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首页> 外文期刊>Clinical and diagnostic laboratory immunology >Prospective Evaluation of a Whole-Blood Test Using Mycobacterium tuberculosis-Specific Antigens ESAT-6 and CFP-10 for Diagnosis of Active Tuberculosis
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Prospective Evaluation of a Whole-Blood Test Using Mycobacterium tuberculosis-Specific Antigens ESAT-6 and CFP-10 for Diagnosis of Active Tuberculosis

机译：使用结核分枝杆菌特异性抗原ESAT-6和CFP-10进行全血试验对活动性结核病的诊断的前瞻性评估

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A new immunodiagnostic test based on the Mycobacterium tuberculosis-specific antigens CFP-10/ESAT-6(QFT-RD1) has been launched as an aid in the diagnosis of latent tuberculosis (TB) infection (LTBI). The aim of this study was to evaluate this test for the diagnosis of active TB. Eighty-two patients with suspicion of TB and 39 healthy BCG-vaccinated persons were enrolled. Forty-eight had active TB, 25 did not, and 9 were excluded. Sensitivity and specificity of the test for active TB were evaluated in a prospective blinded manner in patients suspected of TB. The sensitivity of the QFT-RD1 was 85% (40/48; confidence interval [CI], 75 to 96), and it was higher than the sensitivity of microscopy, 42% (20/48; CI, 27 to 56; P = 0.001), and culture, 59% (27/46; CI, 44 to 73; P = 0.009). Of patients with extrapulmonary TB, 92% (12/13) were QFT-RD1 positive, whereas only 31% (4/13) were positive by microscopy and 42% (5/12) by culture (P < 0.05), and 87% (13/15) of those who were negative by both microscopy and culture were QFT-RD1 positive. By combining microscopy and culture with the QFT-RD1 test, sensitivity increased to 96% (CI, 90 to 102). Ten of 25 (40%) non-TB patients were QFT-RD1 positive, resulting in a specificity of 60%. However, 80% (8/10) of these had risk-factors for TB, indicating latent infection in this group. In healthy controls, only 3% (1/39) were QFT-RD1 positive. In conclusion, the QFT-RD1 test is sensitive for diagnosis of TB, especially in patients with negative microscopy and culture. The accuracy of the QFT-RD1 test will vary with the prevalence of LTBI. We suggest that the QFT-RD1 test could be a very useful supplementary tool for the diagnosis of TB.
机译：基于结核分枝杆菌特异性抗原CFP-10 / ESAT-6（QFT-RD1）的一项新的免疫诊断测试已启动，以帮助诊断潜伏性结核（TB） 。这项研究的目的是评估这项检查对活动性结核病的诊断。入选了82例疑似结核病患者和39名接受卡介苗的健康人。 48例患有活动性结核，25例没有活动，而9例被排除。对活动性结核病测试的敏感性和特异性以前瞻性盲法评估了怀疑患有结核病的患者。 QFT-RD1的灵敏度为85％（40/48;置信区间[CI]为75至96），高于显微镜的灵敏度为42％（20/48; CI为27至56; < em> P = 0.001），培养率为59％（27/46; CI为44至73; P = 0.009）。在肺外结核患者中，QFT-RD1阳性为92％（12/13），而显微镜检查为阳性的仅31％（4/13），而经培养（ P <0.05），在显微镜和培养均阴性的患者中，QFT-RD1阳性的占87％（13/15）。通过将显微镜和培养与QFT-RD1测试结合使用，灵敏度提高到96％（CI为90至102）。 25名非结核病患者中有10名（40％）QFT-RD1阳性，特异性为60％。但是，其中80％（8/10）具有结核病的危险因素，表明该人群中存在潜在感染。在健康对照中，只有3％（1/39）是QFT-RD1阳性。总之，QFT-RD1测试对结核病的诊断非常敏感，特别是对于镜检和培养阴性的患者。 QFT-RD1测试的准确性将随LTBI的流行而变化。我们建议QFT-RD1测试可能是诊断结核病的非常有用的辅助工具。

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