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.
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.
SARS COV-2 VARIANTS REAL TIME KIT 5 targets. One single reaction tube per sample. Identification of the main SARS Cov-2 variants of concern, UK, South Africa, Brazil, Nigeria, Indian (Delta). Rapid qualitative detection, 45 minutes. Certified CE IVD Full furniture directly.
The KAiRA 2019-nCoV PCR Detection Kit is a one step RT-PCR reagent system, based on real-time PCR technology, for the qualitative detection and differentiation of lineage B-beta Coronavirus and severe acute respiratory syndrome coronavirus 2 specific RNA. The test kit has FDA and CE Approval and comes in packs of 100 tests. In combination with Dr PCR the test results for PCR Testing can be given in under an hour and are compatible for use for international travel requirements. Unit - Kit (1 kit contains 100 tests) Unit Price - $900 per kit
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
The Acculaâ?¢ 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
It has CE certificate 25 test per box
Real - Time OneStep RT-PCR based assay system for detection of 2019-nCoV (CE-IVD)
- 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)
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).
SOGENT PCR (Made in Korea) * Authorized distributor *MOQ: 100K Test * FOB KOREA $3.00/test * CE, FDA Approved
Product Description - COVID-19 Test Kit: PCR Price of product ( USD price or FOB price) - Quantity dependent Product origin - United States Key Specifications/Special Features - FDA and CE: Dry swab: 97% sensitivity; 99% specificity. Lab processed Minimum Order Size and Packaging details - 1000 25 per box, 40 box minimum
Taq DNA Polymerase Carmine Taq PCR Master Mix (With Dye) 2X Taq PCR Smart Mix without dye
This kit is used to qualitatively detect in vitro suspected cases of pneumonitis infected by a new type of coronavirus. The PCR reaction solution contains 2 sets of specific primers and fluorescent probes for specific detection of targets, and an additional set of specific primers and fluorescent probes is used as the internal standard control of the kit for detecting endogenous housekeeping genes. Lowest detection line:200copy/mL Specificity: this kit has no cross-reaction with hepatitis B virus, hepatitis C virus, staphylococcus aureus, gram-positive bacteria, shigella bacillus, influenza A, influenza B, enterovirus and human genome DNA/RNA. Precision reference products: After repeated 20 times, the amplified Ct CV of each fluorescence channel was no more than 5%.Ct CV 5%
