| Autor: |
Hang Nguyen TL, Ishizuka Naoki, Keicho Naoto, Hong Le T, Tam Do B, Thu Vu TX, Matsushita Ikumi, Harada Nobuyuki, Higuchi Kazue, Sakurada Shinsaku, Lien Luu T |
| Jazyk: |
angličtina |
| Rok vydání: |
2009 |
| Předmět: |
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| Zdroj: |
BMC Infectious Diseases, Vol 9, Iss 1, p 66 (2009) |
| Druh dokumentu: |
article |
| ISSN: |
1471-2334 |
| DOI: |
10.1186/1471-2334-9-66 |
| Popis: |
Abstract Background When a test for diagnosis of infectious diseases is introduced in a resource-limited setting, monitoring quality is a major concern. An optimized design of experiment and statistical models are required for this assessment. Methods Interferon-gamma release assay to detect tuberculosis (TB) infection from whole blood was tested in Hanoi, Viet Nam. Balanced incomplete block design (BIBD) was planned and fixed-effect models with heterogeneous error variance were used for analysis. In the first trial, the whole blood from 12 donors was incubated with nil, TB-specific antigens or mitogen. In 72 measurements, two laboratory members exchanged their roles in harvesting plasma and testing for interferon-gamma release using enzyme linked immunosorbent assay (ELISA) technique. After intervention including checkup of all steps and standard operation procedures, the second trial was implemented in a similar manner. Results The lack of precision in the first trial was clearly demonstrated. Large within-individual error was significantly affected by both harvester and ELISA operator, indicating that both of the steps had problems. After the intervention, overall within-individual error was significantly reduced (P < 0.0001) and error variance was no longer affected by laboratory personnel in charge, indicating that a marked improvement could be objectively observed. Conclusion BIBD and analysis of fixed-effect models with heterogeneous variance are suitable and useful for objective and individualized assessment of proficiency in a multistep diagnostic test for infectious diseases in a resource-constrained laboratory. The action plan based on our findings would be worth considering when monitoring for internal quality control is difficult on site. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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