Finger-stick whole blood HIV-1/-2 home-use tests are more sensitive than oral fluid-based in-home HIV tests.
Finger-stick whole blood HIV-1/-2 home-use tests are more sensitive than oral fluid-based in-home HIV tests.
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DOI：
10.1371/journal.pone.0101148
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Prazuck T
中科院分区：
文献类型：
--
作者：
Jaspard M;Le Moal G;Saberan-Roncato M;Plainchamp D;Langlois A;Camps P;Guigon A;Hocqueloux L;Prazuck T
一些国家最近建议扩大抗人类免疫缺陷病毒（艾滋病毒）抗体检测，包括使用口腔液进行快速检测的自我检测。已经提出了几种在家使用的测试，但其诊断准确性尚未得到充分评估。评价5种快速诊断检测试剂用于检测抗HIV-1/2抗体的性能，其中4种检测OF，1种检测全血。法国前瞻性多中心研究。HIV感染的成人和HIV未感染的对照组进行了系统的筛选与5个在家里HIV检测使用任何OF或手指针刺血（FSB）标本。由经过培训的卫生工作者进行4项OF检测（OraQuick Advance Rapid HIV-1/2、Chembio DPP HIV 1/2 Assay、检测A和检测B）和1项FSB检测（Chembio Sure Check HIV 1/2 Assay），并与实验室检测进行比较。共纳入179例HIV感染患者（男/女性别比：1.3）和60例对照。在艾滋病毒感染者中，67.6%的人由于抗逆转录病毒治疗而血浆中检测不到艾滋病毒载量。总体而言，OF测试的灵敏度分别为87.2%、88.3%、58.9%和28%（分别针对OraQuick、DPP、测试A和测试B），而FSB测试Sure Check的灵敏度为100%（所有比较p<0.0001）。OraQuick和DPP OF测试的灵敏度显著低于基于FSB的Sure Check（p<0.05）。在可检测到HIV病毒载量（>50拷贝/mL）的患者中，OF检测的灵敏度增加，分别达到94.8%、96.5%、90%和53.1%（OraQuick、DPP、检测A和检测B）。四种OF试验的特异性分别为98.3%、100%、100%和87.5%，而FSB试验的特异性为100%。对艾滋病毒自我检测候选人的评估显示，快速检测的性能存在意想不到的差异：FSB检测的可靠性远远高于OF检测。
Several countries have recently recommended the expansion of anti-human immunodeficiency virus (HIV) antibody testing, including self-testing with rapid tests using oral fluid (OF). Several tests have been proposed for at-home use, but their diagnostic accuracy has not been fully evaluated. To evaluate the performance of 5 rapid diagnostic tests for the detection of anti-HIV-1/2 antibodies, with 4 testing OF and 1 testing whole blood. Prospective multi-center study in France. HIV-infected adults and HIV-uninfected controls were systematically screened with 5 at-home HIV tests using either OF or finger-stick blood (FSB) specimens. Four OF tests (OraQuick Advance Rapid HIV-1/2, Chembio DPP HIV 1/2 Assay, test A, and test B) and one FSB test (Chembio Sure Check HIV1/2 Assay) were performed by trained health workers and compared with laboratory tests. In total, 179 HIV-infected patients (M/F sex ratio: 1.3) and 60 controls were included. Among the HIV-infected patients, 67.6% had an undetectable HIV viral load in their plasma due to antiretroviral therapy. Overall, the sensitivities of the OF tests were 87.2%, 88.3%, 58.9%, and 28% (for OraQuick, DPP, test A, and test B, respectively) compared with 100% for the FSB test Sure Check (p<0.0001 for all comparisons). The OraQuick and DPP OF tests' sensitivities were significantly lower than that of the FSB-based Sure Check (p<0.05). The sensitivities of the OF tests increased among the patients with a detectable HIV viral load (>50 copies/mL), reaching 94.8%, 96.5%, 90%, and 53.1% (for OraQuick, DPP, test A, and test B, respectively). The specificities of the four OF tests were 98.3%, 100%, 100%, and 87.5%, respectively, compared with 100% for the FSB test. An evaluation of candidates for HIV self-testing revealed unexpected differences in performance of the rapid tests: the FSB test showed a far greater reliability than OF tests.
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