COVID-19 Report
Gray, Nelle Dr. Rashan, A.R. 762249226
DOB: 05-10-2006 (FEMALE, 15) ClearMD Date Collected: Feb 4 2022, 12:30pm
Phone: N/A 1051 third avenue Date Reported: Feb 5 2022, 10:09am
Passport #: N/A New York, NY 10065
SARS-CoV2 (COVID-19): POSITIVE
Testing Result
SARS – CoV-2 (COVID-19)
NAAT Molecular rt-PCR Detected
Anterior Nasal Swab
Final Report Electronically signed by Dr. A.R. Rashan MD as approved by the medical director on Feb 5 2022, 10:09am
Test Information:
The SARS-CoV-2(COVID-19) test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test. The SARS-CoV-2 primer and probe set is designed to amplify and detect RNA
from the SARS-CoV-2 in respiratory specimens from patients as recommended for testing by public health authority guidelines. The assay employs the CDC-designed primer/probe sequences
as included in the SARS-CoV-2 (2019-nCoV) CDC qPCR Probe Assay and listed below. SARS-CoV-2-specific sequences target two separate regions of the viral nucleocapsid (N) gene. Also
included is an internal control targeting the human RNase P (RP) gene. All three targets are detected in a single assay in multiplex, each with a unique fluorophore-quencher combination
Limitations:
1. The test was validated for use only with upper and lower respiratory specimens.
2. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. Optimum specimen types and timing
for peak viral levels during infections caused by SARS-CoV-2 have not been determined.
3. Collection of multiple specimens (types and time points) from the same patient may be necessary to detect the virus.
4. A false negative result may occur if a specimen is improperly collected, transported or handled. False negative results may also occur if amplification inhibitors are present in the specimen
or if inadequate numbers of organisms are present in the specimen.
5. Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely when prevalence of disease is high. False positive test results are
more likely when prevalence is moderate to low.
6. If the virus mutates in the RT-PCR target region, SARS-CoV-2 may not be detected or may be detected less predictably. Inhibitors or other types of interference may produce a false
negative result.
7. An interference study evaluating the effect of common cold medications was not performed.
8. Test performance can be affected because the epidemiology and pathology of disease caused by SARS-CoV-2 is not fully known. For example, clinicians and laboratories may not know the
optimum types of specimens to collect, and when during infection these specimens are most likely to contain levels of virus that can be readily detected.
9. Detection of viral RNA may not indicate the presence of infectious virus or that SARS-CoV-2 is the causative agent for clinical symptoms.
10. The performance of this test has not been established for monitoring treatment of SARSCoV-2 infection.
11. The performance of this test has not been established for screening of blood or blood product for the presence of SARS-CoV-2.
12. This test cannot rule out diseases caused by other bacterial or viral pathogens.
This test has not been cleared or approved by the U.S. Food and Drug Administration, however approved under the Emergency Use Authorization (EUA) The FDA has determined that such
clearance or approval is not necessary. The test methodology has been validated in-house and the methodology as well as the validation data, reviewed by the Clinical Laboratory Evaluation
Program of the New York State Department of Health. The laboratory also participates in inter-laboratory testing under the auspices of the College of American Pathologists, in keeping with
the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). Therefore, this test is used for clinical purposes. It should not be regarded as investigational or for research on this basis
alone.
AR Anesthesia LLC is d/b/a ClearMD. | 2007 Broadway New York, NY 10023
CLIA# 33d2197705 | Medical Director: A.R. Rashan MD, MS | 1-866-632-5327
