C.difficile Brochure - Meridian Bioscience Europe

THE ABSOLUTE SOLUTION FOR
C. DIFFICILE LABORATORY DIAGNOSIS
THE LATEST GUIDELINES FOR
C. DIFFICILE LABORATORY DIAGNOSIS:
• Toxins A&B EIAs are inadequate as stand alone assays for clinical
diagnosis of CDI, due to poor Sensitivity and Positive Predictive Value
(PPV)1,2,3
• FDA cleared Nucleic Acid Amplification Tests (NAATs) demonstrate
equivalence to the gold standard for CDI diagnosis, toxigenic culture3
• GDH assays, due to their high Negative Predictive Value (NPV), are
good rule-out tests and can be used in an algorithmic approach
followed by NAAT2,3
• Novel testing options result in rapid turnaround time and economical
convenience, allowing laboratories to maximize clinical utility and
optimize use of resources3
All Solutions for Your Preferred Strategy
illumigene® Molecular Assay can be utilized as stand alone test or for confirmation of GDH screening in compliance with the new guidelines.
1
STAND ALONE TESTING PREFERENCE
Positive
for toxigenic C. difficile
Negative
for toxigenic C. difficile
2
ALGORITHM TESTING PREFERENCE
Negative
for C. difficile
— or —
Positive
for toxigenic C. difficile
Negative
for toxigenic C. difficile
C.
Assay
C.difficile
difficile
Assay
The illumigene C. difficile assay, based on LAMP technology, allows any laboratory
to produce accurate, rapid molecular results with a high procedural flexibility.
®
• Outstanding Clinical Performance4
— ≥ 2 years of age: Sensitivity 95.2%, Specificity 95.3%
— < 2 years of age: Sensitivity 93.3%, Specificity 96.3%
• Detection of all clinically relevant toxigenic strains5
• Compact instrumentation for the amplification of up to 10 specimens
• Minimal hands-on time
• Results in less than one hour
ImmunoCard ® C. difficile GDH (single test) or Premier® C. difficile GDH (ELISA) are
enzyme immunoassays for the detection of C. difficile common antigen (GDH).
These two tests are excellent cost-effective screens for C. difficile in a 2-step testing
algorithm.
• Rapid results
— Less than 30 minutes with ImmunoCard ® C. difficile GDH
— Less than two hours with Premier® C. difficile GDH
• High screening accuracy
— Early elimination of negative results
— High Negative Predictive Value
— Premier® C. difficile GDH: Sensitivity 94%, NPV 97%6
— ImmunoCard ® C. difficile GDH: Sensitivity 97.6%, NPV 99.6%7
C. difficile GDH
C. difficile GDH
How to perform test
TEST PROCEDURE
Substrate
Substrate
Reagent
Reagent
Wash
Wash
Reagent
Reagent
In a test tube, add 200 µL
of
Diluent
In Sample
a test tube,
add using
200 µL
the
dropperDiluent
assembly.
of Sample
using
the dropper assembly.
Add 25 µL of liquid stool
(first
mark
onliquid
the transfer
Add 25
µL of
stool
pipette)
or 2onmm
(first mark
thediameter
transfer
of
solid
stool
to
pipette) or 2 mmthe
diameter
test
tube.stool
Vortex
mixture.
of solid
to the
test tube. Vortex mixture.
Hold Enzyme Conjugate
vertically
and add
3 drops
Hold Enzyme
Conjugate
to
the testand
tube.
vertically
addVortex.
3 drops
Let
the
tube
stand
at
to the test tube. Vortex.
20–26
for 15
minutes.
Let theCtube
stand
at
20–26 C for 15 minutes.
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
Using a transfer pipette,
add
150
µL (second
mark
Using
a transfer
pipette,
on
pipette)
of diluted
addthe
150
µL (second
mark
specimen
to
the
right
and
on the pipette) of diluted
left
sampleto(lower)
ports.
specimen
the right
and
Incubate
5
minutes
at
left sample (lower) ports.
20-26
C. 5 minutes at
Incubate
20-26 C.
Hold Wash Reagent
vertically
and
add 3 drops
Hold Wash
Reagent
to
each reaction
vertically
and add 3 drops
(upper)
port.
to each reaction
(upper) port.
Once Wash Reagent is
absorbed,
Substrate
Once Washhold
Reagent
is
Reagent
and add
absorbed,vertically
hold Substrate
3Reagent
drops to
both
reaction
vertically
and add
(upper)
3 drops ports.
to bothIncubate
reaction
for
5 minutes
20-26 C.
(upper)
ports.atIncubate
Visually
read the
resultsC.
for 5 minutes
at 20-26
within
30
seconds
of the
Visually read the results
end
of 30
incubation.
within
seconds of the
end of incubation.
©2011 SN11085 REV. 03/11
©2011 SN11085 REV. 03/11
C. difficile Assay TEST PROCEDURE
C. difficile Assay
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
CONTROL
TEST
How to perform test
1. Liquid:
Specimens must be fully
immersed.
Mix specimen thoroughly.
Collect
specimen
using
Mix specimen
thoroughly.
Sample
Collectionusing
Brush.
Collect specimen
Sample Collection Brush.
®
Insert brush into Sample
Preparation
Insert brushApparatus.
into Sample
Semi-solid:
Break
off brush
at the
Preparation
Apparatus.
Approximately
one-half
of
“Break”
mark
onatthe
Break
off
brush
the
Rotate brush over
the brush surface
should be
coated.
handle.
Recap
andthe
vortex
“Break”
mark
on
specimen
to
lightly
Rotate brush over
10
seconds.
handle.
Recap
and
vortex
coat
the surfaces
specimen
surfaceof
tothe
lightly
10
seconds.
brush
bristles.
coat the surfaces of the
brush bristles.
© 2010 SN11177 REV. 04/11
© 2010 SN11177 REV. 04/11
Remove cap and squeeze
5-10
drops
sample
into
Remove
capofand
squeeze
Heat
Tube. into
5-10 Treatment
drops of sample
Heat Treatment Tube.
Heat the illumigene
Heat
Tube at®
Heat Treatment
the illumigene
95
C for
10 minutes.
Heat
Treatment
Tube at
Vortex
seconds.
95 C forfor1010minutes.
Vortex for 10 seconds.
Using a new pipette tip for
each,
50 µL tip
of the
Usingtransfer
a new pipette
for
Reaction
Buffer50Tube
each, transfer
µL of the
sample
the TEST
ReactiontoBuffer
Tubeand
CONTROL
chamber
of the
sample to the
TEST and
illumigene
Test Device.
CONTROL chamber
of the
illumigene Test Device.
®
Transfer 50 µL of
heat-treated
sample
Transfer 50 µL
of to the
Reaction
Buffer
Tube.to the
heat-treated
sample
Vortex
forBuffer
10 seconds.
Reaction
Tube.
Vortex for 10 seconds.
Ordering Information
Product
illumigene C. difficile Assay
®
ImmunoCard ® C. difficile GDH
Premier ® C. difficile GDH
Quantity
Catalog #
50 tests
50 tests
96 microwells
280050
716050
611096EU
REFERENCES
1.Crobach et al. Clin Microbial Infect, 2009 (Vol 15)
2.ASM Practical Guidance for the Laboratory Detection of Toxigenic C. difficile, September 2010 (www.asm.org)
3. APIC 2013 - Guide to Preventing Clostridium difficile Infections – (www.apic.org/Professional-Practice/Implementation-guides)
4. illumigene® C. difficile Package Insert, rev. 04/2011.
5. Rupnik M. Heterogeneity of large clostridal toxins: importance of Clostridium difficile toxinotypes, Microbiol Rev, 2008; 32:541-55.
6. Premier® C. difficile GDH Package Insert, rev. 12/2011 (EU).
7. ImmunoCard® C. difficile GDH Package Insert, rev. 11/2011.
CDIFF ALG rev. 05.2013
www.meridianbioscience.eu
®
Close and fasten the latch
securely.
Close andGently
fastentap
thedevice
latch
to
removeGently
air bubbles
securely.
tap device
trapped
onair
thebubbles
bottom of
to remove
the
tubes.
trapped
onCarefully
the bottom of
examine
tubes to
the tubes.reaction
Carefully
ensure
there are
no to
examinethat
reaction
tubes
air
bubbles
in are
tube.
ensure
that left
there
no
air bubbles left in tube.
®
Insert illumigene
Test
into the ®
InsertDevice
illumigene
™
illumipro-10
and
Test Device into the
™
initiate
amplification
illumipro-10
and
reaction
and detection.
initiate amplification
reaction and detection.