Journal of Laboratory Medicine and Quality Assurance

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

Table. 13.

Table. 13.

2017 external quality assessment result of molecular TB identification

1st trial2nd trial3rd trial



GT1701GT1702GT1705GT1706GT1707GT1710GT1711GT1712








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)
 Artus M. tuberculosis RG PCR1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
BioCore2 (100)2 (100)2 (100)2 (100)2 (100)2 (100)2 (100)2 (100)
M. tuberculosis PCR kit (Nested)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)1 (100)1 (100)
Bioneer9 (100)9 (100)9 (100)9 (100)9 (100)9 (100)9 (100)9 (100)
 MTB6 (100)6 (100)3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)
 MTB real-time PCR3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)
 MTB & NTM real-time PCR kit3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)
Biosewoom17 (100)17 (100)18 (100)18 (100)1 (5.6)17 (94.4)21 (100)21 (100)21 (100)
 MTB PCR kit 1 (100)1 (100)3 (100)3 (100)1 (100)1 (100)16 (100)
 Real-Q MTB16 (100)16 (100)15 (100)15 (100)1 (7.7)12 (92.3)16 (100)16 (100)4 (100)
 Real-Q MTB/NTM kit5 (100)4 (100)4 (100)1 (100)
Cepheid3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)1 (33.3)2 (66.7)
 GeneXpert MTB/RIF assay3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)3 (100)1 (33.3)2 (66.7)
LDT4 (100)4 (100)4 (100)4 (100)4 (100)4 (100)4 (100)4 (100)
 LDT4 (100)4 (100)4 (100)4 (100)4 (100)4 (100)4 (100)4 (100)
LG Chem1 (2.4)41 (97.6)41 (97.6)1 (2.4)42 (100)42 (100)10 (24.4)31 (75.6)44 (100)44 (100)1 (2.3)43 (97.7)
 AdvanSure TB/NTM real-time PCR1 (2.4)41 (97.6)41 (97.6)1 (2.4)42 (100)42 (100)10 (24.4)31 (75.6)44 (100)44 (100)1 (2.3)43 (97.7)
Others9 (100)9 (100)7 (100)7 (100)7 (100)7 (100)7 (100)7 (100)
 Others9 (100)9 (100)7 (100)7 (100)7 (100)7 (100)7 (100)7 (100)
Roche Diagnosis17 (100)17 (100)17 (100)17 (100)8 (47.1)9 (52.9)15 (100)15 (100)2 (13.3)13 (86.7)
 COBAS AMPLICOR MTB test1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)1 (100)
 COBAS Taqman MTB test16 (100)16 (100)16 (100)16 (100)7 (43.8)9 (56.2)14 (100)14 (100)2 (14.3)12 (85.7)
Seegene11 (100)11 (100)12 (100)12 (100)1 (8.3)11 (91.7)13 (100)13 (100)13 (100)
 Anyplex MTB/NTM real-time detection11 (100)11 (100)12 (100)12 (100)1 (8.3)11 (91.7)13 (100)13 (100)13 (100)
All1 (0.9)113 (99.1)113 (99.1)1 (0.9)115 (100)115 (100)20 (17.5)64 (82.5)119 (100)119 (100)4 (3.4)115 (96.6)

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