Performance of 2 Finger-Stick Blood Tests to Triage Adults With Symptoms of Pulmonary Tuberculosis: A Prospective Multisite Diagnostic Accuracy Study
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Gian D
van der Spuy
;
Jane A
Shaw
;
Tracy
Richardson
;
Elisa M
Tjon Kon Fat
;
Awa
Gindeh
;
Olumuyiwa
Owolabi
;
Nguyen Thuy Thuong
Thuong
;
Le Hong
Van
;
Nguyen Hoang
Van
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+104 more...
Dang Thi Thanh
Thao
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Harriet
Mayanja-Kizza
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Mary
Nsereko
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AnnRitah
Namuganga
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Sophie
Nalukwago
;
John
Belisle
;
Emmanuel
Moreau
;
Adam
Penn-Nicholson
;
Guy
Thwaites
;
Jill
Winter
;
Hazel M
Dockrell
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Thomas J
Scriba
;
Kim
Stanley
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Bronwyn
Smith
;
Novel N
Chegou
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Stephanus T
Malherbe
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Annemieke
Geluk
;
Paul
Corstjens
;
Gerhard
Walzl
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Jayne S
Sutherland
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Olumuyiwa
Owolabi
;
Amie
Secka
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Bintou
Njai
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Abdou K
Sillah
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Georgetta K
Daffeh
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A
Gindeh
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Amadou
Barry
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Momodou
Rashid
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Joseph
Mendy
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Binta
Sarr
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Abi-Janet
Riley
;
Alhaji
Jobe
;
Monica
Davies
;
Kairaba
Kanyi
;
Momodou
Jallow
;
Salieu
Barry
;
Ousainou
Cham
;
Gerhard
Walzl
;
Stephanus T
Malherbe
;
Bronwyn
Smith
;
Gian D
van der Spuy
;
Kim
Stanley
;
Jane A
Shaw
;
Alicia
Chetram
;
Tracy
Richardson
;
Bernadine
Fransman
;
Isaac
Johnson
;
Marika
Finn
;
Andriette
Hiemstra
;
Novel N
Chegou
;
Helena
Kuivaniemi
;
Gerard
Tromp
;
Susanne
Tonsing
;
Elizma
Smit
;
Balie
Carstens
;
Harriet
Mayanja-Kizza
;
Mary
Nsereko
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AnnRitah
Namuganga
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Sophie
Nalukwago
;
Joseph
Akol
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Saidah
Menya
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Veronica
Kizza
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Yusuf
Kironde
;
Deborah
Banturaki
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Immaculate
Nahereza
;
Simon
Okiror
;
Immaculate
Kemigisha
;
Paul
Mutumba
;
Henry
Ojiambo
;
Lilian
Murungi
;
Joan
Nassuna
;
Gladys
Mpalanyi
;
Michael
Odie
;
Guy
Thwaites
;
Nguyen Thuy Thuong
Thuong
;
Van Le
;
Son Vo
Thanh
;
Hau Nguyen
Thi
;
Ha Vu
Thi Ngoc
;
Ngoc
Le Hong
;
John
Belisle
;
Karen
Dobos
;
Hazel M
Dockrell
;
Thomas J
Scriba
;
Mark
Hatherill
;
Kate
Hadley
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Justin
Shenje
;
Stanley
Kimbung
;
Humphrey
Mulenga
;
Rachel
Oelofse
;
Nicole
Bilek
;
Elma
van Rooyen
;
Simba
Mabwe
;
Paul
Corstjens
;
A
Geluk
;
Elisa M
Tjon Kon Fat
;
Louise
Pierneef
;
Anouk
van Hooij
;
Jill
Winter
;
Morten
Ruhwald
;
Emmanuel
Moreau
;
Adam
Penn-Nicholson
;
Claudia
Schacht
;
Julia
Büech
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(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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