Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens

A fundamental to global tuberculosis (TB) control is timely and accurate diagnosis of infectious cases of the disease. Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently develop...

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Veröffentlicht in:The Journal of infection 2013-06, Vol.66 (6), p.487-493
Hauptverfasser: Aryan, Ehsan, Makvandi, Manoochehr, Farajzadeh, Ahmad, Huygen, Kris, Alvandi, Amir-Hooshang, Gouya, Mohammad-Mehdi, Sadrizadeh, Ali, Romano, Marta
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container_end_page 493
container_issue 6
container_start_page 487
container_title The Journal of infection
container_volume 66
creator Aryan, Ehsan
Makvandi, Manoochehr
Farajzadeh, Ahmad
Huygen, Kris
Alvandi, Amir-Hooshang
Gouya, Mohammad-Mehdi
Sadrizadeh, Ali
Romano, Marta
description A fundamental to global tuberculosis (TB) control is timely and accurate diagnosis of infectious cases of the disease. Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently developed IS6110-based loop-mediated isothermal amplification (LAMP) for detection of Mycobacterium tuberculosis complex (MTBC) in sputum specimens. In this cross-sectional study (2008–2009), IS6110-LAMP was evaluated on 101 sputum specimens from 93 highly suspected TB patients and compared to Amplicor MTB test and in-house IS6110-PCR and -nested PCR assays. Culture results or clinical recovery following anti-TB therapy was considered as a reference to prove the TB cases. The overall sensitivity of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 89.6% (69/77 specimens; 95% confidence interval [CI], 80.5–95.4%), 76.6% (59/77 specimens; CI, 65.6–85.5%), 79.2% (61/77 specimens; CI, 68.5–87.6%) and 59.7% (46/77 specimens; CI, 47.9–70.8%). The specificity and positive predictive value (PPV) were 100% for all the tests, and the negative predictive value (NPV) of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 75%, 57.1%, 60%, and 43.6%. There was an excellent overall agreement between LAMP and nPCR (k 0.828), and between LAMP and Amplicor (k 0.746), in addition to a better tolerance of IS6110-LAMP to inhibitors present in clinical specimens. The better diagnostic performance of IS6110-LAMP compared to Amplicor (p = 0.009), nPCR (p = 0.013) and PCR (p 
doi_str_mv 10.1016/j.jinf.2013.02.005
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Among various methods, techniques based on nucleic acid amplification are the ones with promising prospects. The present study evaluates the diagnostic value of the recently developed IS6110-based loop-mediated isothermal amplification (LAMP) for detection of Mycobacterium tuberculosis complex (MTBC) in sputum specimens. In this cross-sectional study (2008–2009), IS6110-LAMP was evaluated on 101 sputum specimens from 93 highly suspected TB patients and compared to Amplicor MTB test and in-house IS6110-PCR and -nested PCR assays. Culture results or clinical recovery following anti-TB therapy was considered as a reference to prove the TB cases. The overall sensitivity of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 89.6% (69/77 specimens; 95% confidence interval [CI], 80.5–95.4%), 76.6% (59/77 specimens; CI, 65.6–85.5%), 79.2% (61/77 specimens; CI, 68.5–87.6%) and 59.7% (46/77 specimens; CI, 47.9–70.8%). The specificity and positive predictive value (PPV) were 100% for all the tests, and the negative predictive value (NPV) of IS6110-LAMP, Amplicor, nPCR, and PCR were respectively 75%, 57.1%, 60%, and 43.6%. There was an excellent overall agreement between LAMP and nPCR (k 0.828), and between LAMP and Amplicor (k 0.746), in addition to a better tolerance of IS6110-LAMP to inhibitors present in clinical specimens. 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subjects Biological and medical sciences
Cross-Sectional Studies
Diagnostic value
General aspects
Humans
IS6110, sputum
Loop-mediated isothermal amplification
Medical sciences
Molecular Typing - methods
Mycobacterium tuberculosis
Mycobacterium tuberculosis - genetics
Mycobacterium tuberculosis - isolation & purification
Mycobacterium tuberculosis complex
Nucleic Acid Amplification Techniques - methods
Reproducibility of Results
Sensitivity and Specificity
Sputum - microbiology
Tuberculosis, Pulmonary - diagnosis
Tuberculosis, Pulmonary - microbiology
title Clinical value of IS6110-based loop-mediated isothermal amplification for detection of Mycobacterium tuberculosis complex in respiratory specimens
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