dening on-demand molecular diagnostics.

Go from test and wait

to test and treat.
In vitro diagnostic medical device
Xpert

MTB/RIF
Xpert

MTB/RIF
Two-hour detection of MTB and resistance to rifampicin.
The Need
Current Testing Methodologies Are Too Slow
According to the World Health Organization (WHO),
Mycobacterium tuberculosis (MTB) is considered to be vastly
under diagnosed today, despite approximately 500,000 new
active cases reported in the WHO European region during
2007. This is a direct result of current MTB testing methods
requiring weeks to deliver a denitive result, which can lead
to patients being left untreated or placed on ineffective
therapies. These patients may continue to spread MTB to
others in the community, increasing the disease burden.
Drug Resistant Strains
With the worldwide re-emergence of TB, multi-drug resistant
(MDR) and extensively drug resistant (XDR) strains have
become an even greater threat. According to the WHO Global
Tuberculosis Control Report 2009, there may be more than
500,000 cases of MDR-TB worldwide. Current testing for
drug resistance can take more than 4 weeks, leading to higher
mortality and the further spread of MDR strains.
The Solution
Xpert MTB/RIF
S|mu|taneous detect|on o botH V1b and r|amp|c|n
resistance, a marker for MDR strains
0nprecedented sens|t|v|ty or detect|nq V1b even |n
smear negative, culture positive specimens
kesu|ts |n two Hours. requ|res no |nstrumentat|on otHer
tHan tHe 6enexpert System
0n-demand resu|ts enab|e pHys|c|ans to treat rap|d|y
and effectively
If you were to inoculate an Xpert

MTB/RIF test at the

same time you started preparing your acid fast smears,
by the time you nished reading the smears, the Xpert
MTB/RIF test result would be ready, telling you if your
positive acid fast smear was TB and if the strain was
resistant to rifampicin, which is an excellent surrogate
marker for MDR-TB. Im sure Koch and Pasteur would
not only be delighted with the technological advance,
they would probably say, Its about time.
Fred Tenover, Ph.D.
Cepheid Senior Director of Scientic Affairs
Xpert MTB/RIF: Test and Treat
Sensitive
|em|-nested |Ck |ncreases sens|t|v|ty
||qH|y sens|t|ve or conrmat|on o botH smear pos|t|ve and smear neqat|ve samp|es
kobust son|cat|on/mecHan|ca| 0|/ extract|on procedure
|nterna| extract|on contro| assures extract|on perormance
AFB- AFB+
Culture
positive
Culture
negative
Culture
positive
Xpert
V1b/k||
MTB
detected
70 3 275
MTB
not detected
7 171 0
sensitivity: 98.0%
specicity: 98.3%*
XPERT MTB/RIF ASSAY VERSUS AFB AND CULTURE STATUS
Specic
1He xpert V1b/k|| assay uses 3 specic primers and 5 unique molecular probes to ensure a high degree of specicity
/ssay tarqets tHe rpoB gene, which is critical for identifying mutations associated with rifampicin resistance
|o cross react|ons were observed w|tH many otHer bacter|a| spec|es tested. |nc|ud|nq a compreHens|ve pane| o Vycobacter|a
PROBE A PROBE C
PROBE B
PROBE D
PROBE E
5
1
- GCACCAGCCAGCTGAGCCAATTCATGGACCAGAACAACCCGCTGTCGGGGTTGACCCACAAGCGCCGACTGTCGGCGCTG - 3
1
3
1
- CGTGGTCGGTCGACTCGGTTAAGTACCTGGTCTTGTTGGGCGACAGCCCCAACTGGGTGTTCGCGGCTGACAGCCGCGAC - 5
1
rpoB GENE 81 bp RIF RESISTANCE DETERMINING REGION
Efcient
kap|d. on-demand resu|ts mean |nected pat|ents can be p|aced |n |so|at|on ec|ent|y
and treated with the appropriate therapeutics effectively
Mycobacterium tuberculosis treat and |so|ate
kap|d detect|on o r|amp|c|n-res|stance not on|y qu|des |nd|v|dua| pat|ent tHerapy
but aids with infection control and public health activities as well
DST
k|| kes|stant k|| Sens|t|ve
Xpert
V1b/k||
k|| kes|stance
detected
58 4
k|| kes|stance
not detected
2 280
sensitivity: 96.7%
specicity: 98.6%
||v. 93.6%
||v. 99.3%
PERFORMANCE CHARACTERISTICS OF THE XPERT MTB/RIF ASSAY COMPARED TO DRUG
SUSCEPTIBILITY TESTING FOR RIFAMPICIN (RIF)
1He sens|t|v|ty o tHe xpert V1b/k|| assay |n pat|ent samp|es c|ass|ed as smear neqat|ve.
cu|ture pos|t|ve | S-C+I |s 90.9% (70/77) and 100% (275/275I or tHose c|ass|ed |S+C+I.
dening on-demand molecular diagnostics
1|| |0kC|/S| 0| 1||S |k000C1 /||0wS 1|| |0kC|/S|k 10 0S| |1 |0k 1|| ||k|0kV/|C| 0| 0|/6|0S1|C S|kv|C|S |0k |0V/| || v|1k0 0|/6|0S1|CS. |0 6|||k/| |/1||1 0k 01||k ||C||S| 0| /|\ k||0 01||k 1|/| 1||S S||C|||C k|6|1
0| 0S| |k0V |0kC|/S| |S 6k/|1|0 ||k|b\. |0 01||k k|6|1S /k| C0|v|\|0 |x|k|SS|\. b\ |V|||C/1|0| 0k |S10|||| 10 /|\ 01||k |/1||1S. |0k1||kV0k|. |0 k|6|1S |0k k|S/|| /k| C0|||kk|0 w|1| 1|| |0kC|/S| 0| 1||S |k000C1.
References:
1. keduc|nq tHe 6|oba| burden o 1ubercu|os|s. 1He Contr|but|on o |mproved 0|aqnost|cs. |ature 444 (2006): 49-57
2. |ernandez-6arduo |. Cook v. kun|moto 0. ||wood kk. b|ack w/. ||tzqera|d !V. 1ransm|ss|on o tubercu|os|s rom smear neqat|ve pat|ents. a mo|ecu|ar |p|dem|o|oqy study. 1Horax 2004, 59:286-290
3. |at|ona| |nst|tute or C||n|ca| |xce||ence |||C|I C||n|ca| 6u|de||ne 33, 2006
Xpert

MTB/RIF
Pour Sample Reagent into sample tube.
Incubate for 15 minutes at room
temperature.
|/cceptab|e samp|e types. unprocessed
sputum or sediment from concentrated
specimen.)
Pipette diluted sample into cartridge. Insert cartridge and start assay.
TOTAL HANDS-ON TIME = 2 MINUTES
1 2 3
Culture Testing Results: 2-4 Weeks Testing for Drug Resistance Results: 2-4 Weeks
Xpert MTB/RIF
kesu|ts |n 2 hours,
ava||ab|e on-demand
M. tuberculosis detected/not detected
k|amp|c|n res|stance
AFB Smear Test
kesu|ts |n 2-24 hours
/c|d ast bac|||| present/absent
V1b detected/not detected kes|stance detected/not detected
ORDERING INFORMATION
xpert V1b/k|| (10 Cartr|dqes w|tH Samp|e keaqentI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Catalog No. GXMTB/RIF-10
Advantage: Test and Treat
Workow: Self contained cartridge just add sample
C0k|0k/1| ||/000/k1|kS
904 Caribbean Drive
Sunnyvale, CA 94089
USA
toll free: 1.888.336.2743
phone: 1.408.541.4191
fax: 1.408.734.1346
|0k0||/| ||/000/k1|kS
Vira Solelh
81470 Maurens-Scopont
France
phone: +33.563.82.53.00
fax: +33.563.82.53.01
C|||||0 0k |10.
Stretton House
Highstairs Lane, Stretton
Derbyshire DE55 6FD
United Kingdom
phone: +44 1246 860730
fax: +44 1246 866637
www.cepheid.com
0089-01