Molecular Diagnostic Tests for SARS-CoV-2 Other Tests for SARS-CoV-2 Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 IVDs for Management of COVID-19 Patients
INTENDED USE For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection. FEATURES Carefully selected special monoclonal antibody to the nucleocapsid protein antigen from SARS-CoV-2. Various applicable specimen: Nasopharyngeal swab, Nasal swab and Saliva. Easy to use, easy results interpretation by naked eyes. Test result available within 15minutes. TEST PROCEDURE: Very simple as per the instructions stated on the manual inserted in the kit. RESULTS INTERPRETATION Positive: A red line appears on the test line (T) and the control line (C). NOTE: A positive result does not rule out co-infections with other pathogens. Negative: Only the control line (C) appears, and no red line appears on the test line (T). NOTE: A negative result does not exclude infection. Invalid: There is no red line at the position of the control line (C). Regardless of whether the TEST line (T) is displayed, it is an invalid result and the sample should be tested again. CLINICAL PERFORMANCE SARS-CoV-2 Antigen Test Kit Comparator Method (NTA) Positive Negative Total Positive 97 0 97 Negative 3 100 103 Total 100 100 200 - Positive Agreement (95% CI): 97/100 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100 100.0% (95.5% - 100%) - LoD: 1.5�??102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen. - Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable. - No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track. - Positive Agreement (95% CI): 97/100, 97% (83.3% - 99.9%) - Negative Agreement (95% CI): 100/100, 100.0% (95.5% - 100%). [Product Name]: SARS-CoV-2 Antigen Test [Product Code]: Cat# FP-318 [Sample Type]: Nasopharyngeal swab / Nasal swab /Saliva [Detection Method]: Colloidal Gold [Reaction Time]: Within 15min [Packing Size]: 1T x 20 cassettes + Sample buffer 20 vials x 0.5mL + 20 samples collection swab x 1. [Storage Conditions]: 2*C ~ 30*C [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/99/2021.
V8001:Lateral Flow Method, SARS-CoV-2 Saliva Antigen Rapid Test V8002:Colloidal Gold Method, SARS-CoV-2 Saliva Antigen Rapid Test V8003:Colloidal Gold Method, SARS-CoV-2/Flu A/Flu B Saliva Antigen Rapid Test
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
This SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) is intended for use by laypeople in the home environment. The application is carried out using saliva as a sample. - Patient-friendly - Saliva as a sample - User-friendly - simple and time-saving thanks to pre-filled sample tubes - Reliable - meets the valid requirements of the RKI and the BfArM and was evaluated by the Paul Ehrlich Institute PEI - Result within 15 minutes - All necessary materials in the pack contain specifications: - Colloidal gold immunoassay - Sensitivity: 95.51% (7 days after onset of symptoms) - Specificity: 99.45% - Sample material: saliva - Pack size: 1 test - Storage: 2 - 30 C - Shelf life: 18 months - Special approval for laypeople by the BfArM (BfArM GZ: 5640-S-032/21) - Specifications positively evaluated by the PEI (Paul-Ehrlich-Institut) Permitted users: Self-test for laypeople Scope of delivery per pack: 5x test cassette packed in foil pouch 5x sample tubes with extraction buffer 5x sterile disposable swabs 1x instructions for use 1x brief instruction
This product is used for in vitro qualitative detection of SARS-CoV-2 antigen in human oropharyngeal swabs, nasal swabs and nasopharyngeal swabs. It is helpful as an aid in the screening of early mild, asymptomatic, or acute patients for identification of SARS-CoV-2 infection.
We can supply SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Imunoassay), to anywhere in the world, for more details please visit our
Weight: 25.5g/ kit Packaging: 300kits/carton Weight of carton: 8.6kg/carton
CE0197 --> WE HAVE THE CE certificate. WHY US : * Right price. * Excellent distribution. * No middle man. * Someone on the spot. * Boat / Plane. We can handle very large numbers - WOULD YOU BE THE FIRST ? - ORDER NOW, WHILE WE CAN STILL DELIVER ON TIME !!! 15days after Payment ( for now ). Stay Safe
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.
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
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
SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal swab samples) SARS-CoV-2 Antigen Rapid Test Saliva) We have two fast screening reagents for routine detection. One is the antibody iggigm detection reagent (that is, blood for three minutes) One is antigen rapid screening test reagent (the same is three minutes can use nasal mucosa, oral mucosa, and saliva three detection methods) 1.SARS-CoV-2 antigen testing can detect infection earlier than antibody testing 2.SARS-CoV-2 antigen testing can detect SARS-CoV-2 and all mutant virus strains 3.Easy operation and quick results 4.The result is clear. C-line and T-line determines the infection and the result is easy to read 5.The colloidal gold method has stable performance and is not interfered by environmental and experimental conditions 6.Application: for human throat swab , nasal swab and sputum extract Our test kits for COVID-19 as below are still effective to detect the infection of new COVID-19 variant B.1.1.7and The new variant has no effect on the detection performance of products
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%.