Comprehensive multicenter evaluation of a new line probe assay kit for identification of Mycobacterium species and detection of drug-resistant Mycobacterium tuberculosis.
We evaluated a new line probe assay (LiPA) kit to identify Mycobacterium species and to detect mutations related to drug resistance in Mycobacterium tuberculosis. A total of 554 clinical isolates of Mycobacterium tuberculosis (n = 316), Mycobacterium avium (n = 71), Mycobacterium intracellulare (n = 51), Mycobacterium kansasii (n = 54), and other Mycobacterium species (n = 62) were tested with the LiPA kit in six hospitals. The LiPA kit was also used to directly test 163 sputum specimens. The results of LiPA identification of Mycobacterium species in clinical isolates were almost identical to those of conventional methods. Compared with standard drug susceptibility testing results for the clinical isolates, LiPA showed a sensitivity and specificity of 98.9% and 97.3%, respectively, for detecting rifampin (RIF)-resistant clinical isolates; 90.6% and 100%, respectively, for isoniazid (INH) resistance; 89.7% and 96.0%, respectively, for pyrazinamide (PZA) resistance; and 93.0% and 100%, respectively, for levofloxacin (LVX) resistance. The LiPA kit could detect target species directly in sputum specimens, with a sensitivity of 85.6%. Its sensitivity and specificity for detecting RIF-, PZA-, and LVX-resistant isolates in the sputum specimens were both 100%, and those for detecting INH-resistant isolates were 75.0% and 92.9%, respectively. The kit was able to identify mycobacterial bacilli at the species level, as well as drug-resistant phenotypes, with a high sensitivity and specificity.
Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Satoshi
S
Mitarai
Seiya
S
Kato
Hideo
H
Ogata
Akio
A
Aono
Kinuyo
K
Chikamatsu
Kazue
K
Mizuno
Emiko
E
Toyota
Akiko
A
Sejimo
Katsuhiro
K
Suzuki
Shiomi
S
Yoshida
Takefumi
T
Saito
Ataru
A
Moriya
Akira
A
Fujita
Shuko
S
Sato
Tomoshige
T
Matsumoto
Hiromi
H
Ano
Toshinori
T
Suetake
Yuji
Y
Kondo
Teruo
T
Kirikae
Toru
T
Mori
D000995:Antitubercular Agents / Q000494:pharmacology; D001431:Bacteriological Techniques / Q000379:methods*; D024881:Drug Resistance, Bacterial; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000145:classification / Q000187:drug effects* / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000382:microbiology*
D000995:Antitubercular Agents