Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results
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| Názov: | Diagnostic Accuracy of the Cepheid 3-gene Host Response Fingerstick Blood Test in a Prospective, Multi-site Study: Interim Results |
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| Autori: | Jayne S Sutherland, Gian van der Spuy, Awa Gindeh, Nguyen Thuy Thuong Thuong, AnnRitah Namuganga, Olumuyiwa Owolabi, Harriet Mayanja-Kizza, Mary Nsereko, Guy Thwaites, Jill Winter, Hazel M Dockrell, Thomas J Scriba, Annemieke Geluk, Paul Corstjens, Kim Stanley, Tracy Richardson, Jane A Shaw, Bronwyn Smith, Stephanus T Malherbe, Gerhard Walzl, Jayne Sutherland, Amie Secka, Georgetta Daffeh, Joseph Mendy, Binta Sarr, Abi-Janet Riley, Alhaji Jobe, Monica Davies, Kairaba Kanyi, Momodou Jallow, Salieu Barry, Ousainou Cham, Esin Nkereuwem, Stephanus Malherbe, Jane Shaw, Alicia Chetram, Marika Finn, Andriette Hiemstra, Novel Chegou, Helena Kuivaniemi, Gerard Tromp, Susanne Tonsing, Elizma Smit, Balie Carstens, Sophie Nalukwago, Joseph Akol, Dorcas Lamunu, Michael Ordie, Thuong Nguyen, Van Le, Son Vo Thanh, Hau Nguyen Thi, Ha Vu Thi Ngoc, Ngoc Le Hong, John Belisle, Karen Dobos, Hazel Dockrell, Thomas Scriba, Mark Hatherill, Kate Hadley, Justin Shenje, Stanley Kimbung, Humphrey Mulenga, Rachel Oelofse, Nicole Bilek, Elma van Rooyen, Simba Mabwe, Elisa Tjon Kon Fat, Louise Pierneef, Anouk van Hooij, Morten Ruhwald, Emmanuel Moreau, Adam Penn-Nicholson, Claudia Schacht, Julia Büech, Malte Streitz |
| Prispievatelia: | consortium, TrENDx-TB |
| Zdroj: | Clin Infect Dis |
| Informácie o vydavateľovi: | Oxford University Press (OUP), 2021. |
| Rok vydania: | 2021 |
| Predmety: | Adult, 0301 basic medicine, Major Articles and Commentaries, 03 medical and health sciences, Hematologic Tests, Humans, Tuberculosis, HIV Infections, Mycobacterium tuberculosis, Prospective Studies, Sensitivity and Specificity, 3. Good health |
| Popis: | 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. |
| Druh dokumentu: | Article Other literature type |
| Jazyk: | English |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/cid/ciab839 |
| Prístupová URL adresa: | https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciab839/41135773/ciab839.pdf https://pubmed.ncbi.nlm.nih.gov/34550342 https://www.ncbi.nlm.nih.gov/pubmed/34550342 https://pubmed.ncbi.nlm.nih.gov/34550342/ https://ora.ox.ac.uk/objects/uuid:63c2b3a0-adec-4540-b971-b273abc61330 https://doi.org/10.1093/cid/ciab839 |
| Rights: | CC BY URL: http://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
| Prístupové číslo: | edsair.doi.dedup.....493b73ff848d88a69a448c36e0c46b63 |
| Databáza: | OpenAIRE |
Nájsť tento článok vo Web of Science | Abstrakt: | 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. |
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| ISSN: | 15376591 10584838 |
| DOI: | 10.1093/cid/ciab839 |