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
One-step real-time-PCR test for qualitative detection of genetic material of SARS-CoV-2 virus in upper and lower respiratory specimens collected from individuals suspected of COVID-19 infection. Targets the RdRp gene and E gene. Products with high specificity and sensitivity for accurate and reliable results.
For in vitro qualitative detect of Covid-19 antigen in nasal(NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of the onset of the symptoms. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing. 1.Easy to collect samples simple operation without professional equipment. 2.The test results are available in 15 minutes, and the test results are clearly visible. 3.Convenient transportation and low price, higher accuracy. 4.Suitable for large-scale rapid screening. Shelf life: 24 Months Test Result time: 10 Mins Packing: 25 Pieces per Box
Test Kit for self test 1 test/ 5 tests/ 20 test per kit
Test Kit for professional use 1 test/ 5 tests/ 20 test per kit
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
Intended use: AIVD COVID-19(SARS-CoV-2) IgG/IgM Rapid Test is a single use, rapid device for qualitative detection of total antibodies against 2019 novel coronavirus (SARS-CoV-2) in human serum, plasma or whole blood specimens. The kit is intended for screening of patients suspected for infection with SARS-CoV-2, and as an aid in the diagnosis of the coronavirus disease 2019 (COVID-19). Descriptionï¼? Novel coronavirus pneumonia (NCP) or SARS-COV-2, that was officially named by the WHO as â??Corona virus disease 2019â?? (COVID-19), is a respiratory infection caused by a new virus that was first identified in late 2019. IgM/IgG Rapid Kit can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness. This kit utilizes the principle of colloidal gold immunochromatography to qualitatively detect the new coronavirus (COVID-19) IgG / IgM antibodies in human serum and plasma. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well, and then add the required amount of a diluent. The IgG / IgM antibodies in the sample will interact with the colloidal gold-labeled COVID-19 recombinant antigen on the conjugate pad. Then the conjugate pad will release re-solubilized conjugate onto the nitrocellulose membrane. The nitrocellulose membrane (NC membrane) diffuses it forward. As the sample moves along the device binding reagents situated on the nitrocellulose membrane bind to the target at the test line. If the sample contains a COVID-19 IgG antibodies, they will bind to the colloidal gold-labeled novel coronavirus recombinant antigen, diffuse forward, and then react with the anti-human IgG antibodies immobilized on the NC membrane detection line (T2 line). Similarly, if the specimen contains IgM antibodies to COVID-19, the antibodies will react with antigen-coated particles, the conjugate migrate laterally forward, and cause a colored line (T1 line). The darker the color of colloidal gold on the test line, the higher the concentration antibodies to COVID-19 in the sample. Accuracy:ï¼?> 90% Specificity: 97% Basic Protocolï¼? 1. Remove the test specimen, required reagents from storage conditions, and equilibrate to room temperature. 2. Unpack the aluminum foil bag, place the test horizontally on the table and number it. 3. Add 10ul serum, plasma or whole blood sample to the sample well with a pipette or a dropper. Slowly add 2 drops of sample dilution (about 60uL) to the sample well. 4. Read the results within 10-15 minutes after adding the sample, and the results will be invalid after 30 minutes.
AIVD Biotechs COVID-19 Ag test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein (NP) antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19. Description This kit utilizes the principle of latex bead immunochromatography to qualitatively detect the new coronavirus (COVID-19) Np antigen in human nasal swabs. Lateral flow immunochromatographic assay provides an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. The test contains latex bead conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible band appears on the test lines (T) as antibody-antigen-antibody latex bead complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly. This method does not require expensive medical instruments and consumables. Just take the specimen and add it to the sample well. If sample contains the antigen, it will interact with the latex bead-labeled COVID-19 anti-SARS-COV-2 NP antibodies on the conjugate pad. Required components 1. A foil pouch with a desiccant and a single-use test card, 1 piece 3. Sterile swab, 1 piece 3. Extraction buffer tube (1 ml), 1 tube. 4. Instructions for use, 1 piece. Specimen requirements: 1. Nasopharyngeal swab specimen. 2.Specimen should be tested as soon as possible upon collection. If the sample has to be stored, store the swab sample at room temperature for up to 1 hour or 2~8â?? for up to 4 hours prior to testing. Specimen preparation 1. Insert the extraction buffer tube into the tube rack, make sure that the sample tube is firmly upright and touches the bottom of the rack. 2. Insert the swab into an extraction buffer tube. 3. Gently stir the swab in the tube, and then left swab inside the tube for 1 minute or Mix on the vortex mixer for about 30 seconds, 4. The sample should be tested immediately after collection. If it cannot be tested in time, it should be stored in the virus transport matrix. The specimens can be stored at 2-8C for 4 hours Basic Protocol Step 1: If the sample is refrigerated, remove the sample to be tested and the required reagents from the storage conditions, equilibrate to room temperature (15~30C) Step 2: When preparing to test, open the aluminum foil bag, take out the test card, and lay it flat on a table. Step 3: Mark the sample number on the test card, Step 4: Using pipette add 50ul of the sample into a sample well on the device, Step 5: Read the result within 15 minutes, Please read the result after 15 minutes. After observing and recording the result, please discard the test card to avoid affecting the result judgment. Do not read test results after 30 minutes. It may give false results.
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
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.
Pathodetect 2019- nCov Detectioin kit offer an in virto diagnostic real time PCR assay for qualitative detection of 2019 - Novel Coronavirus RNA in respiratory specimens and sera. The kit offer the universal detection of SARS- Like coronavirus and specific detection of 2019-nCOv. Mylab Discovery solutions 2019-nCoV Detection Kit provides ready to use solution for detection of coronavirus using real time PCR technology. Detection is based on the amplification of a specific conserved RNA sequences of coronavirus and detection by Taqman probe-based chemistry. An Internal control is detected along with the coronavirus target controlling the extraction efficacy and possible PCR inhibition. The test is designed to use across wide range of PCR platforms. The recommended CDC protocol for coronavirus detection ensures that the kit leads to highly-specific and ultrasensitive results in short time. KIT CONTENTS Reagents for Nucleic acid extraction from respiratory/sera specimens Reagents for Real time PCR Inclusion of synthetic positive and negative controls
- 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)
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.
RTPCR testing kits are used for testing golden test processes to detect Covid19 viruses in patients.
Anti-SARS-CoV-2 Rapid Test, COVID-19 1. Easier: No special equipment needed, Intuitive visual interpretation. 2. Rapid: Quick sampling by fingertip blood, Results in 10-15min. 3. Accurate: Results with IgG and IgM respectively. 4. Application: as screening tool for potential suspect patients in large numbers. Testing kit is FDA Emergency Use Authorization (EUA) Approved Testing kit is CE MARKED-IVD * Instruction for Use * Interpretation Guide * SARS-CoV-2 immunoassays * Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit * Anti-SARS Rapid Test Brochure * COVID-19 Catalog * EUA Approval Letter * Fact Sheet for Healthcare Providers * FDA Letter * Fact Sheet for Recipients * FAQ * CE IVD Notification Certificate Antibody Performance Measure Estimate of Performance 95% Confidence Interval IgM Sensitivity (PPA) 95.7% (289/302) (92.8%; 97.5%) IgM Specificity (NPA) 99.7% (311/312) (98.2%; 99.9%) IgG Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%) IgG Specificity (NPA) 99.4% (310/312) (97.7%; 99.8%) Combined Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%) Combined Specificity (NPA) 99% (309/312) (97.2%; 99.7%) Combined PPV at prevalence = 5% 84.4% (64.6%; 94.6%) Combined NPV at prevalence = 5% 99.9% (99.8%; 100%) Testing kit is FDA Emergency Use Authorization (EUA) Approved Testing kit is CE MARKED-IVD * Instruction for Use * Interpretation Guide * SARS-CoV-2 immunoassays * Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit * Anti-SARS Rapid Test Brochure * COVID-19 Catalog * EUA Approval Letter * Fact Sheet for Healthcare Providers * FDA Letter * Fact Sheet for Recipients * FAQ * CE IVD Notification Certificate
SARS-CoV-19 IgG/IgM test kit (15min showing result) Manufacturer: Guangzhou Wanfo Biotech Co., Ltd. a China listing company Certificates: CE certificate, China NMPA approval (export allowed), no FDA approval The price is $5.5/test (FOB) Max delivered quantity: 100,000/weekly More details please enquire Barry Liu whatsapp: +8617810331113 sample available: 20 test & DHL delivery: $200 Download introductions: https://kdocs.cn/l/sLLC9O6rc
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.
Test Kit for self test (nasal swab) 1 test/ 5 tests/ 20 test per kit