手指采血的全血HIV-1/-2家用检测比基于口腔液的家用HIV检测更灵敏。
Finger-stick whole blood HIV-1/-2 home-use tests are more sensitive than oral fluid-based in-home HIV tests.
作者信息
Jaspard Marie, Le Moal Gwenaël, Saberan-Roncato Mariam, Plainchamp David, Langlois Aurélie, Camps Pascale, Guigon Aurélie, Hocqueloux Laurent, Prazuck Thierry
机构信息
CHR d'Orléans - La Source, Infectious and Tropical Diseases Department, Orléans, France.
CHU de Poitiers, Infectious and Tropical Diseases Department, Poitiers, France.
出版信息
PLoS One. 2014 Jun 27;9(6):e101148. doi: 10.1371/journal.pone.0101148. eCollection 2014.
BACKGROUND
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.
OBJECTIVE
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.
METHODS
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.
RESULTS
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.
CONCLUSION
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.
背景
最近，几个国家建议扩大抗人类免疫缺陷病毒（HIV）抗体检测，包括使用口腔液（OF）快速检测进行自我检测。已经提出了几种可供家庭使用的检测方法，但其诊断准确性尚未得到充分评估。
目的
评估5种用于检测抗HIV-1/2抗体的快速诊断检测方法的性能，其中4种检测口腔液，1种检测全血。
方法
在法国进行的前瞻性多中心研究。使用口腔液或指尖血（FSB）标本，对HIV感染的成年人和未感染HIV的对照者系统地进行5种家用HIV检测。由训练有素的卫生工作者进行4种口腔液检测（奥奎克快速HIV-1/2检测、Chembio DPP HIV 1/2检测、检测A和检测B）和1种指尖血检测（Chembio Sure Check HIV1/2检测），并与实验室检测结果进行比较。
结果
总共纳入了179例HIV感染患者（男/女性别比：1.3）和60例对照者。在HIV感染患者中，由于抗逆转录病毒治疗，67.6%的患者血浆中HIV病毒载量检测不到。总体而言，口腔液检测的灵敏度分别为87.2%、88.3%、58.9%和28%（分别对应奥奎克、DPP、检测A和检测B），而指尖血检测Sure Check的灵敏度为100%（所有比较的p<0.0001）。奥奎克和DPP口腔液检测的灵敏度显著低于基于指尖血的Sure Check检测（p<0.05）。在HIV病毒载量可检测到（>50拷贝/mL）的患者中，口腔液检测的灵敏度有所提高，分别达到94.8%、96.5%、90%和53.1%（分别对应奥奎克、DPP、检测A和检测B）。4种口腔液检测的特异性分别为98.3%、100%、100%和87.5%，而指尖血检测的特异性为100%。
结论
对HIV自我检测候选者的评估显示，快速检测的性能存在意外差异：指尖血检测显示出比口腔液检测高得多的可靠性。
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