The diagnostic accuracy of three rapid diagnostic tests for typhoid fever at Chittagong Medical College Hospital, Chittagong, Bangladesh

Rapeephan R Maude, Hanna K de Jong, Lalith Wijedoru, Masako Fukushima, Aniruddha Ghose, Rasheda Samad, Mohammed Amir Hossain, Mohammed Rezaul Karim, Mohammed Abul Faiz, Christopher M Parry, CMCH Typhoid Study Group, Abdullah Abu Sayeed, Uddin Hasan, Wirichada Pan-Ngum, Thomas W van der Vaart, Asok Kumar Dutta, Nasir Uddin Mahmud, Murad Hero, Nafiz Iqbal, Zabeen Chaudhury, Tran Vu Thieu Nga, Pham Thanh Duy, Voong Vinh Phat, Richard J Maude, Stephen Baker, W Joost Wiersinga, Tom van der Poll, Nicholas P Day, Arjen M Dondorp, Rapeephan R Maude, Hanna K de Jong, Lalith Wijedoru, Masako Fukushima, Aniruddha Ghose, Rasheda Samad, Mohammed Amir Hossain, Mohammed Rezaul Karim, Mohammed Abul Faiz, Christopher M Parry, CMCH Typhoid Study Group, Abdullah Abu Sayeed, Uddin Hasan, Wirichada Pan-Ngum, Thomas W van der Vaart, Asok Kumar Dutta, Nasir Uddin Mahmud, Murad Hero, Nafiz Iqbal, Zabeen Chaudhury, Tran Vu Thieu Nga, Pham Thanh Duy, Voong Vinh Phat, Richard J Maude, Stephen Baker, W Joost Wiersinga, Tom van der Poll, Nicholas P Day, Arjen M Dondorp

Abstract

Objective: To determine the diagnostic accuracy of three rapid diagnostic tests (RDTs) for typhoid fever in febrile hospitalised patients in Bangladesh.

Methods: Febrile adults and children admitted to Chittagong Medical College Hospital, Bangladesh, were investigated with Bact/Alert(®) blood cultures and real-time PCR to detect Salmonella enterica Typhi and Paratyphi A and assays for Rickettsia, leptospirosis and dengue fever. Acute serum samples were examined with the LifeAssay (LA) Test-it™ Typhoid IgM lateral flow assay detecting IgM antibodies against S. Typhi O antigen, CTKBiotech Onsite Typhoid IgG/IgM Combo Rapid-test cassette lateral flow assay detecting IgG and IgM antibodies against S. Typhi O and H antigens and SD Bioline line assay for IgG and IgM antibodies against S. Typhi proteins.

Results: In 300 malaria smear-negative febrile patients [median (IQR) age of 13.5 (5-31) years], 34 (11.3%) had confirmed typhoid fever: 19 positive by blood culture for S. Typhi (three blood PCR positive) and 15 blood culture negative but PCR positive for S. Typhi in blood. The respective sensitivity and specificity of the three RDTs in patients using a composite reference standard of blood culture and/or PCR-confirmed typhoid fever were 59% and 61% for LifeAssay, 59% and 74% for the CTK IgM and/or IgG, and 24% and 96% for the SD Bioline RDT IgM and/or IgG. The LifeAssay RDT had a sensitivity of 63% and a specificity of 91% when modified with a positive cut-off of ≥2+ and analysed using a Bayesian latent class model.

Conclusions: These typhoid RDTs demonstrated moderate diagnostic accuracies, and better tests are needed.

Keywords: Fiebre tifoidea; PCR a tiempo real; PCR en temps réel; Salmonella enterica serovar Typhi; Salmonella enterica serovar typhi; Salmonella enterica sérotype typhi; blood culture; cultivo de sangre; culture de sang; diagnostic accuracy; fièvre typhoïde; precisión diagnóstica; prueba de diagnóstico rápido; précision diagnostique; rapid diagnostic tests; real-time PCR; tests de diagnostic rapide; typhoid fever.

© 2015 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Flowchart of the 304 febrile patients admitted to the study and the analysis results.

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