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).
Test Covid19 with CE
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.
This kit is intended for qualiativein vitro detection of Orf1ab and N genes of Novel Coronavirus 2019-nCoV which are found in throat swab,sputum and alveolar lavage fuid samples of suspected cases of pneumonia,suspected cases of clustering and other patients who need to carry out diagnosis or differential diagnosis of Novel Coronavirus 2019-nCoV infection.
Lowest detection line:200 copy/ml CE marks
25 tests per box
2X Real-Time PCR Master Mix including SYBR Green in Mixture 2X HRM Master mix
- In vitro diagnostics(IVD) Kits - Designed for the qualitative detection of COVID-19 viral RNA - Oropharyngeal swab, nasopharyngeal swab, sputum and bronchoalveolar lavage (BAL) - Store at -25~ -15 Product description: Detects the novel coronavirus. COVID-19 using one-step real-time RT-PCR in a single tube. The target genes for the detection of the virus are Orf1ab and N gene. The sequence of primers and probes for the amplification were adapted from sources published by China CDC and WHO. The kit includes primers and probe for the amplification of the human RNase P gene that serves as an internal positive control for the real-time RT-PCR. Compatible real-time PCR machines: CFX96(Bio-Rad), ABI 7500/7500Fast(Thermo Fisher Scientific), SLAN-96S(Hongshi), Rotor-Gene Q(QIAGEN)
Cov-inu RT-PCR kit is a probe based Real Time PCR test designed for the qualitative de- tection of SARS-CoV-2 Coronavirus, the etiological agent of COVID-2019 and A + B Group Inuenza virus (orthomyxovirus). It is used to detect S- M2 ve NS1 genes in viral RNA. Description of the Kit Cov-inu RT PCR Kit is a multiplex PCR kit that is used for the simultaneous detection of COVID-19 agent SARS-COV-2 and Inuenza A and Inuenza B viruses from the same sample. Coronaviruses are a large family of viruses that cause infections in humans and other mammals (such as camels, cats, dogs, and bats). The SARS-CoV-2 virus is a new coronavirus that was identified by the World Health Organization (WHO) (1) on February 11, 2020. Inuenza is caused by three types of immunological RNA viruses (A, B and C) in the Orthomyxoviridae family. Seasonal inuenza is typically caused by three main hem- agglutinin subtypes (H1, H2, and H3) and two neuraminidase subtypes (N1 and N2). It is important that public health laboratories around the world conduct detailed surveillance to monitor the spread and impact of the pandemic H1N1 2009 virus, as well as predict future changes in virulence (4). Therefore, methods for rapid diagnosis, case detection and follow-up of this new pathogen in the human population are necessary to develop appropriate management strategies to reduce morbidity and mortality. The test works with single-stage real time reverse transcriptase polymerase chain reaction (On- eStep RT-PCR) with serum, lower respiratory tract samples (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract samples (e.g. nasopharyngeal uids, nasal swab) from individuals who demonstrate clinical criteria set for COVID-19 by WHO (2) and CDC (Center for Disease Control and Prevention) (3). This kit is an In-vitro diagnostic kit using specific primers designed for qualitative detection of genomic RNAs of SARS-CoV-2, Inuenza A and Inuenza B virus.