Home Health & Medical Medical Devices Examination & Testing Instrument Medical Test Kit

Ezplex MTBC NTM Real-time PCR Kit

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Negotiable Min Order Quantity Unit

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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 / 2015

Business type: Manufacturer

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PRODUCT DESCRIPTION COMPANY INFORMATION Related Products

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 Ezplex^TMMTBC/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 Ezplex^TM 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 Ezplex^TM 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
MTBC	Low conc. Positive	37.23	0.59	1.59
NTM	Intermediate conc. Positive	33.90	0.12	0.36
NTM	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 Ezplex^TM 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 (%)
Target	Beginning	6 months	12 months
MTBC	1.45	0.57	0.93
NTM	1.46	0.55	0.66

▶Clinical Sensitivity & Specificity

The Ezplex^TM 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.

① Clinical Sensitivity and Specificity of MTBC

MTBC		Smear, Culture, PCR result
MTBC		Positive	Negative	Total
Ezplex^TM 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%)

② Clinical sensitivity and specificity of NTM

MTBC		Smear, Culture, PCR result
MTBC		Positive	Negative	Total
Ezplex^TM 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 Ezplex^TM 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.