COVID-19 (SARS-CoV-2 RNA RT-PCR)

Provider: Ekan Essien MD Sex: F Collected: 2021-01-09 01:00 PM PST

Patient: RONNIE PRICE Date of Birth: 2002-03-05 Received: 2021-01-09
Sample Type: Nasopharyngeal Swab Accession #: 2021012434 Completed: 2021-01-09

Result: Not Detected Remark: Individual Specimens Reference Range: Not Detected

What Your Results Mean

Not Detected = Negative Detected = Positive

A result of "Detected" indicates that SARS-CoV-2-RNA is present and suggests the diagnosis of coronavirus disease 2019
(COVID-19). Test results should always be considered in the context of the patient’s clinical history, physical examination, and
epidemiologic exposures when making the final diagnosis.

A result on our RT-PCR test is considered critical when positive because this indicates the individual could be infectious. US
BioTek Laboratories must notify the individual’s doctors immediately as well as the public authority.

The RT-PCR tests for three different pieces of COVID-19 viral RNA. If two thirds of the pieces of viral RNA are identified the
test is read as Detected (positive), meaning the virus is present. Quarantine is required if the virus is present; your healthcare
provider will tell you how long your quarantine will last. If no viral RNA is found the test is read as Not Detected (negative),
indicating there is no virus present. Continue all exposure precautions; a negative test does not guarantee that patient will remain
virus-free. Retest if new symptoms develop or if symptoms persist or worsen. If only one piece of viral RNA is found, the test is
read as Inconclusive. Consider submitting a fresh sample if the patient is still symptomatic or symptoms worsen, using the
CDC-recommended nasopharyngeal swab technique.

The test is specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and positive test results do not exclude
the possibility of concurrent infection with other respiratory viruses. Negative results do not preclude infection with SARS-CoV-2
and should not be used as the sole basis for decisions on treatment or other patient care management.

For more COVID-19 resources, please visit cdc.gov/coronavirus/2019-ncov/.

About This Test

This test has been granted an FDA EUA for testing human upper and lower respiratory swab specimens. The saliva collection kit
has also been granted an FDA EUA. Both the saliva collection kit manufacturer and US BioTek have performed studies proving
concordance between the respiratory swab and saliva collection methods.

This test is not yet approved or cleared by the FDA as IVD (In Vitro Diagnostic Medical Device). When there are no
FDA-approved or cleared tests available, and other criteria are met, the 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 declaration that circumstances exist to justify the emergency use of vitro diagnostics for the detection and/or
diagnosis of the virus that causes COVID-19. This EUA will remain in effect, meaning this test can be used, for the duration of
the COVID-19 declaration justifying emergency use of IVDs, unless it is terminated or revoked by the FDA, after which the test
may no longer be used.

The test performance has been validated by US BioTek Laboratories according to high-complexity testing under Clinical
Laboratory Improvement Amendments (CLIA). The sensitivity of the assay is dependent on the quality of the specimen collected
for testing.

US BioTek is required to report SARS-CoV-2 RNA RT-PCR test results to appropriate public health authorities.

Tel:206-365-1256 | Fax:206-363-8790 | Director:Jillian Harrington, PhD, HCLD (ABB) | Address: 16020 Linden Ave North, Shoreline, WA 98133, USA
http://www.usbiotek.com CLIA : 50D0965661 COLA accredited 2021
c US BioTek Laboratories, LLC.
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 State of Hawai'i Safe Travels Program
Trusted Testing Partner COVID-19 Test Result Reporting Form

Trusted Testing Partner US Biotek Laboratories

Name of Lab/Site Performing Test C19PCR

Address of Lab 16020 Linden Ave North, Shoreline, WA 98133, USA

Lab Telephone 206-365-1256

CLIA Number/Waiver 50D0965661

Traveler Information:

Last Name PRICE

First Name RONNIE

Date of Birth (mm/dd/yyyy) 03/05/2002

Test Information:

Test Performed C19PCR

Sample Collection Date 01/09/2021 01:00 PM PST

Sample Reference ID# 2021012434

Test Result: Not Detected

Hawaii Letter (Trusted Testing Partner)(v 2.0)