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r149579893 Omar Lopez Medina CUR149579893

The test results for Omar López Medina show that his Curative SARS-CoV-2 Assay was negative, meaning SARS-CoV-2 RNA was not detected by RT-qPCR in his oral swab specimen. The test was performed by Curative Labs, a CLIA certified high complexity laboratory. A negative result does not rule out infection and should be used together with clinical observations and history. The test detects SARS-CoV-2 RNA during acute infection using real-time reverse transcription polymerase chain reaction (RT-qPCR) on respiratory specimens.

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227 views1 page

r149579893 Omar Lopez Medina CUR149579893

The test results for Omar López Medina show that his Curative SARS-CoV-2 Assay was negative, meaning SARS-CoV-2 RNA was not detected by RT-qPCR in his oral swab specimen. The test was performed by Curative Labs, a CLIA certified high complexity laboratory. A negative result does not rule out infection and should be used together with clinical observations and history. The test detects SARS-CoV-2 RNA during acute infection using real-time reverse transcription polymerase chain reaction (RT-qPCR) on respiratory specimens.

Uploaded by

Dr. Omar Lopez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Curative Labs Inc.

3330 New York Ave NE


Washington, DC
20002
Final Results Report [email protected]

Patient Name: López Medina, Omar Facility: Miami-Dade County

Patient MRN: CUR149579893 Requisition: 41626444

Date of Birth: 1955-05-24 (65 years old) Kit ID: 127476845548

05/10/21 10:41:26 AM
Sex: male Collected:
EDT

12320 SW 249 St Homestead, FL


Address: Received: 05/10/21 06:11:43 PM EDT
33032

Phone Number: 17867257167 Released: 05/10/21 11:51:00 PM EDT

Email: [email protected] Specimen Type: Oral swab

Physician: Zalzala, Sajad (1639311509) Reviewed By: Tia Olarinde

Test Result

Curative 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.

The Curative SARS-CoV-2 Assay is a real-time reverse transcription polymerase chain reaction (RT-qPCR) test. Results are for the detection of SARS-
CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Collection of oral fluid
specimens is limited to patients with symptoms of COVID-19 and should be performed under the supervision of a trained healthcare worker at the
specimen collection site.

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. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative
results for SARS-CoV-2 RNA from oral fluid specimens should be confirmed by testing of an alternative specimen type if clinically indicated.

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.

Testing is only authorized at Curative Labs high-complexity CLIA certified laboratories.

The assay is intended for use under the Food and Drug Administration's Emergency Use Authorization.

Disclaimer:

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.

This test was developed and its performance characteristics determined by Curative Labs, which is certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Lab director: Arthur Baca, MD PhD; CLIA # 09D2180856; Report generated at: 05/11/21 06:36:40 AM EDT

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