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COVID-19 Test Report: Negative Result

A SARS-CoV-2 test was performed on a nasal swab sample collected from Karen Pizano. The test was processed at a Curative Labs facility and used the Alinity M SARS-CoV-2 Assay to detect the presence of SARS-CoV-2 RNA via RT-qPCR. The results were negative, indicating that SARS-CoV-2 RNA was not detected in Ms. Pizano's sample. Negative results do not rule out infection and should be used together with clinical observations and history. The test is authorized by the FDA under an EUA during the COVID-19 public health emergency.

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594 views1 page

COVID-19 Test Report: Negative Result

A SARS-CoV-2 test was performed on a nasal swab sample collected from Karen Pizano. The test was processed at a Curative Labs facility and used the Alinity M SARS-CoV-2 Assay to detect the presence of SARS-CoV-2 RNA via RT-qPCR. The results were negative, indicating that SARS-CoV-2 RNA was not detected in Ms. Pizano's sample. Negative results do not rule out infection and should be used together with clinical observations and history. The test is authorized by the FDA under an EUA during the COVID-19 public health emergency.

Uploaded by

karen
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  • Test Details: Describes the specific test conducted, including the name of the assay and the type of sample used for analysis.
  • Patient Information: Provides identification details about the patient being reported, including name, ID, and contact information.
  • Results: Presents the test results indicating whether the SARS-CoV-2 virus was detected or not in the sample.
  • Interpretation: Explains the significance of the test results, including possible implications and recommendations for the patient.

Curative Labs Inc.

430 S Cataract Ave


San Dimas, CA 91773
[email protected]
Final Results Report

Patient Name: Pizano, Karen Facility: University of Texas at Arlington

Patient MRN: 1001851858 Requisition: 45210533

Date of Birth: 1996-02-27 (25 years old) Kit ID: 458233022071

Sex: female Collected: 08/21/21 12:23:38 PM CDT

Address: 1008 Lanes End Joshua, TX 76058 Received: 08/23/21 03:56:49 AM CDT

Phone
18178913971 Released: 08/23/21 11:19:28 PM CDT
Number:

Specimen
Email: [email protected] Alinity shallow nasal swab
Type:

Physician: Lazar, Alexander (1376643593)

Test Result

SARS-CoV-2 Assay (RNA Detection Test by RT-qPCR) Negative

Interpretation:

Positive: SARS-CoV-2 RNA detected by RT-qPCR


Negative: SARS-CoV-2 RNA not detected by RT-qPCR
Indeterminate: Indeterminate for SARS-CoV-2 RNA by RT-qPCR.

Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is
necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent
detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to
the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. inadequate sample
collection or exposure to extreme heat during transport may decrease the ability to detect SARS-CoV-2 RNA in a sample. Negative results must be
combined with clinical observations, patient history, and epidemiological information.

Indeterminate results may occur in the case of an inadequate specimen such as quantity not sufficient. Specimen must be recollected if test is still
required.

Method: Alinity M SARS-CoV-2 Assay

The Alinity M SARS-CoV-2 assay is a real-time reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of
nucleic acid from SARS-CoV-2, including in nasal swabs self-collected at a health care location. Results are for the identification of SARS-CoV-2 RNA.
The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection.

Disclaimer:

This test is only for use under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Commercial reagents are provided by
Abbott Molecular Inc. Performance characteristics of the EUA have been independently verified by Curative Labs high-complexity CLIA certified
laboratories.

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA 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 (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will be effective until the declaration that
circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated
under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

Lab director: Arthur Baca, MD PhD; CLIA # 05D2141174; Report generated at: 08/29/21 08:47:28 PM CDT

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