Ezplex HP-CLA Real-time PCR Kit

Ezplex HP-CLA 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
test, diagnosis reagent, ivd, pyiori
Category
Medical Test Kit

SML Genetree Co.,Ltd.

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

4

DUNS

Product name Ezplex HP-CLA Real-time PCR Kit Certification -
Category Medical Test Kit Ingredients -
Keyword test , diagnosis reagent , ivd , pyiori Unit Size -
Brand name - Unit Weigh -
origin South Korea Stock -
Supply type - HS code 2852105000

Product Information

Ezplex® HP-CLA Real-time PCR Kit is a reagent that uses the PCR method to qualitatively detect helicobacter pylori and clarismycin-resistant mutations from human driven gastric biopsy tissues. It can test 96 samples at once, quickly and easily with a short time PCR response, along with dedicated software to help you see the results.

 

 

Analytical Sensitivity

Repeated tests with serial dilutions of the standard material have confirmed the high analytical sensitivity of Ezplex® HP-CLA Real-time PCR Kit

Target

Limit of Detection (copies/㎕)

Helicobacter pylori

3.604

Clarithromycin resistance mutations

A2142G

4.174

A2143G

4.626

 

Reproducibility

Reproducibility tests using standard materials all showed stable results of less than 5% CV.

Target

Density

Mean

CV (5%)

 

Helicobacter pylori

Medium

concentration

30.81

1.14

Low

concentration

34.51

0.88

 

 

Clarithromycin resistance mutations

 

A2142G

Medium

concentration

31.03

0.84

Low

concentration

34.39

0.84

 

A2143G

Medium

concentration

30.93

0.83

Low

concentration

34.19

0.92

 

Stability

Ezplex® HP-CLA Real-time PCR Kit was tested reapeatedly at the initial time point and at each storage point for 6 months and 12 months, and both showed CV less than 5%, confirming that it maintains stability.

Target

Density

Initial mean

6 months mean

12 months mean

Total CV (%)

 

Helicobacter pylori

Medium

 

31.00

31.41

31.57

1.17

Low

 

34.56

35.06

35.27

1.28

 

 

Clarithromycin resistance mutations

 

A2142G

Medium

 

31.15

31.61

31.90

1.05

Low

 

34.47

34.95

35.37

1.12

 

A2143G

Medium

 

31.02

31.46

31.65

0.93

Low

 

34.02

34.58

34.90

1.14

 

Clinical Accuracy

In a test conducted by the general clinical laboratories in Korea using human stomach biopsy samples that were already confirmed by the KFDA(Korea Food and Drug Ministration), our high clinical performance was validated.

 

Helicobacter pylori

Control group (licensed product)

Positivity

Negativity

Ezplex®HP-CLA Real-time PCR Kit

Positivity

82

0

Negativity

0

66

Clinical sensitivity (95%CI)

100% (95.60~100%)

Clinical specificity (95%CI)

100% (94.56~100%)

 

 

A2142G

Control group (licensed product)

Positivity

Negativity

Ezplex®HP-CLA Real-time PCR Kit

Positivity

47

0

Negativity

0

66

Clinical sensitivity (95%CI)

100% (92.45~100%)

Clinical specificity (95%CI)

100% (94.56~100%)

 

A2143G

Control group (licensed product)

Positivity

Negativity

Ezplex®HP-CLA Real-time PCR Kit

Positivity

70

0

Negativity

0

66

Clinical sensitivity (95%CI)

100% (94.87~100%)

Clinical specificity (95%CI)

100% (94.56~100%)

 

Ordering information

Ezplex®HP-CLA Real-time PCR Kit includes Taq Polymerase, Primer&Probe, Positive control and Internal control.

Product Classification

Product size

Purpose of use

Ezplex®HP-CLA Real-time PCR Kit

100 reaction

IVD, RUO

Ezplex®HP-CLA Real-time PCR Kit

200 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

4

DUNS

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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