What does IVD mean?

In Vitro Diagnostics (IVD) are a subset of medical devices that are essential to improve health outcomes, and are critical tools in emergencies like we're facing today.

In vitro diagnostic tests are used for in vitro examination of specimens derived from the human body to provide information for screening, diagnosis, or treatment monitoring purposes.

Most treatment decisions today are based on IVD results. They ensure that the right patients receive the right treatments, thus protecting patients from incorrect, ineffective or, at worst, harmful treatments; and reducing unnecessary healthcare expenditures.

What kind of test are being used to diagnose
  1. Rapid test kits
    1. For prescreening
    2. Large scale
    3. Fast results (5-15 min).
  2. PCR test kits:
    1. Collection of saliva, sample sent to lab
    2. Requires large-scale machine to get result
    3. Around 3 hours to conduct the whole test procedure (in reality, it will take more time, like 3 days, as they are in the queue for being run in the machine)
  3. CT scan
    1. Visual confirmation, but requires more time and an experienced Physicians to diagnose.
What does rapidIVD's COVID-19 igG/igM Rapid Test do?

Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Why is the antibody test needed?

Antibody tests are crucial in this battle by detecting infections, especially in people with few or no symptoms - CDC

How does the COVID-19 IgG/IgM Rapid Test work

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 novel coronavirus in human whole blood, serum or plasma.

The COVID-19 IgG/IgM Rapid Test is intended for professionals within highly complex settings and or pharmacies.

The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane.

M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with a monoclonal anti human IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.

Is this test FDA EUA approved?

Pre-EUA Cleared

What is the EUA program?

The Emergency Use Authorization (EUA) Program is an expedited clearance process in order to release medical devices while they are being reviewed by the FDA.

If all serology/antibody tests are still being reviewed, what does the FDA say about using them?
  1. Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers(Download Fact Sheet - Providers)
  2. Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to patients(Download Fact Sheet - Recipients)
Who makes your testing kits?

Our tests are manufactured by MedicalSystem Biotechnology Co., Ltd (SHE: 300439), a China-based publicly traded company that engages in the research, development and manufacturing of bio-tech pharmaceutical products. Its activity includes the provision of medical diagnostics and consultation services. Its products include in-vitro biochemical diagnostic reagents and instruments. The company was founded on July 22, 2003 and is headquartered in Ningbo, China.

Does the kit have any other certifications?

Yes, the kit is CE-IVD Marked. The kit is widely used in China and Europe. It is manufactured by MedicalSystem Biotechnology Co., Ltd (SHE: 300439), a China-based publicly traded company engaged in the research and development, manufacturing and distribution of in-vitro diagnostic products.

Which countries have your test kits been used:

Millions of our rapid tests have been successfully distributed here in the US as well as in Italy, Germany, Malaysia, Ecuador, Indonesia, Chile, Saudi Arabia, Sweden, Poland, Finland, Brazil, Romania, and Australia among others.

What if the test is IgM positive?
  1. In general Immunology, IgM serves as the first kind of defense, which means it is the first antibody to be immediately developed when any foreign particle is introduced, though its function is temporary.
  2. The positive test result for IgM does not confirm that you have an active SARS-CoV-2. Confirmation of COVID-19 IgG/IgM Rapid Test requires additional testing by CDC or by qualified laboratories designated by CDC and in consultation with CDC, and/or other FDA approved molecular SARS-CoV-2 tests.
What if the test is IgG positive?
  1. In general Immunology, IgG is a long-term response for any disease and thus protects our body from viral and bacterial attacks.
  2. Confirmation of COVID-19 IgG/IgM Rapid Test r requires additional testing by CDC or by qualified laboratories designated by CDC and in consultation with CDC, and/or other FDA approved molecular SARS-CoV-2 tests.
Cons of Human IgM IgG antibody tests:
  1. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
  2. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  3. 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.
  4. 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 or for patients who have received SARS and MERS vaccinations.
How long after exposure to the SARS-CoV-2 virus would the test be able to detect antibodies?

It could take up to 8 - 11 days after exposure to the virus to have detectable IgM antibodies for SARS-CoV-2.

How long after initial infection will the COVID-19 test detect antibodies?

At this point, there is still much that is unknown about the serological aspects of this 2019 novel coronavirus (SARS-CoV-2). However, there is serological data from the 2002 SARS outbreak (SARS CoV) that shows detectable IgG antibodies 60 days after initial symptom onset. (Chen X et al. J Infect Dis. 2004;189(7):1158-63)

I want to donate blood, but also want to know if I have COVID-19 infection. What do I do?

The COVID-19 IgG/IgM Rapid Test Cassette is NOT for the screening of donated blood.

Are there any additional procedural instructions other than what is in the Package Insert?

The test protocol in the Package Insert is the best and only available instructions for the COVID-19 IgG/IgM Rapid Test Cassette.

What is the HCPCS Code?

U0002

Is there a CONTROL for the test?

There is an internal control line in the test cassette to assure proper protocol operation.

Can I have help interpreting this test?

RapidIVD cannot interpret test results. If you are unsure of the test result, it is recommended that the test procedure is repeated. Please be sure to follow the test protocol carefully, and also be sure not to overfill the specimen well (S).

What happens if I test COVID-19 negative, but I was very symptomatic a few weeks ago?

A negative COVID-19 IgG/IgM Rapid Test result does not rule out SARS-CoV-2 virus infection, particularly in those who have been in contact with the virus. Follow-up testing via CDC and/or FDA approved molecular diagnostic specifically for SARS-CoV-2 should be considered to rule out infection of SARS-CoV-2.

What if I test COVID-19 positive, but have no symptoms?
  1. A positive result from the COVID-19 IgG/IgM Rapid Test indicates that anti-SARS-Cov-2 IgG, IgM, or both were detected in the patient's specimen. Confirmation of COVID-19 IgG/IgM Rapid Test requires additional testing by CDC or by qualified laboratories designated by CDC and in consultation with CDC, and/or other FDA approved molecular SARS-CoV-2 tests.
  2. Positive COVID-19 IgG/IgM Rapid Test results are not definitive for diagnosis of SARS-CoV-2 virus infection and must be confirmed with additional molecular testing and/or consideration using the latest CDC and/or FDA approved SARS-CoV-2 testing.
How long does it take to get test results?

The run time on the test is 15 minutes after the specimen is applied to the cassette. The results cannot be read out after 20 minutes.

What is the kit's shelf life?

1-year from the date of manufacture.

Is it covered by insurance?

The patient's insurance company should be contacted to determine coverage and pricing.

Who is PMT Medical?

PMT Medical is an innovator and manufacturer of advanced medical equipment, and therapeutic devices. For the past 20 years, PMT Medical has established itself as a national contract holder with the VA and a nationally recognized distributor of advanced medical equipment.

What is your pricing?

See our pricing page or call for volume discounts.

How fast can orders be fulfilled?

Small size orders will ship within 1-2 business days. Larger orders can be scheduled with a 2-week lead time for delivery.

Do you drop ship?

Yes