Measurement of Variation and Significance in Serologic Tests

Taylor, Roger N.

doi:10.1111/j.1749-6632.1983.tb22184.x

Cited by 15 publications

(6 citation statements)

References 1 publication

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“…The second discordant pair of results was in the titers of a syphilis test (TPPA) obtained manually, being twice positive but with titers of 1/2'560 initially and 1/10'240 when redone. The clinical impact was considered significant in this 2 nd case since a high titer of 1/10'240 generally reflects an acute infection and since this difference of two dilutions might be considered as clinically relevant [40,41]. The limited number of discrepant results did not allow to investigate the effect of the time delays between the management of the original samples and their replicates.…”

Section: Results Serologymentioning

confidence: 98%

Internal quality assurance in diagnostic microbiology: A simple approach for insightful data

2017

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Given the importance of microbiology results on patient care, high quality standards are expected. Internal quality assurance (IQA) could mitigate the limitations of internal quality control, competency assessment and external quality assurance, adding a longitudinal insight, including pre- and post-analytical steps. Here, we implemented an IQA program in our clinical microbiology facilities with blind resubmission of routine samples during 22 months. One-hundred-and-twenty-one out of 123 (98.4%) serological analyses and 112 out of 122 (91.8%) molecular analyses were concordant. Among the discordances in molecular biology analyses, 6 results were low positive samples that turned out negative, likely due to stochastic repartition of nucleic acids. Moreover, one identified retranscription error led us to implement automated results transmission from the Applied Biosystems instruments to the laboratory information system (LIS). Regarding Gram stain microscopy, 560 out of 745 (75.2%) of compared parameters were concordant. As many as 67 out of 84 (79.8%) pairs of culture results were similar, including 16 sterile pairs, 27 having identical identification or description and semi-quantification and 24 only showing variations in semi-quantification with identical description or identification of colonies. Seventeen pairs had diverging identification or description of colonies. Culture was twice only done for one member of the pairs. Regarding antibiotic susceptibility testing, a major discrepancy was observed in 5 out of 48 results (10.4%). In conclusion, serological tests were highly reproducible. Molecular diagnosis also revealed to be robust except when the amounts of nucleic acids present in the sample were close to the limits of detection. Conventional microbiology was less robust with major discrepancies reaching 39.5% of the samples for microscopy. Similarly, culture and antibiotic susceptibility testing were prone to discrepancies. This work was ground for reconsidering multiples aspects of our practices and demonstrates the importance of IQA to complete the other quality management procedures.

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Section: Results Serologymentioning

confidence: 98%

Internal quality assurance in diagnostic microbiology: A simple approach for insightful data

2017

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“…The sensitivity and specificity, as well as the confidence intervals (CI) and Youden index were calculated according to Thrusfield (2005). The concordance between the results was calculated using the kappa coefficient (Taylor, 1992) and the results interpreted according to Pereira (2002). The calculations were performed using the EpiR package of statistical software R.…”

Section: Discussionmentioning

confidence: 99%

Difficulties in diagnosis of bovine tuberculosis in suggestive lesions on post-mortem inspection in carcasses

et al. 2018

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“…Relative sensitivity and specificity were evaluated as suggested by Coggon et al [5]. In order to assess the level of agreement between dot-ELISA and commercial ELISA Kit tests, the index of concordance, Kappa (κ), was used [20,23].…”

Section: Discussionmentioning

confidence: 99%

Dot-enzyme linked immunosorbent assay as an alternative technique for the detection of bovine respiratory syncytial virus (BRSV) antibodies

et al. 2002

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-A dot-ELISA test for the detection of anti-BRSV antibodies is described. The objective of this study was the standardisation of a test as a fast, inexpensive and effective alternative to detect anti-BRSV antibodies. Its sensitivity, specificity and usefulness were compared to a commercial ELISA-kit and to the standard serum neutralisation (SN) test. The standardisation of the technique was done using nitrocellulose disks soaked with a viral sample isolated in Brazil, BRSV-25-BR. The best results were obtained when the disks were sensitised with a purified antigen at a concentration of 0.7 µg/disk and the bovine serum was diluted 1: 200. The experiment used 423 samples of bovine serum collected in the main cattle breeding centres in Brazil.

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Measurement of Variation and Significance in Serologic Tests

Cited by 15 publications

References 1 publication

Internal quality assurance in diagnostic microbiology: A simple approach for insightful data

Internal quality assurance in diagnostic microbiology: A simple approach for insightful data

Difficulties in diagnosis of bovine tuberculosis in suggestive lesions on post-mortem inspection in carcasses

Dot-enzyme linked immunosorbent assay as an alternative technique for the detection of bovine respiratory syncytial virus (BRSV) antibodies

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