The Ezplex™ MTBC/NTM Real-time PCR Kit is an in vitro diagnostic test intended for the simultaneous qualitative detection of Mycobacterium tuberculosis complex (MTBC) and 100 types of nontuberculous mycobacteria (NTM) DNA from sputum, bronchial fruid and culture from individuals suspected of MTBC and/or NTM. Testing can be quickly and accurately completed within 2 hours post extraction.

Analytical SensitivityReference material of MTBC and NTM were repeatedly tested through serial dilution to show highly analytical sensitivity of the Ezplex MTBC/NTM Real-time PCR Kit.

Target Limit of Detection (copies/uL)

MTBC 0.584

NTM 47.836

Ezplex™ MTBC/NTM Real-time PCR Kit

For in vitro diagnostic use only.

SpecificitySpecific for Mycobacteria strains with no cross reactivity with 38 potentially cross-reacting bacterial species.

StabilityShelf life of up to 12 months.

ReproducibilityCVs of less than 5%.

Comprehensiveand SensitiveSimultaneous detection of both MTBC and 100 types of NTM in a single test.

VersatileCan utilize sputum, bronchial fluid or culture sample types.

ConvenienceGenetree Viewer analysis software available for users to conveniently produce test results.

SML Genetree Sciences, Inc. 400 Concar Drive, Suite 03-160, San Mateo, CA 94402. www.smlgenetree.comFor more information, please contact info@smlgenetree.com.

©2021 SML Genetree. All rights reserved.Ezplex® is a registered trademark in South Korea. All other trademarks that may appear in this document are the property of their respective owners. SH_EMNK_003

SML Genetree Co. Ltd.255 Baumoe-ro, Seocho-gu,Seoul, 06740, Republic of Korea

Obelis S.A.Bd. Général Wahis, 53, B-1030Brussels, Belgium

Analytical SpecificityTesting of 38 species of microorganisms with the Ezplex MTBC/NTM Real-time PCR Kit showed no cross reactivity.

Mycoplasma hominis, Candida albicans, Mycoplasma genitalium, Gardnerella vaginalis, Trichomonas vaginalis, Neisseria

gonorrhoeae, Haemophilus ducreyi, Candida glabrata, Candida tropicallis, Clostridium difficile, Corynebacterium amycolatum, Corynebacterium diphtheriae, Corynebacterium glutamicum,

Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Klebsiella oxytoca, Klebsiella pnuemoniae subsp pneumoniae,

Lactobacillus crispatus, Lactobacillus gallinarum, Lactobacillus vaginalis, Nocardia sp., Peptostreptococcus anaerobius, Prevotella

bivia, Prevotella disiens, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus

anginosus subsp anginosus, Streptococcus constellatus subsp constellatus, Streptococcus gordonii, Streptococcus mutans,

Streptococcus oralis, Streptococcus parasanguinis, Streptococcus salivarius, Streptococcus sanguinis, Veillonella parvula

Microorganisms

Precision (Reproducibility)Reproducibility testing of MTBC and NTM standard materials and positive specimens confirmed that CVs were 5% or less.

Clinical PerformanceResults from testing left-over archived sputum, bronchial fluid and culture specimens previously tested by smear, culture and another PCR method.

Specimen Type Target Positive Agreement(95% CI)

Negative Agreement(95% CI)

SputumMTBC

NTM

MTBC

NTM

MTBC

NTM

97.6%(92.6 - 99.4%)

100%(90.9 - 100%)

100%(90.6 - 100%)

100%(90.2 - 100%)

100%(90.2 - 100%)

100%(90.2 - 100%)

98.2%(94.5 - 99.5%)

100%(97.2 - 100%)

100%(89.8 - 100%)

100%(89.8 - 100%)

100%(90.2 - 100%)

100%(90.2 - 100%)

Bronchial Fluid

Culture

3) Internal control amplification curve

StabilityShelf life of 12 months at -20°C (-4°F) unopened and 6 months after opening.

Ordering information100 Tests. Catalog Number: GNT-2003-1200 Tests. Catalog Number: GNT-2003-2Genetree Viewer Software. Catalog Number: GNT-2003-3

Example Amlicfication Curves

2) NTM amplication curve

1) MTBC amplification curve