Covid-19 Sars-Cov-2 Igm Antibody Test Kit

Product Name : COVID-19 SARS-CoV-2 IgG/Ig Manti body Test Kit (Colloidal Gold) with CE and FDA Product Description : shouldbenoobviousgap.The inner teststrip shouldbefirmlyattachedwithoutwaggle.Thediluentshouldbeclearandfreeof foreignmatter. 1.2 Size:thesizeoftheinnerstripshouldnotbelessthan2.5mm. 1.3 Liquidmigrationspeedshouldnotbelessthan10mm/min. 1.4 2. Minimum detection limit The minimum test limit reference products S1 should be negative, S2 and S3 should be positive. 3. Negative compliance rate:5 pieces of negative referenceproducts of the test companyshall be all negative, with a negative compliancerateof100%. 4.Positivecompliancerate:5pieces of positivereferenceproducts,eachreferencetestonetimes andshallbeallpositive,with apositivecompliancerateof 100%. 5.Repeatability:Test1pieceoftheenterprisepositivereference,testit10times,thecolor shouldbeconsistentandallpositive. 6.Specificity 6.1 Cross Reaction: This product do not cross-react with the positive specimens including vice influenza virus antibodies, influenza a virus, influenza b virus antibodies, pneumonia chlamydia, mycoplasma pneumoniae antibody, adenovirus antibody, respiratory syncytial virus antibody, hepatitis b surface antibody, hepatitis c virus antibody, treponema pallidum antibody,human immunodeficiencyvirus (HIV) antibodies, EBvirus antibody,measles virus,CMVantibodies, enterovirus type71,mumpsvirusantibody,varicella- zostervirus. 6.2 Thereisnocross-reactionbetweenRF,ANAandAMA. 6.3 Interferingsubstance: (1) When bilirubin concentration 250 mol/L, hemoglobin content 9g/L, triglyceride content 15mmol/L, content of rheumatoid factor 80IU/mL, titer ofANA1:240, anti-mitochondrial antibody (AMA) 80U/mL, content of mouse IgG1000g/mL,therewillbenointerferencewiththetestresultsofthisproduct. (2) 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) hasnointerferenceinthedetectionofthisproduct. 7. Hook effect: No hook effect was found inthe test results of this product within the titer range of clinically positive samples ofthenovelcoronavirusantibody. 8. The minimum detection limit and reproducibility of 10 samples of clinically positive serum of COVID-19 novel coronavirus werestudied. 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)

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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.