• 1. Women and Children Hospital of Gnasu Province, Lanzhou 730000, China2. Women and Children Hospital of Lanzhou City,Lanzhou 730000 China3. Ttuberculosis Rresearch Ccenter of Lanzhou University, Lanzhou 730000 China4. Evidence-Based Medicine Center of Lanzhou University, Lanzhou 730000 China;
YANG Kehu, Email: yangkh@lzu.edu.cn
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Objective  To evaluate the diagnostic accuracy of LiPA and phage-based assays in detecting rifampicin resistance in Mycobacterium tuberculosis.
Methods  A fully recursive literature search was conducted in PUBMED, EMBASE, CBMWeb, CSJD and CJFD. QUADAS items were used to evaluate the quality of the included studies. Meta-disc software was used to handle data from the included studies. SEN, SPE and SROC were used to assess the diagnostic accuracy of every individual diagnostic test.
Results  A total of 42 studies were included finally. (1) LiPA for detection of rifampicin resistant Mycobacterium tuberculosis: 7 studies took BACTEC 460 assay as the reference test, and meta-analysis showed that the summary SEN = 0.98, summary SPE = 0.98, SROC (AUC) = 0.9924; 6 studies chose proportion assay as the reference test, and meta-analysis showed that the summary SEN = 0.97, summary SPE = 1.00, SROC (AUC) = 0.9961; and 3 studies took both BACTEC 460 assay and proportion assay as the reference tests, and meta-analysis showed that the summary SEN = 0.92, summary SPE = 0.98, SROC (AUC) = 0.9842. (2)Seven studies detected the rifampicin resistant Mycobacterium tuberculosis using Phage amplification assays (Commercial), taking BACTEC 460 assay and proportion assay as the reference tests. Meta-analysis showed that the summary SEN = 0.95, summary SPE = 0.95, SROC (AUC) = 0.9842. (3) Seven studies detected the rifampicin resistant Mycobacterium tuberculosis using Phage amplification assays (in-house), taking BACTEC 460 assay, proportion assay and absolute concentration as the reference tests. Meta-analysis showed that the summary SEN = 0.98, summary SPE = 0.98, SROC (AUC) = 0.9949. (4)Seven studies detected the rifampicin resistant Mycobacterium tuberculosis using Luciferase reporter phage assays (In-house), taking BACTEC 460 assay, proportion assay and absolute concentration as the reference tests. Meta-analysis showed that the summary SEN = 0.98, summary SPE = 0.98, SROC (AUC) = 0.9788.
Conclusion  Current research confirms that Phage assay is a highly sensitive and specific test for the detection of rifampicin resistance in culture isolates and has a potential in improving the diagnostic accuracy of all diagnostic tests in detecting the rifampicin resistant Mycobacterium tuberculosis. LiPA is also a highly sensitive and specific test for the detection of rifampicin resistance, but the sensitivity appears to relatively decrease when it was used directly on clinical specimens. The results mentioned above need to be further confirmed by more high-quality studies.

Citation: QIU Jie,ZHANG Junyu,ZHANG Peizhen,ZHANG Ying,MA Bin,YANG Kehu. Diagnostic Value of LiPA and Phage-Based Assays for Rifampicin Resistance in Mycobacterium Tuberculosis: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2008, 08(8): 642-651. doi: 10.7507/1672-2531.20080147 Copy

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