Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods.
<h4>Background</h4>The QuantiFERON®-TB Gold In-Tube test (QFT-GIT) detects Mycobacterium tuberculosis (Mtb) infection by measuring release of interferon gamma (IFN-γ) when T-cells (in heparinized whole blood) are stimulated with specific Mtb antigens. The amount of IFN-γ is determined by...
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2014
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oai:doaj.org-article:bc99d0d8a54046db99ca6332c7671f922021-11-18T08:36:04ZVariability of the QuantiFERON®-TB gold in-tube test using automated and manual methods.1932-620310.1371/journal.pone.0086721https://doaj.org/article/bc99d0d8a54046db99ca6332c7671f922014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24466211/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>The QuantiFERON®-TB Gold In-Tube test (QFT-GIT) detects Mycobacterium tuberculosis (Mtb) infection by measuring release of interferon gamma (IFN-γ) when T-cells (in heparinized whole blood) are stimulated with specific Mtb antigens. The amount of IFN-γ is determined by enzyme-linked immunosorbent assay (ELISA). Automation of the ELISA method may reduce variability. To assess the impact of ELISA automation, we compared QFT-GIT results and variability when ELISAs were performed manually and with automation.<h4>Methods</h4>Blood was collected into two sets of QFT-GIT tubes and processed at the same time. For each set, IFN-γ was measured in automated and manual ELISAs. Variability in interpretations and IFN-γ measurements was assessed between automated (A1 vs. A2) and manual (M1 vs. M2) ELISAs. Variability in IFN-γ measurements was also assessed on separate groups stratified by the mean of the four ELISAs.<h4>Results</h4>Subjects (N = 146) had two automated and two manual ELISAs completed. Overall, interpretations were discordant for 16 (11%) subjects. Excluding one subject with indeterminate results, 7 (4.8%) subjects had discordant automated interpretations and 10 (6.9%) subjects had discordant manual interpretations (p = 0.17). Quantitative variability was not uniform; within-subject variability was greater with higher IFN-γ measurements and with manual ELISAs. For subjects with mean TB Responses ±0.25 IU/mL of the 0.35 IU/mL cutoff, the within-subject standard deviation for two manual tests was 0.27 (CI95 = 0.22-0.37) IU/mL vs. 0.09 (CI95 = 0.07-0.12) IU/mL for two automated tests.<h4>Conclusion</h4>QFT-GIT ELISA automation may reduce variability near the test cutoff. Methodological differences should be considered when interpreting and using IFN-γ release assays (IGRAs).William C WhitworthDonald J GoodwinLaura RacsterKevin B WestStella O ChukeLaura J DanielsBrandon H CampbellJamaria BohanonAtheer T JaffarWanzer DranePaul A SjobergGerald H MazurekPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 1, p e86721 (2014) |
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DOAJ |
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EN |
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Medicine R Science Q |
| spellingShingle |
Medicine R Science Q William C Whitworth Donald J Goodwin Laura Racster Kevin B West Stella O Chuke Laura J Daniels Brandon H Campbell Jamaria Bohanon Atheer T Jaffar Wanzer Drane Paul A Sjoberg Gerald H Mazurek Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. |
| description |
<h4>Background</h4>The QuantiFERON®-TB Gold In-Tube test (QFT-GIT) detects Mycobacterium tuberculosis (Mtb) infection by measuring release of interferon gamma (IFN-γ) when T-cells (in heparinized whole blood) are stimulated with specific Mtb antigens. The amount of IFN-γ is determined by enzyme-linked immunosorbent assay (ELISA). Automation of the ELISA method may reduce variability. To assess the impact of ELISA automation, we compared QFT-GIT results and variability when ELISAs were performed manually and with automation.<h4>Methods</h4>Blood was collected into two sets of QFT-GIT tubes and processed at the same time. For each set, IFN-γ was measured in automated and manual ELISAs. Variability in interpretations and IFN-γ measurements was assessed between automated (A1 vs. A2) and manual (M1 vs. M2) ELISAs. Variability in IFN-γ measurements was also assessed on separate groups stratified by the mean of the four ELISAs.<h4>Results</h4>Subjects (N = 146) had two automated and two manual ELISAs completed. Overall, interpretations were discordant for 16 (11%) subjects. Excluding one subject with indeterminate results, 7 (4.8%) subjects had discordant automated interpretations and 10 (6.9%) subjects had discordant manual interpretations (p = 0.17). Quantitative variability was not uniform; within-subject variability was greater with higher IFN-γ measurements and with manual ELISAs. For subjects with mean TB Responses ±0.25 IU/mL of the 0.35 IU/mL cutoff, the within-subject standard deviation for two manual tests was 0.27 (CI95 = 0.22-0.37) IU/mL vs. 0.09 (CI95 = 0.07-0.12) IU/mL for two automated tests.<h4>Conclusion</h4>QFT-GIT ELISA automation may reduce variability near the test cutoff. Methodological differences should be considered when interpreting and using IFN-γ release assays (IGRAs). |
| format |
article |
| author |
William C Whitworth Donald J Goodwin Laura Racster Kevin B West Stella O Chuke Laura J Daniels Brandon H Campbell Jamaria Bohanon Atheer T Jaffar Wanzer Drane Paul A Sjoberg Gerald H Mazurek |
| author_facet |
William C Whitworth Donald J Goodwin Laura Racster Kevin B West Stella O Chuke Laura J Daniels Brandon H Campbell Jamaria Bohanon Atheer T Jaffar Wanzer Drane Paul A Sjoberg Gerald H Mazurek |
| author_sort |
William C Whitworth |
| title |
Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. |
| title_short |
Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. |
| title_full |
Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. |
| title_fullStr |
Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. |
| title_full_unstemmed |
Variability of the QuantiFERON®-TB gold in-tube test using automated and manual methods. |
| title_sort |
variability of the quantiferon®-tb gold in-tube test using automated and manual methods. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2014 |
| url |
https://doaj.org/article/bc99d0d8a54046db99ca6332c7671f92 |
| work_keys_str_mv |
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