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Sample Types / Medium
The test is intended for use with stool swab samples in eNAT® medium
(Regular 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 selected and collected. After collection, examine the swab to make sure
there is fecal 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. 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 for homogenization and use a pipettor in order to fill
300 μl of homogenized patient sample in the sample input of the cartridge.
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 50 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. difficile positive, C. difficile negative or
invalid. In case of a positive detection of C. difficile, 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. difficile
Human
(tcdA / tcdB)
Control
+
+/–
–
–
Retesting is recommended.
1
PCR – Curve and C
Real-time PCR curves (software-modified) are shown and classified as
positive or negative by the software. In case of positive curves, the respective
C
value is displayed. Inconclusive results are marked by the software ().
q
Retesting is advised.
Vivalytic C. difficile
Validity
valid
+
valid
–
invalid
Value
q
– Instructions for Use
).
5
Result
Sample is considered positive for C. difficile
(tcdA/tcdB toxin gene detected).
Sample is considered negative for C. difficile
(tcdA/tcdB toxin gene not detected)
Not evaluable.
1
4
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