COVID-19 IgG and IgM RAPID TEST

Our test vendor(s) are authorized to market and distribute these SARS-CoV-2 IgM / IgG Rapid Test kits to any licensed healthcare practitioner in the United States for diagnostic use, while awaiting final approval on FDA EUA applications.  (FDA EUA Policy)

Immunoglobulins are antibodies themselves and are part of our immune system. When we get an infection, such as COVID-19, immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be produced and is a general antibody that can bind to many different types of pathogen. The presence of IgM is an indicator of early infection. IgG is a more specialized antibody that specifically binds to the SARS-CoV-2 virus. The presence of IgG is an indicator of later stage infection (usually 7 days or longer after infection).

The terms “serological” or “antibody” tests are generally used to refer to tests that detect antibodies to the SARS-CoV-2 virus. Because the antibodies are part of the body’s immune response to exposure and not the virus itself, such testing cannot be used for diagnosis of infection. Based on the underlying scientific principles of antibody tests, we do not expect that an antibody test can be shown to definitively diagnose or exclude COVID-19 infection. SARS-CoV-2 antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies to SARS-CoV-2 in human blood specimens.

As stated in the Policy for Coronavirus Disease-2019 Tests, validated antibody tests offered under the policy in that guidance should, among other things, include in instructions for use and test reports information to convey that negative results do not preclude acute SARS-CoV-2 infection and that, if acute infection is suspected, direct testing for SARS-CoV-2 is necessary. SARS-CoV-2 serology tests should be ordered only by clinicians who are familiar with the use and limitations of the test.

Serology (antibody) tests may detect different types of antibodies. The most common are IgM and IgG. High quality serological tests can help us understand whether a person or population of people have developed antibodies indicative of an adaptive immune response to COVID-19.

Because a serology test can yield a negative test result even in infected patients (e.g., if antibody has not yet developed in response to the virus) or may be falsely positive (e.g., if antibody to a coronavirus type other than the current pandemic novel strain is present), antibody tests should not be used in the immediate diagnosis of a patient where COVID-19 infection is suspected. That is, these tests should not be used to diagnose acute COIVD-19 infection. Using this type of test on many patients may help the medical community better understand how the immune response against the SARS-CoV-2 virus develops in patients over time and how many people may have been infected. While there is a lot of uncertainty with this new virus, it is also possible that, over time, broad use of antibody tests and clinical follow-up will provide the medical community with more information on whether or not, and how long, a person who has recovered from the virus is at lower risk of infection if they are exposed to the virus again.

Positive results from appropriately validated serology tests that are designed to be very specific to the SARS-CoV-2 virus can indicate whether a patient has had recent or prior COVID-19 infection. In addition, although not everyone who is infected will develop an antibody response, appropriately validated serology tests, when used broadly, can be useful in understanding how many people have developed an adaptive immune response to the virus and how far the pandemic has progressed.

Serology tests can play a critical role in the fight against COVID-19 by helping healthcare professionals identify individuals who have antibodies to SARS-CoV-2 virus and have developed an adaptive immune response. In the future, this may potentially be used to help determine, together with other clinical data, whether these individuals may be less susceptible to infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. In addition, these test results can aid in determining who may be eligible to donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.

Sensitivity > Over 90+%

Specificity > Over 95+%

Accuracy > Over 95+%

Yes.  We can share information on past and ongoing clinical trials with you after your identity has been verified, and you after you sign and return our NDA and Non-Circumvent agreement.

The AMA held a series of virtual town halls specific to coding and reimbursement for Coronavirus testing via rapid test kits. Code 86328 was established for antibody tests using a single step method immunoassay. It is reported that Medicare reimburses $51.00 for the test, but that has not been verified as of this post. The AMA recommends contacting individual payers for reimbursement guidelines. Long, medium and short form descriptors may have to be manually uploaded to the system. To download the reimbursement guide for COVID-19 Dual IgG/IgM Rapid test, Click Here.

Yes. The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes point of care tests (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver or Certificate of Compliance.

We note that the term point of care in the EUAs may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.  To read the full Guidance, Click Here (and scroll to General FAQ). 

Yes.  As of April 8, 2020.  Click Here to read the guidance from the U.S. Department of Health and Human Services.

Yes.  One of our strategic partners does indeed have a registered NDC number with a specific PBM that reimburses an amount of $80.  Details will be shared after you are verified and have signed and returned our NDA/Non-Circumvent agreement.

When performing the test, delivering the appropriate whole blood sample volume to the sample well is critical. It is always recommended to use the accompanying pipette. Per the package insert, one drop of whole blood (approximately 10 µL) is required. Over-saturating the well has not been known to cause interference with the test results (for purposes of this article, over-saturating would be 20 µL). However, delivering less than 10 µL of whole blood to the sample well has been shown to produce inaccurate results. We recognize that every person “bleeds differently” and recommend having several gauges of lancets to choose from. Filling the pipette half-way up the second chamber ensures an adequate blood supply to the device. Positive results may be called as soon as an IgG or IgM line is visible to the naked eye, with the control line visible as well.

The test cassette will work with whole blood, plasma or serum. Capillary blood is the easiest to obtain via a finger pinprick, however, venous blood obtained via venipuncture is also suitable. The type of sample will not affect the sensitivity or accuracy of the test.

The buffer solution (Or Reagent) has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antibodies. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.

The test strip has three different lines; one for IgG, one for IgM and one control line. There are four different valid results:

IgM + Control – The sample is positive for IgM. This means the patient is in the early stages of an infection and combined with the common symptoms, is positive for COVID-19

IgG + IgM + Control – The sample is positive for both IgG and IgM and therefore positive for COVID-19

Control only – The sample is negative

If the control line does not appear, the test is void and should be repeated, irrespective of how many test lines are visible.

For the result, the window of accuracy is 10-15 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate, and you should repeat it.

The test strip has three different lines; one for IgG, one for IgM and one control line. There are four different valid results:

IgM + Control – The sample is positive for IgM. This means the patient is in the early stages of an infection and combined with the common symptoms, is positive for COVID-19

IgG + IgM + Control – The sample is positive for both IgG and IgM and therefore positive for COVID-19

Control only – The sample is negative

If the control line does not appear, the test is void and should be repeated, irrespective of how many test lines are visible.

If you test positive, you should follow the FDA’s advice on COVID-19 infection. This usually means self-isolation for 7 days, avoiding contact with others and remaining hydrated. Most cases of COVID-19 are mild, and recovery only takes a few days, so there’s no need to panic. Speak to your healthcare practitioner for further advice.

A negative result means the biomarkers are not present in your blood, but you should still exercise caution, as you may still be in the early stages of infection (before IgM levels rise to a detectable level). If symptoms develop, follow the protocols as above and retest as necessary. If symptoms do not develop, it is unlikely you have COVID-19 but should still follow strict hygiene procedures. Ensure you wash your hands regularly, avoid social gatherings and work from home if possible. There’s no need to retest unless you suspect you have contracted the infection and are displaying symptoms.

In this case, there are two options. Either you are infected and may begin to display symptoms in the next few days, or you are infected but are asymptomatic (you won’t display symptoms). In both cases, you should treat it as though you are positive for the virus and should follow the appropriate healthcare guidelines. Speak to your healthcare practitioner for further advice.

Yes, the test will be able to detect IgM/IgG in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.

If you have the common symptoms of COVID-19 (fever and cough), you likely have contracted the infection and should self-isolate. It is likely your IgG/IgM levels haven’t risen to a detectable level yet. You can be tested again 24 hours later for confirmation id required. Speak to your healthcare practitioner for further advice.

To date we have tested numerous common pharmaceuticals, none of which have interfered with the test. Also, Rheumatoid Factor does not interfere with the test, hence we currently see no cross-reactivity issues. We are looking at more drugs and will update customers accordingly.

There is some evidence that IgG/IgM remains in the blood after recovery to prevent reinfection. We have tested some patients and noticed that they still test positive for at least 33 days after first displaying symptoms. You won’t be infectious after you recover, even if you test positive, but you should still be cautious as long-term immunity has not yet been confirmed and reinfection may still occur.

Yes, there is no harm to the mother or baby when performing a test.

Yes, there are no issues with testing babies and young children.

No, the more people that are tested, the better it will be to understand the spread of the virus, which will result in better measures being taken to prevent its spread

However, as the test requires a blood sample, anyone with a blood-related health condition (such as hemophilia) should discuss this with a healthcare professional before performing a test.

The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.

The shelf-life is 18 months from the date of manufacture. The product expiry is printed onto the packaging for reference. Do not use after the expiry date.

More than 60 million people ages 65 and older and younger adults with long-term disabilities are covered by Medicare. Due to their older age and higher likelihood of having serious medical conditions than younger adults, virtually all Medicare beneficiaries are at greater risk of becoming seriously ill if they are infected with the new coronavirus that causes COVID-19. COVID-19 is an infectious respiratory disease, which currently has no vaccine or cure. Diagnosis of COVID-19 is confirmed through testing, and treatment varies based on the severity of illness.

These FAQs review current policies for Medicare coverage and costs associated with testing and treatment for COVID-19, including changes adopted in three recent bills: the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, enacted on March 6, 2020 (Public Law 116-123); the Families First Coronavirus Response Act, enacted on March 18, 2020 (Public Law 116-127); and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020 (Public Law 116-136).

Yes, testing for COVID-19 is covered under Medicare Part B when it is ordered by a doctor or another health care provider that accepts Medicare, and if the test was ordered after February 4, 2020. Medicare Advantage plans are required to cover all Medicare Part A and Part B services, including COVID-19 testing.

Medicare beneficiaries who get tested for COVID-19 are not required to pay the Part B deductible or any coinsurance for this test, because clinical diagnostic laboratory tests are covered under traditional Medicare at no cost sharing. (Under traditional Medicare, beneficiaries typically face a $198 deductible for Part B services and coinsurance of 20 percent.) A provision in the Families First Coronavirus Response Act also eliminates beneficiary cost sharing for COVID-19 testing-related services, including the associated physician visit or other outpatient visit (such as hospital observation, E-visit, or emergency department services). A testing-related service is a medical visit furnished during the emergency period that results in ordering or administering the test. The law also eliminates cost sharing for Medicare Advantage enrollees for both the COVID-19 test and testing-related services.  This also prohibits the use of prior authorization or other utilization management requirements for these services.