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Infographic: Testing is key to reopening

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Infographic: Testing is key to reopening communities, businesses, and the economy

Test accuracy is critical to minimize risks for employees and communities

There are numerous tests to help detect the virus that causes COVID-19 (SARS-CoV-2) or antibodies to the virus. Only a few are highly accurate.

Infographic—The value of COVID-19 testing: Highly accurate tests are critical

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Why Antibody Tests?

Accurate antibody serology testing for COVID-19

Why Antibody Tests?*

Highly accurate antibody tests are critical to help inform clinical and public health decisions as we look towards safely opening our communities.

Clinical Use Summarized

Determine immune response to the virus, indicating some potential level of immunity^1,2
- Some tests detect antibodies that may be associated with neutralizing the virus^1,2
When swab sample collection is compromised, thus affecting PCR test results (antigen or PCR testing should be performed as soon as possible afterwards)
Testing as an adjunct to PCR tests to aid in clinical assessment, including when viral load is low ^3,4
Potentially verifying effectiveness of vaccines when they become available^1,2

Infographic: Complementary roles of PCR and Serology Testing — Complementary roles of PCR and Serology Testing

Antibody Tests Complement PCR Tests By:

Supporting the clinical assessment of COVID-19 illness as an adjunct to PCR in patients that test negative while presenting with COVID-19 signs and symptoms³
Providing an alternative when swab sample collection is compromised, which may affect PCR test results (antigen or PCR testing should be performed as soon as possible afterwards)
Supporting the assessment of recent or prior infection as an adjunct to PCR testing, including, for example patients in clinical settings (e.g. Pre-op, ED, acute hospitalized)⁴

Antibody Tests Help Improve Public Health and Safety By:

Informing infection prevalence and the COVID-19 related death rate
Allowing testing following outbreaks in high density work settings (i.e. food processing industry) and communal living (college dorms)—where prevalence may be higher^†
Enabling testing of healthcare and elder care workers and first responders–serving high-risk populations^†
Testing workforce to return and stay safe in the workplace—when social distancing is a challenge† (e.g. manufacturing, correctional facilities, military, transportation, childcare, teachers)

^†Combined with PCR testing for active infection.

Quality and Accuracy are Paramount

A good antibody test is one that has a high degree of sensitivity and specificity.

Test sensitivity indicates the ability of the test to correctly identify patients that have the disease (true positives).
Test specificity indicates the ability of the test to correctly identify patients that do not have the disease (true negatives).

The CDC guidelines indicate a specificity of >99.5% for antibody tests is desirable.⁴

What tests should you be given and how should you interpret the results?

Accurate virus detection test		Accurate antibody detection test
Detection of virus to show present and active infection	Current use	Detection of antibodies, which indicate prior exposure to the virus and some likely level of immunity^2,3
Swab, sample mucous from nose or throat	Type of test	Blood draw, using a test tube
Detects genetic information that indicates the virus is present and may be active	How it works	Detects existence of antibodies, which may likely indicate some level of immunity^2,3,5
• If you have COVID-19 symptoms or may have been exposed to the virus • If you are asymptomatic and want to return to the workplace—to check that you are not infected and spreading the virus	When it should be taken	• If you think you had COVID-19 more than 2 weeks ago and want to want to know if you had the virus • In conjunction with a virus test, if you are asymptomatic, to determine if it is safe for you and others to travel or return to the workplace • Your doctor may order an antibody test as a complement to the virus test to aid in your clinical assessment/diagnosis
2 Hours to 5 Days**	Average speed For the patient to receive results from a highly accurate test	30 Minutes to 5 Days**
Highly accurate tests should maximize sensitivity. Some have 100% sensitivity Sensitivity is important because it correctly detects who has the virus	Accuracy A highly accurate test should reduce false results	Highly accurate tests have over 99.5% specificity and over 90% sensitivity. Some have 99.8% specificity and 100% sensitivity. Sensitivity defines the test's ability to identify those with antibodies to SARS-CoV-2, and specificity defines the ability to identify those without antibodies to SARS-CoV-2
Most likely you do have a current infection and may give it to others Follow guidance for additional steps5 Actions: Quarantine to stop transmission To end quarantine, demonstrate two consecutive negative virus detection tests and take an antibody test to see if you have antibodies to virus	Results and actions If you test positive	You likely had COVID-19 and may have some level of immunity to future re-infection Actions: Take a virus detection test. If negative, you may return to the workplace. Self-protect and test again regularly to ensure antibodies are still present
Most likely, you do NOT currently have COVID-19 You could still get COVID-19 Actions: Take steps to protect yourself and others Take an antibody test to see if you may have been infected but were asymptomatic	Results and actions If you test negative	You likely never had COVID-19 You could still get COVID-19 Actions: Take a virus test. If negative, you may return to the workplace. Self-protect and test again frequently
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Deep dive into virus detection test

For the identification of Coronavirus SARS-Cov-2, Now CE-IVD Registered

Deep dive into IgG antibody test

Detects the level of IgG antibodies in a blood sample, an important step in the global pursuit to establish an individual’s immunity

Deep dive into total antibody detection test

Secure your community with science and scale

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*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.

**Depending on healthcare provider

References:

1. Bao L, Deng W, Gao H, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus macaques. Posted 2020 May 1. https://doi.org/10.1101/2020.03.13.990226

2. Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody. Pinto, D. et al. Nature https://doi.org/10.1038/s41586-020-2349-y (2020).

3. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf Accessed June 21, 2020

4. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html Accessed June 21, 2020

5. https://www.ama-assn.org/delivering-care/public-health/serological-testing-sars-cov-2-antibodies. Accessed June 21, 2020