Ezplex MTBC NTM Real-time PCR Kit

Ezplex MTBC NTM Real-time PCR Kit


Negotiable Min Order Quantity Unit

Required Quantity
Place of Origin
South Korea
Payment Terms
Negotiable
Production method
Negotiable
Shipping / Lead Time
Negotiable / Negotiable
Keyword
diagnosic kits, ivd, pcr, mtbc ntm,
Category
Medical Test Kit
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SML Genetree Co.,Ltd.

Country / Year Established
South Korea South Korea / 2015
Business type
Manufacturer
Verified Certificate

3

Product name Ezplex MTBC NTM Real-time PCR Kit Certification -
Category Medical Test Kit Ingredients -
Keyword diagnosic kits , ivd , pcr , mtbc ntm Unit Size -
Brand name - Unit Weigh -
origin South Korea Stock -
Supply type - HS code -

Product Information

The EzplexTM MTBC/NTM Real-time PCR kit is an in vitro diagnostic medical device that can simultaneously detects Mycobacterium tuberculosis complex (MTBC) and nontuberculus mycobacteria (NTM) by using Real-time PCR device. Specifically, this kit is designed to specigically detect 100 types of NTM.

It Includes internal control for checking out PCR inhibition, and also uses UNG/dUTP system for minimizing carry over contamination.

 

The EzplexTM MTBC/NTM Real-time PCR kit has a high sensitivity and specificity for testing up to 96 samples within two hours in a single PCR reaction.

 

Analytical Sensitivity

 

The EzplexTM MTBC/NTM Real-time PCR kit has high sensitivity for detecting MTBC/NTM.  By targeting multiple genes in the MTBC/ NTM genome, it is possible to prevent false negatives by some mutations such as substitution, insertion, and deletion.

Target

Limit of Detection

Confidence Interval

MTBC

1 copy

0.5 copy ~10 copy

NTM

50 copy

50 copy ~150 copy

 

Precision and Reproducibility

The reproducibility test using MTBC and NTM standards and positive specimens confirmed that the CV was 5% or less.

Target

Concentration

Mean

SD

CV (%)

MTBC

Intermediate conc. Positive

32.43

0.35

1.06

Low conc. Positive

37.23

0.59

1.59

NTM

Intermediate conc. Positive

33.90

0.12

0.36

Low conc. Positive

37.93

0.55

1.45

 

Analytical Specificity

All 25 Mycobacteria strains tested were positive. In contract, the analytical specificity results with 40 bacterial strains (not mycobacteria) were all negative. Therefore, the detection of MTBC/NTM specific gene was verified.

Target

Result

25 species of Mycobacteria

Positive

40 species without Mycobacteria

(Included Nocardia sp.)

Negative

 

Stability

The EzplexTM MTBC/NTM Real-time PCR kit has been validated its stability by confirming consistent equal results from the beginning t o12 months.

Target

Test period CV (%)

Beginning

6 months

12 months

MTBC

1.45

0.57

0.93

NTM

1.46

0.55

0.66

 

Clinical Sensitivity & Specificity

 

The EzplexTM MTBC/NTM Real-time PCR kit also has been validated on Sputum, Bronchial fluid and culture specimens at a tertiary hospital in Korea. All results were shown high sensitivity and specificity which are remarkably higher that AFB smear, culture, and conventional PCR method.

 

    Clinical Sensitivity and Specificity of MTBC

MTBC

Smear, Culture, PCR result

Positive

Negative

Total

EzplexTM MTBC/NTM Real-time PCR kit

Positive

213

3

216

Negative

3

254

257

Total

216

257

473

Clinical Sensitivity: 98.6 % (95% CI,95.6-99.6%)

Clinical specificity: 98.8 % (95% CI. 96.3-99.7%)

    Clinical sensitivity and specificity of NTM

MTBC

Smear, Culture, PCR result

Positive

Negative

Total

EzplexTM MTBC/NTM Real-time PCR kit

Positive

139

0

139

Negative

0

257

257

Total

139

257

396

Clinical Sensitivity: 100 % (95% CI,96.6-100%)

Clinical specificity: 100 % (95% CI,98.2-100%)

 

 

Ordering Information

The EzplexTM MTBC/NTM Real-time PCR kit consists of the reagents for extraction, Taq polymerase, dNTP, Probe, Primer, Internal Control and Positive Control. Not only of extraction solution involved in the package, automated DNA extraction device also is able to be compatible with the Ezplex kit.

The name of reagents

Product size

Purpose

MTBC&NTM

100 reaction

IVD, RUO

MTBC&NTM

500 reaction

IVD, RUO

 

 

 

B2B Trade

Price (FOB) Negotiable transportation -
MOQ Negotiable Leadtime Negotiable
Payment Options Negotiable Shipping time Negotiable

SML Genetree Co.,Ltd.

Country / Year Established
South Korea South Korea / 2015
Business type
Manufacturer

3

President
AN JI HUN
Address
6F Hanmaeum Bldg 225 Bauroiro, Seocho-gu, Seoul, Korea
Product Category
Other Monitoring & Diagnostic Equipment
Year Established
2015
Company introduction

 

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