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%
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%.
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.
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.
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 .
From as little as $1.00 FoB per test - including IFU in Language of your choice! COVID Rapid Test / Lateral Flow - SARS-CoV-2 Antigen Kit Self Test Kit - Nasal Swab based - Qualitative - IVD (Invitro diagnostic medical device) - Rapid immunochromatographic assay - 12 Minutes to result - Shelf Life 18 months - EU common list approved. - In use: BE, BG, CY, FR, RO, SI, ES - Validation Completed: - FR, DE, ES UK DHSC Approved. - Validation completed & In use - Specificity 100.0% - Sensitivity 93.0% Certifications: EU HSC Approved UK DHSC Approved (included in JRC database) CE Directive 98/79/EC EN ISO 13485:2016 BS EN 13612:2002 ISO 14971:2019 EN ISO 23640:2015 ISO 15223-1:2016 EN ISO 18113-1:2011 EN ISO 18113-4:2011 EN 62366-1:2015 More Information is available at our website. Please contact us directly, visit our website, follow us on LinkedIn and/or Instagram. @fiigureofficial in = fiigureofficial
Great for Kids. From as little as $1.00 FoB per test - including IFU in Language of your choice! COVID Rapid Test / Lateral Flow - SARS-CoV-2 Antigen Kit Self Test Kit - Saliva based - Lollipop Style - Qualitative - IVD (Invitro diagnostic medical device) - Rapid immunochromatographic assay - 15 Minutes test to result - Shelf Life 18 months - EU common list approved. - In use: BE, BG, CY, FR, RO, SI, ES - Validation Completed: - FR, DE, ES UK DHSC Approved. - Validation completed & In use - Specificity 100.0% - Sensitivity 93.0% Certifications: EU HSC Approved UK DHSC Approved (included in JRC database) CE Directive 98/79/EC EN ISO 13485:2016 BS EN 13612:2002 ISO 14971:2019 EN ISO 23640:2015 ISO 15223-1:2016 EN ISO 18113-1:2011 EN ISO 18113-4:2011 EN 62366-1:2015 More Information is available at our website. Please contact us directly, visit our website, follow us on LinkedIn and/or Instagram. @fiigureofficial in = fiigureofficial
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
INVBIO Covid Antigen Ag saliva rapid test card Sensitivity: 97.1% Specificity: 99% Agreement: 99.57% 10 miuntes to get the result. MOQ for each: 500 tests, 25 tests/box,
Rapid detection kit, ribonucleic acid detection reagent, medical syringes, medical mask, medical ventilator, medical glove, medical isolation gown, surgical gown level 3+4, protective gown (overall ), oximeter, other medical products.
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
Our Panodyne Sars-CoV-2 Antigen rapid swab test kits offers a quick and efficient solution for the early detection of COVID-19 infection within both symptomatic and asymptomatic individuals. Uses a specially designed swab to take samples from either the nasal cavity or tonsils to reveal if a person is infected or not. Suitable for mass testing and for screening workforce in business settings.
My company Marco&Micro test,based in china ,founded in 2010, is a leading manufacture of IVD manufacturers in China. We have successfully developed more than 200 detection test kits so far, like COVID-19 ,Tumor, Gene Test,Reproductive�¯�¼?HIV, TP, ZIKA, Dengue, Malaria etc. Of course, OEM or ODM service are also available from us, also, worldwide distributors are very welcomed to discuss for win-win collaboration. My whatsup:+8613814857410 sofia.zhang@hongweitest.com Our hot prevailing Covid19 product lines are: 1)Antigen rapid test kits: 2)saliva pen lollipop type rapid test kit 3)Ag rapid test kit 4)3combo of covid19 and FluA&B rapid test 5)Neutralizing Antibody Rapid Test Fast PCR test solution:sample release agent and Loyphilized pcr kit: 1)extractor-free sample releasing agent 2)3combo pcr liquid/loyphilized test of covid19 an 3) pcr pcr liquid/loyphilized test with target genes Orflab&N
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)
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GENEDIA W COVID-19 Ag (Nasal swab) 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
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
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The current test kit is based on specific antibody antigen reaction and immunoassay technique. The test card contains a gold labeled novel coronavirus N protein monoclonal antibody p re coated on the binding pad and a paired novel coronavirus N protein monoclonal antibodies fixed in the test line (T) and corresponding antibodies in the quality control line (C). During the test, the N protein in the specimen binds to the gold-labeled nove lcoronavirus N protein antibody pre-coated on the binding pad, and the conjugate moves upward under the capillary effect, and then is trapped by N protein monoclonal antibody conjugate fixed in the Test Line (T). The higher the N protein content in the specimen, the more conjugates are trapped, and the darker the color of the Test Line (T). If there is no novel coronavirus in the specimen or the virus content is below the detection limit, no colour appears in the Test Line (T). A purple red band will app ear in the Control Line (C) regardless of whether there is a virus in the specimen. The purple red band that appears in the Control Line (C) is the criteria for determining whether there is enough specimen and whether the chromatography process is normal.
