Curative Labs Inc.

**** * **** **

Orlando, FL **825

adr35q@r.postjobfree.com

Final Results Report

Patient Name: Rojek, Cherie ann Facility: Latino Leadership/ Clínica Mi Salud Patient MRN: CUR151968620

Requisition: 56312753

Date of Birth: 1972-01-06 (50 years old) Kit ID: IDN719732323851 Sex: female Collected: 02/18/22 08:03:10 AM EST

Address: 4050 howard road Hamburg, NY 14075 Received: 02/18/22 08:28:51 AM EST Phone Number: 1-716-***-**** Released: 02/18/22 08:28:51 AM EST Email: adr35q@r.postjobfree.com Specimen Type: Abbott ID Now Test Physician: Zalzala, Sajad (163*******)

Test Result

Abbott ID Now COVID-19 Test Negative

Interpretation:

Positive: SARS-CoV-2 (RNA) was detected

Negative: SARS-CoV-2 (RNA) was not detected

Indeterminate: the assay is invalid; test should be repeated. Abbott ID NOW COVID-19 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in direct anterior nasal (nasal), nasopharyngeal or throat swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a,that meet the requirements to perform high, moderate, or waived complexity tests. The ID NOW COVID-19 assay is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Abbott ID NOW COVID-19 results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory samples during the acute phase of infection. 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. Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with different authorized or cleared molecular tests. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The Abbott ID Now Test is only for use under the Food and Drug Administration's Emergency Use Authorization. Patient Fact Sheet: https://www.fda.gov/media/136524/download Health Care Provider Fact Sheet: https://www.fda.gov/media/136523/download Lab director: Arthur Baca MD, PhD; CLIA # 45D2192800; Sample reviewed at: 02/18/22 07:58:51 AM EST; Report generated at: 02/18/22 08:31:03 AM EST