Ezplex®* SARS-COV-2 Fast G Kit**

•  CE-IVD  

•  Emergency Use Approval by the Ministry of Food and Drug Safety of South Korea (MFDS) 

•  Result turnaround time of 35 minutes*** post extraction with high clinical performance

*Registered trademark in South Korea.

**Not for sale in the U.S.

***Run time may vary by testing lab parameter.

The Ezplex SARS-CoV-2 FAST G Kit is a real-time PCR in vitro diagnostic test intended for the qualitative detection of nucleic acid SARS-CoV-2 (RdRp, N genes) in individuals suspected of COVID-19 (nasopharyngeal/oropharyngeal and sputum specimens).
The test can be quickly completed within 35 minutes post extraction through Real-time PCR assays with extracted RNA, and the results can be conveniently checked using Genetree Viewer assay software.

How is the Ezplex SARS-CoV-2 FAST G Kit different from the Ezplex SARS-CoV-2 G Kit?   

The Ezplex SARS-CoV-2 FAST G Kit is an alternative version of the Ezplex SARS-CoV-2 G Kit, with reduced testing completion time of approximately 35 minutes post extraction. We recommend using the CFX96 Dx Touch Real-Time PCR instrument (Bio-Rad) or ABI QuantStudio 6 Flex Real-Time PCR Instrument (ThermoFisher Scientific) for the Ezplex SARS-CoV-2 FAST G Kit. 

Features and Benefits

Fast Results

35 minutes post extraction.

Real-time PCR

Detection and identification of target genes (RdRP, N) specific for COVID-19.


Clinical Performance

99-100% clinical sensitivity and 100% clinical specificity.


Accuracy

Reproducibility of less than 5% CV.


Analytical Sensitivity

Detection of SARS-CoV-2 (RdRp and N genes) with high sensitivity, regardless of virus mutations.

Accessibility

Test results can be easily analyzed with dedicated user-friendly Genetree Viewer assay software.


Product Specifications

Sample Type
- Upper Respiratory Swabs (Nasopharyngeal/Oropharyngeal)
- Lower Respiratory Swabs (Sputum)

Extraction Platforms
- Nextractor® NX-48 (Genolution)

PCR Platform

- CFX96 Dx Touch Real-time PCR instrument (Bio-Rad)
- ABI QuantStudio 6 Flex Real-time PCR Instrument (ThermoFisher Scientific)

Analytes
- COVID-19 (N gene)
- COVID-19 (RdRp gene)

Kit components

*100 tests

NO.
Kit Component
Volume
Lid Remarks
1RQ 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

Storage 

  • Reagents* should be stored under -20℃ with opened/unopend status. Shelf life is 6 months from date of manufacture. (* RQ Mixture, RdRp P+P, N P+P, Positive Control, Negative Control, Internal Control)
     
  • Products that are packaged shall be stored in a storage freezer.
     
  • To transport the products to a client, the products shall be put in a cooler with dry ice so that the products are not exposed to the ambient temperature.

Work Flow