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Sample Types / Medium
The test is intended for use with stool swab samples in eNAT® medium (Reg-
ular Flocked Swab FLOQSwabs® 552C, eNAT® transport medium Ref. 606C,
COPAN Italia s.p.a.).
Collect and store samples as indicated in the manufacturer's instructions.
In case the sample is not processed immediately after sample collection,
nucleic acids will be preserved in eNAT® transport medium for up to 4 weeks
at room temperature and at 4 °C and up to 6 months at -20 °C to – 80 °C (see
Instructions for Use eNAT® transport medium
Sample Preparation
Use a Regular Flocked Swab FLOQSwabs® (COPAN Italia s.p.a.) to collect a
small amount of stool by inserting the tip of the flocked swab into the stool
sample and rotate it. Bloody, slimy, or watery area of stools should be select-
ed and collected. After collection, examine the swab to make sure there is fe-
cal material visible on the tip. In case it is not, again insert the flocked swab
into the stool sample and rotate taking care that all the area of the swab tip
is in contact with the sample. Make sure that the swab is just covered with
stool and remove excess stool by gently rotating the swab against the rim of
the sample. After collection transfer the swab into the 2 ml Copan eNAT®
tube with eNAT® transport medium. Hold the swab shaft between thumb
and finger, mash and mix the stool specimen against the side of the tube
to evenly disperse and suspend the specimen in the preservation medium.
Hold the swab shaft close to the rim of the tube, bend it at a 180 degrees
angle to break it off at the marked breakpoint. Discard the broken upper part
of the swab shaft and tighten the cap. Shake the sample tube containing the
swab sample and eNAT® medium (COPAN Italia s.p.a.) thoroughly at least
for 10 seconds for homogenization. Use a pipettor in order to fill 300 μl of
homogenized patient sample in the sample input of the cartridge. Ensure to
only pipet from the supernatant (top of the sample) to prevent the carryover
of stool particles. In case of an excess amount of particles in the sample it
is recommended to place the sample tube on a flat surface and let the parti-
cles sediment for 5 minutes.
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 58 min. For high titer specimens results are available after
less than 44 min and the test run can be terminated earlier (see Chapter Test
Termination).
The sample is classified either as Norovirus positive, Norovirus negative or
invalid. In case of a positive detection of Norovirus, 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.
Human
Norovirus
Control
+
+/–
–
+
–
–
Retesting is recommended.
1
Vivalytic Norovirus
Validity
Result
valid
Sample is considered positive for Norovirus.
valid
Sample is considered negative for Norovirus.
invalid
Not evaluable.
4
– Instructions for Use
).
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