Assessment and comparative analysis of a rapid diagnostic test (Tubex) for the diagnosis of typhoid fever among hospitalized children in rural Tanzania.

Benedikt Ley, Kamala Thriemer, Shaali M Ame, George Mtove, Lorenz Von Seidlein, Ben Amos, Ilse Hendriksen, Abraham Mwambuli, Aikande Shoo, Deok Ryun Kim, R Ochiai, M Favorov, John D Clemens, Harald Wilfing, Jaqueline Deen, Ali Said

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    Abstract

    Background: Typhoid fever remains a significant health problem in many developing countries. A rapid test with a performance comparable to that of blood culture would be highly useful. A rapid diagnostic test for typhoid fever, Tubex®, is commercially available that uses particle separation to detect immunoglobulin M directed towards Salmonella Typhi O9 lipopolysaccharide in sera.

    Methods: We assessed the sensitivity and specificity of the Tubex test among Tanzanian children hospitalized with febrile illness using blood culture as gold standard. Evaluation was done considering blood culture confirmed S. Typhi with non-typhi salmonella (NTS) and non - salmonella isolates as controls as well as with non-salmonella isolates only.

    Results: Of 139 samples tested with Tubex, 33 were positive for S. Typhi in blood culture, 49 were culture-confirmed NTS infections, and 57 were other non-salmonella infections. Thirteen hemolyzed samples were excluded. Using all non - S. Typhi isolates as controls, we showed a sensitivity of 79% and a specificity of 89%. When the analysis was repeated excluding NTS from the pool of controls we showed a sensitivity of 79% and a specificity of 97%. There was no significant difference in the test performance using the two different control groups (p > 0.05).

    Conclusion: This first evaluation of the Tubex test in an African setting showed a similar performance to those seen in some Asian settings. Comparison with the earlier results of a Widal test using the same samples showed no significant difference (p > 0.05) for any of the performance indicators, irrespective of the applied control group.
    Original languageEnglish
    Pages (from-to)147-
    Number of pages6
    JournalBMC Infectious Diseases
    Volume24
    Issue number11
    DOIs
    Publication statusPublished - 2011

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    Salmonella typhi
    Hospitalized Child
    Tanzania
    Typhoid Fever
    Routine Diagnostic Tests
    Salmonella
    Control Groups
    Salmonella Infections
    Developing Countries
    Immunoglobulin M
    Lipopolysaccharides
    Fever
    Sensitivity and Specificity
    Blood Culture
    Health
    Infection
    Serum

    Cite this

    Ley, Benedikt ; Thriemer, Kamala ; Ame, Shaali M ; Mtove, George ; Von Seidlein, Lorenz ; Amos, Ben ; Hendriksen, Ilse ; Mwambuli, Abraham ; Shoo, Aikande ; Kim, Deok Ryun ; Ochiai, R ; Favorov, M ; Clemens, John D ; Wilfing, Harald ; Deen, Jaqueline ; Said, Ali. / Assessment and comparative analysis of a rapid diagnostic test (Tubex) for the diagnosis of typhoid fever among hospitalized children in rural Tanzania. In: BMC Infectious Diseases. 2011 ; Vol. 24, No. 11. pp. 147-.
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    title = "Assessment and comparative analysis of a rapid diagnostic test (Tubex) for the diagnosis of typhoid fever among hospitalized children in rural Tanzania.",
    abstract = "Background: Typhoid fever remains a significant health problem in many developing countries. A rapid test with a performance comparable to that of blood culture would be highly useful. A rapid diagnostic test for typhoid fever, Tubex{\circledR}, is commercially available that uses particle separation to detect immunoglobulin M directed towards Salmonella Typhi O9 lipopolysaccharide in sera.Methods: We assessed the sensitivity and specificity of the Tubex test among Tanzanian children hospitalized with febrile illness using blood culture as gold standard. Evaluation was done considering blood culture confirmed S. Typhi with non-typhi salmonella (NTS) and non - salmonella isolates as controls as well as with non-salmonella isolates only.Results: Of 139 samples tested with Tubex, 33 were positive for S. Typhi in blood culture, 49 were culture-confirmed NTS infections, and 57 were other non-salmonella infections. Thirteen hemolyzed samples were excluded. Using all non - S. Typhi isolates as controls, we showed a sensitivity of 79{\%} and a specificity of 89{\%}. When the analysis was repeated excluding NTS from the pool of controls we showed a sensitivity of 79{\%} and a specificity of 97{\%}. There was no significant difference in the test performance using the two different control groups (p > 0.05).Conclusion: This first evaluation of the Tubex test in an African setting showed a similar performance to those seen in some Asian settings. Comparison with the earlier results of a Widal test using the same samples showed no significant difference (p > 0.05) for any of the performance indicators, irrespective of the applied control group.",
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    author = "Benedikt Ley and Kamala Thriemer and Ame, {Shaali M} and George Mtove and {Von Seidlein}, Lorenz and Ben Amos and Ilse Hendriksen and Abraham Mwambuli and Aikande Shoo and Kim, {Deok Ryun} and R Ochiai and M Favorov and Clemens, {John D} and Harald Wilfing and Jaqueline Deen and Ali Said",
    year = "2011",
    doi = "10.1186/1471-2334-11-147",
    language = "English",
    volume = "24",
    pages = "147--",
    journal = "BMC Infectious Diseases",
    issn = "1471-2334",
    publisher = "BioMed Central",
    number = "11",

    }

    Ley, B, Thriemer, K, Ame, SM, Mtove, G, Von Seidlein, L, Amos, B, Hendriksen, I, Mwambuli, A, Shoo, A, Kim, DR, Ochiai, R, Favorov, M, Clemens, JD, Wilfing, H, Deen, J & Said, A 2011, 'Assessment and comparative analysis of a rapid diagnostic test (Tubex) for the diagnosis of typhoid fever among hospitalized children in rural Tanzania.', BMC Infectious Diseases, vol. 24, no. 11, pp. 147-. https://doi.org/10.1186/1471-2334-11-147

    Assessment and comparative analysis of a rapid diagnostic test (Tubex) for the diagnosis of typhoid fever among hospitalized children in rural Tanzania. / Ley, Benedikt; Thriemer, Kamala; Ame, Shaali M; Mtove, George; Von Seidlein, Lorenz; Amos, Ben; Hendriksen, Ilse; Mwambuli, Abraham; Shoo, Aikande; Kim, Deok Ryun; Ochiai, R; Favorov, M; Clemens, John D; Wilfing, Harald; Deen, Jaqueline; Said, Ali.

    In: BMC Infectious Diseases, Vol. 24, No. 11, 2011, p. 147-.

    Research output: Contribution to journalArticleResearchpeer-review

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    T1 - Assessment and comparative analysis of a rapid diagnostic test (Tubex) for the diagnosis of typhoid fever among hospitalized children in rural Tanzania.

    AU - Ley, Benedikt

    AU - Thriemer, Kamala

    AU - Ame, Shaali M

    AU - Mtove, George

    AU - Von Seidlein, Lorenz

    AU - Amos, Ben

    AU - Hendriksen, Ilse

    AU - Mwambuli, Abraham

    AU - Shoo, Aikande

    AU - Kim, Deok Ryun

    AU - Ochiai, R

    AU - Favorov, M

    AU - Clemens, John D

    AU - Wilfing, Harald

    AU - Deen, Jaqueline

    AU - Said, Ali

    PY - 2011

    Y1 - 2011

    N2 - Background: Typhoid fever remains a significant health problem in many developing countries. A rapid test with a performance comparable to that of blood culture would be highly useful. A rapid diagnostic test for typhoid fever, Tubex®, is commercially available that uses particle separation to detect immunoglobulin M directed towards Salmonella Typhi O9 lipopolysaccharide in sera.Methods: We assessed the sensitivity and specificity of the Tubex test among Tanzanian children hospitalized with febrile illness using blood culture as gold standard. Evaluation was done considering blood culture confirmed S. Typhi with non-typhi salmonella (NTS) and non - salmonella isolates as controls as well as with non-salmonella isolates only.Results: Of 139 samples tested with Tubex, 33 were positive for S. Typhi in blood culture, 49 were culture-confirmed NTS infections, and 57 were other non-salmonella infections. Thirteen hemolyzed samples were excluded. Using all non - S. Typhi isolates as controls, we showed a sensitivity of 79% and a specificity of 89%. When the analysis was repeated excluding NTS from the pool of controls we showed a sensitivity of 79% and a specificity of 97%. There was no significant difference in the test performance using the two different control groups (p > 0.05).Conclusion: This first evaluation of the Tubex test in an African setting showed a similar performance to those seen in some Asian settings. Comparison with the earlier results of a Widal test using the same samples showed no significant difference (p > 0.05) for any of the performance indicators, irrespective of the applied control group.

    AB - Background: Typhoid fever remains a significant health problem in many developing countries. A rapid test with a performance comparable to that of blood culture would be highly useful. A rapid diagnostic test for typhoid fever, Tubex®, is commercially available that uses particle separation to detect immunoglobulin M directed towards Salmonella Typhi O9 lipopolysaccharide in sera.Methods: We assessed the sensitivity and specificity of the Tubex test among Tanzanian children hospitalized with febrile illness using blood culture as gold standard. Evaluation was done considering blood culture confirmed S. Typhi with non-typhi salmonella (NTS) and non - salmonella isolates as controls as well as with non-salmonella isolates only.Results: Of 139 samples tested with Tubex, 33 were positive for S. Typhi in blood culture, 49 were culture-confirmed NTS infections, and 57 were other non-salmonella infections. Thirteen hemolyzed samples were excluded. Using all non - S. Typhi isolates as controls, we showed a sensitivity of 79% and a specificity of 89%. When the analysis was repeated excluding NTS from the pool of controls we showed a sensitivity of 79% and a specificity of 97%. There was no significant difference in the test performance using the two different control groups (p > 0.05).Conclusion: This first evaluation of the Tubex test in an African setting showed a similar performance to those seen in some Asian settings. Comparison with the earlier results of a Widal test using the same samples showed no significant difference (p > 0.05) for any of the performance indicators, irrespective of the applied control group.

    KW - adolescent

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    KW - major clinical study

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    KW - Tanzania

    KW - test strip

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    KW - widal reaction

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    KW - male

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    KW - Child, Preschool

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