1. Generic Name: Novel Coronavirus COVID-19 IgG Antigen Test Kit
2. Brand Name: NIL
3. Notified Category: Other than above substances intended for qualitative determination of COVID-19 infection
4. Class of Medical Device: Class D
5. Shelf life :15 months
6. Sterile/Non-Sterile: Non-Sterilized
7. Contains Drugs: No
8. Medical Device Grouping Category: IVD-Kit
9. Grouping Description: Intended for qualitative determination of COVID-19 infection
10. Intended Use: The Novel Coronavirus COVID-19 IgG Kit is intended for the qualitative detection of human anti-COVID- 19 IgG antibody in human serum/plasma. Any reactive specimen with the Novel Coronavirus COVID-19 IgG Kit must be confirmed with alternative testing method(s).
11. Product Description: Assay controls and 1:10 diluted human serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length recombinant protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of "COVID-19 recombinant antigen-human anti-COVID-19 IgG antibody - HRP labeled anti human IgG tracer antibody" is formed if there is specific Coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP-Labeled tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen.
SALIENT FEATURES:
â?¢ Recombinant COVID-19 Spike subunit Protein coated on Microwell Plate
â?¢ HRP Conjugated Polyvalent Anti-Human IgG
â?¢ Assay Time: 80 mins (30mins+30 Mins+20mins)
â?¢ Strip Format Microwell Plate
â?¢ Ready to use Substrate and Controls
â?¢ Only 20 pL of human serum is required for measurement in duplicate.
â?¢ Works on any open ELISA system
â?¢ Assay procedure is easy to automate
OUR TEST:
â?¢ Principle: Indirect ELISA
â?¢ The normal healthy patients with samples collected prior to the COVID-19 outbreak [December 3, 2019] (n = 150) and RT-PCR confirmed positive patients in after the second week of the onset of the disease (n = 32). The Positive sample evaluation was done at external Approved Lab. The results are as follows:
â?¢ Diagnostic sensitivity is 100% (>98%)
â?¢ Diagnostic specificity is 98.67% (>97%)
â?¢ PPV: 94.12�°/0
â?¢ NPV: 100%
Please contact us for more information and product details.
Easy-to-use "All-in-one" test for the detection of anti SARS-CoV-2 antibodies (lgM & lgG)
The Novel Coronavirus 2019-nCoV) lgM/lgG Antibody Combo Test Kit (Colloidal Gold) is intended for the qualitative detection of the antibodies of lgM/lgG against novel coronavirus in serum, plasma, or whole blood from patients with clinical suspicion of 2019-nCoV infection
RAPID ANTIBODY/Finger Prick 10 to 15 Minute Results
An antibody test is also known as a serology test looks for the presence of antibodies, which are specific proteins made in response to infections. It is effective at detecting the recent past SARS-CoV2 infection. This test can detect the body's IgM Antibody response in as little as 7 days (IgG in 14 days) from infection with CDC validated 100% specificity and 100% sensitivity.
The highest accuracy serological test on the market
FDA EUA Approved
Manufactured by one of the leaders in lateral flow technology
COVID finger prick, rapid antigen test, or rapid test, is a rapid diagnostic test suitable for point-of-care testing that directly detects the presence or absence of an antigen. It is commonly used for the detection of SARS-CoV-2, the virus that causes COVID-19. Rapid tests are a type of lateral flow tests that detect protein, distinguishing it from other medical tests that detect antibodies or nucleic acid, of either laboratory or point-of-care types. Rapid tests generally give a result in 1 to 15 minutes, require minimal training or infrastructure, and have significant cost advantages. NO Lab Required for results.
We supply all things PPE: Covid Antigen & Antibody Test Kits: Nasal swab, oral swab and finger stick tests; Nitrile Gloves, Vgloves, Top Gloves; Face Shields; 3-ply masks; reusable masks; Gowns, shoe and head covers; thermometers, hand sanitizer.� Also, we are able to supply Covid supply VENDING MACHINES, disinfectant sprays and wipes; disinfectant fogger machines and sprayers.� We currently supply US distributors and medical supply companies coast-to-coast. (Top Quality/Extreme Wholesale). Contact us with your immediate requirement. Tell us what you want, bring us your target price. Satisfaction GUARANTEED! We look forward to working with you. We move a lot of quality products fast, so contact us IMMEDIATELY and join our team!!
We can supply the following Covid-19 Rapid Antigen Test Kits: Sienna-Clarity, Indicaid, Celltrion Diatrust, InBios Detect, GenBody, QuickVue (Home Test), Binax Now (Home Test). Pricing as low as $6.00 per unit but ultimately depends on the brand and how many units/boxes you require. Please reach out with any inquiries.
We have the ability to supply both POC as well as OTC kits. POC kits start at $4.25 per test. OTC kits start at $6.75 per test.
All Test Kits are OTG in the US at the Celltrion Warehouse. Delivery is available for a minimal fee, or no fee at all depending on the order. The Test Kits are either picked up at the Celltrion warehouse in TN or NJ or drop shipped to your facility.
For large Bulk orders with weekly or monthly allocation, a 10% deposit is required to reserve the specific allocation, and the balance is paid prior to pickup or delivery.
Both the POC and OTC Test Kits are available for delivery also in large quantities, however due to the high demand, a pick up schedule or delivery schedule will be determined at the moment the PO is issued and will become an integral part of the supply agreement.
Clinitest OTC covid test kits (by Siemens) - FDA approved for use in the USA - Capacity to supply 5M per week - 50% payment up front, then the remaining 50% after the airway bill and packing slip are provided
Access Bio CareStart rapid antigen POC test kits - We are now shipping (within the US) by the pallet at as low as $10.00 per test. 20 pcs per kit/box, 640 boxes per pallet.
BinaxNOW COVID-19 Ag Card
For Rapid Detection of SARS-CoV-2 | FDA EUA | IVD Use | RX Only
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests. BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration's EUA.
Kit Details
Test Card: 40 cards with test strips
Extraction Reagent: bottle containing 7.5 mL of extraction reagent
Nasal swabs: 40 sterile, single use specimen sampling swabs
Positive Control Swab: 1 each â??individually wrapped for single use
Negative Control Swab: 1 each â??individually wrapped for single use
Documentation: Product Insert, Procedure Card
Performance Data
