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.
COVID-19 Rapid Test Kit IgG + IgM (Colloidal Gold) comes in packs of 40 tests and contains: 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 Price and Minumum Quantity Price FOB in USD: negotiable 0.8 to 1.8Minimum Order Qty: None Pieces Production Capacity: 3,000,000/monthPackaging: 20 Tests/kit, 30 Kits/box, 12 Boxes/pallet Sample: Available. Sample Cost Born By Supplier Product Model And Origin Brand: GENEDIAModel: 643G-S (Saliva) Seller Code: Genedia w covid 19 agHS Code: 3002.15 Standards: Ce Competitive Advantages Allow wider testing with fast test time (10 minutes) All necessary materials provided / no equipment needed Sensitivity: 93.33%, specificity: 100% Free sample. no moq. price is negotiable. customized packing. Other Details 20 tests / kit 24 months from the date of manufacture 2 ~ 30c(35.6 ~ 86f) available for room temperature deliver In stock. fast delivery. 1 x Instructions for Use Manual 40 x Test Cassettes 1 x Buffer 40 x Dropper
SARS-CoV-19 IgG/IgM test kit (15min showing result) Manufacturer: Guangzhou Wanfo Biotech Co., Ltd. a China listing company Certificates: CE certificate, China NMPA approval (export allowed), no FDA approval The price is $5.5/test (FOB) Max delivered quantity: 100,000/weekly More details please enquire Barry Liu whatsapp: +8617810331113 sample available: 20 test & DHL delivery: $200 Download introductions: https://kdocs.cn/l/sLLC9O6rc
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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SARS-CoV-2 Rapid Antigen Test kit Colloidal Gold Method Medical Simple Rapid Convenient Sensitivity : 98.4% Specificity : 98.1% Test Time : 10-15min
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