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

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

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Minimum Purchase:
25 units
  • Product Description
  • Insurance & FDA Information
  • Instructions For Use
  • Product Insert
  • Studies & Fact sheets

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

 

*For Medical Professional Use Only*

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.

IgM antibodies will appear within blood as soon as 3-5 days for symptomatic patients and 7 days for asymptomatic patients.

IgG antibodies will appear in blood within 2 weeks after infection.

Over time blood concentrations of both IgM and IgG decrease, where IgM will become undetectable, but IgG will remain elevated.

Warning:

This test has been authorized by FDA under an EUA for use by authorized laboratories.

This test has not been FDA cleared or approved.

This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This product is intended for professional use and not for home use.

Not for the screening of donated blood.

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.

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.

 

Package Contents:

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

Insurance Coverage

 

Medicare: View Here

All Other Insurance Companies:  View Here

86769: Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

4/10/20 - Medicare Coverage: $42.13

86328: Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]

4/10/20 - Medicare Coverage: $45.23

FDA (EUA) Authorization

 

These tests are FDA EUA Approved as of May 29th, 2020. View FDA EUA Authorization Letter

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 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 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.

Product Insert
Healthcare Providers Fact Sheet
Recipients Fact Sheet
NIH Clinical Study

Are you authorized to purchase these tests? Find out below!

Thank you!

If you answered the above question with options 1 or 3 please give us a call to place your order at 724-515-2637!

1 Review Hide Reviews Show Reviews

  • 5
    COVID -19 antibody tests

    Posted by Jonathan Kaplan on May 19th 2020

    Antibody tests are getting a bad rap in the news but I’ve been really happy with the Healgen product from All Source Screening. The customer service is very personal. You actually get a response if you email them! They’ve been so great that I’ve already reordered from them three times! Highly recommend.