Item Brochure

SL1213 | SSM307000EN00 (05/17)
Solana C. difficile Assay – 48 Test Kit: Cat. #M307
Quidel Molecular C. difficile Control Set – 40-Reaction Kit: Cat. #M108
Solana C. difficile Assay Startup Kit – Cat. #M923
Solana Instrument – Cat. #20278
Procedure
in.5 M
95°C
50 µL
ubeT
tionReac
i
on
e
parat
S
ample Pr
PQKVCEƂKNRO#
50 µL
PQKVEGVG&
Clinical Performance
Performance Characteristics of the Solana C. difficile Assay Compared to
Broth Enhanced Toxigenic Bacterial Culture (Combined Sites – Raw Specimen)
Enhanced Toxigenic Culture
POS NEG Total Sensitivity 93.0%
POS 107 6* 113 Specificity 99.2%
NEG 8** 731 739
Total 115 737 852
Solana C. difficile
*Three (3) of the six (6) specimens were positive for C. difficile toxin gene DNA by an alternative molecular device, three (3) were negative.
**Six (6) of eight (8) specimens were found positive for C. difficile toxin gene DNA by an alternative molecular device, two (2) were negative.
R
efer to Package Insert for additional performance claims.
Performance Characteristics of the Solana C. difficile Assay Compared to
FDA-cleared molecular device (Combined Sites – Raw Specimen)
FDA-cleared Molecular Device
POS NEG Total Sensitivity 97.0%
POS 97 16* 113 Specificity 97.9%
NEG 3** 736 739
Total 100 752 852
Solana C. difficile
*Twelve (12) of the sixteen (16) specimens were positive for C. difficile toxin gene DNA by an alternative molecular device, four (4) were
negative.
**Two (2) of three (3) specimens were found positive for C. difficile toxin gene DNA by an alternative molecular device, one (1) was negative.
Refer to Package Insert for additional performance claims.
SSM307000EN00.qxp_Layout 1 5/18/17 7:22 AM Page 2