13C Urea Breath Test

1.

13C Urea Breath Test

2.

C o n ten t
☞
1. F eatu re
2. H arm
3. M eth o d
4. P rin cip le
5. C o m p etito r C o m p ariso n
6. M arket P ro m o tio n

3.

H.p Introduction
Helicobacter pylori(abbr. H.p), be found by Austrilian scholar Marshall and
Warren in 1983, accordingly they won Nobel Prize for Medicine
Featu re
1. Patchy distribution
2. Secrete specific urease
3. Zero Self-Cure Rate(once infected,can’t
be self-cure without professional treatment)
3

4.

Urease Role
Urease is a substance produced by Hp, it can decompose the urea into
carbon dioxide and ammonia. Ammonia can form cloud shape around Hp
bacteria, neutralize gastric acid, play a protective role on Hp
Hp invasive
gastric juice/gastric juice
layer/epithelia cell
release
urease
decompose
urea
viscous layer/gastric acid
neutralizing/gastric epithelia cell
ammonia
cloud
Protect Hp

5.

Relationship between pH and Urease
Stronger acidic, bigger urease activity of Hp, bigger ability of
decompose urea
but other bacteria is opposite
low pH
high acidity
big urease activity of Hp
Urea
high pH
low acidity
big urease activity of other bacteria
Urea

6.

Hp Transmission
• Mouth to mouth,stool to mouth,
endoscope
• Family party,office

7.

Content
1. Feature
☞
2. Harm
3. Method
4. Principle
5. Competitor Comparison
6. Market promotion

8.

Related gastric diseases of HP infection
Chronic gastritis
Peptic ulcer(gastric ulcer/duodenal ulcer)
Gastric cancer
MALT lymphoma

9.

Other diseases of HP infection
Atherosclerosis
Ischemic heart disease
Fibromyalgia
Anaphylactoid purpura
Vitamin B12 deficiency
Autoimmune thyroid disease
diabetes
Chronic urticaria
The diverse chronic prurigo
Idiopathic central serous
chorioretinopathy(IC-SC)
Glaucoma
Hepatic encephalopathy
Hepatic fibrosis
Liver and gallbladder stone
Autoimmune pancreatitis
Iron deficiency anemia
Idiopathic thrombocytopenic
purpura (ITP)
Migraine
Idiopathic Parkinson’s disease
Alzheimer’s disease
Stroke

10.

China is high HP infection area
700 million
infected people in
China
Africa
70-90%

11.

H.p Infection in some African countries
Hp Infection In Some African Countries
100
90
87,7
77,6
80
77,4
76,4
74,1
72,8
70
60
46,8
50
40,9
40
30
20
10
0
Nigeria
South Africa Congo King
Libya
Benin
Tunisia
Burkina Faso
Egypt

12.

New data of epidemiological
50% gastric cancer growth and death in China
The trend will still increase from 2012 to 2030
Hp causes 64% gastric cancer
Eradication Hp infection can reduce 39% of gastric
cancer and precancerous lesion
Most of gastric cancer(>95%) caused by HP

13.

Significance of detection and treatment of HP
Long-term remission of chronic gastritis
Completely cure peptic ulcer
Decrease incidence of gastric cancer

14.

Clin ical sign ificance o f H p in tervention
Hp positive diseases
prognosis
Peptic ulcer
completely cure
(MALT)lymphoma
74.2% remission
Chronic gastritis with dyspepsia
Long-term remission
Chornic gastritis with atrophy or erosion of gastric mucosa
Prevent cancer
Early gastric tumor has been removed under endoscope or subtotal
Prevent relapse
gastrectomy
Long time take proton pump inhibitor(PPI)
Family history of gastric cancer
Long time take NSAIDs including low dose aspirin
Interf
erence
Prevent gastric cancer
Prevent gastric cancer
Prevent peptic ulcer
Iron deficiency anemia of unkown reason
Cure
Idiopathic thrombocytopenic purpura ITP
Cure
other diseases related HP
Cure
other diseases
Cure or prevent
complication

15.

Content
1. Feature
2. Harm
☞
3. Method
4. Principle
5. Competitor Comparison
6. Market Promotion

16.

Detection Method
Gastroscope
Rapid urease test
Histological detection
Gastroscope
Urea breath test
Stool antigen test
Bacterial culturing
Serological test
PCR
《第四次全国幽门螺杆菌感染处理共识报告》2012.7

17.

Method Comparison
Method
Comparison
Histological
Need endoscopy, due to patchy distribution,sampling different point,easy to be false
negative. Applicable to current infection diagnosis
Need endoscopy,due to patchy distribution,sampling different point,easy to be false
Bacterial culturing negative.Take a long time. Applicable to current infection diagnosis
Need endoscopy,due to patchy distribution,sampling different point,easy to be false
Rapid urease test negative.Depend on urease activity.Applicable to current infection diagnosis
PCR
Need endoscopy,complicated operation,request professional lab,not applicable to
current infection diagnosis
Collect finger blood, unfriendly to patient, hysteresis, not applicable to current
Serology Antibody infection diagnosis
Saliva test
Collect sample from saliva or teeth,only test Hp in month,but not stomach

18.

Efficiency Comparison
Sensitivity
78.39%
Specificity
89.13%
Accuracy
86.15%
Histology
91.47%
93.98%
91.89%
Rapid urease test
88.14%
89.08%
88.42%
Gastric mucosa smear
94.53%
95.56%
96.65%
PCR
97.57%
89.09%
95.44%
Urea breath test
95.49%
94.76%
95.53%
Stool antigen
95.57%
93.17%
94.24%
Serum antibody
92.04%
87.70%
98.83%
Bacteria culturing
Need
endoscopy
No need
endoscopy
《中国检验幽门螺杆菌感染方法诊断效能的分析》张莉 张建中 中国疾病预防控制中
心传染病预防控制所-世界华人消化杂志 2007年2月28日

19.

Content
1. Feature
2. Harm
3. Method
☞
4. Principle
5. Competitor Comparison
6. Market Promotion

20.

13C-UBT Principle
Urease
(NH 2)2 13CO + H 2O
Urea
H p Urease
2NH 3 + 13CO2

21.

UBT 13C 与 14C
① Same principle
release
Urease
② Different marker
③ 14C is radioactive
Deco
mpos
e
13C-Urea
13CO
2
1 4C-Urea
14CO
2
Radioactive
Radioactive

22.

13C-UBT P rocess
Uninfected
in Body
Infected
by infrared spectrometer
13C Urea
13C Urea
To test the abundance of 13CO2
13CO
13CO
13C Urea
NH3
2
2
NH3

23.

13C-UBT
Operation P rocedure
Easy to operate,result in 100 seconds
Only exhale air into 2 bags,good compliance

24.

Content
1. Feature
2. Harm
3. Method
4. Principle
☞
5. Competitor Comparison
6. Market Promotion

25.

Im pro ve Accuracy o f 13C UBT
Interference factors
Inactive
Hp
Other bacteria
in Stomach
Solution
Acid formula
reduce influence by other
bacteria,activate hibernation Hp
Promote absorption,
Malabsorption Absorption
delay
diffuse formula
Full absorption at the peak of breath test

26.

Granula/Powder/Capsule/Tablet
Granule
Capsule
Made from the extracts of medicinal materials
and suitable excipients or fine powder
Solid preparation stuff into hollow
capsule
Powder
Tablet
Made by one or more kinds of durgs after
crushing and mixing, powder preparation
Drug and excipient be evenly mixed and
compacted

27.

Helifo rce (13C UBT kit)
Optimized formula-acidizing &
promote diffusion absorption
Granule
Zero disintegration time,
Best PH value,activate hibernant Hp,
fastly absorb,
truly reflect infected status
Good taste,easy to be accepted
sampling at peak
Fastly diffuse to whole stomach,
no dead corner
by patient,good compliance
Leading production technology
Guarantee for stable quality

28.

Key Points of Reagent Comparison
Disin teg ration tim e
Form ula effectiveness
Production technology

29.

High Efficient Spectrometer Feature
Stability
Speed
Accuracy

30.

Infrared Spectrometer
First time use Dual-core
High Tech,save test time
best speed reach to 89s/t
Wordlwide advanced MEMS
tech, 0.1‰ Precision higher
than national standard
0.25‰
2
1
More models for
optional,with 2,10
channels
4
Based on TCP/IP
interface, customized
for hospitals
3

31.

Spectrometer VS Mass spectrometer
Spectrometer
Mass spectrometer
Accuracy
High accuracy, 0.2 ‰
0.2 ‰, applicable to industrial field like oil
exploration
Market share
80%
20%
Stability &
operation
High stability & easy to
operate
Need professional guide, operate
complicated
Consumable
FOC gas bag
Chargeable gas bag, need to buy every 2
months, cost $1500-3000 every year
Sampling
Electromagnetic valve
sampling automatically, 1
million times lifecycle
Sampling by needle, easy to be broken or
blocked, short lifecycle
Life time
Core light source: 10 years +
Core parts, molecular:5years.High
cost:$7000-14000
After-sales
low cost
High cost, high tech request maintaining
Cost
performance
high
low

32.

13C UBT Test System-The best Way for H.p Detection
Golden Standard for H.p
Optimized formula
classical granula
Worldwide leading Tech
Original factory
Customized
Best combination
Advanced core tech
First time use dual core
Customized Network
Full models for optional
detection
Accuracy
Easy to use
13C UBT Test System,is the
industrial standard
Preferred for detecting H.p,
non-invasive

33.

Attention
False negative
Take medicine, bleeding, atrophy of gastric mucosa, old people
False positive
Other bacteria in digestive tract, produced urease interfere the result
Result abnormal or failure
Uncalibrated, high concentration of the sample, collecting sample after
exercise
Eat some special food with more 13CO2

34.

Content
1. Feature
2. Harm
3. Method
4. Principle
5. Competitor Comparison
☞
6. Market Promotion

35.

Applcation of Test Methods
UBT + Gastroscopy: First UBT,then decide gastrocopy or not
Evidence for antibacterial therapy or recommend to test gastrocopy
Avoid cross infection
Only detect by 13C UBT
Market share
Digestive
35%
Evidence for antibacterial therapy
Health examination-Gastric cancer screen
Reduce gastric cancer
Health
examination
55%
Others
10%

36.

Eradication Solution for H.p

37.

International New Consensus

38.

Promotion Direction
Clinical Department
Health Examination