We have started facilitating COVID-19 nasal swab testing and antibodies testing and is limited to those who need it most as medically appropriate based on symptoms, risk factors and likelihood of exposure.

COVID-19 Real Time RT-PCR, DNA for Antigen by Nasal Swab

Swab collection is administered by a healthcare worker using a COVID-19 Collection kit, your sample is sent directly to a State of The Art Laboratory that is CLIA Certified and CAP Accredited where samples are processed and tested that day. The Real Time RT-PCR, DNA instrumentation that they use is cleared by the FDA’s Emergency Use Authorization (EUA).

COVID-19 lgG & IgM Antibodies

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses – 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.

Coming Soon

Healgen COVID-19 Rapid Test Cassette

WARNING

This test has been validated but independent review by the FDA is not yet complete. This product is intended for professional use and not for home use. Results from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. A negative result may appear and not correlate with symptoms. A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result. This product can only be purchased by a healthcare worker or healthcare company.

FAQ

COVID-19 lgG & IgM Antibodies

Who can order this test?

Physicians or Patients that will have their blood drawn by a healthcare professional.

What is an IgM and what is an IgG?

Upon infection with the SARS-CoV-2 virus, the patient’s immune system tries to fight the virus by producing blood circulating molecules known as antibodies. IgM is a class of antibodies that appears early after an infection (as early as 3-5 days).

Can I send my patients to a draw site to be collected for this test?

Yes. Usually, IgG antibodies appear in the blood circulation within 3-4 weeks after initial infection. The presence of SARS-CoV-2-specific IgM and/or IgG antibodies in the blood of a patient is a strong indication that the patient has been infected with the SARS-CoV-2 virus.

How long does it take to develop the IgG & IgM antibodies after exposure to the Coronavirus?

IgM as early as 3-5 days. IgG as early as 3-4 weeks post infection.

Can a mobile phlebotomist be sent to my patients for this test?

Yes

What are the accepted specimen requirements, stability, shipping protocols?

Serum in an SST tube. Spin tube after 15min of draw. Ship ambient and it is stable for 48hrs.

What does a positive IgG result mean?

Most likely the individual was exposed at least 3-4 weeks prior to testing.

What does a positive IgM result mean?

IgM is the body’s first line of defense against a foreign antigen, so the individual was recently exposed to an infection (as early as 3-5 days)

What is the test methodology for COVID-19 IgG & IgM Antibody Testing?

Chemiluminescence Immunoassay

What is the clinical specificity of this test?

97.50%

If neither are positive, does this mean the patient was never exposed?

No, only the Real Time RT-PCR,DNA, swab test is a current indicator searching for the presence of SARS-COV-2.

What is the clinical sensitivity of this test?

89.89%

If a patient shows the presence of the antibodies, does this mean they cannot become infected with the virus in the future?

If the IgG is positive, there is a good chance the individual’s body built a defense against the virus.

Is this an at home test?

No, this requires a venipuncture by a healthcare professional and will be tested in our CLIA certified High Complexity Lab

Is the testing method authorized by the FDA?

Our instrumentation is listed on the FDA’s list of authorized instrumentation online and we follow their guidance.

Access 2019 Novel Coronavirus (COVID-19), NAA TEST [C19]

Does the lab offer a test to detect the presence of the 2019 novel coronavirus?

Yes. The 2019 Novel Coronavirus (COVID-19), NAA, is available for ordering by physicians and other authorized health care providers anywhere in the U.S. The test detects the presence of the underlying virus (SARS­CoV-2) that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.

What is the test methodology for 2019 Novel Coronavirus (COVID-19), NAA?

This is a qualitative test using PCR technology.

How should samples be shipped?

Samples can be shipped at room temperature and are stable up to 72 hours