Charting methods to monitor the operational performance of ELISA method for the detection of antibodies against trypanosomes

Rebeski, Dierk E.; Winger, E.M; Ouma, Johnson O.; Pages, S Kong; Büscher, Philippe; Sanogo, Youssouf; Dwinger, R.H.; Crowther, John R.

doi:10.1016/s0304-4017(00)00422-2

Cited by 11 publications

(4 citation statements)

References 11 publications

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“…After the process was first described by Luckins (1977), several indirect ELISAs were developed for the detection of anti-T. vivax antibodies in samples of bovine serum using crude antigen preparations or purified antigen fractions (Greiner et al 1997, Hopkins et al 1998, Desquesnes & Gardiner 1993, Desquesnes 1997a, Rebeski et al 2001. Luckins (1977) An ELISA for the detection of IgG-isotype immunoglobulins was developed and compared with IFA.…”

Section: Diagnosis and Differential Diagnosismentioning

confidence: 99%

Trypanosoma (Duttonella) vivax: its biology, epidemiology, pathogenesis, and introduction in the New World - a review

Osório

Madruga

Desquesnes

et al. 2008

Mem. Inst. Oswaldo Cruz

168

121

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Section: Diagnosis and Differential Diagnosismentioning

confidence: 99%

Trypanosoma (Duttonella) vivax: its biology, epidemiology, pathogenesis, and introduction in the New World - a review

Osório

Madruga

Desquesnes

et al. 2008

Mem. Inst. Oswaldo Cruz

168

121

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“…Recently, four antibody enzyme-linked immunosorbent assays (ELISAs) for animal trypanosomiasis (Trypanosoma congolense and T. vivax) were evaluated in a multicenter validation trial (5). Given that ELISAs generate quantitative data, modified Youden plots could be used to analyze the interlaboratory reproducibility of these assays.…”

mentioning

confidence: 99%

Validation of a PCR-Oligochromatography Test for Detection of Trypanozoon Parasites in a Multicenter Collaborative Trial

et al. 2007

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A PCR-oligochromatography test for diagnosis of human and animal trypanosomiasis was evaluated through a multicenter ring trial with six laboratories testing a set of 21 blinded samples, resulting in qualitative data (positive or negative). Results showed an intralaboratory repeatability (accordance) of 88.7% (credible interval [CI], 84.4 to 92.5%) and an interlaboratory repeatability (concordance) of 88.1% (CI, 84.3 to 92.3%).

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“…Key QbD elements that were not published included systematic risk ranking and management as well as the exploration of the method's design space. A number of similar publications, going back all the way to Levey and Jennings, discuss monitoring of method performance through statistical control charts [19,[24][25][26][27][28][29]. Typically, these studies were limited to charting measured results from assay control samples over time.…”

Section: Risk Management and Methods Controlmentioning

confidence: 99%

Application of Quality by Design and Statistical Quality Control Concepts in Immunoassays

Verch¹

2014

Bioanalysis

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Quality by design (QbD) expanded in recent years from pharmaceutical processing into analytical chemistry. Beyond online process analytical technology, off-line assays including immunoassays are also starting to benefit from QbD. Although analytical QbD is still a relatively new development, underlying concepts, such as target-oriented development and statistical quality control have been applied to diagnostic assays under the term 'design control' for several years. We reviewed how QbD and statistical quality control concepts have been applied both to diagnostic and bioanalytical immunoassays ranging from the use of individual tools to end-to-end QbD-based workflows. We will discuss some of the results of the different approaches to immunoassays, how they fit into the QbD framework and how individual tools may complement a QbD workflow.

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Charting methods to monitor the operational performance of ELISA method for the detection of antibodies against trypanosomes

Cited by 11 publications

References 11 publications

Trypanosoma (Duttonella) vivax: its biology, epidemiology, pathogenesis, and introduction in the New World - a review

Trypanosoma (Duttonella) vivax: its biology, epidemiology, pathogenesis, and introduction in the New World - a review

Validation of a PCR-Oligochromatography Test for Detection of Trypanozoon Parasites in a Multicenter Collaborative Trial

Application of Quality by Design and Statistical Quality Control Concepts in Immunoassays

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