Journal of Laboratory Medicine and Quality Assurance

Indexed in /covered by CAS, KoreaScience & DOI/Crossref:eISSN 2288-7261   pISSN 2384-2458

Table. 14.

Table. 14.

2018 external quality assessment result of molecular TB identification

1st trial2nd trial3rd trial



GT1801GT1802GT1803GT1806GT1807GT1808GT1811GT1812GT1813









MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)MTB neg. (%)MTB pos. (%)
Artus (Qiagen)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
artus M. tuberculosis RG PCR1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
BioCore2 (100)2 (100)2 (100)2 (100)2 (100)2 (100)1 (100)1 (100)1 (100)
M. tuberculosis PCR kit (Nested)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
 TB/NTM real time PCR1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
Bioneer6 (100)6 (100)6 (100)7 (100)7 (100)4 (57.1)3 (42.9)7 (100)7 (100)7 (100)
 MTB1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
 MTB real-time PCR1 (100)1 (100)1 (100)2 (100)2 (100)1 (50.0)1 (50.0)2 (100)2 (100)2 (100)
 MTB&NTM real-time PCR kit4 (100)4 (100)4 (100)4 (100)4 (100)3 (75.0)1 (25.0)4 (100)4 (100)4 (100)
Biosewoom21 (100)21 (100)21 (100)21 (100)21 (100)3 (14.3)18 (85.7)22 (100)22 (100)22 (100)
 MTB PCR kit1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
 Real-Q MTB17 (100)17 (100)17 (100)17 (100)17 (100)2 (11.8)15 (88.2)3 (100)3 (100)3 (100)
 Real-Q MTB/NTM kit3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)18 (100)18 (100)18 (100)
Cepheid5 (100)5 (100)4 (80.0)1 (20.0)5 (100)5 (100)5 (100)5 (100)5 (100)5 (100)
 GeneXpert MTB/RIF assay5 (100)5 (100)4 (80.0)1 (20.0)5 (100)5 (100)5 (100)5 (100)5 (100)5 (100)
LDT3 (100)3 (100)1 (33.3)2 (66.7)4 (100)4 (100)1 (25.0)3 (75.0)4 (100)4 (100)4 (100)
 LDT3 (100)3 (100)1 (33.3)2 (66.7)4 (100)4 (100)1 (25.0)3 (75.0)4 (100)4 (100)4 (100)
LG Chem44 (100)44 (100)5 (11.4)39 (88.6)45 (100)45 (100)14 (31.1)31 (68.9)46 (100)45 (97.8)1 (2.2)46 (100)
 AdvanSure TB/NTM real-time PCR44 (100)44 (100)5 (11.4)39 (88.6)45 (100)45 (100)14 (31.1)31 (68.9)46 (100)45 (97.8)1 (2.2)46 (100)
Others7 (100)7 (100)1 (14.3)6 (85.7)5 (100)5 (100)1 (20.0)4 (80.0)5 (100)5 (100)5 (100)
 Others7 (100)7 (100)1 (14.3)6 (85.7)5 (100)5 (100)1 (20.0)4 (80.0)5 (100)5 (100)5 (100)
Roche15 (100)15 (100)5 (33.3)10 (66.7)14 (100)14 (100)14 (100)15 (100)15 (100)15 (100
 COBAS AMPLICOR MTB test1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
 COBAS Taqman MTB test14 (100)14 (100)4 (28.6)10 (71.4)13 (100)13 (100)13 (100)14 (100)14 (100)14 (100)
Seegene7 (100)7 (100)14 (100)14 (100)14 (100)10 (71.4)4 (28.6)14 (100)14 (100)14 (100)
 Anyplex MTB/NTM real-time Detection14 (100)14 (100)14 (100)14 (100)14 (100)10 (71.4)4 (28.6)14 (100)14 (100)14 (100)
All118 (100)118 (100)16 (13.6)102 (86.4)118 (100)118 (100)33 (28.0)85 (72.0)120 (100)119 (99.2)1 (0.8)120 (100)

The instrument used was from the following company: Qiagen (Hilden, Germany); Biocore Inc. (Seoul, Korea); Bioneer (Daejeon, Korea); Biosewoom (Seoul, Korea); Cepheid (Sunnyvale, CA, USA); LG Chemical (Seoul, Korea); Roche Diagnosis (Basel, Switzerland); and Seegene (Seoul, Korea).

Abbreviations: TB, tuberculosis; MTB, Mycobacterium tuberculosis; neg, negative; pos, positive; PCR, polymerase chain reaction; NTM, nontuberculous mycobacteria; LDT, laboratory developed test.

J Lab Med Qual Assur 2019;41:82-104 https://doi.org/10.15263/jlmqa.2019.41.2.82
© 2019 J Lab Med Qual Assur