Download CareStart™+COVID-19-Antigen Brochure NEO

ANTIGEN
Rapid Diagnos�c Test for the Detec�on
of SARS-CoV-2 An�gen
For in vitro diagnos�c use only
For professional use only
CE marked
The CareStart™ COVID-19 An�gen Test is a lateral flow immunochromatographic
assay intended for the qualita�ve detec�on of the SARS-CoV-2 nucleocapsid
protein in nasopharyngeal and nasal swab specimens directly collected from
individuals who are suspected of COVID-19 by their healthcare provider.
Fast and easy to use in Point-of-Care setting
Qualitatively detect the SARS-CoV-2 nucleocapsid protein
Use for nasopharyngeal (NP) and nasal swab specimen
Fast results only in 10 minutes
No special equipment or training required
All-in-one package
Identify individual’s current infection status to COVID-19
distributed by;
Nasopharyngeal (NP) Swab Collec on
Nasal Swab Collec on
1
Remove a swab from the pouch.
2
Place the swab into one of patient’s
nostrils until it reaches the posterior
nasopharynx.
1
Remove a swab from the pouch.
2
Insert the swab into one of patient’s
nostrils up to 1 inch from the edge
of the nostril..
3
Slowly rotate 5 times the swab over
the surface of the posterior
nasopharynx.
4
Remove the swab from the
nostril.
3
Slowly rotate 5 times the swab over
the surface of the nasal cavity.
4
Remove the swab from the
nostril.
PEEL OFF
5
6
Peel o aluminum foil seal.
Place the swab into the extraction
vial. Rotate the swab vigorously
at least 5 times.
7
Remove the swab by rotating
against the extraction vial while
squeezing the sides of the vial to
release the liquid from the swab.
Properly discard the swab.
PUSH FIRMLY
CLICK
TAP
90°
8
Close the vial by pushing the cap
rmly onto the vial.
9
Mix thoroughly by icking
the bottom of the tube.
10
Invert the extraction vial and
hold the sample vertically
above the sample well.
Squeeze the vial gently. Allow
three (3) drops of sample to
fall into the sample well.
Order Informa�on
Start the timer
COVID-19
Ag
C
T
Read the result
at 10 minutes.
The test result should
not be read after
15 minutes.
Result Interpretation
SARS-CoV-2 Positive
Negative
Invalid
C
C
C
C
C
T
T
T
T
T
Cat. No.
RCMM-02072
Package Unit
20 tests/kit
Kit Component
NOTES
- The color intensity in the test region will vary
depending on the amount of SARS-CoV-2
antigen present in the sample.
- Any faint colored line(s) in the test region(s)
should be considered as positive.
NOTES
- Re-run the test one time using
the remaining specimen in
the extraction vial.
20 Test devices
20 Extrac�on vial/cap
1 Posi�ve control swab
1 Nega�ve control swab
1 Package insert
*Specimen collection swab will be supplied separately.
distributed by;