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20 views

Test Result

Uploaded by

redpanda4255
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Covid-19 Test results for order # IDX2541101:

Patient: Matias Kramer


Date of birth: 09/20/2006
Sample collected: 02/14/2022 14:52 PT
Test: COVID-19 RT-PCR
Results sent: 02/15/2022 10:47 PT

NEGATIVE

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. Optimum specimen types and timing for peak
viral levels during infections caused by SARS-CoV-2 have not
been determined. Collection of multiple specimens or types
of specimens may be necessary to detect virus. Improper
specimen collection and handling, sequence variability
under primers/probes, or viruses present below the limit of
detection may lead to false negative results. Positive and
negative predictive values of testing are highly dependent
on prevalence.

The SARS-CoV-2 test is intended for the qualitative


detection of nucleic acids from SARS-CoV-2 in nasal,
nasopharyngeal and oropharyngeal swab samples from
patients who meet COVID-19 clinical and/or
epidemiological criteria. Testing methodology is real-time
RT-PCR. TaqPath(TM). The assay targets the ORF1/a, N-
gene, and the E-gene.

Test results must be correlated with clinical presentation


and other laboratory data. Test performance can be affected
by specimen type, collection time during the course of
infection, and concentration of viral RNA.

This test has not been Food and Drug Administration (FDA)
cleared or approved and has been authorized by FDA under
an Emergency Use Authorization (EUA). The test 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 SARS-CoV-2 under Section 564(b)(1) of
the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the
authorization is terminated or revoked sooner. Inspire
Diagnostics Labs is certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. section
263a, to perform high complexity tests.

CLIA:05D2203452 | 26497 Rancho Parkway South, Lake


Forest, CA 92630
[email protected] | LD: Daniel Leighton

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