Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis
Background: The NOVA Tuberculosis Total Antibody Rapid Test is a commercially available lateral flow serological assay that is intended to be used as an aid in the diagnosis of tuberculosis. We conducted a study to estimate diagnostic accuracy of this assay for diagnosis of active pulmonary tubercul...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-05-01
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| Series: | Journal of Clinical Tuberculosis and Other Mycobacterial Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405579423000189 |
| _version_ | 1797837760779780096 |
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| author | Gideon Nsubuga Samuel Kennedy Yasha Rani Zibran Hafiz Soyeon Kim Morten Ruhwald David Alland Jerrold Ellner Moses Joloba Susan E. Dorman Adam Penn-Nicholson Lydia Nakiyingi |
| author_facet | Gideon Nsubuga Samuel Kennedy Yasha Rani Zibran Hafiz Soyeon Kim Morten Ruhwald David Alland Jerrold Ellner Moses Joloba Susan E. Dorman Adam Penn-Nicholson Lydia Nakiyingi |
| author_sort | Gideon Nsubuga |
| collection | DOAJ |
| description | Background: The NOVA Tuberculosis Total Antibody Rapid Test is a commercially available lateral flow serological assay that is intended to be used as an aid in the diagnosis of tuberculosis. We conducted a study to estimate diagnostic accuracy of this assay for diagnosis of active pulmonary tuberculosis disease and for detection of M. tuberculosis infection. Methods: This study used existing frozen plasma specimens that had been obtained previously from consenting HIV-negative adults in Cambodia, South Africa, and Vietnam whose tuberculosis status was rigorously characterized using sputum mycobacterial cultures and blood interferon gamma release assay. The investigational assay was performed in a single laboratory by laboratory staff specifically trained to conduct the assays according to the manufacturer’s procedures. In addition, intensity of the test band was subjectively assessed. Results: Plasma specimens from 150 participants were tested. All testing attempts yielded a determinate result of either positive or negative. For diagnosis of active pulmonary tuberculosis disease, test sensitivity and specificity were 40.0 % (20/50, 95 % confidence interval [CI] 27.6 % to 53.8 %) and 85.0 % (95 % CI 76.7 % to 90.7 %), respectively. For detection of M. tuberculosis infection, test sensitivity and specificity were 28.0 % (95 % CI 20.5 % to 37.2 %) and 86.0 % (95 % CI 73.8 % to 93.0 %), respectively. Among the 35 positive tests, no statistically significant band intensity trend was found across participant groups (p = 0.17). Conclusion: Study findings do not support a role for the NOVA Tuberculosis Test in current tuberculosis diagnostic algorithms. |
| first_indexed | 2024-04-09T15:29:51Z |
| format | Article |
| id | doaj.art-2e1218e8ee2546c99f669e0b2aadd7b1 |
| institution | Directory Open Access Journal |
| issn | 2405-5794 |
| language | English |
| last_indexed | 2024-04-09T15:29:51Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Clinical Tuberculosis and Other Mycobacterial Diseases |
| spelling | doaj.art-2e1218e8ee2546c99f669e0b2aadd7b12023-04-28T08:55:55ZengElsevierJournal of Clinical Tuberculosis and Other Mycobacterial Diseases2405-57942023-05-0131100362Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosisGideon Nsubuga0Samuel Kennedy1Yasha Rani2Zibran Hafiz3Soyeon Kim4Morten Ruhwald5David Alland6Jerrold Ellner7Moses Joloba8Susan E. Dorman9Adam Penn-Nicholson10Lydia Nakiyingi11College of Health Sciences, Makerere University, Kampala, UgandaMedical University of South Carolina, Charleston, SC, USAFrontier Science Foundation, Brookline, MA, USARutgers University – New Jersey Medical School, Newark, NJ, USAFrontier Science Foundation, Brookline, MA, USAFIND, Geneva, SwitzerlandRutgers University – New Jersey Medical School, Newark, NJ, USARutgers University – New Jersey Medical School, Newark, NJ, USACollege of Health Sciences, Makerere University, Kampala, UgandaMedical University of South Carolina, Charleston, SC, USA; Corresponding author at: Medical University of South Carolina, 135 Rutledge Avenue, Room 1207, Charleston, SC 29425, USA.FIND, Geneva, SwitzerlandCollege of Health Sciences, Makerere University, Kampala, UgandaBackground: The NOVA Tuberculosis Total Antibody Rapid Test is a commercially available lateral flow serological assay that is intended to be used as an aid in the diagnosis of tuberculosis. We conducted a study to estimate diagnostic accuracy of this assay for diagnosis of active pulmonary tuberculosis disease and for detection of M. tuberculosis infection. Methods: This study used existing frozen plasma specimens that had been obtained previously from consenting HIV-negative adults in Cambodia, South Africa, and Vietnam whose tuberculosis status was rigorously characterized using sputum mycobacterial cultures and blood interferon gamma release assay. The investigational assay was performed in a single laboratory by laboratory staff specifically trained to conduct the assays according to the manufacturer’s procedures. In addition, intensity of the test band was subjectively assessed. Results: Plasma specimens from 150 participants were tested. All testing attempts yielded a determinate result of either positive or negative. For diagnosis of active pulmonary tuberculosis disease, test sensitivity and specificity were 40.0 % (20/50, 95 % confidence interval [CI] 27.6 % to 53.8 %) and 85.0 % (95 % CI 76.7 % to 90.7 %), respectively. For detection of M. tuberculosis infection, test sensitivity and specificity were 28.0 % (95 % CI 20.5 % to 37.2 %) and 86.0 % (95 % CI 73.8 % to 93.0 %), respectively. Among the 35 positive tests, no statistically significant band intensity trend was found across participant groups (p = 0.17). Conclusion: Study findings do not support a role for the NOVA Tuberculosis Test in current tuberculosis diagnostic algorithms.http://www.sciencedirect.com/science/article/pii/S2405579423000189TuberculosisMycobacteriaDiagnostic accuracySpecificitySensitivityLateral flow |
| spellingShingle | Gideon Nsubuga Samuel Kennedy Yasha Rani Zibran Hafiz Soyeon Kim Morten Ruhwald David Alland Jerrold Ellner Moses Joloba Susan E. Dorman Adam Penn-Nicholson Lydia Nakiyingi Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Tuberculosis Mycobacteria Diagnostic accuracy Specificity Sensitivity Lateral flow |
| title | Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis |
| title_full | Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis |
| title_fullStr | Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis |
| title_full_unstemmed | Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis |
| title_short | Diagnostic accuracy of the NOVA Tuberculosis Total Antibody Rapid test for detection of pulmonary tuberculosis and infection with Mycobacterium tuberculosis |
| title_sort | diagnostic accuracy of the nova tuberculosis total antibody rapid test for detection of pulmonary tuberculosis and infection with mycobacterium tuberculosis |
| topic | Tuberculosis Mycobacteria Diagnostic accuracy Specificity Sensitivity Lateral flow |
| url | http://www.sciencedirect.com/science/article/pii/S2405579423000189 |
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