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免疫胶体金色谱法检测结核分枝杆菌:何时检测最佳?

Immunochromatographic assays for detection of Mycobacterium tuberculosis: what is the perfect time to test?

机构信息

P. D. Hinduja National Hospital and Medical Research Centre, Microbiology Department, S1 Building, 5th Floor, Veer Savarkar Marg, Mahim, Mumbai 400016, Maharashtra, India.

出版信息

Diagn Microbiol Infect Dis. 2012 Nov;74(3):282-7. doi: 10.1016/j.diagmicrobio.2012.06.018. Epub 2012 Aug 4.

Abstract

In this study, we aimed to correlate the analytical performance of SD BIOLINE TB Ag MPT64 Rapid Test kit (MPT64 assay) with the mycobacterial growth unit (GU) reported by the BACTEC MGIT 960 (MGIT 960) instrument. A total of 394 culture isolates reported positive by MGIT 960 were processed daily (until 'day 4') with the MPT64 assay until a positive MPT64 result was obtained and their GU values were noted daily before MPT64 testing. Based on this correlation of MPT64 positivity and corresponding GU values, a GU cut-off was determined. In the validation phase, with the experimentally determined GU cut-off value, 99.1% (576/581) of culture isolates were correctly identified as MTB within 2 days from instrument positivity. All results were available using a single-MPT64 assay strip, making the assay cost-effective. Thus, systematic implementation of the MPT64 assay proved to be cost-effective in a high-throughput laboratory without any delay in patient reporting.

摘要

在这项研究中,我们旨在将 SD BIOLINE TB Ag MPT64 Rapid Test 试剂盒(MPT64 检测)的分析性能与 BACTEC MGIT 960(MGIT 960)仪器报告的分枝杆菌生长单位(GU)相关联。每天处理 394 个由 MGIT 960 报告阳性的培养分离物(直到“第 4 天”),用 MPT64 检测进行处理,直到获得阳性 MPT64 结果,并在 MPT64 检测前每天记录其 GU 值。根据 MPT64 阳性与相应 GU 值的这种相关性,确定了 GU 截止值。在验证阶段,使用实验确定的 GU 截止值,在仪器阳性后 2 天内,99.1%(576/581)的培养分离物被正确识别为 MTB。所有结果都可通过单个 MPT64 检测条获得,使检测具有成本效益。因此,在没有任何延迟报告患者的情况下,在高通量实验室中系统地实施 MPT64 检测被证明是具有成本效益的。

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