Transcript Slide 1

CT/NG Testing
Driven by CDC Guidelines
CT infections reported in the US continue to rise…
Chlamydia trachomatis (CT)
Infection Rates by Sex, 1990–2009
Neisseria gonorrhoeae
 Chlamydia is the most frequently
reported bacterial STD in the US
 1.2 million cases of Chlamydia
and 300,000 cases of
gonorrhoeae were reported in
2009
 Untreated Chlamydia infection
can ascend to the upper genital
tract resulting in:


Pelvic inflammatory disease (PID)
Infection and inflammation of the
uterus, fallopian tubes, ovaries, or
adjacent peritoneum
From CDC STD Surveillance 2009 – http://www.cdc.gov/std/stats09/surv2009-Complete.pdf
The Burden for Adolescents and Young Adults
It is estimated that persons aged 15 – 24 yrs. represent 25% of sexually
experienced population, but they acquire nearly
half of all new STD’s
15 – 19 yr. olds represent a 2.4 % increase for CT during 2008
20 – 24 yr. olds represent a 4.0% increase for CT during 2008
Under reporting is considered to be substantial
80%–90% of CT infections and 50% of NG infections in women are
asymptomatic
http://www.cdc.gov/std/Chlamydia/STDFact-Chlamydia.htm
Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, 2010
From CDC STD Surveillance 2009 – http://www.cdc.gov/std/stats09/surv2009-Complete.pdf
Routine Screening is Key to Reducing the Burden
CDC recommends the following:
 Annual CT screening of sexually active women <25 yrs.
and NG screening for those at risk
 Screening of women >25 yrs. with risk factors; risk
factors include new partners or multiple partners
 All pregnant women should be screened for Chlamydia
trachomatis during the first prenatal visit and those at
risk for NG
Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, 2010
Men aged 15 – 24 years
Carry the burden of the highest chlamydia rates
Chlamydia rates for men 2008 -2009

15 – 19 yr. old men represent a 5 % increase in CT

20 – 24 yr. old men represent the highest rate of CT infection with an increase of 6%
Screening of sexually active young men should be considered in clinical settings with a high
prevalence of chlamydia; adolescent clinics, correctional facilities, and STD clinics
The CDC also recommends annual screening for men engaged in receptive anal or oral
intercourse (MSM)
Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, 2010
From CDC STD Surveillance 2009 – http://www.cdc.gov/std/stats09/surv2009-Complete.pdf
CDC Recommended specimen types
New guidelines encourage movement toward
self collected specimen types
Recommended Specimen Types for Women
Endocervical swabs specimens
Vaginal swabs; provider collected or self collected specimens
Urine specimens
Liquid based cytology specimens
Urine is the Preferred Specimen Type for Men
when a NAAT is used for Testing
 Urine specimen
 Urethral swab
Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, 2010
Self collected specimens such as urine and vaginal swabs reduce
barriers to testing
• Urine is the preferred sample type for testing or screening men using NAATs.
There is little need for urethral swab specimens and in some studies these
samples are less sensitive than urine; urethral swab specimens and male urine
were equivalent in specificity.
• For female screening, vaginal swab specimens are the preferred specimen type.
Vaginal swab specimens are as sensitive as cervical swab specimens and there
is no difference in specificity. Cervical samples are acceptable when pelvic
examinations are done, but vaginal swab specimens are an appropriate sample
type even when a full pelvic exam is being performed.
• Source: APHL Laboratory Diagnostic Testing for Chlamydia trachomatis and Neisseria gonorrhoeae, Expert
Consultation Meeting Summary Report, January 13‐15, 2009
• Self-collected vaginal swab specimens perform at least as well as with other
approved specimens using NAATs, and women find this screening strategy highly
acceptable.
• Source: Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, 2010
Oropharyngeal and rectal swab specimens
 Not cleared for use with any nucleic acid amplification tests
 Some public and private laboratories have established
performance specifications for using NAATs with oropharyngeal and
rectal swab specimens
- Allows results to be used for clinical management as an LDT
Sexually Transmitted Diseases Treatment Guidelines, 2010; CDC, December 17, 2010
cobas® CT/NG v2.0 Test
The true solution for efficiency, confidence &
cost-effectiveness
20 July 2015
page 9
© 2014 Roche
cobas CT/NG v2.0 Test
The true solution for efficiency, confidence & cost-effectiveness
cobas x 480 instrument –
automated nucleic acid extraction
cobas z 480 analyzer
automated amplification
and detection
cobas CT/NG v2.0 test
cobas 4800 system
20 July 2015
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© 2014 Roche
Only system with primary vial loading
for all specimen types
Specimen types for
symptomatic/asymptomatic
patients that have been validated
using the cobas CT/NG v2.0 test:
• Endocervical swabs*
• Vaginal swabs (clinician- or selfcollected in a clinical setting)*
• Male and female urine (stabilized with
the cobas® PCR Urine Sample kit)
• Cervical specimens collected in
ThinPrep® PreservCyt® Solution
Fully automated
sample extraction and
result generation
De-cap primary vial & load
*In cobas® PCR Media collected with the cobas PCR Female Swab sample kit
Note: cobas PCR Media provides room-temperature specimen stability for up to one year.
20 July 2015
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© 2014 Roche
Lowest hands-on time & faster turnaround time
when compared to other systems1
1Argent
Global Services. CT/NG Comparison Study. 2012. Data on file.
20 July 2015
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© 2014 Roche
Easy-to-use, easy-to-train test & system
A truly smart answer is at hand for your laboratory
cobas z 480 analyzer
cobas x 480 instrument
automated nucleic acid extraction Real-time amplification &
detection
Easy-to-use system
• ~ 4 mins daily maintenance
• No daily decontamination
by bleaching components
required
20 July 2015
Easy-to-use test
• No reagent preparation
• Assay specific reagents
provided in bar-coded vials
page 13
© 2014 Roche
Only third-generation test with dual-targets
for CT, NG and internal controls
Chlamydia trachomatis
Neisseria gonorrhoeae
• Detects both cryptic plasmid
and ompA gene Major Outer
Membrane Protein (MOMP)
targets
• Detects both the Direct Repeat
(DR9) sequence A and the
Direct Repeat (DR9) sequence
B targets
• Detects all major serovars of
CT and the Swedish CT mutant
(nvCT)
• Target region is repeated x3 in
the NG genome and has 2
highly conserved sequence
variations
• Detects variants that may
harbor deletions in the cryptic
plasmid
• Detects combinations of both
target variations
Internal Control
• Two individual IC
plasmids provide
consistent signal
with high target input
• No cross-reactivity with
commensal Neisseria or other
bacterial species has been
observed
Dual-probe, single-tube multiplex
assay design with automatic internal control
• Detects variants that do not
carry the cryptic plasmid
20 July 2015
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© 2014 Roche
Sensitivity of new NG target
delivers true confidence
NG
strains
DR9A
DR9A/DR9
Hybrid
DR9B
Japanese Collection
147
147
0
0
University of
129
101
26
2
RMSCC NG Panel 1
94
77
17
0
RMSCC NG Panel II
87
71
14
2
Australia collection
81
80
1
0
Staten Serum Institute
in Denmark
51
39
7
5
Total
589
515
65
9
Collection site
DR9A and DR9B prototype assay testing results using geographically diverse NG culture
panel
20 July 2015
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© 2014 Roche
• All 589 culture isolates were
positive for the presence of
DR9
• There are geographical
differences on the
prevalence of DR9A or
DR9B
High specificity of new NG target
eliminates the need for confirmatory testing
Neisseria commensal sps
N Tested
cobas 4800
N. canis
1
neg
N. cinerea
10
neg
N. elongata
1
neg
N. flavescens
2
neg
N. lactamica
20
neg
N. meningitidis
36
neg
N. mucosa
9
neg
N. polysacchareae
5
neg
N. sicca
8
neg
N. subflava
37
neg
N. weaveri
1
neg
14
144
neg
N Tested
cobas 4800
76
All positive
Moraxella (Branhamella) catarrhalis
Total
N. gonorrhea isolates
• All 144 non-gonococcal
isolates provided
negative results
• All 76 gonococci provided
positive results
QPID Neisseria species culture panel
20 July 2015
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© 2014 Roche
cobas CT/NG v2.0 Test
Reliable sensitivity & specificity for all specimen types1
CT
NG
Sample Type
N
Sens %
Spec %
N
Sens %
Spec %
Endocervical Swab
2,926
94.9%
99.4%
5,104
96.6%
99.9%
Female Urine
2,945
94.0%
99.6%
5,127
95.6%
99.7%
Vaginal Swab
(Clinician-collected)
1,902
98.2%
99.1%
3,138
100.0%
99.7%
Vaginal Swab
(Self-collected)
2,037
97.6%
99.3%
2,037
96.7%
100.0%
PreservCyt
(Pre-ThinPrep)
2,937
94.2%
99.7%
5,131
96.7%
99.9%
PreservCyt
(Post-ThinPrep)
2,878
93.7%
99.5%
4,868
95.6%
99.7%
738
98.4%
99.2%
738
100.0%
99.3%
Male Urine
1cobas
CT/NG v2.0 Test package insert, 2013.
20 July 2015
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© 2014 Roche
Only test with AmpErase enzyme & internal controls
to minimize false positives & negatives
True confidence
Designed with layers of
safeguards for accurate results
20 July 2015
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© 2014 Roche
Definitive results
in high- & low-prevalence populations1
CT
Prevalence (%)
1cobas
NG
PPV (%)
NPV (%)
PPV (%)
1
69.0
99.9
3
87.2
99.8
93.3
99.9
5
92.0
99.7
96.0
99.8
10
96.1
99.3
98.0
99.7
15
97.5
99.0
98.8
99.5
20
98.2
98.5
99.1
99.3
30
98.9
97.5
99.5
98.8
50
99.5
94.4
99.8
97.2
82.0
CT/NG v2.0 Test package insert, 2013.
20 July 2015
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© 2014 Roche
NPV (%)
100.0
Dependable results
virtually eliminate costly retests
New generation “kinetic” algorithm for results
eliminates need to visually analyze growth curves
Eliminates the guessing game
by providing clear results
• Consistency checks
• No gray zone area
• Algorithm based on 250,000
curves
• Algorithm result
correspondence >99.95%
20 July 2015
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© 2014 Roche