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快速简便地检测念珠菌血症试验第二部分(DIRECT2):T2Candida -panel 的前瞻性多中心研究。

Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel.

机构信息

University of Pittsburgh Medical Center, Pennsylvania.

University of Alabama at Birmingham Hospital, New York.

出版信息

Clin Infect Dis. 2018 May 17;66(11):1678-1686. doi: 10.1093/cid/cix1095.

DOI:10.1093/cid/cix1095
PMID:29438475
Abstract

BACKGROUND

Blood cultures are approximately 50% sensitive for diagnosing invasive candidiasis. The T2Candida nanodiagnostic panel uses T2 magnetic resonance and a dedicated instrument to detect Candida directly within whole blood samples.

METHODS

Patients with Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, or Candida krusei candidemia were identified at 14 centers using diagnostic blood cultures (dBCs). Follow-up blood samples were collected concurrently for testing by T2Candida and companion cultures (cBCs). T2Candida results are reported qualitatively for C. albicans/C. tropicalis, C. glabrata/C. krusei, and C. parapsilosis. T2Candida and cBCs were positive if they detected a species present in the dBC.

RESULTS

Median time between collection of dBC and T2Candida/cBC samples in 152 patients was 55.5 hours (range, 16.4-148.4). T2Candida and cBCs were positive in 45% (69/152) and 24% (36/152) of patients, respectively (P < .0001). T2Candida clinical sensitivity was 89%, as positive results were obtained in 32/36 patients with positive cBCs. Combined test results were both positive (T2+/cBC+), 21% (32/152); T2+/cBC-, 24% (37/152); T2-/cBC+, 3% (4/152); and T2-/cBC-, 52% (79/152). Prior antifungal therapy, neutropenia, and C. albicans candidemia were independently associated with T2Candida positivity and T2+/cBC- results (P values < .05).

CONCLUSIONS

T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative.

CLINICAL TRIALS REGISTRATION

NCT01525095.

摘要

背景

血培养对诊断侵袭性念珠菌病的敏感性约为 50%。T2Candida 纳米诊断试剂盒使用 T2 磁共振和专用仪器直接检测全血样本中的念珠菌。

方法

在 14 个中心,通过诊断性血培养(dBC)鉴定出白色念珠菌、光滑念珠菌、近平滑念珠菌、热带念珠菌或克柔念珠菌血症患者。同时采集后续血样进行 T2Candida 和配套培养(cBC)检测。T2Candida 结果定性报告白色念珠菌/热带念珠菌、光滑念珠菌/克柔念珠菌和近平滑念珠菌。如果 dBC 中存在的物种在 T2Candida 和 cBC 中检测到,则 T2Candida 和 cBC 为阳性。

结果

152 例患者中,dBC 与 T2Candida/cBC 样本采集之间的中位时间为 55.5 小时(范围,16.4-148.4 小时)。T2Candida 和 cBC 在 45%(69/152)和 24%(36/152)的患者中阳性(P<.0001)。T2Candida 的临床灵敏度为 89%,因为在 36 例 cBC 阳性患者中获得了阳性结果。联合检测结果均为阳性(T2+/cBC+),占 21%(32/152);T2+/cBC-,占 24%(37/152);T2-/cBC+,占 3%(4/152);T2-/cBC-,占 52%(79/152)。先前的抗真菌治疗、中性粒细胞减少症和白色念珠菌血症与 T2Candida 阳性和 T2+/cBC-结果独立相关(P 值<.05)。

结论

T2Candida 对诊断阳性血培养时的念珠菌血症具有敏感性。在接受抗真菌治疗的患者中,T2Candida 识别出 cBC 漏诊的血流感染。与血培养相比,T2Candida 可通过缩短念珠菌检测和种属鉴定时间来改善患者的护理,并且在抗真菌治疗期间保持灵敏度,从而使阴性结果不太可能发生活动性念珠菌血症。

临床试验注册

NCT01525095。

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