SD HIV/SYP DUO Publication 
Oxford University Press Release

Open Forum Infectious Diseases 


Multi‐site laboratory evaluation of a dual HIV/syphilis point‐of‐care rapid test for simultaneous detection of HIV and syphilis

Claire C. Bristow1, Yaw Adu‐Sarkodie2, Raphael O. Ondondo3,4, Elizabeth Anne Bukusi3, Claver Anoumou Dagnra5, Khin Yi Oo6, Eh Htoo Pe6, Chanthavysouk Khamsay7,*, Le Thi Houng8, Roberto Vázquez Campuzano9, Jason Estes10, Jeffrey D. Klausner11


Background

Recently, test developers have created rapid point‐of‐care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid pointof‐ care test uses a solid phase immunochromatographic assay to detect IgG, IgM and IgA antibodies to HIV specific antigens (HIV‐1 gp41, sub O, HIV‐2 gp36) and recombinant Treponema (T.) pallidum antigens (17KDa) in human serum. This study was a multisite laboratory‐based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in six countries.


Methods

Laboratories in Ghana, Mexico, Laos, Togo, Kenya, and Myanmar participated in the evaluation during 2012‐2013. Each site characterized sera using T. pallidum Particle Agglutination assay or T. pallidum Hemaglutination Assay and HIV enzyme immunoassay, Western Blot, and/or HIV antibody rapid tests. Those gold standard test results were compared with SD BIOLINE Duo test results. We calculated the sensitivity and specificity of test performance and used the exact binomial method to calculate 95% confidence intervals (CI).


Results

The sensitivity and specificity for the HIV antibody test component (N=2336) were estimated at 99.91% (95% CI: 99.51%, 100%) and 99.67% (95% CI: 99.16, 99.91%), respectively. For the T. pallidum test component (N=2059), the sensitivity and specificity were estimated at 99.67% (95% CI: 98.82%, 99.96%) and 99.72% (95% CI: 99.29%, 99.92%), respectively.


Conclusions

The sensitivity and specificity of the SD BIOLINE HIV/Syphilis Duo test were consistently high across sera specimens from 6 countries around the world. Dual rapid tests should be considered for improved HIV and syphilis screening coverage.


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