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Ezplex SARS-CoV-2 G Kit (FAST)

Ezplex SARS-CoV-2 G Kit (FAST)

Medical equipment reagent


Negotiable Min Order Quantity Unit

Required Quantity
Place of Origin
South Korea
Payment Terms
T/T
Production method
Available
Shipping / Lead Time
Negotiable / Negotiable
Keyword
fast, real-time, covid, molecular diagnosis,
Category
Other Monitoring & Diagnostic Equipment
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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 SARS-CoV-2 G Kit (FAST) Certification CE
Category Other Monitoring & Diagnostic Equipment Ingredients -
Keyword fast , real-time , covid , molecular diagnosis Unit Size -
Brand name - Unit Weigh -
origin South Korea Stock 500000
Supply type Available HS code 382200

Product Information

The Ezplex® SARS-CoV-2 G Kit (FAST) is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test.The 2019-nCoV primer and probe set(s) is designed to detect RNA from the SARS-CoV-2 Virus in Upper Respiratory(Nasopharyngeal/Oropharyngeal) swabs and Lower Respiratory specimens(Sputum) from patients with signs and symptoms of infection who are suspected of COVID-19.

 

Workflow

 

Compatible Device

CFX96 Real-time PCR Instrument

QuantStudio 6 Flex Real-time PCR Instrument

 

Performance Evaluation

 

1) Analytical Sensitivity

Using standard SARS-CoV-2 material, it was serially spiked in both of Upper respiratory(Nasopharyngeal) and Lower respiratory specimens(Sputum), and RNA were extracted from those prepared specimens. The test was performed 20 times on every diluted concentrations and the limit of detection is calculated as below using probit analysis of 95% positive rate.

 

Target

CFX96

QuantStudio 6 Flex

Upper

Lower

Upper

Lower

RdRp

1.585 copies/uL

1.367 copies/uL

2.587 copies/uL

2.587 copies/uL

N

1.045 copies/uL

1.259 copies/uL

2.272 copies/uL

1.887 copies/uL

 

2) Analytical Specificity

2.1) Cross reactivity

The 15 species of microorganisms, which are expected of cross reactivity, are chosen for the test and the test repeated three times on every chosen species. As a result of the test, there were no cross reactivity as those were observed as all negative result.


Microorganism

SARS-

CoV-2 (O)

SARS-CoV-2 (X)

Microorganism

SARS-

CoV-2 (O)

SARS-

CoV-2 (X)

Influenza A H3

Pos

Neg

Coronavirus 229E

Pos

Neg

Influenza B

Pos

Neg

Enterovirus 71

Pos

Neg

Bordetella pertussis

Pos

Neg

Adenovirus

Pos

Neg

Respiratory Synncytial virus B

Pos

Neg

Rhinovirus

Pos

Neg

Parainfluenza virus 1-3

Pos

Neg

Bordetella parapertussis

Pos

Neg

Coronavirus OC43

Pos

Neg

Legionella pnermophila

Pos

Neg

Coronavirus NL63

Pos

Neg

 

 

2.2) Interference

The interference materials were prepared with 3 materials of endogenous - Albumin (0.24g/mL), Hemoglobin (0.2g/mL), Bilirubin (0.05mg/mL) - those were tested three times with and without positive materials of SARS-CoV-2 diluted in low concentration. As a result of the test, there were no interference by observing the coefficient of variation(CV) value which were less than 5% in all cases.


Controls

Interference

Albumin

Hemoglobin

Billirubin

O

X

O

X

O

X

SARS-CoV-2 Virus

Positive

(CV 5%>)

Positive

Positive

(CV 5%>)

Positive

Positive

(CV 5%>)

Positive

Negative control

Negative

Negative

Negative

Negative

Negative

Negative

 

3) Analytical Precision

 

3.1) Analytical Precision (Reproducibility)

A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 1 Lot by 2 investigators and each investigator tested several times repeatedly. The detection results were same across the tests with CV < 5%, and it was confirmed that results did not differ between investigators.

 

3.2) Analytical Precision (Repeatability)

A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 2 Lots by 1 investigator and the investigator tested 10 times repeatedly, 5 times a day for 2 days. All the detection results were same with CV < 5%, and it was confirmed that results did not differ within a test, between tests and between lots.

 

4)Clinical Evaluation

The clinical performance was evaluated by a clinical performance testing institution in Republic of Korea using the left-over upper respiratory (nasopharyngeal and oropharyngeal) and lower respiratory (sputum) specimens that were positive and negative through the emergency use approved product (Kosen Biotech, PowerchekTM 2019-nCoV Real-time PCR kit) by Korea CDC, and the results are as follows.

 

(1) CFX96 Real-time PCR Instrument


Upper

(Nasopharyngeal/

Oropharyngeal)

Reference

Lower

(Sputum(

Reference

Positive

Negative

Total

Positive

Negative

Total

Ezplex®

Positive

99

0

100

Ezplex®

Positive

99

0

100

Negative

1

100

100

Negative

1

100

100

Total

100

100

200

Total

100

100

200

Sensitivity

(95% CI)

99 % (94.55 ~ 99.97 %)

Sensitivity

(95% CI)

99 % (94.55 ~ 99.97 %)

Specificity

(95% CI)

100 % (96.38 ~ 100 %)

Specificity

(95% CI)

100 % (96.38 ~ 100 %)

 

(2) QuantStudio 6 Flex Real-time PCR Instument


Upper

(Nasopharyngeal/

Oropharyngeal)

Reference

Lower

(Sputum(

Reference

Positive

Negative

Total

Positive

Negative

Total

Ezplex®

Positive

30

0

30

Ezplex®

Positive

30

0

30

Negative

0

30

30

Negative

0

30

30

Total

30

30

60

Total

30

30

60

Sensitivity

(95% CI)

100 % (88.43 ~ 100 %)

Sensitivity

(95% CI)

100 % (88.43 ~ 100 %)

Specificity

(95% CI)

100 % (88.43 ~ 100 %)

Specificity

(95% CI)

100 % (88.43 ~ 100 %)

 

Kit Components

 

* 50 tests

 

No.

Kit Component

Volume

Lid Remarks

1

RQ Mixture

1 vial, 600uL

RQ

2

RdRp P+P

1 vial, 200uL

RdRp

3

N P+P

1 vial, 200uL

N

4

Positive Control

1 vial, 100uL

PC

5

Negative Control

1 vial, 100uL

NC

6

Internal Control

1 vial, 20uL

IC

 

* 100 tests

 

No.

Kit Component

Volume

Lid Remarks

1

RQ Mixture

2 vials, 600uL

RQ

2

RdRp P+P

2 vials, 200uL

RdRp

3

N P+P

2 vials, 200uL

N

4

Positive Control

1 vial, 100uL

PC

5

Negative Control

1 vial, 100uL

NC

6

Internal Control

1 vial, 20uL

IC

 

 

 

 

 

Verified Certificate

CE

B2B Trade

Price (FOB) Negotiable transportation Air Transportation
MOQ Negotiable Leadtime Negotiable
Payment Options T/T 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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