The Korean Journal of Clinical Laboratory Science : eISSN 2288-1662 / pISSN 1738-3544

Table. 3.

Table. 3.

Performance evaluation of FDA approved or not approved TB IVDs in references

AuthorYearSample sizeSensitivity (%)Specificity (%)Reference
FDA approvedXpert®Hai H et al.20172,910 sputum specimens96.798.3[12]
 MTB/RIF assayKampen SC et al.20155,611 sp, utum specimens93.196.4[13]
Geleta DA et al.2015227 sputum specimens65.596.3[14]
Detjen AK et al.20154,768 respiratory specimens62.098.0[15]
Antonenka U et al.2013121 respiratory specimens74.696.2[16]
AmplifiedChen X et al.2012178 sputum specimens95.297.9[17]
Mycobacterium tuberculosisPapaventsis D et al.2012152 clinical specimens100.085.0[18]
Guerra RL et al.20071,151 respiratory specimens91.798.7[19]
 Direct testDavid WD et al.2003499 respiratory specimens99.699.7[20]
Cobas®Fegou E et al.2005Sputum (684) BAL (1473)77.5a, 45.6b88.1a, 98.0b[21]
 AmplicoreSAB (625) TA (296)
 MTB testPleural (189) Gastric (23) fluids(124)
Mitarai S et al.2001Sputum (1088)61.897.4[22]
Choi WS et al.2006807 respiratory specimens93.3%c, 100.0%d, and 50.0%e83.3%c, 89.0%d, and 95.7%e[23]
FDA not-approvedCobas®Cho WH et al.20159,728 respiratory specimens67.298.4[24]
 Taqman®2,401 non-respiratory specimens
MTB testHuh HJ et al.2015629 respiratory specimens78.899.5[25]
Lee M et al.2013586 respiratory specimens82.796.5[26]
Moon JW et al.2005111 pleural effusion specimens17.598.1[27]
Lim TK et al.2003168 respiratory specimens88.097.0[28]

, sensitivity based on smear positive result;

, a sensitivity based on smear negative results;

, sensitivity from bronchial washing fluid;

, sensitivity from sputum;

, sensitivity from body fluid. Abbreivation; BAL, bronchoalveolar lavage; SAB, sputa expectorated after bronchoscopy; TA, tracheal aspirate.

Korean J Clin Lab Sci 2018;50:20-8 https://doi.org/10.15324/kjcls.2018.50.1.20
© 2018 Korean J Clin Lab Sci