Covid-19(Sars-Cov-2) Igg/igm Rapid Test

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.

Supplier: We are manufacturer and supplier of high quality molecular diagnostics product among covid 19 detection kits consisting of: 1]. covid 19/sars cov 2 nucleic acid test kits to detect the covid 19 standard, uk and south africa variants (rt pcr). 2]. covid 19/sars cov 2 antigen rapid test kits. 3]. covid 19/sars cov 2 antibody (igg/igm) rapid test kits. in addition to a product of quality, we offer very competitive price and we have high production capacities to assure a continuous supply of product without shortage.
Services: Manufacture, oem

[Intended Usage] This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites. [Storage Conditions & Validity] 1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box. 2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times. 3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period. [Applicable Instruments] 1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument. 2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support. NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels. [Sample Requirements] 1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices. [Test Results Interpretation] 1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements. 2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition. 3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample. [Product Performance Index] 1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%. 2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%. 3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL. [CE Mark Registration No.]: RPS/499/2021. [EC REP.]: CMC MEDICAL DEVICES & DRUGS S.L. C/ Horacio Lengo n18, C.P 29006, Milaga, Spain.

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