- 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
RT PCR-Detection Kit
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.
This product is the rapid testing of COVID-19, the result come out within 10 minutes.
[Intended Usage] This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites. [Storage Conditions & Validity] 1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box. 2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times. 3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period. [Applicable Instruments] 1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument. 2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support. NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels. [Sample Requirements] 1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices. [Test Results Interpretation] 1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements. 2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition. 3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample. [Product Performance Index] 1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%. 2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%. 3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL. [CE Mark Registration No.]: RPS/499/2021. [EC REP.]: CMC MEDICAL DEVICES & DRUGS S.L. C/ Horacio Lengo n18, C.P 29006, Milaga, Spain.
RT PCR TEST KITS FOR COVID ARE AVAILABLE DIRECTLY FROM MANUFACTURERS IN SOUTH KOREA. No intermediaries. Please contact For quotes only if you are a buyer.
OUR AUTHORIZED BIO TECH FATORY HAD QUICKLY TEST KIT (Saliva in 10 minutes 94.6-99.7% accurate, the world's most advanced, Europe, Canada, big seller) ANS PCR FROM SOUTH Korea Pls Send The Loi To Long Turn International Consulting Group Ltd
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.
Product Description : The PaxView COVID -19 real-time RT-PCR Kit detects the novel coronavirus, COVID-19 using one-step real-time RT-PCR in a single tube intended for in vitro diagnostic use. The target genes for the detecton 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 set targeting the human RNase P gene that serves as an internal positive control for the real-time RT-PCR. Price of product ( USD price or FOB price) : 1no testing 20 USD 1kit testing = 96no testing 1kit = 96no * 24 USD = 2208 USD (base on Qty negociable) Product origin ; korea Key Specifications/Special Features : 1. with in 3hour testing result in come 2. One item 96person can check 3. 100% correct result coming then other method 4. It is same process in korea Minimum Order Size and Packgaing details : 50kit in box 500 x 460 x350 6kg MOQ : 500
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: 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
The 2019-nCoV Ag Saliva Rapid Test is a lateral flow immunoassav intended for the qualitative detection of nucleocapsid protein antigen from2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset
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