africa. Here we describe the comprehensive screening of 17 immunogenicMycoplasma mycoidessubsp.mycoidesproteins using well-characterized bovine sera for the development of a novel cocktail enzyme-linked immunosorbent assay (ELISA) for laboratory use. Two recombinantMycoplasmaimmunogens, MSC_0136 and MSC_0636, were used to set up a standardized cocktail ELISA protocol. According to the results from more than 100 serum samples tested, the sensitivity and specificity of the novel cocktail ELISA were 85.6% and 96.4%, respectively, with an overall diagnostic accuracy comparable to that of the Office International des Epizooties (OIE)-prescribed serological assays. In addition, we provide a proof of principle for a field-applicable, easy-to-use commercially produced prototype lateral-flow test for rapid (<30-min) diagnosis of CBPP.

scholarly journals Performance Evaluation of Commercial Dengue Diagnostic Tests for Early Detection of Dengue in Clinical Samples

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Tuan Nur Akmalina Mat Jusoh ◽  
Rafidah Hanim Shueb
Keyword(s):  
Dengue Virus ◽  
Real Time ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Dengue Infection ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Rt Pcr ◽  
Serum Samples ◽  
Kappa Agreement

The shattering rise in dengue virus infections globally has created a need for an accurate and validated rapid diagnostic test for this virus. Rapid diagnostic test (RDT) and reverse transcription-polymerase chain reaction (RT-PCR) diagnostic detection are useful tools for diagnosis of early dengue infection. We prospectively evaluated the diagnostic performance of nonstructural 1 (NS1) RDT and real-time RT-PCR diagnostic kits in 86 patient serum samples. Thirty-six samples were positive for dengue NS1 antigen while the remaining 50 were negative when tested with enzyme-linked immunosorbent assay (ELISA). Commercially available RDTs for NS1 detection, RTK ProDetect™, and SD Bioline showed high sensitivity of 94% and 89%, respectively, compared with ELISA. GenoAmp® Trioplex Real-Time RT-PCR and RealStar® Dengue RT-PCR tests presented a comparable kappa agreement with 0.722. The result obtained from GenoAmp® Real-Time RT-PCR Dengue test showed that 14 samples harbored dengue virus type 1 (DENV-1), 8 samples harbored DENV-2, 2 samples harbored DENV-3, and 1 sample harbored DENV-4. 1 sample had a double infection with DENV-1 and DENV-2. The NS1 RDTs and real-time RT-PCR tests were found to be a useful diagnostic for early and rapid diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.

scholarly journals High-Quality, Cost-Effective Strategy for Detection of Autoantibodies to Extractable Nuclear Antigens

2001 ◽  
Vol 8 (3) ◽  
pp. 471-474 ◽  
Author(s):  
Tri G. Phan ◽  
Watson W. S. Ng ◽  
Dana Bird ◽  
Kara Smithers ◽  
Vicky Wong ◽  
...  
Keyword(s):  
Cost Effective ◽  
Turnaround Time ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Quality Cost ◽  
Nuclear Antigens ◽  
Cost Effective Method ◽  
Meaningful Result ◽  
Clinical Diagnoses

ABSTRACT We evaluated methods for the detection of autoantibodies to extractable nuclear antigens (ENAs) to determine the strategy that yielded the most cost effective and clinically meaningful result. We prospectively compared counterimmunoelectrophoresis (CIEP) with and without serum prediffusion (SPD) and found that SPD significantly improved the quality of precipitation lines. This resulted in a decreased requirement for repeat testing and, consequently, was associated with a significant decrease in reagent costs and specimen turnaround time. We also retrospectively compared reactivity by CIEP, CIEP plus SPD, enzyme-linked immunosorbent assay (ELISA), and line immunoassay (LIA) of 52 serum samples that were previously determined to be positive for ENAs, and we correlated the results with clinical diagnoses. There was significant agreement among CIEP, CIEP plus SPD, ELISA, and LIA for the detection of anti-SS-A, anti-SS-B and anti-RNP. In general, CIEP, CIEP plus SPD, and LIA correlated better with the clinical diagnoses than ELISA, even though ELISA detected anti-ENAs more often than the other methods. CIEP plus SPD is therefore the most cost effective method for the identification of clinically meaningful ENAs. Based on our experience, we now screen for ENAs by CIEP, and positive samples are then typed by CIEP plus SPD. Samples that are difficult to interpret are then further assessed by an alternative method.

scholarly journals A novel, reproducible, and objective method for volumetric magnetic resonance imaging assessment of enhancing glioblastoma

2014 ◽  
Vol 121 (3) ◽  
pp. 536-542 ◽  
Author(s):  
Charles W. Kanaly ◽  
Ankit I. Mehta ◽  
Dale Ding ◽  
Jenny K. Hoang ◽  
Peter G. Kranz ◽  
...  
Keyword(s):  
Interobserver Variability ◽  
Intraclass Correlation ◽  
Evaluation Criteria ◽  
Correlation Coefficients ◽  
Response Assessment ◽  
Volumetric Method ◽  
Kappa Statistics ◽  
Macdonald Criteria ◽  
Automated Method ◽  
Radiological Response

Object Robust methodology that allows objective, automated, and observer-independent measurements of brain tumor volume, especially after resection, is lacking. Thus, determination of tumor response and progression in neurooncology is unreliable. The objective of this study was to determine if a semi-automated volumetric method for quantifying enhancing tissue would perform with high reproducibility and low interobserver variability. Methods Fifty-seven MR images from 13 patients with glioblastoma were assessed using our method, by 2 neuroradiologists, 1 neurosurgeon, 1 neurosurgical resident, 1 nurse practitioner, and 1 medical student. The 2 neuroradiologists also performed traditional 1-dimensional (1D) and 2-dimensional (2D) measurements. Intraclass correlation coefficients (ICCs) assessed interobserver variability between measurements. Radiological response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) guidelines and Macdonald criteria. Kappa statistics described interobserver variability of volumetric radiological response determinations. Results There was strong agreement for 1D (RECIST) and 2D (Macdonald) measurements between neuroradiologists (ICC = 0.42 and 0.61, respectively), but the agreement using the authors' novel automated approach was significantly stronger (ICC = 0.97). The volumetric method had the strongest agreement with regard to radiological response (κ = 0.96) when compared with 2D (κ = 0.54) or 1D (κ = 0.46) methods. Despite diverse levels of experience of the users of the volumetric method, measurements using the volumetric program remained remarkably consistent in all users (0.94). Conclusions Interobserver variability using this new semi-automated method is less than the variability with traditional methods of tumor measurement. This new method is objective, quick, and highly reproducible among operators with varying levels of expertise. This approach should be further evaluated as a potential standard for response assessment based on contrast enhancement in brain tumors.

Measuring Physical Characteristics of Housing: The Built Environment Site Survey Checklist (BESSC)

10.1068/b3038 ◽  
2005 ◽  
Vol 32 (2) ◽  
pp. 265-280 ◽  
Author(s):  
Elizabeth Burton ◽  
Scott Weich ◽  
Martin Blanchard ◽  
Martin Prince
Keyword(s):  
Built Environment ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Physical Characteristics ◽  
Categorical Variables ◽  
Urban Forms ◽  
Intraclass Correlation Coefficients ◽  
Site Survey ◽  
Wide Range ◽  
Measurement Tools

Empirical research in the built environment field is hampered by a lack of reliable measurement tools. The authors argue that there is a need for measures of built form that are objective, descriptive, comprehensive, reliable, practical, and address all environmental scales. They outline the development of an instrument to measure physical characteristics of housing for use in a study funded by the Wellcome Trust, on the effects of regeneration on mental health. The Built Environment Site Survey Checklist (BESSC) contains a wide range of items designed to be rated by built environment specialists for individual predetermined ‘housing areas’. The interrater reliability of the BESSC was tested using the κ and weighted κ statistics for categorical variables and item rankings and intraclass correlation coefficients for continuous measures. The majority of the items were found to be reliable and, although the instrument requires further refinement, it offers substantial potential for investigation of the relative merits of alternative urban forms and the generation of research-based design guidance.

scholarly journals Evaluation of the performance of three serological tests for diagnosis of Leishmania infantum infection in dogs using latent class analysis

2020 ◽  
Vol 29 (4) ◽  
Author(s):  
Asier Basurco ◽  
Alda Natale ◽  
Katia Capello ◽  
Antonio Fernández ◽  
María Teresa Verde ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Leishmania Infantum ◽  
Latent Class ◽  
Rapid Test ◽  
Antibody Test ◽  
Latent Class Models ◽  
Canine Leishmaniasis ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Serological Tests

Abstract Canine leishmaniasis (CanL) is a disease caused by Leishmania infantum. Serological methods are the most common diagnostic techniques used for the diagnosis of the CanL. The objective of our study was to estimate the sensitivity and specificity of one in-house ELISA kit (ELISA UNIZAR) and three commercially available serological tests (MEGACOR Diagnostik GmbH) including an immunochromatographic rapid test (FASTest LEISH®), an immunofluorescent antibody test (MegaFLUO LEISH®) and an enzyme-linked immunosorbent assay (MegaELISA LEISH®), using latent class models in a Bayesian analysis. Two hundred fifteen serum samples were included. The highest sensitivity was achieved for FASTest LEISH® (99.38%), ELISA UNIZAR (99.37%), MegaFLUO LEISH® (99.36%) followed by MegaELISA LEISH® (98.49%). The best specificity was obtained by FASTest LEISH® (98.43%), followed by ELISA UNIZAR (97.50%), whilst MegaFLUO LEISH® and MegaELISA LEISH® obtained the lower specificity (91.94% and 91.93%, respectively). The results of present study indicate that the immunochromatographic rapid test evaluated FASTest LEISH® show similar levels of sensitivity and specificity to the quantitative commercial tests. Among quantitative serological tests, sensitivity and specificity were similar considering ELISA or IFAT techniques.

scholarly journals A comparison between indirect ELISA and tuberculin skin test in the diagnosis of bovine tuberculosis in Kenya

2019 ◽  
Vol 1 (1) ◽  
Author(s):  
Daniel Muasya ◽  
George Karuoya Gitau ◽  
Thaiyah Gitau Andrew ◽  
Daniel Waweru Gakuya ◽  
John Vanleeuwen ◽  
...  
Keyword(s):  
Bovine Tuberculosis ◽  
Tuberculin Test ◽  
Elisa Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Kappa Statistics ◽  
Fisher Exact Test ◽  
Limited Information ◽  
Serum Samples ◽  
Apparent Prevalence ◽  
Kappa Agreement

Bovine tuberculosis (BTB) is an important zoonotic disease which has remained persistent in many areas of the World. Control and eradication has proved problematic due to the challenges in effective screening and diagnosis. Limited information on the status of BTB in Kenya presents a need to investigate its occurrence in cattle population. The study was carried out using an indirect antibody Enzyme Linked Immunosorbent Assay (ELISA-IDEXX-USA) to assess the agreement with Comparative Intradermal Tuberculin Test (CITT) test results between August and December 2013 in Laikipia County. The study also determined the apparent prevalence of cattle BTB antibodies in Laikipia County. A total of 276 bovine serum samples were tested using MPB70 and MPB83 recombinant proteins as capture antigens in the ELISA kit. Data were recorded in Microsoft Excel and exported to SPSS 16.0 for analysis. Apparent prevalence was calculated as a proportion at 95% CI, Kappa statistics computed, and test of significance assessed by Chi-square and Fisher exact test.  The results showed an individual animal apparent prevalence of 3.9% (11/276) and a herd prevalence of 58.3% (7/12). There was no significant association between BTB infection and both animal level factors, breed and sex. Kappa agreement test between ELISA test and TST showed a good agreement at K= 0.65. This study reported the prevalence of BTB in cattle for the first time in Laikipia County Kenya using the IDEXX ELISA. The ELISA test was comparable to the tuberculin test which is used as the gold standard for screening TB on live animals. The two tests can be used alongside for series or parallel interpretation to achieve desirable diagnostic sensitivity and specificity in disease control programs.

scholarly journals Evaluation of designed IS711 primers and universal primers of B4 and B5 for detection of Brucella spp. in clinical samples

2019 ◽  
Author(s):  
Pedram Heidari ◽  
Mitra Salehi ◽  
Abbas Akhavan Sepahi ◽  
Mohamad Reza Razavi
Keyword(s):  
Blood Culture ◽  
Universal Primers ◽  
Clinical Samples ◽  
Target Sequence ◽  
Serum Samples ◽  
Serological Tests ◽  
Molecular Approaches ◽  
Bacterial Agent ◽  
Detection And Identification ◽  
Wide Range

Abstract Background Brucellosis as a global concern is a zoonotic infectious disease which affects a wide range of individual in developing countries. A confirmed diagnosis is required to isolate the bacterial agent from clinical specimens like blood, bone marrow, CSF or tissues. Microbiological, serological and molecular approaches are useful for detection and identification of Brucella spp. and blood culture is known as the gold standard for Brucella spp. Diagnosis of brucellosis through polymerase chain reaction (PCR) could be more sensitive and specific than other classical methods such as blood culture and conventional serological tests. Until now different Brucella specific sequences like BCSP 31, IS711 and 16SrRNAwere amplified for detection of Brucella Spp. Results Amplification of extracted DNA from serum of 49 suspected patients were tested with two sets of specific primers. The BCSP31 sequence amplicon was 223 bp and all the 49 (100%) serum specimens isolated from suspected patients were positive by B4 and B5 primers, even the 4 cases out of 49 2ME negative samples were positive. Detection of Brucella in serum samples by designed IS711 primers revealed the amplicon of IS711 with 448 bp length. Among the 49 serum samples isolated from patients, 46 (93.87%) cases were positive. The B4-B5 primers and IS711 designed primer recognized 100% (49/49) and 94% (46/49) of the cases, respectively. Conclusion This study shows that the specificity of the 2 primer sets is 100% and the sensitivity of B4-B5 primers is 100%, while the sensitivity of the designed primers of IS711 is 94%. The B4-B5 primers can detect the least number of both B. melitensis and B. abortus, 0.05 CFU/reaction. However, the designed IS711 set is able to detect 2 CFU/reaction, about 2.5×102 times more sensitive than results of other experiments for detection of IS711 target sequence in the specimens.

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