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Collect and store samples as indicated in the manufacturer's instructions.
In case the sample is not processed immediately after sample collection, nu-
cleic acids will be preserved in liquid Amies transport medium for up to 5 days
at room temperature, 7 days at 4 °C and up to 6 months at – 20 ° C (see Instruc-
tions for Use eSwab®
Sample Preparation
Use two Regular Flocked Swabs (FLOQSwabs® COPAN Italia s.p.a.) to col-
lect human samples separately in 1 ml liquid Amies. The first swab is used
for the bilateral axilla and groin sample and the second swab is used for the
nasal sample.
Sample collection procedure description using bilateral axilla and
groin swabs
Firmly rub swab tip across left axilla skin surface for at least 3 to 5 times. Re-
peat procedure with the same swab on the right axilla skin surface.
With the same swab used on the axilla, firmly rub the swab tip across the left
groin skin surface for at least 3 to 5 times. Repeat the procedure on the right
side. Transfer the swab into 1 ml liquid Amies transport medium, "break the
swab" and close the tube.
Sample collection procedure description using nasal swabs
Insert a swab into the nostril parallel to the palate. Leave the swab in place
for a few seconds to absorb secretions. Rotate the swab tip against the nasal
mucosa 3 to 5 times. Transfer the swab into 1 ml liquid Amies transport
medium, "break the swab" and close the tube. Transfer 300 µl with a pipette
into the cartridge sample inlet.
Sample collection and procedure description using bilateral axilla,
groin and nasal combination swabs
Take the bilateral axilla and groin swab and the nasal swab as mentioned
above.
After transferring each swab to 1 ml liquid Amies transport medium gently
mix the samples for homogenization (avoid foaming). Take 150 µl with a
pipette from either the nasal sample or the bilateral axilla and groin sample
and transfer it into the cartridge sample inlet. Again take 150 µl from the
matching sample of the remaining sample type and transfer it into the car-
tridge sample inlet. Gently mix the sample in the cartridge sample inlet by
using the pipette (avoid foaming).
Do not use viscous samples that are difficult to pipette.
Test Result
After automatic processing of the sample with the Vivalytic one analyser the
test result is shown on the screen of the Vivalytic one analyser. The time to
result is about 60 min. For high titer specimens results are available after
less than 35 min and the test run can be terminated earlier (see Chapter Test
Termination).
The sample is classified either as C. auris positive, C. auris negative or in-
valid. In case of a positive detection of the pathogen, the test is considered
valid even if the Human Control is negative.
Detection of the human cell based whole process control (Human Control)
in negative samples shows a successful extraction procedure and excludes
an inhibition of the PCR reaction. Interpretation of results is shown in the
table below.
C. auris
Human Control
+
+/–
–
+
–
–
Retesting is recommended
1
Vivalytic C. auris
).
5
Validity
Result
valid
Sample is considered C. auris positive.
valid
Sample is considered C. auris negative.
invalid
Not evaluable.
4
– Instructions for use
1
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