5. Frequently AskedQuestions
Will this testhurt?
No,thenasals
wabisnotsharpanditshouldnothurt.S
o
m
e
t
i
m
e
sthes
w
a
bc
a
nfeelslightly
uncomfortableortickly.If youfeelpain,pleasestopthetestandseekadvicefroma
healthcareprovider.
Whataretheknownandpotentialrisks andbenefitsof this test?
Potential risks include:
⢠P
ossiblediscomf
ortduringsampl
ecollection.
⢠P
ossibleincorrecttestresults(seeR
esultssection).
Potential benefits include:
⢠Th
e re
su
lts, a
lo
n
g w
ith o
th
e
r inform
a
tio
n
, c
a
n h
e
lp y
o
u
r h
e
a
lth
c
a
re p
ro
vid
e
r m
a
k
e
info
rm
ed recommendationsaboutyourcare.
⢠TheresultsofthistestmayhelplimitthespreadofCOVID-19toyourfamilyandothersinyour
community.
You have the option to refuse this test. However, your doctor has prescribed this test because they
believe it could help with your care.
BinaxNOWCOVID-19AgCARDHOMETESTKIT
6. What is the difference between an antigen and molecular test?
BinaxNOWCOVID-19AgCARDHOMETESTKIT
There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect
genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very
specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is
highly accurate, but a negative result does not rule out infection. If your test result is negative, you
should discuss with your healthcare provider whether an additional molecular test would help with
your care, and when you should discontinue home isolation.
7. HowAccurate is this Test?
Basedontheinterimresultsofaclinicalstudyw
h
e
retheBin
a
x
NOWTM
COVID-1
9AgCa
rdH
ome
T
estwascomparedtoanFD
AauthorizedhighsensitivitySARS-CoV-2test,BinaxNOWCO
VID-19
AgCardH
o
m
eT
estcorrectlyidentified91.7%ofpositivespecimensand100%ofnegative
specimens.
BinaxNOW COVID-19 Ag Card Home Test Study*
In the graph above, BLUE bars represent samples where the both the BinaxNOW COVID-19 Ag Card
Home Test and molecular test result were positive. The ORANGE bars represent samples where
the BinaxNOW COVID-19 Ag Card Home Test results that were negative and the molecular test
was positive. All of the ORANGE bars occurred in samples where there were very low levels of
virus detected by the molecular test. In a separate larger study, the BinaxNOW COVID-19 Ag Card
clinical study where tests were performed by healthcare providers, BinaxNOW COVID-19 Ag Card
correctly identified 90.6% (116/128) positive specimens with high amounts of virus.
BinaxNOWCOVID-19AgCARDHOMETESTKIT
8. Due to the relatively small sample size for the home use clinical study, the BinaxNOW⢠COVID-19
Ag Card Home Test is estimated to correctly identify between 73.0% and 98.9% of positive
specimens as reflected in the 95% Confidence Interval. This is consistent with the performance
established in a separate multi-site clinical study in the US, where the BinaxNOW COVID-19 Ag
Card test was performed and results interpreted by test operators with no laboratory experience.
In that study, BinaxNOW⢠COVID-19 Ag Card test correctly identified 84.6% of positive specimens
and 98.5% of negative specimens.
Based on this information, negative results may require additional testing to confirm your result.
Please talk to your healthcare provider to determine if you need additional testing.
BinaxNOWCOVID-19AgCARDHOMETESTKIT
14. Apply Fluid to Top Hole
A. Remo
vedropper
bottlecap.
B. Hold dropper bottle
straightoverTOPHOLE,
notatanangle.
C. Put6DROPSinto
TOPHOLE.Donot
touchcardwithtip.
6 drops
Note:Falsenegativeresults
mayoccuriflessthan6drops
BinaxNOWCOVID-19AgCARDHOMETESTKIT
15. of fluid is used.
BinaxNOWCOVID-19AgCARDHOMETESTKIT
18. Swab LeftNostril
A. Inserttheentireabsorbenttip
of the s
wab (usually 1/2 to 3/4
of aninch)intoleftnostril.
B.Firmlybrushagainstinsidesof
nostrilinacircularmotion5times
ormoreforatleast15
seconds.
Upto3/4of
aninch.
x5
BinaxNOWCOVID-19AgCARDHOMETESTKIT
24. Wait 15Minutes
Note: False results can
occur if the card is
disturbed/moved or test
results are read before 15
minutes.
15:00
BinaxNOWCOVID-19AgCARDHOMETESTKIT
32. confirmatory testing should be conducted.
Itisimportantthatyouworkwithyourhealthcareprovidertohelp
youunderstandthenextstepsyoushouldtake.
BinaxNOWCOVID-19AgCARDHOMETESTKIT
35. Reporting Patient Results Using NAVICA
Uponcompletionofthetestandresultinterpretation,thetelehealthproctorwillsendyourtest
resultsviatheNAVICAapp.Y
o
uwillbenotifiedbyemailandonyourmobiledevicethatyour
resultsareready.Y
o
uwillgototheresultsscreeninNAVICAtoobtainyourtestresults.
IfyourBinaxNOWCOVID-19AgCardHomeTest
resultisNegative,youwillreceivethefollowing:
IfyourBinaxNOWCOVID-19AgCardHomeTest
resultisPositive,youwillreceivethefollowing:
BinaxNOWCOVID-19AgCARDHOMETESTKIT
36. Reporting Patient Results Using NAVICA
Uponcompletionofthetestandresultinterpretation,thetelehealthproctorwillsendyourtest
resultsviatheNAVICAapp.Y
o
uwillbenotifiedbyemailandonyourmobiledevicethatyour
resultsareready.Y
o
uwillgototheresultsscreeninNAVICAtoobtainyourtestresults.
IftheBinaxNOWCOVID-19AgCardHomeTest
resultisInvalid,youwillreceivethefollowing:
Š2020Abbott.All rights reserved.
Alltrademarksreferencedaretrademarksofeitherthe
Abbottgroupofc
o
m
p
a
n
i
e
sortheirrespectiv
eo
wners.
IN195101Rev12020/12
BinaxNOW COVID-19 Ag CARD HOME TEST KIT
