Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru

Claire C. Bristow, Segundo R. Leon, Emily Huang, Brandon J. Brown, Lourdes B. Ramos, Silver K. Vargas, Juan A. Flores, Carlos F. Caceres, Jeffrey D. Klausner

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives Screening for HIV and syphilis in key populations is recommended by the WHO to reduce the morbidity, mortality and transmission associated with undiagnosed and untreated infections. Rapid point-ofcare tests that can detect multiple infections with a single fingerprick whole blood specimen using a single device are gaining popularity. We evaluated the field performance of a rapid dual HIV and syphilis test in people at high risk of HIV and syphilis infections. Methods Participants included men who have sex with men and transgender women recruited in Lima, Peru. Reference standard testing for detection of HIV and syphilis infections, conducted using blood samples from venipuncture, included Treponema pallidum particle agglutination and fourth-generation HIV enzyme immunoassay for which positive results had a confirmation HIV Western blot test. For the evaluation test, SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea), a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95% CIs. Results A total of 415 participants were recruited for the study. The dual test sensitivity for detection of T. pallidum infection was 89.2% (95% CI 83.5% to 93.5%) and specificity 98.8% (95% CI 96.5% to 99.8%). For detection of HIV infection, the sensitivity of the dual test was 99.1% (95% CI 94.8% to 100%) and specificity 99.4% (95% CI 97.7% to 99.9%). Conclusions This high performing dual test should be considered for the use in clinical settings to increase uptake of simultaneous testing of HIV and syphilis and accelerate time to treatment for those who need it.

Original languageEnglish (US)
Pages (from-to)182-185
Number of pages4
JournalSexually Transmitted Infections
Volume92
Issue number3
DOIs
StatePublished - May 1 2016
Externally publishedYes

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Peru
Syphilis
Routine Diagnostic Tests
HIV Infections
HIV
Treponema pallidum
Infection
Transgender Persons
Phlebotomy
Agglutination
Korea
Immunoenzyme Techniques
Western Blotting
Morbidity
Sensitivity and Specificity
Equipment and Supplies
Mortality
Population

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

Bristow, C. C., Leon, S. R., Huang, E., Brown, B. J., Ramos, L. B., Vargas, S. K., ... Klausner, J. D. (2016). Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru. Sexually Transmitted Infections, 92(3), 182-185. https://doi.org/10.1136/sextrans-2015-052326

Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru. / Bristow, Claire C.; Leon, Segundo R.; Huang, Emily; Brown, Brandon J.; Ramos, Lourdes B.; Vargas, Silver K.; Flores, Juan A.; Caceres, Carlos F.; Klausner, Jeffrey D.

In: Sexually Transmitted Infections, Vol. 92, No. 3, 01.05.2016, p. 182-185.

Research output: Contribution to journalArticle

Bristow, CC, Leon, SR, Huang, E, Brown, BJ, Ramos, LB, Vargas, SK, Flores, JA, Caceres, CF & Klausner, JD 2016, 'Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru', Sexually Transmitted Infections, vol. 92, no. 3, pp. 182-185. https://doi.org/10.1136/sextrans-2015-052326
Bristow, Claire C. ; Leon, Segundo R. ; Huang, Emily ; Brown, Brandon J. ; Ramos, Lourdes B. ; Vargas, Silver K. ; Flores, Juan A. ; Caceres, Carlos F. ; Klausner, Jeffrey D. / Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru. In: Sexually Transmitted Infections. 2016 ; Vol. 92, No. 3. pp. 182-185.
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abstract = "Objectives Screening for HIV and syphilis in key populations is recommended by the WHO to reduce the morbidity, mortality and transmission associated with undiagnosed and untreated infections. Rapid point-ofcare tests that can detect multiple infections with a single fingerprick whole blood specimen using a single device are gaining popularity. We evaluated the field performance of a rapid dual HIV and syphilis test in people at high risk of HIV and syphilis infections. Methods Participants included men who have sex with men and transgender women recruited in Lima, Peru. Reference standard testing for detection of HIV and syphilis infections, conducted using blood samples from venipuncture, included Treponema pallidum particle agglutination and fourth-generation HIV enzyme immunoassay for which positive results had a confirmation HIV Western blot test. For the evaluation test, SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea), a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95{\%} CIs. Results A total of 415 participants were recruited for the study. The dual test sensitivity for detection of T. pallidum infection was 89.2{\%} (95{\%} CI 83.5{\%} to 93.5{\%}) and specificity 98.8{\%} (95{\%} CI 96.5{\%} to 99.8{\%}). For detection of HIV infection, the sensitivity of the dual test was 99.1{\%} (95{\%} CI 94.8{\%} to 100{\%}) and specificity 99.4{\%} (95{\%} CI 97.7{\%} to 99.9{\%}). Conclusions This high performing dual test should be considered for the use in clinical settings to increase uptake of simultaneous testing of HIV and syphilis and accelerate time to treatment for those who need it.",
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AU - Leon, Segundo R.

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AU - Ramos, Lourdes B.

AU - Vargas, Silver K.

AU - Flores, Juan A.

AU - Caceres, Carlos F.

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N2 - Objectives Screening for HIV and syphilis in key populations is recommended by the WHO to reduce the morbidity, mortality and transmission associated with undiagnosed and untreated infections. Rapid point-ofcare tests that can detect multiple infections with a single fingerprick whole blood specimen using a single device are gaining popularity. We evaluated the field performance of a rapid dual HIV and syphilis test in people at high risk of HIV and syphilis infections. Methods Participants included men who have sex with men and transgender women recruited in Lima, Peru. Reference standard testing for detection of HIV and syphilis infections, conducted using blood samples from venipuncture, included Treponema pallidum particle agglutination and fourth-generation HIV enzyme immunoassay for which positive results had a confirmation HIV Western blot test. For the evaluation test, SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea), a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95% CIs. Results A total of 415 participants were recruited for the study. The dual test sensitivity for detection of T. pallidum infection was 89.2% (95% CI 83.5% to 93.5%) and specificity 98.8% (95% CI 96.5% to 99.8%). For detection of HIV infection, the sensitivity of the dual test was 99.1% (95% CI 94.8% to 100%) and specificity 99.4% (95% CI 97.7% to 99.9%). Conclusions This high performing dual test should be considered for the use in clinical settings to increase uptake of simultaneous testing of HIV and syphilis and accelerate time to treatment for those who need it.

AB - Objectives Screening for HIV and syphilis in key populations is recommended by the WHO to reduce the morbidity, mortality and transmission associated with undiagnosed and untreated infections. Rapid point-ofcare tests that can detect multiple infections with a single fingerprick whole blood specimen using a single device are gaining popularity. We evaluated the field performance of a rapid dual HIV and syphilis test in people at high risk of HIV and syphilis infections. Methods Participants included men who have sex with men and transgender women recruited in Lima, Peru. Reference standard testing for detection of HIV and syphilis infections, conducted using blood samples from venipuncture, included Treponema pallidum particle agglutination and fourth-generation HIV enzyme immunoassay for which positive results had a confirmation HIV Western blot test. For the evaluation test, SD BIOLINE HIV/Syphilis Duo test (Standard Diagnostics, Korea), a fingerprick blood specimen was used. Sensitivity and specificity were calculated and the exact binomial method was used to determine 95% CIs. Results A total of 415 participants were recruited for the study. The dual test sensitivity for detection of T. pallidum infection was 89.2% (95% CI 83.5% to 93.5%) and specificity 98.8% (95% CI 96.5% to 99.8%). For detection of HIV infection, the sensitivity of the dual test was 99.1% (95% CI 94.8% to 100%) and specificity 99.4% (95% CI 97.7% to 99.9%). Conclusions This high performing dual test should be considered for the use in clinical settings to increase uptake of simultaneous testing of HIV and syphilis and accelerate time to treatment for those who need it.

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