Bibliographic Details
| Title: |
Evaluation of INSTAND e.V.’s external proficiency testing program for tetanus and diphtheria antitoxin detection: Lessons for assessing levels of immunoprotection |
| Authors: |
Nathalie Wojtalewicz, Laura Vierbaum, Ingo Schellenberg, Klaus-Peter Hunfeld |
| Source: |
International Journal of Infectious Diseases, Vol 104, Iss , Pp 85-91 (2021) |
| Publisher Information: |
Elsevier, 2021. |
| Publication Year: |
2021 |
| Collection: |
LCC:Infectious and parasitic diseases |
| Subject Terms: |
EQA scheme, Proficiency testing, Diphtheria, Tetanus, Vaccine, Standardization, Infectious and parasitic diseases, RC109-216 |
| More Details: |
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. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1201-9712 |
| Relation: |
http://www.sciencedirect.com/science/article/pii/S1201971220325704; https://doaj.org/toc/1201-9712 |
| DOI: |
10.1016/j.ijid.2020.12.046 |
| Access URL: |
https://doaj.org/article/e738dd042b0c4df889cc7b3e726c9422 |
| Accession Number: |
edsdoj.738dd042b0c4df889cc7b3e726c9422 |
| Database: |
Directory of Open Access Journals |
