Noydeen Medical Group CLIA Waived Laboratory
Verified COVID TEST RESULTS.
COVID-19
Lab:SARS-COV-2 RNA, QUAL RT-PCR
*Negative*
SOURCE Nasopharyngeal Swab
SARS-COV-2 RNA *UNDETECTED-NEGATIVE* Procedure:COVID
PCR ID NOW
Procedures:
The Severe Acute Respiratory Syndrome Coronavirus 2 test is an RT-PCR test developed by Abbott company.
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, RT-PCR intended for the qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct 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 authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate complexity/high 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. This test was performed via the ID NOWTM Platform at Noydeen Sisters Medical group CLIA waived certificate laboratory ID number 04D2118445. Laboratory director is Dr Ahmed A Ali MD. Address is 655 Dave Ward Dr Conway AR Ste 103 72034.
The ID NOWTM COVID-19 has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings.
The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. A negative result does not exclude the possibility of SARS-CoV-2 infection below the limit of the detection of the assay. The results of this test should be used in conjunction with the clinical presentation to guide patient management. Qualitative RT-PCR for the detection of SARS-CoV-2 was performed using the ID NOWTM COVID-19 instrument.
Detection was based upon the generation and detection of fluorescent signals. A negative result does not exclude the possibility of SARS-CoV-2 infection below the limit of the detection of the assay. The results of this test should be used in conjunction with the clinical presentation to guide patient management.
Qualitative RT-PCR for the detection of SARS-CoV-2 was performed using the ID NOW instrument. Detection was based upon the generation and detection of fluorescent signals. This test was granted FDA Emergency Use Authorization.
For more details please visit https://www.fda.gov/media/136522/download.