Pathodetect 2019- nCov Detectioin kit offer an in virto diagnostic real time PCR assay for qualitative detection of 2019 - Novel Coronavirus RNA in respiratory specimens and sera. The kit offer the universal detection of SARS- Like coronavirus and specific detection of 2019-nCOv. Mylab Discovery solutions 2019-nCoV Detection Kit provides ready to use solution for detection of coronavirus using real time PCR technology. Detection is based on the amplification of a specific conserved RNA sequences of coronavirus and detection by Taqman probe-based chemistry. An Internal control is detected along with the coronavirus target controlling the extraction efficacy and possible PCR inhibition. The test is designed to use across wide range of PCR platforms. The recommended CDC protocol for coronavirus detection ensures that the kit leads to highly-specific and ultrasensitive results in short time. KIT CONTENTS Reagents for Nucleic acid extraction from respiratory/sera specimens Reagents for Real time PCR Inclusion of synthetic positive and negative controls
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Vannin Healthcare offers several effective COVID-19 tests: SGTi-flex COVID-19 IgM/IgG (25 tests per kit) STANDARD Q COVID-19 IgM/IgG Duo Test (40 tests per kit) Anti-SARS-CoV-2 Rapid Test (50 tests per kit) General Features Can detect and differentiate between IgM and IgG antibodies Convenient: no additional equipment necessary Extremely fast: results in 10-15 minutes Point-of-care testing Allow rapid decision-making in high-stakes situations Why our tests Certified: CE-IVD marked, FDA-cleared, ISO 13485, Korea GMP-certified Reliable: high clinical specificity and selectivity Easy to interpret Can detect antibodies even in asymptomatic patients Vannin Healthcare Global offers various diagnostic and serology tests for identifying the presence of Severe Acute Respiratory Syndrome Coronavirus2 (SARS-CoV-2). SARS-CoV-2 is the virus that causes COVID-19 which means that its presence could indicate that a person has been infected. There are two types of tests currently used to determine the presence of the virus: Molecular diagnostic tests or viral tests (Swab tests) Antibody serology tests (Blood tests) Vannin Healthcare Global's Serology Tests To find out whether antibodies are present in an obtained sample (whole blood, plasma, or serum), serology tests are used. The presence of antibodies could indicate a past infection. And depending on the type of the immunoglobulins present, it could also determine the approximate time when the infection occurred. After fighting a coronavirus, our bodies are likely to produce two classes of antibodies: IgM and IgG. In the case of SARS-CoV-2, both IgM and IgG are most likely to occur simultaneously within two to three weeks after a person's been infected. For a firmer diagnosis, Vannin Healthcare Global offers serology tests that check for both IgM and IgG antibodies. Can detect and differentiate between IgM and IgG antibodies Differentiating between the antibodies is crucial when it comes to providing proper medical advice to your patients. The appearance of IgM antibodies is the initial response of the organism fighting to suppress the virus. These antibodies could indicate that the patient is still infectious, and advising patients to self-isolate is the appropriate course of action. IgG antibodies can be detected in the blood sample usually within7-10 days after the onset of infection. If a patient has IgG antibodies, and no IgM antibodies, they have developed a temporary immunity to COVID-19. No additional equipment necessary The test design makes it a perfect choice for remote areas without access to fully-equipped laboratories. Simply obtain a blood sample from a patient, and add 10�µl into the appropriate place on the testing cassette along with three drops (90µl) of the buffer. The results will appear in 10-15 minutes.
FAST: Results in under 2 minutes ACCURATE: 99.9% specificity and 98.7% sensitivity EASY TO USE: Convenient for testing at home PAINLESS: Simple and painless saliva collection RELIABLE: 24-Hour RT-PCR Confirmation (100% specific and 100% sensitive) 99.9% specificity. Test specificity this high ensures that almost all the people who are not infected get a negative test result with the Sensiva React Rapid Covid-19 Testing Kit. Using a fast and accurate test such as this one is vital when we are trying to stop virus transmission and protect general health. 98.7% sensitivity Test sensitivity refers to the percentage of infected people who get a positive test result. In our case that means that 98.7% of people with an infection get a positive test result. How to use it? Step 1 â?? Do the test Sensiva React Rapid Test is a simple test that can be� easily done at home. It is convenient and� painless� since it requires you to collect a saliva sample instead of a nasal swab. How to do it? First, use the mobile application to scan the QR code to register. After that, collect a saliva sample and add it into the saliva hole in the reader device before adding the liquid solution. You will be able to interpret your� results in under 2 minutes. Watch a video with detailed instructions on how to do the test in the video below. Please follow the instructions carefully to obtain a valid test result. Step 2 â?? Get RT-PCR confirmation in 24 hours You can use the prepaid shipping label and send the saliva sample used for the rapid test to us. You will get an official PCR result (100% sensitivity and 100% specificity) in 24 hours. Our lab is certified under the Clinical Laboratory Improvement Amendments (CLIA), so you can rely on us to provide you with accurate and reliable test results. Who is Sensiva React Rapid Covid-19 Test for? Sensiva React Rapid Covid-19 Test is designed for patients with COVID-19 symptoms or those who are asymptomatic but suspected of having exposure. Its easy-to-follow instructions make it convenient for testing at home. The kit contains: (1) Specimen Tube (1) Saliva Funnel (1) Dropper (1) Bio-hazard bag with absorbent pad (1) Lateral flow device (1) 5ml EZ-Tear Saline Solution (1) 0.3ml EZ-Tear Buffer Solution (1) Written Instruction Card
Covid -19 Test Kit (Colloidal Gold Method) For Self-testing Use (Nasal Swab) Top 10 In China Having Ce Mark For Rapid Covid - 19 Antigen Self-test Precise Rapid Sensitive For At-home Testing For Early Detection Able To Sell Across All Eu Member States
USD$18.00 AccuPowe COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 infections, detects SARS-CoV-2 (E gene and RdRp gene) RNA from a suspected infection patient's sample (such as sputum, nasopharyngeal swab, oropharyngeal swab) through Real-Time Polymerase chain reaction(PCR) using ExiStation Universal MDx system. Validated to: Bio-Rad CFX96 ABI 7500 Fast Target Genes: Rdrp, E
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
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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.
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
One-step real-time-PCR test for qualitative detection of genetic material of SARS-CoV-2 virus in upper and lower respiratory specimens collected from individuals suspected of COVID-19 infection. Targets the RdRp gene and E gene. Products with high specificity and sensitivity for accurate and reliable results.
Brand: LAB Genomics Product name: Labgun Covid-19 RT-PCR Kit Order Type: future / at once Product Type: PCR based Detection kit Season: 2020
RT PCR-Detection Kit
