柬埔寨孕妇中 SD Bioline HBsAg 全血快速检测的现场评估：ANRS 12345 TA PROHM 研究。
In-field Evaluation of SD Bioline HBsAg Whole Blood Rapid Test in Pregnant Women in Cambodia: the ANRS 12345 TA PROHM Study.
机构信息
University of Health Sciences/ANRS, Phnom Penh, Cambodia.
Laboratory Department, Jayavarman VII Hospital, Siem Reap, Cambodia.
出版信息
Diagn Microbiol Infect Dis. 2021 Oct;101(2):115452. doi: 10.1016/j.diagmicrobio.2021.115452. Epub 2021 Jun 11.
The objective is to assess the in-field performance of HBsAg whole blood rapid diagnosis test (RDT) as compared to plasmatic HBsAg RDT to diagnose HBV infection among pregnant women in Cambodia. Blood was collected on EDTA tubes from pregnant woman screened for the TA PROHM - ANRS 12345 study. Whole blood HBsAg RDT results were crossed compared with the plasmatic HBsAg RDT results, which was defined for this study as the gold standard. From December 2018 to May 2019, 4997 pregnant women were screened. The median age was 27.2 years old, 14% were screened in Phnom Penh and 86% in Siem Reap. Whole blood HBsAg RDT perform excellently with a sensitivity of 100% (95% CI, 98.7 - 100) and specificity of 100% (95% CI, 99.9 - 100). Whole blood HBs Ag RDT is as accurate as plasmatic one and could be used in remote areas.
目的是评估 HBsAg 全血快速诊断检测（RDT）在现场的表现，与血浆 HBsAg RDT 相比，以诊断柬埔寨孕妇中的 HBV 感染。从接受 TA PROHM-ANRS 12345 研究筛查的孕妇中采集 EDTA 管中的血液。全血 HBsAg RDT 结果与血浆 HBsAg RDT 结果进行交叉比较，后者为本研究定义的金标准。2018 年 12 月至 2019 年 5 月，共筛查了 4997 名孕妇。中位年龄为 27.2 岁，14%在金边筛查，86%在暹粒筛查。全血 HBsAg RDT 的表现非常出色，灵敏度为 100%（95%CI，98.7-100），特异性为 100%（95%CI，99.9-100）。全血 HBsAg RDT 与血浆型 RDT 一样准确，可用于偏远地区。
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