Bristow Claire C, Severe Linda, Pape Jean William, Javanbakht Marjan, Lee Sung-Jae, Comulada Warren Scott, Klausner Jeffrey D
Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.
Division of Global Public Health, University of California San Diego, 9500 Gilman Drive 0507, La Jolla, CA, 92093-0507, USA.
BMC Infect Dis. 2016 Jun 18;16:302. doi: 10.1186/s12879-016-1574-3.
Dual rapid tests for HIV and syphilis infections allow for detection of HIV infection and syphilis at the point-of-care. Those tests have been evaluated in laboratory settings and show excellent performance but have not been evaluated in the field. We evaluated the field performance of the SD BIOLINE HIV/Syphilis Duo test in Port-au-Prince, Haiti using whole blood fingerprick specimens.
GHESKIO (Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections) clinic attendees 18 years of age or older were invited to participate. Venipuncture blood specimens were used for reference testing with standard commercially available tests for HIV and syphilis in Haiti. The sensitivity and specificity of the Duo test compared to the reference standard were calculated. The exact binomial method was used to determine 95 % confidence intervals (CI).
Of 298 study participants, 237 (79.5 %) were female, of which 49 (20.7 %) were pregnant. For the HIV test component, the sensitivity and specificity were 99.2 % (95 % CI: 95.8 %, 100 %) and 97.0 % (95 % CI: 93.2 %, 99.0 %), respectively; and for the syphilis component were 96.5 % (95 % CI: 91.2 %, 99.0 %) and 90.8 % (95 % CI: 85.7 %, 94.6 %), respectively. In pregnant women, the sensitivity and specificity of the HIV test component were 93.3 % (95 % CI: 68.0 %, 99.8 %) and 94.1 % (95 % CI: 80.3 %, 99.3 %), respectively; and for the syphilis component were 100 % (95 % CI:81.5 %, 100 %) and 96.8 % (95 % CI:83.3 %, 99.9 %), respectively.
The Standard Diagnostics BIOLINE HIV/Syphilis Duo dual test performed well in a field setting in Haiti and should be considered for wider use.
用于检测艾滋病毒和梅毒感染的双重快速检测可在护理点检测出艾滋病毒感染和梅毒。这些检测已在实验室环境中进行了评估,表现出色,但尚未在实地进行评估。我们在海地太子港使用全血手指刺血标本评估了SD BIOLINE艾滋病毒/梅毒双联检测的实地性能。
邀请18岁及以上的GHESKIO(海地卡波西肉瘤和机会性感染研究组)诊所就诊者参与。静脉穿刺血标本用于在海地使用标准商用艾滋病毒和梅毒检测进行参考检测。计算双联检测与参考标准相比的敏感性和特异性。使用精确二项式方法确定95%置信区间(CI)。
298名研究参与者中,237名(79.5%)为女性,其中49名(20.7%)为孕妇。对于艾滋病毒检测部分,敏感性和特异性分别为99.2%(95%CI:95.8%,100%)和97.0%(95%CI:93.2%,99.0%);对于梅毒检测部分,分别为96.5%(95%CI:91.2%,99.0%)和90.8%(95%CI:85.7%,94.6%)。在孕妇中,艾滋病毒检测部分的敏感性和特异性分别为93.3%(95%CI:68.0%,99.8%)和94.1%(95%CI:80.3%,99.3%);对于梅毒检测部分,分别为100%(95%CI:81.5%,100%)和96.8%(95%CI:83.3%,99.9%)。
标准诊断BIOLINE艾滋病毒/梅毒双联检测在海地的实地环境中表现良好,应考虑更广泛地使用。