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COVI0-1__9 PCR
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!II' Collected Result Units Range Comments Group
! ,;} /20/2~~? 13:58 Negative Nf,i;~ e
Comment for COVIDI 9 _SARs~cov- 2 HR
Negative (Not ~t~ct_ed) r ~~~ts do not exclude infecl ion caused by SARS-CoV-2 and s h ou~ d not
b . • ..
e used as the sol~'. basis for treatment or other patient . management decisions·
Optimum specimen t ~ s and-ttiming for peak viral lev~ls duf~p l 1f~~ions -.~clll;ied by
SARS-CoV-2 have not} Been det ermined. Collection of mult:tp l:e~ ~f~ s (types and time points)
from the same patient" may be nece:,:,ary to detect the virus 'i;t p 111~:r;o~r specimen colle~ion and
handl~ng, ~equen~ .'~gi abiiity underlying assay prime: s an~ / ?~,- ~robes, or the ' pres~c...~ , ? f
organisms in quiqiti ties less than the limit of detection . ~f _"t~e: assay may lead to · fal'.se
negative result~•-; . Positive and negative predictive valu~ia~~~. testing ar~ highl~ depen_den t on
prevalence. Fals~ _negative results are more likely when prev~ence of disease is high .
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Toe expected r ~ uit ' is Negative (Not Detected), r,. ·
The SARS-CoV-2 : _e :,t is intended for the presumptive,_qyp,Utativ~. detection nucleic aci d
from SARS-CoV-2 _in upper and lower respiratory spec~~ "· -r_estJfg _,m ethodolggy is real-t~ e
RT-PCR.
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T~s : r~:,u lts J,must be correlated ! ith ~l! ni~} pres ~ ation and ev~lu ated in
the context of
other l ~ ratory and epidemiolog::i.c data; , Test perfo ~cJ .can be affected because the
epidemiology and clinical spect~ ; of infection causea b y SARS-CoV-2 •is n ot fully known. ~~i,
example, the optimum types of ~pecimens, and when to col lect during the course of infection,, _ _
may not be known. • ,,.
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Fact Sheet for Healthcare Providers: ..... -,:,.
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https://tinyurl.com/r7awxyh
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Fact Sheet for Patients:
https://ti~~ rl.com/rlqe72t
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This assa:y'? i~' a real time Reverse Transcriptase PCR assay. Val.idation d ~ nstrated the assay
has acceptab~e characteristics to detect C0VID-l 9 f r ~ human ·cl.inical respiratory specime:ns.
Independent 'review of this assay by the FDA is not fin al. ~t t ti;:, time. ,.
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