Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting
<p>Abstract</p> <p>Background</p> <p>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.</p>...
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doaj-8a38b00a6dde436dbc117fd9c94447472020-11-25T03:12:12ZengBMCBMC Infectious Diseases1471-23342009-05-01916610.1186/1471-2334-9-66Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited settingHang Nguyen TLIshizuka NaokiKeicho NaotoHong Le TTam Do BThu Vu TXMatsushita IkumiHarada NobuyukiHiguchi KazueSakurada ShinsakuLien Luu T<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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 (<it>P </it>< 0.0001) and error variance was no longer affected by laboratory personnel in charge, indicating that a marked improvement could be objectively observed.</p> <p>Conclusion</p> <p>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.</p> http://www.biomedcentral.com/1471-2334/9/66 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting BMC Infectious Diseases |
author_facet |
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 |
author_sort |
Hang Nguyen TL |
title |
Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting |
title_short |
Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting |
title_full |
Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting |
title_fullStr |
Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting |
title_full_unstemmed |
Quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting |
title_sort |
quality assessment of an interferon-gamma release assay for tuberculosis infection in a resource-limited setting |
publisher |
BMC |
series |
BMC Infectious Diseases |
issn |
1471-2334 |
publishDate |
2009-05-01 |
description |
<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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 (<it>P </it>< 0.0001) and error variance was no longer affected by laboratory personnel in charge, indicating that a marked improvement could be objectively observed.</p> <p>Conclusion</p> <p>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.</p> |
url |
http://www.biomedcentral.com/1471-2334/9/66 |
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