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Covid-19 IgG/IgM Antibody Test 

IN STOCK

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MANUFACTURED BY HEALGEN

COVID-19 IgG/IgM Rapid

Antibody Test Benefits:

  • Fast Results in 15 minutes • Highly accurate (IgM and IgG combined sensitivity and specificity is 90.6% and 99-2% respectively. Total accordance rate equals 95.3%. 92% sensitivity

  • NO laboratory equipment required, intuitive visual interpretation

  • NO specialized training required, easy-to-use

  • Provides actionable information to all patients to help determine if a COVID-19 viral PCR test is needed

  • Provides insightful information for when it is safe for individuals to go back to work and resume normal activities of daily life

  • Test kits can be stored and used at room temperature

  • Antibody testing is improved over nasopharyngeal swab testing by the fact that antibodies are more uniformly present in blood sampling

How does the Covid-19 Antibody test work?

The Rapid test is a qualitative detection of IgM and IgG antibodies that bind to the virus that causes COVID-19. With a simple finger blood specimen, it will provide results in minutes. The presence of antibody Immunoglobulin G and Immunoglobulin M (IgG and IgM) proteins specific for SARS-Cov-2 IgG and IgM antibodies are indicated by a visible line in the specific region indicated on the device.

 Covid-19 Rapid Antibody test

What is the COVID-19 Rapid Antibody Test? The COVID-19 IgM/IgG Rapid Antibody Test is a serological test can help give us a broader picture of COVID-19 infection spread. Unlike molecular tests, serological tests can identify those that were infected and have recovered. The COVID-19 IgM/IgG Rapid Antibody Test is a single-use, self-contained test that provides results in 15 minutes, helping authorities, employers and healthcare workers make informed decisions to contain the spread of COVID-19.

FREQUENTLY ASKED QUESTIONS

What is the Covid-19 IgG/IgM Rapid Antibody test?

VitaPlasmaâ„¢ COVID-19 IgM/IgG Rapid Antibody Test is a serological test can help give us a broader picture of COVID-19 infection spread. Unlike molecular tests, serological tests can identify those that were infected and have recovered. VitaPlasmaâ„¢ COVID-19 IgM/IgG Rapid Antibody Test is a single-use, self-contained test that provides results in 15 minutes, helping authorities, employers and healthcare workers make informed decisions to contain the spread of COVID-19.



How does the Covid-19 IgG/IgM Rapid test work?

The Rapid test is a qualitative detection of IgM and IgG antibodies that bind to the virus that causes COVID-19. With a simple finger blood specimen, it will provide results in minutes. The presence of antibody Immunoglobulin G and Immunoglobulin M (IgG and IgM) proteins specific for SARS-Cov-2 IgG and IgM antibodies are indicated by a visible line in the specific region indicated on the device.



Is this test for home use?

This is not intended for home use. The test must be administered by a licensed medical professional.



We want to order large quantities, are there enough available?

We are already receiving shipments and will have shipments arriving weekly.



What is the storage and stability?

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.



Is this kit approved by the FDA?

We are distributors for 3 different manufacturers of the Covid-19 Antibody kit. We carry one kit from a manufacturer that is FDA Authorized. The other two kits that we carry and have been submitted for Emergency Use Authorization following guidance from the FDA on March 16, 2020. The tests have 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 (COVID-19) infection or to inform infection status.



What is the product availabilty?

We have begun shipping orders. Due to a surge in worldwide demand for rapid antibody tests, demand has outstripped available supply. We are filling orders already received but must now temporarily restrict orders to 750 tests or more. We are working diligently with our suppliers to secure additional inventory. Please note: all new orders will filled when additional inventory is received. We expect to ship new orders in 14-21 days. Orders can only be placed by licensed medical professionals for use in point-of-care setting. At this time, we cannot ship to consumers for home use.



How is this test administered?

Need answer here.



What are the COVID-19 Rapid Antibody Test Benefits?

• Fast Results in 15 minutes • Highly accurate (IgM and IgG combined sensitivity and specificity is 90.6% and 99-2% respectively. Total accordance rate equals 95.3%. 92% sensitivity • NO laboratory equipment required, intuitive visual interpretation • NO specialized training required, easy-to-use • Provides actionable information to all patients to help determine if a COVID-19 viral PCR test is needed • Provides insightful information for when it is safe for individuals to go back to work and resume normal activities of daily life • Test kits can be stored and used at room temperature • Antibody testing is improved over nasopharyngeal swab testing by the fact that antibodies are more uniformly present in blood sampling



What is antibody testing?

Antibody tests involve analyzing a patient’s sample (usually blood) for the presence or absence of a particular antibody. Antibodies are part of the body's immune system. They are immunoglobulin proteins that help protect people against microscopic invaders such as viruses, bacteria, chemicals, or toxins. When you’re exposed to the virus, your body develops antibodies, which can take several days to over a week. The presence of immunoglobulin M (IgM) antibodies indicate recent exposure to COVID-19, while the presence of immunoglobulin G (IgG) antibodies indicate later-stage infection. VitaPlasma™ COVID-19 IgM/IgG Rapid Antibody Test detects the presence of antibodies IgM and IgG, developed in response to the SARS-CoV-2 virus. • IgM: develop EARLY after SARS-CoV-2 virus exposure • IgG: develop LATER after SARS-CoV-2 virus exposure; indicates long-term immunity



What will the test results tell you?

Since it can take several days for the body to develop an antibody response to the virus, VitaPlasmaâ„¢ COVID-19 Rapid Antibody Test can identify individuals who have had the infection and have recovered, suggesting that those people are now immune to the virus.



What does a positive test result mean?

A positive test result indicates that the patient has been exposed to the SARS-CoV-2 virus and has developed antibodies associated with immunity. A patient with a positive test result may or may not be contagious.



What does a negative test result mean?

A negative test result indicates that the patient has not developed detectable antibodies associated with the SARS-CoV-2 virus and most likely does not have immunity to the virus. A person with a negative test result may or may not be contagious.



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