Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study
; van der Spuy, GD; Shaw, JA; Richardson, T; Tjon Kon Fat, EM; Gindeh, A; Owolabi, O; Thuong, NTT; Van, LH; Van, NH; +104 more...Thao, DTT; Mayanja-Kizza, H; Nsereko, M; Namuganga, A; Nalukwago, S; Belisle, J; Moreau, E; Penn-Nicholson, A; Thwaites, G; Winter, J; Dockrell, HM; Scriba, TJ; Stanley, K; Smith, B; Chegou, NN; Malherbe, ST; Geluk, A; Corstjens, P; Walzl, G; Sutherland, JS; Owolabi, O; Secka, A; Njai, B; Sillah, AK; Daffeh, GK; Gindeh, A; Barry, A; Rashid, M; Mendy, J; Sarr, B; Riley, A; Jobe, A; Davies, M; Kanyi, K; Jallow, M; Barry, S; Cham, O; Walzl, G; Malherbe, ST; Smith, B; van der Spuy, GD; Stanley, K; Shaw, JA; Chetram, A; Richardson, T; Fransman, B; Johnson, I; Finn, M; Hiemstra, A; Chegou, NN; Kuivaniemi, H; Tromp, G; Tonsing, S; Smit, E; Carstens, B; Mayanja-Kizza, H; Nsereko, M; Namuganga, A; Nalukwago, S; Akol, J; Menya, S; Kizza, V; Kironde, Y; Banturaki, D; Nahereza, I; Okiror, S; Kemigisha, I; Mutumba, P; Ojiambo, H; Murungi, L; Nassuna, J; Mpalanyi, G; Odie, M; Thwaites, G; Thuong, NTT; Van Le; Thanh, SV; Thi, HN; Thi Ngoc, HV; Le Hong, N; Belisle, J; Dobos, K; Dockrell, HM; Scriba, TJ; Hatherill, M; Hadley, K; Shenje, J; Kimbung, S; Mulenga, H; Oelofse, R; Bilek, N; van Rooyen, E; Mabwe, S; Corstjens, P; Geluk, A; Tjon Kon Fat, EM; Pierneef, L; van Hooij, A; Winter, J; Ruhwald, M; Moreau, E; Penn-Nicholson, A; Schacht, C; Büech, J and
(2025)
Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study.
Clinical infectious diseases.
ciaf105.
ISSN 1058-4838
DOI: 10.1093/cid/ciaf105
(In Press)
Background: Non–sputum-based, point-of-care triage tests for pulmonary tuberculosis could enhance tuberculosis diagnostic programs. We assessed the diagnostic accuracy of 2 finger-stick blood tests: the Cepheid 3 gene host-response cartridge (Xpert-HR), which measures 3 host messenger RNA transcripts, and the 3-host protein multibiomarker test (MBT).
Methods: We performed a prospective diagnostic accuracy study of consecutive participants with symptoms compatible with pulmonary tuberculosis in The Gambia, South Africa, Uganda, and Vietnam. A composite reference standard for active pulmonary tuberculosis incorporated chest radiography, symptom resolution, and sputum microbiological test results. A training-test set approach was used to evaluate test cutoff specificities at 90% sensitivity.
Results: Between 1 November 2020 and 1 May 2023, we screened 1262 participants aged 12–70 years with cough lasting >2 weeks and another symptom suggestive of tuberculosis. Of those who were classifiable by reference tests, 1154 participants had evaluable Xpert-HR results and 961 had evaluable MBT results. Xpert-HR had an area under the receiver operating characteristic (AUROC) curve of 0.92 at a cutoff of −1.275 or below, with a sensitivity of 92.8%, specificity of 62.5%, positive predictive value of 47.9%, and negative predictive value of 95.9%. The MBT had an AUROC of 0.91 at a cutoff of ≥0.42, with a sensitivity of 91.4%, specificity of 73.2%, positive predictive value of 52.0%, and negative predictive value of 96.4%.
Conclusions: Our results show that both Xpert-HR and the MBT are promising non–sputum-based point-of-care tests. The MBT met the World Health Organization target product profile for a triage test, which suggests it should be further developed.
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