Ezplex SARS-COV-2 G

Frequently Asked Questions

How does the assay work?
The Ezplex SARS-CoV-2 G Kit is designed to detect RNA from the SARS-CoV-2 virus that causes COVID-19 in upper respiratory (Oropharyngeal and Nasopharyngeal swabs) and lower respiratory (sputum specimen) specimens.



What materials are needed to perform the assay?
This kit does not contain RNA extraction reagents or PCR equipment. The RNA extracted from the sample using the Ezplex compatible extraction method can be tested with this kit and the Genetree Viewer analysis software can be used to automatically analyze the results.



Where is the test performed?
Testing is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.



Are pooling tests verified using SML Genetree’s Products?
Yes. The Ezplex SARS-CoV-2 G Kit can be used to test up to five pooled upper respiratory swab specimens that were collected under observation using individual vials containing transport media. Sample pooling is an important public health tool because it allows for more people to be tested using fewer testing resources.



How many tests can we run?
Assuming that the test runs for 24 hours a day, the Ezplex SARS-CoV-2 G Kit can test about 768 specimens (excluding time for extraction). If pooling verification is possible, five times as many tests can be conducted (3,840 people per day with the Ezplex SARS-CoV-2 G Kit), increasing the test efficiency significantly.



Where is the test made?
The test was designed and is manufactured in Seoul, South Korea.



What is the sensitivity of the assay?
Reference material of SARS-CoV-2 virus was repeatedly tested through serial dilution to show high analytical sensitivity of the Ezplex SARS-CoV-2 G Kit (LoD range of 0.64-1 copies/µL). Testing of the FDA SARS-CoV-2 Reference Panel showed a detection limit of 1200 NDU*/mL.



Does SML Genetree have rapid kits? What is the difference between the Ezplex SARS-CoV-2 G and Ezplex SARS-CoV-2 FAST G Kits?
Yes. The Ezplex SARS-CoV-2 FAST G Kit is an alternate version of the Ezplex SARS-CoV-2 G Kit, with reduced test result turnaround time of approximately 35 minutes (excluding extraction time). Genetree recommend using the CFX96 Dx Touch Real-Time PCR instrument (Bio-Rad) or QuantStudio 6 Flex Real-Time PCR Instrument (Thermofisher Scientific) for the Ezplex SARS-CoV-2 FAST Kit. Pooled specimens are not validated for use with this kit. This product is approved by the MFDS in Korea and is CE marked but is not FDA EUA authorized.



What is the track record of SML Genetree in this field?

•  SML Genetree is recognized as a leading developer of multiplex molecular technologies and multiplex clinical  molecular diagnostics in Korea. SML Genetree has succeeded in commercializing the world’s first Ezplex HPV 100 NGS Kit, gaining global recognition.

•  SML Genetree is an affiliate of Samkwang Medical Laboratories(SML), one of the largest diagnostic commercial labs in Korea since 1985. SML Genetree has continued to provide diagnostic results to customers across 3,000 government medical institutions in Korea, including the Military Manpower Administration (MMA), university hospitals, and local medical institutions.

•  The Ezplex SARS-CoV-2 Fast G Kit has been approved by the MFDS for emergency use. Of the 14 companies that applied for this emergency use approval, only three companies, including SML Genetree, were approved in the first round.



Where can patients get a test?
Those with COVID-19 consistent symptoms should consult a medical professional for evaluation. The medical professional can order the test if the patient meets the COVID-19 test criteria.



How many tests can you supply?
We can produce up to 500,000 tests per week (2,000,000 tests per month).



What are the delivery specifications?
Our products ship from SML Genetree in South Korea through EXW, with CIF options available.

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