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Coronavirus COVID-19 IgG/IgM Rapid Test Kit (25 Units Per Box)

Model Drugs Tested
DTS-COVID-19 /

To Place Your Order, Please Call (321) 206-0302 

**For Professional Medical Use Only**

Now Accepting Pre-Orders for Qualified Healthcare Professionals.

Available for Shipment May 15th. 

We are a US based manufacturer for a rapid results COVID-19 antibody blood test – we are aiming to provide as many testing supplies as possible to healthcare providers to help meet current testing demands.

Currently on back order due to high demand. Place order today to reserve your supply.

  • 25 single units per box
  • Performance: COVID-19 IgG/IgM Rapid Test Device
    • Relative Sensitivity: 93.7%
    • Relative Specificity: 99.1%
    • Overall Agreement: 97.7%
    • Not to be used as sole diagnosis – very high sensitivity and specificity allows providers to make an informed decision for next step of treatment. 
  • Results: Results are displayed as positive/negative within 10 minutes of providing the sample. 
  • Sanitary collection: Administering a blood spot check poses much less of a risk for contamination for caregivers (less risk of coughing, sneezing during sample collection which occurs with nasal swab method) 
  • Inventory: Our US based manufacturing line will be open for production on May 1st, 2020. We will be capable of filling all current pre-orders and will be able to maintain a steady flow of product for the next 60-90 days. We are projecting to produce between 12,500 – 25,000 units per day. As of now, we are the only company with a US based production line for this product.
  • FDA EUA Approval – We have been granted Emergency Use Authorization (EUA) with the FDA – CLIA certified facilities will be able to administer and bill this test as a high complexity device.
  • Supply Quality – Our manufacturing facility has been producing high quality, FDA approved / CLIA waived onsite diagnostic kits for 20+ years. While producing under the EUA in this circumstance, end users can be confident this device and production line adheres to the same quality standards and requirements.

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.

Disclosure:

The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

FDA Submission Number: EUA200056

$625.00 $450.00

Model: DTS-COVID-19 Category:

Out of stock

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

The virus is thought to spread mainly from person-to-person.

  • Between people who are in close contact with one another (within about 6 feet).
  • Via respiratory droplets produced when an infected person coughs or sneezes.
  • These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

Instructions For Use

This test is conducted by taking a small blood sample from a finger prick, placing it in the center well of the cassette followed by adding two drops of the buffer to the buffer well labeled B. Results should appear within 3 minutes and are invalid after 10 minutes.

 

Additional information

Weight 1.25 oz
DOT Approved?