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.
- 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)
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).
COVID-19 RT-PCR TEST - NO RNA PURIFICATION NEEDED!
Results in less than 60 minutes, very easy-to-use.
Made in USA, with clinical validations all over the world.
FDA-EUA approved and CE cleared.
Sample Types :
Including Nasopharyngeal swab, Oropharyngeal swab, Sputum
Controls :
Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results
Product Information
Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.
Authorized Laboratories
Laboratories certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests.
About Emergency Use Authorization
(EUA)
This test (1) has not been FDA cleared or approved, (2) has been authorized by
FDA under an EUA for use by authorized laboratories, (3) has been authorized
only for the detection of nucleic acid from SARS-CoV-2, not for any other
viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.360bbb-3(b)(1), unless the authorization
is terminated or revoked sooner.
