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Healgen COVID-19 Rapid Test Kit (Box of 25) - FDA EUA Authorized on 5/29

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*For Professional Use Only*

 

 

FDA Submission Number: EUA200056

 

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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.

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.

All clinical study reports and data have been completed and are pending FDA Approval. 

If you develop emergency warning signs for COVID-19 get medical attention immediately. Emergency warning signs include*:

  • Difficulty breathing or shortness of breath
  • Persistent pain or pressure in the chest
  • New confusion or inability to arouse
  • Bluish lips or face

*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.

 

Box of 25 Includes - 25 Test Cassettes, 25 Droppers, 1 Bottle of Buffer, Product Insert

*One bottle of buffer per box.  (Each test requires 2 drops of buffer.  A bottle of buffer contains 50 drops.)

*Lancets and Alcohol Prep Pads are not included

 

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.
*Next Day Air shipping applies on the day we receive inventory

Instructions for Use:

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):

a. For Serum or Plasma Specimen: with the 5 μL plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen: Hold the 5 μL plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.