Certification - Test Report/CE Daily manufacturer output - TBD Price - $25 Volume dependent
NAME COVID-19 Nucleic Acid Detection Kit(PCR-fluorescent Probe) USE Diagnosis COVID-19 rapidly for public disease control Manual Biological cabinet, Appropriate real time PCR instrument, Appropriate nucleic acid extraction system or kit, Desktop centrifuge ( suitable for 96- well plate or 8-strip tube), Centrifuge with a rotor for 0.2ml reation tubes or plate. Vortex mixer, Adjustable piperres(with maximum capacity of 2 L, 10L, 50L, 100L, and 200L, respectively), Disposible pipette tips with filters, Disposable powder-free gloves, RNase FREE 1.5mL centrifuge tube, PCR reation tube / PCR reaction plate. Storage and Transportation Store in -20 - 5 and transport with carbon diaxide ice, avoid being repeated freezing and thawing. Expiration date 9 months * Please be noted the above is the price including the tax, NOT FOB.
Application Suspected case test in epidemic area Early test of fever clinic and CDC Screening of primary medical institutions Inspection of floating population in public areas Performance Characterisitics Sample tyep: nasal swab Time to result: 15-20 minutes Sensitivity: 97.70% Specificity: 99.84% Accuracy:98.97% Layperson study statistics 99.84% of non-professionals carried out the test without requiring assistance 99.82% of different types of results were interpreted correctly. Parameters: A Short Test Time: 15 mintues B Accuracy: More than 98.1% C Sensitivity: 96.4% Specificity: 100% D Easy operation: Nasal Swab E One Step solution F Lower cost with high efficiency G Package: 1 Test/Kit, 5 Tests/Kit, 25 Tests/Kit H It can detection for Omicron Virus Price and Minumum Quantity Price FOB in USD: 1.5Minimum Order Qty: 500000 Pieces Production Capacity: 100 Million Boxes Per WeekPackaging: 1,5,20,25,40,100,200 Pcs Per Box Sample: Available. Sample Cost Born By Buyer Product Model And Origin Brand: jwfModel: jwf01 Seller Code: Jwf Standards: Ce Competitive Advantages Lower cost with high efficiency Detection for omicron virus Easy operation Short test time Other Details Omicron covid test kit Covid test kit Omicron test card Covid test card
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
Angiten-COVID-19 Virus Test Kit (Colloidal Gold) Quantity of box: 25 persons/box Brand: Easysweet NMPA (National Medical Products Administration): Approved CE: with CE mark BfArM: listed Test Method: Antigen Test Result Time: 10-15 mins Sample Type: Nasal Swab Sensitivity: 96.70% Specificity: 100% Accuracy: 98.94% Shelf Life: 24 months Storage Temperature: 2-30 Degree Celsius Country of Origin: Made in China Additional Information: Production Capacity: 1 million Delivery Time: 10-15 days Packaging Details: 25 tests in a pack, 40packs/ carton Angiten-COVID-19 Virus Test Kit is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19clinical and / or epidemiological criteria. It can be used by professional only. Price and Minumum Quantity Price FOB in USD: NegotiableMinimum Order Qty: 10000 Production Capacity: 1000000Packaging: 25 Persons/box Sample: Available. Sample Cost Born By Buyer Product Model And Origin Brand: Easysweet HS Code: 3822009020 Standards: Ce Competitive Advantages Best price with shortest delivery time Best price with shortest delivery time Best price with shortest delivery time Best price with shortest delivery time Other Details Angiten-covid-19 virus test kit (colloidal gold) Angiten-covid-19 virus test kit (colloidal gold) Angiten-covid-19 virus test kit (colloidal gold) Angiten-covid-19 virus test kit (colloidal gold)
Access Bio Care Start Covid-19 Rapid Antigen Test Kit Product Details: Number of Reactions(Preps) per Kit : 1 Brand : Access Bio Test Method : Antigen Test Result Time (Rapid Kits) : 10 min Sample Type ; Nasal Swab Packaging Size : 20 Test Kits/Box Packaging Type : Box The CareStart COVID-19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within first five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains: GCMS manufactures COVID-19 antigen test kit, the GENEDIA W COVID-19 Ag which is listed on the EU common list, also with GMP and ISO certifications. GENEDIA W COVID-19 Ag is unaffected based on the in-silicon analysis of the mutations in the nucleocapsid (N gene) of Omicron viruses. Letter of statement is available upon your request. To get over COVID-19 pandemic, especially the recent Omicron breakout, currently we are doing big promotions for three kinds of COVID-19 Ag kit. All are in stock and available right away. 1. Nasopharyngeal 2. Nasal 3. Saliva Price and Minumum Quantity Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet Sample: Available. Sample Cost Born By Supplier Product Model And Origin Brand: GENEDIAModel: 643G-S (Saliva) Seller Code: Genedia w covid 19 agHS Code: 3002.15 Standards: Ce Competitive Advantages Allow wider testing with fast test time (10 minutes) All necessary materials provided / no equipment needed Sensitivity: 93.33%, specificity: 100% Free sample. no moq. price is negotiable. customized packing. Other Details 20 tests / kit 24 months from the date of manufacture 2 ~ 30c(35.6 ~ 86f) available for room temperature deliver In stock. fast delivery. 1 x Instructions for Use Manual 40 x Test Cassettes 1 x Buffer 40 x Dropper
Covd-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and dierential detection of IgG and IgM antibodies to 2019 Novel Corona Virus in human whole blood, serum or plasma. Specification.jpg Product: Rapid Diagnostic Test Kit Item: Corona Virus Test Kit Specimen: Whole Blood/Serum/Plasma Format: Strip/Cassette Port of Loading: Shanghai OEM and ODM: OEM/ODM Welcome Shipping: By UPS, FEDEX, DHL, TNT, by air or by sea MOQ for Private label: Low MOQ 1600 boxes, Please contact us. Note: Store this product in a cool and dry place, avoid direct sunlight, stay away from places that children can contact, and avoid eye contact. If you have allergies to this product, please stop using and consult a doctor. COVID-19 Corona Virus Rapid Test Kit11.pngCOVID-19 Corona Virus Rapid Test Kit12.png
RT PCR-Detection Kit
Description This kit utilizes fluorescence quantitative probe-based PCR and guarantees a high specificity to ensure accurate one-step identification of ORF1ab and N genes of 2019-nCoV. The kit offers a highly sensitive test with a limit of detection as low as 500 copies/ml. The results are available within 1.5 hour. Kit Contents (48 Tests /Kit) Dual Enzyme solution A 50 µl Dual Ncvo-O / N reaction solution A 1 ml Dual Ncvo-O / N positive control A 200 µl Dual Negative control A 200µl Applicable equipment ABI series, Bio-Rad, Roche series and other fluorescent real-time PCR instruments. Specimens requirements Specimen type: nasopharyngeal swab from suspected infection; virus cell culture fluid, etc. Basic Protocol 1. Sample preparation. Take the test sample and extract the RNA nucleic acid according to the instructions of the nucleic acid extraction kit. The nucleic acid extraction product should be stored at -20 C. 2. Reaction mixture preparation According to the total number of test samples, the number of PCR reaction tubes needed is. N = number of samples + 1 negative control + 1 positive control. The following protocol is recommended for a 20 µl reaction volume. If the volume of reaction changes, please adjust proportionally. Components Volume Dual Enzyme solution A 1 µl Dual Ncvo-O / N reaction solution A 19µl Final Volume: 20 µl 3. Sample adding. Add 5 µl each of the extracted RNA, positive and of negative control to corresponding reaction tubes. After assembling all the components, cover the tube caps and gently mix the contents of the tube, mix well, and centrifuge briefly. 4. Perform quantitative PCR Place the reaction tube inside a real-time PCR instrument. Set the channel and sample information, reaction system volume 25 µl. Select the following channels: FAM channel for nCOV-ORF1ab, VIC channel for nCOV-N. Perform quantitative PCR using recommended cycling parameters settings: Step Temperature Time Number of cycles Fluorescence Detector 1 50C 15 min 1 Off 2 95C 3 min 1 Off 3 95C 10sec 45 Off 60C 30 sec On Result analysis: 1) Set the baseline: Generally, it is set to 6-15cycle for ABI 7500, 7700 and other instruments, 3-15cycle for PE5700, and 6-12cycle for MJ Research Option2. Under special circumstances, the baseline can be adjusted accordantly. 2) Set the threshold: The threshold line just exceeds the highest point of the negative control amplification curve (random noise line).
ExProbeTM SARS-CoV-2 qPCR Testing Kit EU CE Marked, US FDA EUA Approved, Taiwan FDA EUA Approved Intended Use: To detect RdRP/N/E RNA SARS-CoV-2 (COVID-19) in NP/O swabs and sputum. Product Format: 96 tests/kit Kit Contents: PCR Mix, Enzyme Mix, Pos. Control, Neg. Control and Instruction For Use. Storage / Stability: -20C + 5C / 6 months, repeat freeze thaw x 4. Testing kit is compatible for ABI7500,Roche 4800, TBG Q6000 qPCR Systems Reproducibility / Precision 100% Concordant across 3 lots with CV + 5% Limits of Detection (LOD) 50 copies/reaction Performance Comparison* Positive Samples 5 / 5 Negative Samples 199/200
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.