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The Journal of the Japanese Society for Clinical Microbiology |
Biblioraphy Information
| ArticleTitle |
Evaluation of Q-Line KyokutoTB, a rapid chromatographic immunoassay for identification of Mycobacterium tuberculosis complex |
| Language |
J |
| AuthorList |
Yuriko Igarashi1), Kinuyo Chikamatsu1), Akio Aono1), Lina Yi2,3), Kentaro Sakashita3,4), Takashi Ohfuji2,3), Hiroyuki Yamada1), Akiko Takaki1), Satoshi Mitarai1,3) |
| Affiliation |
1) Bacteriology Division, Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association
2) Respiratory Medicine Section, Fukujuji Hospital, JATA
3) Nagasaki University Graduate School of Biomedical Sciences
4) Department of Respiratory Medicine, Tokyo Metropolitan Tama Medical Center |
| Publication |
J.J.C.M.: 26 (2), 97-104, 2016 |
| Received |
June 20, 2015 |
| Accepted |
December 8, 2015 |
| Abstract |
Q-Line KyokutoTB (Kyokuto Pharmaceutical Industrial Co., Japan) is a newly developed Mycobacterium tuberculosis complex (MTC) identification assay based on thin-layer immunochromatography utilizing anti-MPT64 monoclonal antibody. In this study, we evaluated the performance of Q-Line KyokutoTB with clinical mycobacterial isolates and the type strains compared with CapiliaTB-Neo (tauns).
A total of 151 type strains (4 MTC and 147 non-tuberculosis mycobacteria: NTM) and 155 clinical isolates (147 MTC and 4 NTM) were tested. Both kits correctly identified four MTC tested. Q-Line KyokutoTB showed one false positive to Mycobacterium riyadhense. The species specificity of CapiliaTB-Neo to type strains was 100%. False-positive caused by M. riyadhense was considered to be solved by confirmation of colony morphology and cord formation.
Q-Line KyokutoTB and CapiliaTB-Neo showed same results for clinical MTC and NTM isolates. The sensitivity and specificity of both kits to clinical isolates were then 97.1% (102/105) and 100% (50/50). Two Mycobacterium tuberculosis isolates with mutation and deletion in mpt64, and Mycobacterium bovis BCG Connaught were test-negative by both kits.
With 2% Ogawa medium and MGIT positive medium, Q-Line KyokutoTB showed positive to M. tuberculosis H37Rv. Detection sensitivity about M. tuberculosis H37Rv was 5.7×105 CFU/mL on Q-Line KyokutoTB and 2.9×106 CFU/mL on CapiliaTB-Neo.
In conclusion, Q-Line KyokutoTB is a useful test for the identification of MTC. Q-Line KyokutoTB showed high sensitivity and specificity as CapiliaTB-Neo. The mutation and/or deletion in mpt64 still cause false negative result, which is common in CapiliaTB-Neo, even in Q-Line KyokutoTB. |
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