Cov Inu Rt Pcr Kit Suppliers and Manufacturers

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.

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.

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).

RT PCR-Detection Kit

The COVID-19 RT-PCRT est is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test can be run in a singleplex format (three individual assays) or multiplexed into a single reaction and amplification set up.

RTPCR testing kits are used for testing golden test processes to detect Covid19 viruses in patients.

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

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

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.

Lowest detection line:200 copy/ml CE marks

25 tests per box

Intended Use Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in oropharyngeal swabs and bronchoalveolar lavage fluid collected form individuals suspected of COVID-19 by their healthcare provider. About SARS-CoV-2 Specific antibodies will be produced within days to weeks as the immune system makes immune defense against the SARS-CoV-2 infection. Total antibody detection is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical symptoms and result of other diagnostic methods. The test result should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection. Total antibody may not be detected in the first few days of infection. SARS-CoV-2 neutralizing antibody is a protective soluble protein secreted by adaptive immunizing cells after inoculation with SARS-CoV-2 vaccine or infection with SARS-CoV-2. These antibodies can specific bind with virus RNA binding domain (RBD) to block the binding of RBD with angiotensin-converting enzyme 2 (ACE2) on human cells surface, thus prevent the virus or its genetic material into the human cell and virus infection. Benifits of the Kit 1) Room Temperature Transportation 2) Cost-Effective Shipping The shipping is at room temperature, with no need of cold chain shipping. 3) Highly Sensitive, Highly Specific Highly sensitive and highly specific for 2019-nCoV, reliable identification of COVID-19. 4) Environmentally Friendly The kit needs neither bulky packaging nor cold chain shipping. Contents A kit contains: Package specifications: 24 tests/kit, 48 tests/kit 1) 2019-nCoV-PCR Master Mix (Lyophilized Powder): 1 bottle/box 2) 2019-nCoV-PCR Positive Control (Lyophilized Powder):1 bottle/box 3) 2019-nCoV Diluent: 1 bottle/box 4) User Manual Note: Do not mix or interchange different batches of kits.

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.

Molecular Diagnostic / RT-PCR Quality Control Kit Cobas Liat SARS-CoV-2 and Influenza A / B Positive Level / Negative Level 3 X 0.25 mL / 3 X 10 µL / 3 X 0.3 mL UOM: 1/KT Product Number: 09211128190 Manufacturer: Roche

WE CAN PROVIDE YOU PCR KIT AT PRICE: $1.20/KIT IN BULK QUANTITY VALIDITY: DECEMBER 2023 PRICE: FOB/ CIF (AVAILABLE) QUANTITY AVAILABILITY: 400,000 PCS

- RT-PCR Test Kit Manufactured from South Korea - FDA EUA - CE - ISO - 1 Kit = 100 Tests - MOQ = 30,000 Tests or 300 Kits - Price is $11.00 per test or $1,100 per test kit

Cat No : RP10243X. Detection of COVID-19 specific target genes in a single tube- Reliable result with three target genes- Results within 1 hour and 50 minutes after extraction- Convenient work now on the automated MDx platform- Suitable for high-throughput- Providing whole process control for assay validity- Automated data interpretation with Seegene Viewer.