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.
The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in 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) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C.
263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper and lower respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infective status. The agent detected may not be
the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The COVID-19 RT-PCR Detection Kit is intended for use by qualified trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-19 RT-PCR Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization.
PRINCIPLE OF DETECTION
This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will
be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N
gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel.
dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products.
Internal reference is used in the kit for quality control starting from sample collection
Indication: Qualitative detection of nucleic acid from SARS-CoV-2 in 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) from individuals suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high
complexity tests.
This letter is in response to your1 request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3). On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and, 3. There is no adequate, approved, and available alternative to the emergency use of your
product.
4
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.
Commodity: Covid-19 RT-PCR Detection Kit
Spec.96 tests/kit
Price:FOB SHANGHAI USD3.30/test, USD316.8/kit
$3.60/TEST CIF NY AIRPORT OR OTHER MAJOR AIRPORTS USA OR EUROPE OR S. AMERICA OR MIDDLE EAST
Payment: T/T ADVANCE 50% BALANCE BEFORE DEPARTURE OR Sight Irrevocable TRANSFERABLE LC Delivery: By AIR, 50days after receipt and confirmation of LC
Our test kit has been approved and endorsed by Singapore's MOH (Ministry of Health) and HSA (Health Science Authority) since last year and we have been constantly supplying to the APAC countries during this period. (Japan, India, Singapore, Malaysia, Indonesia and etc.)
* CE mark was attained in December 2020. *
Our Tepat 1.0 SARS-CoV-2 RT-PCR provides for high-throughput, sensitive and specific detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs*.
It can detect 6 copies of viral RNA per reaction with > 95% confidence. Clinical validation shows 100% sensitivity, with no cross-reaction with non-SARS-CoV-2 species.
Key Highlights
1.5 hours from RNA to results
Multiplex RdRp and M viral genes detection enhances sensitivity and specificity
100% coverage with 100% identity of all SARS-CoV-2 genomes in the world
Detects 6 copies of viral RNA
Whole process control: human RNase P
!!!!!!!!!!Buy 40000 Test will free one machine !!!!!!!!
Economical
Practical
Stable and accurate heating and temperature control system
Excellent optical system
Powerful comprehensive performance
Capacity
96x 0.2ml tubes (low profile and standard)
slides tube,
1x 96-well microplate
Dynamic range 1~1010 Copies
Applied probe
1st channel: FAM/ SYBR-Green
2nd channel: HEX, JOE, VIC, TET
3rd channel: ROX Texas -Red
4th channel: CY5
Test method four-fold fluorescence detection
Thermal cycle temperature control semiconductor thermoelectric module
Temperature Range 4.0�°C - 99.0�°C
Heating and cooling Rate â?¥1.5�°C/sec
Thermal Accuracy â?¤0.5�°C (at 90�°C)
Thermal Uniformity â?¤0.5�°C (at 90�°C)
Hot cover temperature range 50�°C - 108�°C
Optical detection excitation wavelength 300-800nm
Detection wavelength 500-800nm
Fluorescence repeatability CVâ?¤ 3%
Fluorescent linearity râ?¥0.99 coefficient of correlation
Software application genotyping by qualitative, absolute quantitative, standard solution curve, relative quantitative and endpoint method
Scanning method full plate, specified rank scanning
Data export format Excel, CVS
Custom report form support
The operating system Window 7/8/8.1/10
Minimum computer configuration Intel or AMD Dual-2.8GHz, more than 4G memory and 128GB
Power Supply AC 220V~, 50Hz, <800VA
Communication Ports RS232, USB
Size 490mmX355mmX284mm
Weight 20Kg
ThermoFisher Scientific Accula System Rapid & Reliable RT-PCR Test for Corona in 30mins
Product Details:
Number of Reactions(Preps)/Kit : 25
Brand : Thermo
Test Method : (SARS-CoV-2) RT-PCR
Sample Type : Nasal Swab
Test Time 30 min
The Accula System from Thermo Fisher Scientific is a rapid diagnostic platform that combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Acculaâ?¢ SARS-CoV-2 Test has received an Emergency Use Authorization (EUA) from the FDA for the detection of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA) waived environments. Designed for use with the palm-sized Accula Dock, the Accula SARS-CoV-2 Test provides reliable, qualitative results in approximately 30 minutes
Product Details:
Brand : Applied Biosystems
Model Name/Number : QuantStudio 7 Flex
Sample Capacity/Format 48 wells
Volume Thermal Block Sample : 0.2 mL
No of Channel : 4
Features:
Increased application versatility through the accomodation of 4 different block types
Compatible with over 8 million TaqMan�® assays for gene expression, genetic variation, gene regulation, or protein expression experiments
The intelligent design of the QuantStudioâ?¢ platform combined with Applied Biosystem instrument reliability and accuracy
Easy-to-use software, responsive touch-screen, automation capabilities, and effortless block exchange without the need for any tools
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