AccessDx

10301 Stella Link Rd, Suite C, Houston, TX 770255

346.571.6627
Laboratory Director: Thomas Huard, PhD COVID-19 Report
Clinical Molecular Pathology Supervisor: Arsalan
Salimi, PhD
CLIA#: 45D2034771 CAP#: 8034463-01

Patient Information Specimen Information Facility Information

Name: FARRUKH AHMAD Accession Number: C000155653 Facility Name: WEST FIELD URGENT CARE
DOB: 06/15/1945 Date Collected: 08/10/2020 Provider Name: AMJAD AKHTAR

Gender: F Date Received: 08/10/2020 Address: 2010 Farm to Market 1960 Road
East, Houston, Texas, 77073
Ethnicity: undisclosed Report Date: 08/12/2020

Medical Record Number: Sample Type: Nasopharyngeal Swab

Clinical Notes from Ordering Physician:

COVID-19 Test Result Summary

NEGATIVE

SARS-CoV-2/2019-nCoV
Assay Results

2019-nCoV_N1 Not Detected

2019-nCoV_N2 Not Detected

The Analytical Specificity of this test is 99.99% as determined by the Primer Blast against common organisms and flora found in the respiratory tract and the Analytical
Sensitivity of this test is 95% at 40 GCE, 99.99% at 200 GCE as determined by RT-PCR.

Interpretation statement for all SARS-CoV-2 test reports:

This test was intended to detect SARS-CoV-2 (also known as 2019-nCoV) the pathogen associated with COVID-19 pneumonia. A Positive (Detected) result for this test is
indicative of an active infection with this virus. A Negative (Not Detected) result does not rule out the presence of infection as patients in the pre-symptomatic or convalescent
phases of the infection may not express the virus in the nasopharyngeal airway. In rare cases the result may be Inconclusive. That case arises if the results do not meet all the
requirements for a reliable determination of the presence of the virus. A second sample should be collected to resolve those cases.

These tests were developed, characterized and interpreted by Access. The tests in this report have not been approved by the Food and Drug Administration. The FDA has
determined that such approval is not necessary, provided that the laboratory both (1) maintains its good standing as a clinical testing laboratory with all mandatory accrediting
bodies, and (2) continually demonstrates that its testing protocols and procedures achieve a high degree of analytical accuracy.

The COVID-19 (SARS-CoV-2) has not been FDA cleared or approved. This test is currently under an Emergency Use Authorization (EUA) review by the FDA. This test has
been validated in accordance with the FDA's Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA
prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency) issued on February 29th, 2020. FDA independent review of this
validation is pending. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro
diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner.

Processing and Detection Methodology:

The COVID19 (SARS_CoV-2) assay utilizes RT-PCR for the qualitative detection of nucleic acid from SARS_CoV-2.

Disclaimer: Limitation: An absence of detection does not imply the absence of microorganisms other than those listed or does not exclude the possibility that the target
sequence is present below the limit of detection.
Any questions or concerns regarding this test may be directed to Dr. Thomas Huard, Laboratory Director at Access Dx, 703-408-1750 or thomas.huard@accessdxlab.com.

This test was performed by AccessDx, 10301 Stella Link Rd, Suite C, Houston, TX 770255 Phone: 346.571.6627 CLIA#: 45D2034771 CAP#: 8034463-01

Patient - FARRUKH AHMAD Accession - C000155653 Page 1 of 1

This report, associated with order #C000155653, has been approved by the following reviewers:

Covid-19 Reporter:
Electronically signed and dated on 08/12/2020 11:07
Nejat Berhan