Sars Cov 2 Ag Diagnostic Test Kit Suppliers and Manufacturers

Product Name : COVID-19 SARS-CoV-2 IgM Antibody Test Kit Product Description : Material attachment is good. The shell of the detection card should be flat, the upper and lower covers should be closed evenly, and there should be no obviousgap.Thediluentshouldbeclearandfree offoreignmatter. 1.6 Size:thesizeofteststripshouldnotbelessthan2.5mm. 1.7 Liquidmigrationspeedshouldnotbelessthan10mm/min. 2.Minimumdetectionlimit TheminimumtestlimitreferenceproductsS1shouldbenegative,S2andS3shouldbepositive. 3.Negativecompliancerate 5copiesofnegativereferenceproductsof thetestcompanyshallbeallnegative,withanegativecompliancerateof100%. 4.Positivecompliancerate 5copiesofnegativereferenceproductsof thetestcompanyshallbeallpositive,withanegativecompliancerateof 100%. 5.Repeatability Test1copyoftheenterprisepositivereference,test10times,shouldbeconsistentcolor,arepositive. 6.Specificity 6.4 Cross Reaction: This product with vice influenza virus antibodies, influenza a virus, influenza b virus antibodies, pneumonia chlamydia, mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitisbsurfaceantibody,hepatitis cvirusantibody,treponemapallidumantibody,humanimmunodeficiencyvirus(HIV) antibodies,EBvirusantibody,measlesvirus,CMVantibodies,enterovirustype71,mumpsvirusantibody,varicella - zoster viruspositivesamples nocrossreaction. 6.5 Thereisnocross-reactionbetweenRF,ANAandAMA. 6.6 Interferingsubstance: (3) When bilirubin concentration =250 mol/L, hemoglobin content =9g/L, triglyceride content =15mmol/L,content of rheumatoid factor =80IU/mL, titer ofANA=1:240, anti-mitochondrial antibody (AMA) =80U/mL, content of mouse IgG=1000g/mL,therewillbenointerferencewiththetestresultsof thisproduct. (4) The commonly used antiviral drugs epiztin acid (=4mg/L), ribavirin (=40mg/L), interferon (=200mg/L), oseltamivir (=30mg/L), abidol (=40mg/L), levofloxacin (=200mg/L), azithromycin (=100mg/L), ceftriaxone (=400mg/L), meropenan(=200mg/L) havenointerferenceinthedetectionofthisproduct. 7. Hookeffect No hook effect was found in the test results of this product within the titer range of clinically positive samples of the novel coronavirusantibody. Price of product ( USD price or FOB price) : $4.23 Product origin : China Key Specifications/Special Features : CE FDA Hospital professional testing and use, family and individuals can not use Minimum Order Size and Packgaing details: MOQ:10000pieces 25pieces/box box size:15*14*6.5cm ,150g/box 100boxes /CTN,CTN Size 72*62*36cm 21KG(without lancet and alcohol cotton)

Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit We have developed a Multiplex 2-target (N & E genes) direct RT-LAMP assay, without any need of RNA extraction. It has a very high sensitivity ( > 95%) with a fast (30 mins) and easy-to-read result. It works both colorimetric and fluorimetric. Our price is very competitive ranging between 10 USD - 5 USD depending on order volume. The test has CE IVD mark and it is currently under review for NHS & FDA EUA. You can find more details on the attached presentation and IFU.

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.

Cat No : 09N77-095. The Abbott RealTime SARS-C0V-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories, using real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria.

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.

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 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)

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

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

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