- search hit 1 of 1
Evaluation of INSTAND e.V.’s external proficiency testing program for tetanus and diphtheria antitoxin detection: Lessons for assessing levels of immunoprotection
- Objectives: The aim of this study was to evaluate the development and status quo of the quality of high throughput in vitro diagnostic testing for tetanus and diphtheria antitoxin antibody (ATX) concentrations based on external quality assessment (EQA) data. Methods: We analyzed manufacturer-specific data of 22 EQA surveys—each for the detection of tetanus and diphtheria ATX—to check the diagnostic strength of the corresponding in vitro diagnostic systems. Results: While the results were mostly well aligned, individual surveys showed widely dispersed ATX concentrations. The medians of manufacturer collectives deviated from the overall median by up to 8.9-fold in the case of diphtheria ATX and by up to 3.5-fold in the case of tetanus ATX. Such a distribution in the results is particularly critical in the cut-off range for immunity and may lead to an incorrect assessment of vaccination status. Conclusion: These results were surprising as there are International Standards for both ATX; however, the results may be linked to the high ATX concentration of the reference material, which deviates considerably from clinically significant concentrations. To increase the accuracy and diagnostic strength of both assays, we recommend a recalibration of the test systems and verification of their traceability to the International Standards.
Author: | Nathalie Wojtalewicz, Laura Vierbaum, Ingo Schellenberg, Klaus-Peter HunfeldORCiD |
---|---|
URN: | urn:nbn:de:hebis:30:3-781476 |
DOI: | https://doi.org/10.1016/j.ijid.2020.12.046 |
ISSN: | 1201-9712 |
Parent Title (English): | International Journal of Infectious Diseases |
Publisher: | Elsevier |
Place of publication: | Amsterdam |
Document Type: | Article |
Language: | English |
Date of Publication (online): | 2021/01/20 |
Date of first Publication: | 2021/01/06 |
Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
Release Date: | 2024/02/02 |
Tag: | Diphtheria; EQA scheme; Proficiency testing; Standardization; Tetanus; Vaccine |
Volume: | 104 |
Page Number: | 7 |
First Page: | 85 |
Last Page: | 91 |
Institutes: | Medizin |
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Sammlungen: | Universitätspublikationen |
Licence (German): | Creative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International |