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).
Ezplex MTBC/NTM Real-time PCR Kit is an in vitro diagnostic test that simultaneously detects Mycobacterium tuberculosis complex (MTBC) and 20 types of nontuberculous mycobacteria (NTM).
Sensitivity : Multiple gene targets for MTBC and NTM.
Clinical Performance: Validated clinical performance.
Fast Results: Testing can be completed within 2 hours post extraction.
Ezplex Respiratory Pathogens Real-time PCR Kit is an in vitro diagnostic test for the qualitative detection of 19 respiratory viruses and 6 types of pneumonia-causing bacteria through nucleic acids isolated and extracted from human throat swabs using real-time polymerase chain reaction
Comprehensive Panel- One test can identify 19 respiratory viruses and 6 bacterial species simultaneously.
Sensitivity Detection of all targeted viruses and bacteria with high sensitivity.
Convenience Genetree Viewer analysis software available for users to conveniently produce test results.
Clinical Performance: Clinical testing confirmed the high sensitivity and specificity.
Stability: Shelf life of up to 12 months.
Analytical Specificity: Testing of 31 species of microorganisms showed no cross reactivity.
Description
Foot-and-mouth disease virus (FMDV) causes an acute vesicular disease of cloven-hoofed animals and continues to be a threat to livestock worldwide with outbreaks causing severe economic losses.
RIDX FMDV 3Diff/PAN Ag Combo Test Kit is a lateral flow chromatographic immunoassay for the qualitative detections of all 7 serotypes antigens of FMDV in bovine or porcine samples.
3Diff Ag Test: FMDV 3Diff detects FMDV Asia1, type A, and type O antigens. Three test lines (AS, A, O) and the control (C) line on the surface of the device.
PAN Ag Test: FMDV PAN detects all 7 serotypes (type O, type A, type C, Asia1, SAT1, SAT2, and SAT3) of FMDV antigens. The test line (PAN) and the control (C) line on the surface of the device.
If the FMDV antigens exist in the sample, that bind to the gold-conjugated FMDV antibodies. The complexes move through the membrane by capillary force and respond to the FMDV antibodies on the test line, resulting in a red line. The control line indicates that the test is performed correctly.
The highly selective and sensitive four monoclonal antibodies to FMDV are used as capture and detector in RIDX�® FMDV 3Diff/PAN Ag Combo Test Kit. These antibodies are capable of detecting FMDV antigens in bovine and porcine samples with high accuracy.
Specimen
Bovine or porcine saliva, tissue or vesicular fluid around lip, tongue, gums, nose, or hoof
Features
Clinical Sensitivity
1. Type O 88.2% (n=60/68) vs. PCR
2. Type A 100% (n=70), Asia1 100% (n=62), SAT1 100% (n=20), SAT2 100% (n=20), SAT3 100% (n=20), C 100% (n=20), in spiking samples with virus (titer: 1.0x105 TCID50/ml or higher)
Clinical Specificity
1. Type O, type A and PAN: Bovine 100% (n=92), Swine 100% (n=400)
2. Type Asia1: Bovine 100% (n=92), Swine 99.5% (n=398/400) Differential diagnosis of 3 different serotypes (O, A, Asia1) of FMDV
Concurrent diagnosis both of viral common antigens (all 7 serotypes) and serotype-specific antigens (O, A, Asia1)
Dr. Guard is space sterilization and deodorant using pure chlorine dioxide.
[Dr. Guard]
* Sterilization test against COVID-19 showed a high result of 99.99% effectiveness
* Registered as a disinfectant for general disinfection in the Central Defense Countermeasures Headquarters of Korean government
* Corona 19 self-disinfecting environment approved product
* Completed safety check test and the only product certified by the Ministry of Environment
* Registered with the FDA. Safety verification completed in WHO.
* With proven technical skills, Dr. Guard has been recognized for its effectiveness in removing germs and odors.
* Obtained certifications from honorable global health institutions such as CE, FDA, PFDA and KEMENKES
[ClO2 Chlorine Dioxide]
* Chlorine Dioxide (ClO2) is a World Health Organization (WHO) recognized safety class A-1 safety material.
As a sanitary disinfectant already in Korea under the Drinking Water Management Act of 1999. It is soluble in chlorine dioxide. This is because there is no problem even when used for drinking water.
* The fatal drawback is that it is difficult to commercialize because it vaporizes quickly and is not easy to manufacture in gaseous form. However, since the sterilizing and deodorizing power is strong, manufacturers have added additional additives (sulfur, surfactant, etc.) for long-term storage.
* So, to make pure chlorine dioxide, special and difficult differentiated technology is required. Dr. Guard is a pure chlorine dioxide product made by a purely Korean technology by an honest company.
[Germs that can be sterilized by Dr. guard]
COROPNA-19 virus, N1N1, Pneumococcus, Dermatophyte, Norovirus, Pseudomonas aeruginosa, Fungi, Salmonella typhi, Staphyococcus aureus, Legionella
[Applications of Dr. Guard]
Using pure silicon dioxide chlorine sterilizing and deodorizing agent, we use the best technology in producing Dr. Guard for variety of purposes.
Bedroom, Bathroom, Refrigerator, Kitchen
No alcohol, No cancerous agents, No preservatives
Air purification, Antivirul action
[How to use Dr. Guard]
The stick contains main solution�?� and an ample (secondary solution)
1. Bend central part of the stick.
2. Once the ample inside the stick cracks, shake it enough to mix the power with the solution well.
3. As it turns yellow, the active ingredients are released to the surface of the stick.
4. After 3~4 weeks of usage, dispose stick into normal trash bag once solution inside turns transparent.
An established PCR test kit that has had exceptional results both in the lab and in real world settings with major countries reporting sensitivity results. The PCR is the first Korean test kit to receive FDA, EUA, and CE approval, allowing this test kit to be sold globally without restrictions. We are able to secure ample volume reliably.
South Korea-based RapiGEN is a leading manufacturer of in vitro diagnostic industry. The company has developed and manufactured rapid diagnostic test devices for over 15 years. RapiGEN's core raw material, black gold particle, has brought innovation to the in vitro rapid test field with their high specificity, sensitivity, and reproducibility.
Ionebio produces the iLAMP Novel-CoV19 Detection Kit, a real-time Reverse Transcription LAMP-PCR assay system. The test kits are widely used in South Korea, including at ports of entry into the country. Ionebio has secured a facility in the United States which can produce 1 million test per day. This PCR has a 20 minute test time.
