Academic Journal
Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results.
| العنوان: | Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results. |
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| المؤلفون: | Sutherland, Jayne S, van der Spuy, Gian, Gindeh, Awa, Thuong, Nguyen Thuy Thuong, Namuganga, AnnRitah, Owolabi, Olumuyiwa, Mayanja-Kizza, Harriet, Nsereko, Mary, Thwaites, Guy, Winter, Jill, Dockrell, Hazel M, Scriba, Thomas J, Geluk, Annemieke, Corstjens, Paul, Stanley, Kim, Richardson, Tracy, Shaw, Jane A, Smith, Bronwyn, Malherbe, Stephanus T, Walzl, Gerhard, TrENDx-TB Consortium |
| بيانات النشر: | Oxford University Press (OUP) |
| سنة النشر: | 2021 |
| المجموعة: | London School of Hygiene & Tropical Medicine: LSHTM Research Online |
| الوصف: | BACKGROUND: The development of a fast and accurate, non-sputum-based point-of-care triage test for tuberculosis (TB) would have a major impact on combating the TB burden worldwide. A new fingerstick blood test has been developed by Cepheid (the Xpert MTB Host Response [MTB-HR] prototype), which generates a "TB score" based on messenger RNA (mRNA) expression of 3 genes. Here we describe the first prospective findings of the MTB-HR prototype. METHODS: Fingerstick blood from adults presenting with symptoms compatible with TB in South Africa, The Gambia, Uganda, and Vietnam was analyzed using the Cepheid GeneXpert MTB-HR prototype. Accuracy of the Xpert MTB-HR cartridge was determined in relation to GeneXpert Ultra results and a composite microbiological score (GeneXpert Ultra and liquid culture) with patients classified as having TB or other respiratory diseases (ORD). RESULTS: When data from all sites (n = 75 TB, 120 ORD) were analyzed, the TB score discriminated between TB and ORD with an area under the curve (AUC) of 0.94 (95% confidence interval [CI], .91-.97), sensitivity of 87% (95% CI, 77-93%) and specificity of 94% (88-97%). When sensitivity was set at 90% for a triage test, specificity was 86% (95% CI, 75-97%). These results were not influenced by human immunodeficiency virus (HIV) status or geographical location. When evaluated against a composite microbiological score (n = 80 TB, 111 ORD), the TB score was able to discriminate between TB and ORD with an AUC of 0.88 (95% CI, .83-.94), 80% sensitivity (95% CI, 76-85%) and 94% specificity (95% CI, 91-96%). CONCLUSIONS: Our interim data indicate the Cepheid MTB-HR cartridge reaches the minimal target product profile for a point of care triage test for TB using fingerstick blood, regardless of geographic area or HIV infection status. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| Relation: | https://researchonline.lshtm.ac.uk/id/eprint/4665966/1/ciab839.pdf; Sutherland, Jayne S ; van der Spuy, Gian; Gindeh, Awa; Thuong, Nguyen Thuy Thuong; Namuganga, AnnRitah; Owolabi, Olumuyiwa; Mayanja-Kizza, Harriet; Nsereko, Mary; Thwaites, Guy; Winter, Jill; +11 more. Dockrell, Hazel M ; Scriba, Thomas J; Geluk, Annemieke; Corstjens, Paul; Stanley, Kim; Richardson, Tracy; Shaw, Jane A; Smith, Bronwyn; Malherbe, Stephanus T; Walzl, Gerhard; TrENDx-TB Consortium; (2021) Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results. Clinical infectious diseases, 74 (12). pp. 2136-2141. ISSN 1058-4838 DOI: https://doi.org/10.1093/cid/ciab839 |
| الاتاحة: | https://researchonline.lshtm.ac.uk/id/eprint/4665966/ https://researchonline.lshtm.ac.uk/id/eprint/4665966/1/ciab839.pdf |
| Rights: | cc_by_4 |
| رقم الانضمام: | edsbas.F39B530A |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |