SARS-CoV-2 IgG/IgM Rapid Test Kit Intended Use: To detect IgM and IgG antibodies against N and S protein of SARS-CoV-2 in whole blood, serum and plasma Product Format: 25 tests/kit Kit Contents: test card, diluent, capillary, lancet, and instruction for use. Storage/Stability: 2 C to 30C for 12 months.� eproducibility /Precision 100% Concordant across 3 lots with CV ±5% Performance Comparison (A) China Validation Test Positive Samples 100 / 102 Sensitivity: 98.04% Negative Samples 491/492 Specificity: 99.80% Overall Accuracy: 99.49% Performance Comparison (B) Positive Samples 23 / 25 Sensitivity: 92% Negative Samples 25 / 25 Specificity: 100% Overall Accuracy: 96%
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
The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C). During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad. Theconjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area. If it is a negative sample, there is not a purple-red band appeared in the M and G test area. Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.
1. Nasopharynx swab specimen, non-invasive 2. Very simple to use 3. Convenient, no devices required 4. Rapid, results within 20 minutes 5. Cost-efficient 6:Listed on German BfArm ,got approval by PEI Clinical report from local CDC Sensitivity is 97.14%, Specificity is 100%, total accuracy rate is 99.68%.
Sensitivity: 95.06% Specificity: 99.62% Content of each kit: Test card (innovative and unique system), detailed instructions for use, sterile disposable swab, reactive solution for sample treatment, illustrative manual for use and operation. General characteristics: CE self-diagnostic certification, holographic security label with individual code for authenticity verification, non-invasive, easy to use, no prescription required, rapid results in less than 15 minutes, high precision. Sale restrictions: Exclusive sale to pharmacies, authorized companies, pharmaceutical distribution, socio-sanitary establishments, health establishments, occupational risk prevention, public organizations and health professionals. Restricted sale to individuals. Sale subject to the provisions of Royal Decree 588/2021, of July 20, which modifies Royal Decree 1662/2000, of September 29, on medical devices for "in vitro" diagnosis, in order to regulate the sale to the public and the advertising of covid-19 self-diagnosis products. Sale subject in relation to tax matters to the provisions of Royal Legislative Decree 35/2020, of December 22, seventh final provision. Applicable tax rate of Value Added Tax to deliveries, imports and intra-community acquisitions of certain goods and provision of services necessary to combat the effects of SARS-CoV-2 as well as for the purposes of the special regime of the equivalence surcharge .
BOSON RAPID SARS CoV-2 Antigen Test Card (Self Test) Manufactured by Xiamen Boson Biotech Co., Ltd. DHSC - UK Approved - 3rd Phase Approved. NASAL TEST CE & ISO Approved Full Home Test - Self Test Approval for UK and Europe Test Result in 15 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 Each Test have Unique Identifier Number - Easy to track Approved By - UK, Germany, France, Spain, Netherlands, Greece, Belgium, Italy, Portugal. 1 Test / Kit Catalog No.: 1N40C5-2 Kit Components: 1 Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 sterilized swab 1 extraction tube 1 sample extraction buffer IFU Tube holder on back of box Box / Carton Specifications : 1 Test / Kit Box size - 190*60*15 mm Carton size - 42*42*33 cm Carton gross weight - 9.9 kg 250 tests (boxes) / carton Euro 1.12
PocRoc SARS-CoV-2 Antigen Rapid Test Kit (TRFIA) is intended for qualitative detection of SARS-CoV-2 nucleocapsid antigen from NS specimen or VTM sample without guanidine -Target: nucleocapsid antigen -Specimens: Nasal Swab (NS) /Oropharynge al Swab(OP) Virus Transport Medium (VTM) - Time: Specimen lysis time: 1min; Detection Time: 15min -Instrument: LTRIC-300,LTRIC-600,UV Flashlight -Shelf Time: 18months -LoD: Estimated 25 TCID50/Swab
The FlowFlex Rapid Antigen Test uses the latest patented technology to detect proteins in nasal samples, ensuring that it can detect all strains of the COVID-19 virus within just 15 minutes. Using a simple nasal swab with 2cm of the nose - it makes it extremely easy to personally administer an accurate lateral flow test without medical supervision. Each individually packaged kit comes complete with: 1 x Test Cassette 1 x Extraction Buffer Tube with Reagent 1 x Disposable Swab 1 x Waste Bag 1 x Package Insert Performance Efficacy: Relative Sensitivity: 97.1% (83.8%-99.9%)* Relative Specificity: 99.6% (97.7%-99.9%)* Accuracy: 99.3% (97.5%-99.9%)* *95% Confidence Intervals
The lab indicated that the recombinant protein of Indian mutant (B.1.617.2), A.23.1(Unit Kingdom), AT.1 (Russia), B.1.1.7(Unit Kingdom), B.1.351 (South Africa), B.1.616 (France), B.1.621 (Colombia), C.36 (Egypt), C.37 (Peru), P.1 (Japan/Brazil), P.2 (Brazil) can be detected by Jinwofu SARS-CoV-2 Antigen Test Kit. For the newly descovered mutant Omicron(B.1.1.529), we performed sequence alignment analysis on its mutation sites, and found that all the mutation sites were outside the epitope region recognized by the monoclonal antibody selected by our company. By bioinformatics analysis, Jinwofu SARS-CoV-2 Antigen Test Kit can also effectively detect mutant Omicron(B.1.1529)
ANTIGEN RAPID TEST Price 6.5 EUR + VAT We send a POL after receiving the LOI. We deliver in Europe only. Only for Hospitals. More information? The new VivaDiag SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab,oropharyngeal swab or nasopharyngeal swab specimen. The test is for in vitro diagnostic use only. Special features: For nasal or throat swab samples CE marked Professional Use Only High Sensitivity Short Turnout Time High Specificity Test Principle: Colloidal gold Sample Type: Nasal swab, oropharyngeal swab or nasopharyngeal swab Sample Volume: 60 L Test Time: 15 min
SARS-CoV-2 Antigen Rapid Test Cassette 1 pcs/pack, 25pcs/pack available saliva, nasal, nasopharengeal Products are in European common list. High sensitivity and specificity All documents available to sell in EU We have tests with multilingual instructions manual. English, Bulgarian, Romanian, Greece, Spanish and Italian. Available for immediate shipping. Delivery to all European countries in 4-10 days.
FlowFlex Sars-CoV-2 Antigen Rapid Test Self Test - Single Pack The Flowflex SARS-CoV-2 Antigen Rapid Lateral FlowTest is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection by their healthcare provider within the first seven days of the onset of symptoms. Supplied in a single pack Cassette Format Detects the nucleocapsid protein antigen from SARS-CoV-2 Nasal Specimen sample. Anterior Nares Only Test (2-4cm inside the nostril) Results in 15 minutes CE Marked for Self Test Used by NHS track and trace as home test Unique ID QR code number on each cassette Pack Contents 1 x Test Cassette with QR code and unique ID number 1 x Extraction Buffer Tube 1 x Disposable Swab 1 x Waste Bag 1 x Package Insert Features: Fully Home Use Approved FDA Approved Validation from Public Health England Porton Down. Full Home Test Approval Granted in the UK & EU Registered with MHRA and CE Marked. Used and trusted by companies around the world including all UK airports and the NHS.
Cat. No : 9901-NCOV-01G. Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment.
Product Details: Number of Reactions(Preps)/Kit : 25 Brand : Roche ICMR Approved : Yes Test Method : Antigen Test Result Time (Rapid Kits) : 10-15 mins Cat. No : 9901-NCOV-01G Reliable, rapid chromatographic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment
Self-test received notified body approved CE Marking on April 1, 2021 A home test for the rapid qualitative detection of SARS-Cov-2 virus antigen in anterior nasal swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 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. Specifications 1 Test/kit Catalog No.: 1N40C5-2 Kit components: 1 Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 sterilized swab 1 extraction tube 1 sample extraction buffer IFU Tube holder on back of box 5 Tests/Kit Catalog No.: 1N40C5-4 Kit components: 5 Rapid SARS-Cov-2 Antigen Test Card (sealed foil pouch) 5 Sterilized swabs 5 extraction tubes 5 sample extraction buffer IFU 1 tube stand 20 Tests/Kit Catalog No.: 1N40C5-6 Kit components: 20 Rapid SARS-Cov-2 Antigen Test Card (sealed foil pouch) 20 Sterilized swabs 20 extraction tubes 20 sample extraction buffer IFU 1 tube stand
RAPID SARS-CoV-2 antigen test card