Detection of Mycobacterium tuberculosis complex in sputum specimens using a loop-mediated isothermal amplification assay in Korea.
Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis complex (MTC), remains one of the leading causes of death in the world. In Korea, the current prevalence of multidrug-resistant TB (MDR-TB) poses a major problem. The most common method for diagnosing TB in developing countries is sputum smear microscopy; however, the sensitivity of this test is relatively low and it usually requires well-trained laboratory staff. Cultures of MTC require up to several weeks in sophisticated facilities, such as Biosafety Level 3. Effective diagnostic techniques are necessary to control TB. In Korea, we evaluated a loop-mediated isothermal amplification (LAMP) assay targeting the hspX gene (TB-hspX-LAMP) of MTC. For clinical evaluation, culture confirmation, smear microscopy and TB-hspX-LAMP were performed on 303 sputum specimens obtained from suspected TB patients in Korea. The sensitivity, specificity, positive predictive value and negative predictive value of TB-hspX-LAMP were 71.1, 98.8, 91.4 and 95.1%, respectively, compared with TB culture, which is the gold standard for diagnosis of TB. In contrast, the comparable values of smear microscopy were 24.4, 98.1, 68.8 and 88.2%, respectively. Therefore, we concluded that TB-hspX-LAMP was superior to the use of smear microscopy for the detection of MTC in sputum specimens in clinical settings in Korea.
Department of Pharmacy, College of Pharmacy, Hanyang University, Ansan, Republic of Korea.|Institute of Pharmacological Research, Hanyang University, Ansan, Republic of Korea.|Korea University Medical Center Ansan Hospital, Ansan, Republic of Korea.
Se Hoon
SH
Moon
Department of Pharmacy, College of Pharmacy, Hanyang University, Ansan, Republic of Korea.|Institute of Pharmacological Research, Hanyang University, Ansan, Republic of Korea.
Eun Jin
EJ
Kim
Kaneka Co., Ltd, Osaka, Japan.
Jun
J
Tomono
Kaneka Co., Ltd, Osaka, Japan.
Shigehiko
S
Miyamoto
Department of Mycobacterium Reference and Research, Bacteriology Division, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Satoshi
S
Mitarai
Department of Pharmacy, College of Pharmacy, Hanyang University, Ansan, Republic of Korea.|Institute of Pharmacological Research, Hanyang University, Ansan, Republic of Korea.
Dong Wook
DW
Kim
Dental Research Center, Nihon University School of Dentistry, Tokyo, Japan.|Department of Oral Health Sciences, Nihon University School of Dentistry, Tokyo, Japan.
Mitsuko
M
Seki
D001426:Bacterial Proteins / Q000235:genetics / Q000378:metabolism; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification* / Q000378:metabolism; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D056910:Republic of Korea; D013183:Sputum / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000382:microbiology*
D001426:Bacterial Proteins