Ezplex�® SARS-CoV-2 G Kit, developed by SML Genetree, is a product that has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This is an in vitro diagnostic test that qualitatively detects the nucleic acids of SARS-CoV-2 (RdRp and N genes) in sputum to aid in emergency screening for COVID-19. This product can be used for a large amount of screening tests because it can perform a pooling test, unlike the products that the existing domestic companies have approved for emergency use by the FDA. For the combined test, samples are collected in units of 5 people and tested. If positive, individual tests are performed. In the case of a negative test, all tests are performed in a negative way. In particular, since a large number of samples are tested at once, the test is only possible with high sensitivity and specificity compared to existing diagnostic kits. According to the FDA, it was confirmed that 100% agreement was achieved in the result comparison test of individual and collective tests, and it was the 20th in the world and the first Korean company to pass the test. Excellent clinical performance was demonstrated by confirming high sensitivity and specificity through clinical evaluation, and stability was confirmed for 12 months through long-term storage tests. In January 2021, it was officially approved by the Korean Ministry of Food and Drug Safety (MFDS).
SARS-CoV-2 IgG/IgM Rapid Test Kit
Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma
Product Format:Â 25 tests/kit
Kit Contents: test card, diluent, capillary, lancet, and instruction for use.
Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision
100% Concordant across 3 lots with CV ±5%
Performance Comparison (A)
China Validation Test
Positive Samples 100 / 102
Sensitivity: 98.04%
Negative Samples 491/492
Specificity: 99.80%
Overall Accuracy: 99.49%
Performance Comparison (B)
Positive Samples 23 / 25
Sensitivity: 92%
Negative Samples 25 / 25
Specificity: 100%
Overall Accuracy: 96%
SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal swab samples)
SARS-CoV-2 Antigen Rapid Test Saliva)
We have two fast screening reagents for routine detection. One is the antibody iggigm detection reagent (that is, blood for three minutes) One is antigen rapid screening test reagent (the same is three minutes can use nasal mucosa, oral mucosa, and saliva three detection methods) 1.SARS-CoV-2 antigen testing can detect infection earlier than antibody testing 2.SARS-CoV-2 antigen testing can detect SARS-CoV-2 and all mutant virus strains 3.Easy operation and quick results 4.The result is clear. C-line and T-line determines the infection and the result is easy to read 5.The colloidal gold method has stable performance and is not interfered by environmental and experimental conditions 6.Application: for human throat swab , nasal swab and sputum extract Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
CoVirion-CV19-2 SARS-CoV-2 OneStep RT-PCR kit is a probe-based Real Time PCR test designed for the qualitative detection of SARS-CoV-2 Coronavirus, the etiological agent of COVID-2019. It is used to detect N-gene and S-gene in viral RNA.
