Rt Pcr Test Kits Suppliers and Manufacturers

Monkeypox virus real time pcr kit.

m6 pcr test kit.

Covid 19 rapid test kit, covid 19 rt pcr tests, covid 19 antibody.

RT PCR-Detection Kit

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

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.

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.

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%

This is our new product, it is non cold chain transport , it more convenient for transportation and it will be reduce shipping costs. Product performance index 1.Lowest detection line:200 copies/mL Compliance rate of negative reference: 10 negative references were tested, and the test results were all negative; 2.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. 3.Precision reference products: After repeated 20 times, the amplified Ct CV of each fluorescence channel was no more than 5%.Ct CV 5%

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.

* KOREA Brand : 1) GenBody 2) ASAN PHARAM 3) SD BIOSENSOR 4) BIOCREDIT 5) Wells Bio * Test Type : IgG/IgM Antigen, antibody test * Accuracy rate : 92%~95% * Read result time : 5~10 mins * Package : 25 kit + 1 Reagent / 1 box * Price : FOB Korea 8.5 ~ 10.5 USD / 1 kit * MOQ : 10,000 KIT * Payment Terms : T/T 50% advance and Balance SGS inspection * Product Certificate : KFDA, CE, FDA

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

Product Description - COVID-19 Test Kit: ANTIGEN (n) Price of product ( USD price or FOB price) - Quantity dependent Product origin - Switzerland Key Specifications/Special Features - CE Mark: 98% sensitivity; 99% specificity (clinical). Approx.10 minute result time Minimum Order Size and Packaging details - 1000 25 per box, 40 box minimum

Product Description - COVID-19 Test Kit: ANTIGEN (s) Price of product ( USD price or FOB price) - Quantity dependent Product origin - Switzerland Key Specifications/Special Features - CE Mark: 97.69% sensitivity; 99.9% specificity (clinical). Approx.10 minute result time Minimum Order Size and Packaging details - 1000 25 per box, 40 box minimum

Product Description - COVID-19 Test Kit: ANTIBODY Price of product ( USD price or FOB price) - Quantity dependent Product origin - Switzerland Key Specifications/Special Features - CE Mark: 96%/92% sensitivity; 100%/100% specificity (clinical). Approx. 10 minute result time Minimum Order Size and Packaging details - 1000 10 per box, 100 box minimum

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.