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OnSite S. Typhi/Paratyphi Ag Rapid Test
Product training Presentation
CTK-MK-PPT-R0162C Rev.1.0
Contents
1
2
3
4
5
CTK’s Solution to Typhoid Fever Diagnostic Needs
Disease Info
CTK’s Typhoid Dx Range in Detail
Available Marketing Collateral
Sales Support, Training, FAQs
Closing, KOL Support, References6
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CTK’s Solution
Our Solution to a common problem of diagnosing typhoid fever
Previous testing methods
Blood culture and Widal
A better diagnostic option
Typhoid IgG/IgM Rapid Test
CTK’s solution
s. Typhi/Paratyphi Ag Rapid Test
Both blood culture and
Widal testing standards
were
• time consuming
• procedurally difficult
A better diagnostic option
(more rapid, simple and
accurate) of typhoid fever
is needed
Clinician concern is how to
differentiate the two pathogens:
• Salmonella typhi (S. typhi)
• Salmonella paratyphi (S.
paratyphi)
A differentiating, ACTIVE
diagnostic solution with
unparalleled
performance
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CTK’s Solution
OnSite S. Typhi/Paratyphi Ag Rapid Test
Designed to surpass market demands with
unparalleled benefits:
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Disease Info
Typhoid fever=Typhoid + paratyphoid fever
• Typhoid fever: caused by S. typhi• Paratyphoid fever: caused by either S. paratyphi A, B, or C
• Both were commonly grouped together under the collective term 'enteric fever’
• via the fecal-oral route or from urine of infected individuals
• fever, fatigue, headache• diarrhea or constipation• enlarged lymph nodes, spleen, liver
• S. paratyphi infection – increasing• S. typhi infection – decreased
Bacterial infections
Enteric fever
Transmission
Symptoms
Infection rates
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Disease Info
Case for S. paratyphi Differentiation
S. typhi infection decreases dramatically
S. paratyphi is predominant now
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Disease Info
Epidemiology
21 million cases >600,000 deaths
Every year
-- from WHO
Salmonella infection is
a global threat
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Disease Info
A History To Present Day Diagnosis Options
Blood Culture “Reference Method”
• 40% - 90% positive rate - Currently
WHO’s standard for diagnosis
o 1st week - 90%
o 2nd week - 60%
o 3rd week - 45%
• Takes 48 hours to get results
Bone Marrow
Aspirate Biopsy
Results not affected by
disease timeline
Widal Test Serology Test
• Still used by many labs throughout the world
• Complicated test to perform
• Delayed elevation of titer results in slow
patient management
• Many recent publications describe false
positives from previous vaccinations, chronic
hepatitis and other auto-immune diseases
IgG & IgM Rapid Tests
• Simple, one-step procedure
• Differentiates between IgG and IgM to
determine the stage of infection
• CTK’s IgG/IgM rapid test can utilize either
whole blood, serum, plasma specimens
Ag Rapid Tests
• Simple, one-step procedure
• Differentiates between S. typhi
and S. paratyphi
• CTK’s S. Typhi/Paratyphi Ag rapid
test can utilize either Blood
culture, fecal specimen, whole
blood, serum, plasma
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Disease Info
Specimen options
• Week 1-2 blood culture is best for Ag detection,
followed by fecal specimen!!
CTK’s various specimen options are optimal for bacteriology testing
0
30
60
90
1 2 3 4 5 6 7 8
Dete
cti
on
po
ss
ibil
ity
Weeks
Fecal specimen
Blood culture
Urine specimen
1
2
3
• OnSite S. Typhi/Paratyphi Ag Rapid Test utilizes:
Blood culture, fecal, whole blood, serum, or plasma specimens
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Disease Info
Differentiation of S. typhi & S. paratyphi
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CTK’s Typhoid Dx Product Range in Detail
Typhoid Fever Test Options
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CTK’s Typhoid Dx Product Range in Detail
CTK is #1 in Providing A Rapid Typhoid Test Portfolio
throughout the full spectrum of Salmonella infection
OnSite Rapid Tests detect
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CTK’s Typhoid Dx Product Range in Detail
OnSite Typhoid IgG/IgM Rapid Tests - Launched in 2005!
#1 In the Global Market!!
• Utilizes O antigen and H antigen from both S. typhi and S. paratyphi serovars to maximize
sensitivity
• Differentiates between IgG and IgM to determine stage of infection
• Test result within 15 minutes allows medical professionals to take immediate action
• One-step procedure minimizes operator error due to sample preparation
• High level of reproducibility
• Test kits can be used and stored in a wide range of temperatures
• Confident in the numbers: CTK produces MILLIONS of Typhoid IgG/IgM Rapid Tests that
are used in 80+ countries around the globe
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CTK’s Typhoid Dx Product Range in Detail
OnSite S. Typhi/Paratyphi Ag Rapid Test – launched Jan. 2018
C
ID
P
T
S
Detects and Differentiates S. typhi and S. paratyphi• Overlap of symptoms for S. typhi and S. paratyphi infection
• S. typhi infection is typically more severe, longer lasting and more likely to result in death if not
promptly treated
• The incidence of S. paratyphi infections is rising more rapidly than S. typhi infections worldwide
• Medication used to treat S. typhi infection are more toxic than those used to treat S. paratyphi
• Broader detection capability especially growing incidence of S. paratyphi A
Rapid Typhoid Fever TestA rapid lateral flow test provides faster, easier and more accurate diagnosis of a Salmonella infection
Antigen TestAn antigen test provides faster and more accurate diagnosis of an active Salmonella infection vs. other
testing options
Allows for the use of blood culture, fecal, serum, plasma, or whole blood specimens• Blood culture is best for Ag detection followed by fecal specimen
• Various specimen options make this test OPTIMAL for Bacteriology testing
• Easy of use for clinicians
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CTK’s Typhoid Dx Product Range in Detail
OnSite S. Typhi/Paratyphi Ag Rapid Test
PRODUCT COMPONENTS:
• Individually sealed foil pouch
• Stool collection devices
• Sample diluent
• Plastic droppers
• Patient ID stickers
• Instruction for use
R0162C
24 M
Blood culture/Fecal/Whole blood/Serum/Plasma
Cat #
Shelf life
Specimen
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CTK’s Typhoid Dx Product Range in Detail
Unparalleled Performance
The most sensitive Typhoid Ag test on the market
Simplicity
• Only test on the market that detects & differentiates
S. typhi and S. paratyphi in the same device
• Specimen options enhancing diagnostic performance
include: blood culture, fecal, whole blood, serum, or
plasma specimens
Fast, easy-to-interpret results that improve diagnosis
and treatment efficiency
Innovation
Quality
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Available Marketing Collateral
Package Insert and Marketing Support Materials
Package insert
Pre-launch Social Media Messages
Product Flyer
Website Additions
Product Video
Promotions
Reminder!
Contact us at [email protected] for any questions!
www.ctkbiotech.com
Sales Support, training, FAQs
Key sales openers to end usersREPLIES
FOR TESTS
CURRENTLY
USED
RESPONSE TO CLINICIAN
Blood Culture
1. The reference method, very good
2. I am aware that test takes a while for the results and requires a lot of skill and equipment
3. Have you ever had the need for a rapid AND very accurate test which differentiates between S. typhi
and S. paratyphi?
Widal Test
1. I understand that this test has been around for many years
2. Have you ever had any issues of difficulty reading results etc.?
3. Have you seen some of the recent negative articles regarding this test?
4. Have you ever had the need for a rapid AND very accurate test which differentiates between S. typhi
and S. paratyphi?
Antibody
Tests
1. There are several of them on the market, we also have a very good one from CTK
2. Their typhoid Ab test differentiates between IgG and IgM antibodies
3. They also just launched a new Ag Test which…
Antigen Tests
1. Outstanding, who’s test are you using?
2. We are launching a NEW test which:
• Provides a separate result for either S. typhi OR S. paratyphi
• Can detect S. paratyphi
• Allows for a variety of specimen option that allow for optimum testing based on patient’s infection
status
3. Do you use Antigen tests for screening of treatment efficacy?
• CTK’s antigen test that’s detecting active infection is fast, easy, and cost effective to help ensure
treatment is working
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Sales Support, training, FAQs
Who are your rapid test competitors?
CTK clearly stands above the rest!
Manufacturer Brand or Product NameS. typhi & S.
paratyphi
differentiation
FecalBlood
Culture
Serum/
Plasma
USA
Manufactured
External Control
CTK
OnSite
S. typhi/paratyphi Ag Rapid
Test
● ● ● ● ●Coming
soon
Biocan
Diagnostics //
Biogate
Laboratories
Biocan Diag - ”Tell Me Fast”
Biogate Labs - S. typhi,
paratyphi A,B,C Test
● ● ●
Labcare
Diagnostics
Accucare - s. typhi/s.
paratyphi
Direct Antigen Test
● ● ●
Medsource
OzoneTyphoid Antigen Rapid Test ●
Wondfo
One Step Salmonella Typhi
Feces Antigen Test ●
CortezRapid Card Insta Test
● ● ●
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Sales Support, training, FAQs
Frequently Asked Questions
Q Isn’t the Blood Culture test the reference method for diagnosing Typhoid Fever?
A Yes, but the Blood Culture method takes 1 - 2 days for obtaining results and also
its sensitivity decreases based on the time the sample is taken after disease onset.
Our advantages of various testing options ensures patient screening is available
for a much longer window.
Q I have heard that the Widal test is the most frequently performed test for
diagnosing typhoid fever
A Yes, that is true historically, but with recently developed Typhoid Antibody and
Antigen tests available the Widal has been shown to be not very accurate in its
results. Additionally, it is a very time consuming and labor intensive test to
perform.
Q What is the benefit of a typhoid Ag test vs. a typhoid Ab test?
A The antigen test can detect ACTIVE typhoid fever earlier into the infection cycle
compared to a typhoid Ab test as it takes a while for antibodies to develop and an
antigen positive test helps to support a diagnosis of an active infection.
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Sales Support, training, FAQs
Frequently Asked Questions
Q What is the benefit of a test which differentiates between S. typhi and S.
paratyphi?
1. S. typhi is the more severe and long-lasting disease than S. paratyphi and it’s
more serious in younger and older patients. S. typhi is the more likely to result
in death if prompt treatment is not given
2. Cases of S. typhi are decreasing while S. paratyphi is on the rise. It’s important
to catch every possible case!
3. In older patients, they may have become antibiotic resistant over the years.
Q What should the clinician do if an Ag test result is negative using a blood culture
sample, BUT the patient is still exhibiting symptoms of typhoid fever.
A It is recommended that the patient be tested using a fecal sample as a secondary
test. We also recommend CTK’s Typhoid IgG/IgM Rapid Test.
Q How can I get additional information on CTK’s other diagnostic tests?
A CTK offers a broad range of diagnostic test kits covering many disease states and
formats. I can provide you with any information you need and you can visit their
website for specific details on ALL their products at: www.ctkbiotech.com
A
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Sales Support, training, FAQs
Frequently Asked Questions
Q Who are most at risk for serious complications with typhoid infection?
A Children with under-developed immune systems and the elderly with potentially
immunocompromised systems are at much higher risk for severe and dangerous
S. typhi infections.
Q Why is it important to offer multiple specimen options in a test?
A Throughout infection, bodily fluids used in diagnostics change in detection
possibility. Blood culture followed by fecal specimen are optimum for
bacteriological testing.
CTK understands that not all labs are alike. Resources are different throughout. So
designing a test allowing for multiple specimen options equates to faster
diagnostics and treatment for the patient.
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Closing, KOL Support, References
Key Opinion Leaders in Typhoid Diagnostics
“Enteric fever can present in many different and non-specific ways, thus posing a diagnostic challenge for the health professional. Enteric fever is usually diagnosed on clinical grounds and treated presumptively. The diagnosis may be delayed or missed, while other febrile illnesses are being considered”
- Parry, 2002 -
“Typhoid and paratyphoid fevers are caused by related but different strains of Salmonella spp. There is considerable overlap in symptoms, although typhoid is the more severe and long-lasting disease, and is the one more likely to result in death if prompt treatment is not given”
- Dr. Mary Lowth, 25 February 2015 -
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Closing, KOL Support, References
Reference Article Links
• Rapid diagnostic tests for typhoid and paratyphoid (enteric) fever (Review)
https://www.ncbi.nlm.nih.gov/pubmed/28545155
• Salmonella typhi (Typhoid Fever) and S. paratyphi (Paratyphoid Fever)
http://antimicrobe.org/b106.asp
• Rapid diagnostic tests for typhoid and paratyphoid (enteric) fever
http://www.coalitionagainsttyphoid.org/publications/rapid-diagnostic-tests-for-typhoid-and-paratyphoid-enteric-fever/
• Performance of widal test and stool culture as diagnostic methods for salmonella typhi infection in chuka
general hospital, tharaka nithi county
http://ir-library.ku.ac.ke/handle/123456789/15032
• Diagnostic Value of Widal Test in the Diagnosis of Typhoid Fever: A Systematic Review
https://www.omicsonline.org/open-access/diagnostic-value-of-widal-test-in-the-diagnosis-of-typhoid-fever-asystematic-
review-2161-0703- 1000248.php?aid=85621
Conclusion: The systematic review results show that the reliability of Widal test is comparatively poor. Therefore, Widal
test should not be used as a diagnostic tool to rule out typhoid fever unless supported by invasive clinical pictures and
other confirmatory tests
• Evaluation of Serological Diagnostic Tests for Typhoid Fever in Papua New Guinea Using a Composite
Reference Standard
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491554/
• Davis, B. D., Dulbecco, R., Eisen, H. N., Ginsberg, H. S., Wood, W. B., & McCarty, M. (1973). Microbiology (2nd ed.).
Hagerstown, MD: Harper & Rowe.
Headquarters in California, USA
1 (858) 457-8698
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Technical Support
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