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Simplexa® C. difficile Direct Kit
An Essential Component of Clostridium difficile Infection TestingDirect detection of toxigenic C. difficile using real-time PCR
INFECTIOUS DISEASE
The quality of treatment starts with diagnosis.
CDIF
FBR1
017a
Fast, simple and accurate molecular C. difficile testing
• Improved workflow with timely results: CLIA moderate complexity with results in about an hour.
• True sample-to-answer solution: No DNA extraction required.
• Reliable performance you can count on.
Simplexa® C. difficile Direct Clinical Agreement Summary1
METHOD N Simplexa® POSITIVE % AGREEMENT
Simplexa® NEGATIVE % AGREEMENT
NAAT 1 829 93.4% 96.6%
NAAT 2 776 93.9% 94.0%
NAAT 3 721 84.8% 99.2%
Direct Culture 2330 95.7% 92.1%
Simplexa® C. difficile Direct Kit
An Essential Component of Clostridium difficile Infection TestingA real-time PCR assay targeting the C. difficile toxin B gene (tcdB) present in unformed stool samples that can fit into any testing algorithm.
In a thorough study of over 2,300 prospective samples, our Simplexa® C. difficile Direct assay demonstrated excellent clinical agreement against three US on‑market assays.
INFECTIOUS DISEASE
REFERENCES: 1. MOL2950, Simplexa® C. difficile Direct instructions for use.
Streamlined, simple workflow
SCAN samples and reagents.
PIPETTE samples and reagents directly onto the disc.
LOAD and press RUN.
0.00%
1.00%
2.00%
3.00%
4.00%
≥4.4xfewer
0.65% 2.90% 3.10% 3.20%
Inva
lid R
ate
(%)
ŋ=2351 ŋ=697
Sim
plex
a® D
irect
Illum
igen
e - 1
0
BD M
ax
Ceph
eid
Gene
Xper
t
ŋ=1860 ŋ=2208
Simplexa® Direct Invalid rate
Competitors Direct Invalid rate
0.00%
1.00%
2.00%
3.00%
4.00%
≥4.4xfewer
0.65% 2.90% 3.10% 3.20%
Inva
lid R
ate
(%)
ŋ=2351 ŋ=697
Sim
plex
a® D
irect
Illum
igen
e - 1
0
BD M
ax
Ceph
eid
Gene
Xper
t
ŋ=1860 ŋ=2208
Simplexa® Direct Invalid rate
Competitors Direct Invalid rate
0.00%
1.00%
2.00%
3.00%
4.00%
≥4.4xfewer
0.65% 2.90% 3.10% 3.20%
Inva
lid R
ate
(%)
ŋ=2351 ŋ=697
Sim
plex
a® D
irect
Illum
igen
e - 1
0
BD M
ax
Ceph
eid
Gene
Xper
t
ŋ=1860 ŋ=2208
Simplexa® Direct Invalid rate
Competitors Direct Invalid rate
DIP swab into stool specimen and dilute in TE Buffer.
Reduce costly delays and repeat testing with lower invalid rates
≥4.4x fewer invalids compared to other NAAT Assays
p: +1 (562) 240‑6500 e: [email protected] w: www.molecular.diasorin.com
Cypress, CA USA
Simplexa and the associated logo are all trademarks or registered trademarks of DiaSorin Molecular LLC in the U.S. and/or other countries. ©2016 DiaSorin Molecular LLC. All rights reserved.
The use of Scorpions™ probes for human in vitro diagnostic purposes is covered by a license to DiaSorin Molecular LLC from QIAGEN Manchester, UK. Scorpions is a registered trademark of QIAGEN Manchester, UK.
Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. DiaSorin products incorporating the Black Hole Quencher, CAL Fluor, and Quasar dye technology are licensed and sold pursuant to an agreement with Biosearch Technologies, lnc., and these products are sold exclusively for clinical, diagnostic, or research and development purposes.
Product availability subject to required regulatory approvals.
Simplify your C. difficile Testing Today
Ordering information – Simplexa® C. difficile Direct
CATALOG NUMBER DESCRIPTION REACTIONS/KIT
MOL2950 Simplexa® C. difficile Direct Kit* 24
MOL2960 Simplexa® C. difficile Positive Control Pack 10 x 100 µL
* Direct Amplification Discs included in kit.
Contact DiaSorin Molecular today! Call +1 (562) 240‑6500 or visit: www.molecular.diasorin.com
CDIF
FBR1
017a
Also available for higher throughput needs Simplexa® C. difficile Universal Direct
• Perform up to 94 patient samples per run
• Simple workflow: No DNA extraction required
• Fast: Results in about an hour
Ordering information – Simplexa® C. difficile Universal Direct
CATALOG NUMBER DESCRIPTION REACTIONS/KIT
MOL2975 Simplexa® C. difficile Universal Direct Kit 100