DEPLOYING COMPREHENSIVE RAPID AND POLYMERASE CHAIN REACTION (rRT-PCR) TESTING AS COMBINATION THERAPY

The Road to Herd Immunity

ESTABLISH BASELINE

It’s critical to quickly and accurately identify which employees can continue in their duties and which may be infectious

RAPID DETECTION

Avoid costly PCR testing by utilizing rapid response point of care IgG/IgM testing to quickly determine who is safe to return to work (results in 15 minutes)

SOPs

Quarantine positive results and reflex to a definitive PCR test; return all others to work with follow-up repeat testing schedules

PCR TEST

Determines definitive status of the infection vs. antibodies (24 – 72 hour turnaround)

RESULT

Avoid the time and expense of testing all employees via PCR and only test via PCR when indicated. This will facilitate noninfected/infectious employees to continue their duties and isolate infected/infectious employees

RESULT MANAGEMENT

Get immediate step-by-step coaching from health practitioners for employees that test positive to rapid or PCR test

Immunity Passport

PERFORM IgG / IgM ANTIBODY TEST

PERFORM PCR TEST

Quick Education

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RT-PCR Molecular Test

This is a very sensitive and definitive test that looks for the RNA of the coronavirus using a technique called RT-PCR. This test is intended for the qualitative detecting of nucleic acid from SARS-CoV-2 in nasopharyngeal / oropharyngeal swabs and nasal swabs. All employees that test positive for Rapid IgM antibody should get this test performed on them for confirming the infection.

Rapid IgM /IgG Antibody Testing

Rapid IgM/IgG Antibody test for infection is used to qualitatively detect IgM/IgG antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro. This test can be used for rapid screening of employees to identify carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening all working is vitally important to ensure they do not infect the other employees at work.

Serology IgG/IgM Antibody Test

If you have a positive test result, it is likely that you have or previously had the infection and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, including any previous symptoms, possible exposure to the infection, and the location of places you have recently traveled. There is also the chance that this test can give a positive result that is wrong (a false positive result).

FAQ'S

What is the IgG assay?

The test is designed to detect antibodies in a blood sample that would indicate that you may have current or prior the infection. SARS-CoV-2 IgG assay is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.

What does it mean if I have a positive test result?

If you have a positive test result, it is likely that you have or previously had the infection and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, including any previous symptoms, possible exposure to the infection, and the location of places you have recently traveled. There is also the chance that this test can give a positive result that is wrong (a false positive result).

What does it mean if I have a negative test result?

A negative test result means that the antibodies to the virus that causes the infection were not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with the infection. A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection.

Is this test FDA-approved or cleared?

No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes the infection. This EUA will remain in effect (meaning this test can be used) for the duration of the infection declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

A positive test result with the SARS-CoV-2 IgG assay indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to the infection. IgG antibodies are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

When IgG antibodies are present it often indicates a past infection but does not exclude recently infected individuals who are still contagious. It is unknown how long IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection. A positive result for IgG may not mean that an individual’s current or past symptoms were due to the infection. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

The SARS-CoV-2 IgG assay has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to individuals could include the following: risk of infection by exposure to persons with an active infection. If a recent infection is suspected a false positive result may lead to a recommendation for isolation of the individual, monitoring of household or other close contacts for symptoms, isolation that might limit contact with family or friends and may increase contact with other potentially infected individuals, limits in the ability to work, or other unintended adverse effects. All laboratories using this test must follow standard confirmatory testing and reporting guidelines according to their appropriate public health authorities.