Diagnostic Kit For Sars Cov 2 Igm Igg Suppliers and Manufacturers

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

INTENDED USE For qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, sodium citrate and lithium heparin) or fingerstick whole blood, venous whole blood specimens from patients suspected of COVID-19 infection. FEATURES Coated with carefully selected specific Nucleocapsid and Spike protein antigen. Detection for IgM and IgG antibodies simultaneously. Simple operation, easy result interpreted. Rapid test within 15 minutes. RESULTS INTERPRETATION Positive: 1. The presence of 3 red lines (T1, T2 and C) within the reaction window, no matter which band appears first, indicates presence of both SARS-CoV-2 IgM and IgG antibodies. 2. The presence of 2 red lines (T1 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgM antibody. 3. The presence of 2 red lines (T2 and C) within the reaction window, no matter which band appears first, indicates presence of SARS-CoV-2 IgG antibody. Negative: 1. The presence of line (control line) only within the reaction window indicates that no SARS-CoV-2 antibodies are detected. The results is negative. Invalid: 1. If the control(C) line is not displayed in 10-15 min, regardless of whether T1 and/or T2 line is present, the test result is invalid. It is recommended that the specimen should be re-tested. 2. The test result is invalid after 15 min. CLINICAL PERFORMANCE - Positive Percent Agreement (PPA) = 91.07% (153/168) (95% CI: 85.70%-94.92%). - Negative Percent Agreement (NPA) = 95.37% (103/108) (95% CI: 89.53%-98.48%). - Overall Rates of Agreement (ORA) = 92.75% [(153+103)/ (168+108)] (95% CI: 89.03%-95.52%). [Product Name]: SARS-CoV-2 IgM/IgG Duo Test [Product Code]: Cat# FP-319 [Sample Type]: Whole blood /Plasma/Serum [Sample Volume]: 20L /10L/10L [Detection Method]: Colloidal Gold [Reaction Time]: 10-15min [Packing Size]: 1T x 20 cassettes per box + Sample diluent 1 vial x 5mL. [Storage Condition]: 2oC ~ 30oC [Shelf Life]: 12 months [CE Mark Registration No.]: RPS/499/2021.

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.

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)

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

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Corona viruses are enveloped RNA viruses that are distributed broadly among humans, birds and other mammals, that cause respiratory, enteric, hepatic, and neurologic disease. SPECIFICATIONS: Whole blood/serum/plasma may be used for testing. Results available in only 15 minutes. Easy to use. Result can be read visually. No need for an analyser. Cost effective method for assisting in screening COVID-19 disease.

Product Details: Number of Reactions(Preps)/Kit ; 25 Brand : Cellex Test Method : (SARS-CoV-2) IgM/IgG Rapid Antibody Result Time (Rapid Kits) 30 minutes Time To Result 15 mins Cat. No : 5513C COVID-19 serology test.Cellex qSARS-CoV-2 IgG/IgM Rapid Test.qSARS-CoV-2 IgG/IgM Rapid Test Cassette.FDA Grants Emergency Authorization for First Rapid Antibody Test for COVID-19

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TEST KIT FOR THE SARS-COV-2 ALSO KNOW AS THE NOVEL CORONA VIRUS 2019 (NCOV-19).