Transcript Toxo IgG/IgM Rapid Test Presentation

OnSite Toxo IgG/IgM Rapid Test
Providing the Full Spectrum of Infection with Toxoplasma
Toxoplasmosis
• Caused by Toxoplasma gondii (T. gondii)
• Principal transmission
o Foodborne
o Animal-to-human
o Mother-to-child (congenital)
• Worldwide
o A third of population carry infection
o Up to 95% of some population in some
regions have been infected
• In U.S.
o More than 60 million carry T. gondii
o 10.8% overall seroprevalence
o 11% among women of childbearing age
(15 to 44 years)
T. gondii oocysts in a fecal floatation
Life Cycle of T. gondii
• In the human host, the parasites
form tissue cysts, most commonly
in myocardium, brain, skeletal
muscle and eyes
• The cysts may remain throughout
the life of the host
Clinical Feature of Toxoplasmosis
• Healthy people (nonpregnant)
o Usually mild with “flu-like” symptoms
o The parasite can remain in the body in an inactive state
• Pregnant mother
o Induce miscarriage
o A stillborn child with potential eye and behavior problem
o Can be treated and reduce the fetal effects during pregnancy
• Person with suppressed immune systems, such as AIDS
o Develop a severe primary infection or a relapse
Pregnant women and HIV infected individual
should be tested for T. gondii infection.
Current Diagnosis Methods and Feature
Histologic
Diagnosis
T. Gondii
Isolation
Method
Serologic Test
PCR
Advantage
High sensitivity
& specificity
Accurate
Accurate
Specimen
Serum, Plasma,
whole blood
Equipment
Moderate
Stained tissue,
body fluid (CSF,
amniotic fluid)
Expensive
Blood, body fluid
(CSF, amniotic
fluid)
Expensive
Sensitive;
Specific;
Quantitative
Blood, , body
fluid (CSF,
amniotic fluid)
Expensive
Skill
Moderate
Significant
Significant
Significant
Shortage
A screening test Difficult to
obtain sample
Difficult to obtain Costly
sample, Time
consuming
Serologic test for detection of IgG /IgM is the most common method.
Serologic Tests For Toxoplasmosis
Method
Rapid Test
ELISA
Agglutination
Advantage
Simple procedure,
Results in 15 min,
Easy to read results
Multiple procedure,
2-3 hours
Multiple procedure
Sensitivity
&specificity
Variant
High
Moderate
Equipment
No
Moderate
No
Skill
Minimal training
Moderate
Moderate
Shortage
Good product is not
common
Time consuming,
IgG &IgM separately
tested
Difficult to read result,
Unable to detect IgM
alone
Storage
Room temperature
4℃
4℃
Rapid Test is a practical screening choice.
OnSite Toxo IgG/IgM Rapid Test
Development History
• Started to explore antigen since 1998
• In 2006, developed preparatory antigens
• Launched in 2007 in multiple format to meet the needs
o Strip (Serum/Plasma)
o Cassette (Serum/Plasma)
o Cassette (Serum/Plasma /Whole Blood)
OnSite Toxo IgG/IgM Combo Rapid Test
Simple Procedure, Fast Result, Cost Effective
R0234C
Detects IgG/IgM in the same test device
Key Feature
In house, unique antigen for the highest
performance
3 test formats for different needs
Specimens
Serum, Plasma,
Whole blood: suitable for remote area
Procedure
Simple
Results
Clear, easy-to-read, within 15 minutes
Equipment
Not required
Required training
Minimal training
Storage
2-30℃
Simple, Rapid Procedure
1 drop of specimen
（S/P/WB)
1 drops of sample diluent
15 minutes
Clear, Easy-To-Read Result
Negative
C line only
Positive
C + G line: IgG (+)
C + M line: IgM (+)
C + G + M line: IgG(+)/IgM (+)
Provide Full Spectrum of Infection in 1 Test
IgM
IgG
Indication
Risk to Pregnancy
+
-
Acute infection
+
+
Current infection or past infection, Further test to discriminate an
since IgM may persist for long time acute infection from a past
for Toxo
infection. IgG avidity testing or
IgG titer may be determined
-
+
• Latent infection or past infection Remote risk of fetus detect
• Congenital transmission unlikely
• Low
risk
of
congential
toxoplasmosis
-
-
No infection
High risk of fetus defect
Risk of Toxo infection, minimize
exposures (raw meat,
suspicious cats and so on)
Clinical Performance - High Accuracy
• For IgM Test
A total of 302 samples from susceptible subjects were tested by the
OnSite Toxo IgG/IgM Rapid Test and by a commercial IgM EIA kit.
OnSite Toxo IgM
Positive Negative
Total specimens
(n=302)
4
298
Reference IgM ELISA
Positive Negative
2
300
Relative Sensitivity: 100%, Relative Specificity: 99.3%, Overall Agreement: 99.3%
Clinical Performance - High Accuracy
• For IgG Test
A total of 324 samples from susceptible subjects were tested by the
OnSite Toxo IgG/IgM Rapid Test and by a commercial IgG EIA kit.
OnSite Toxo IgG
Positive Negative
Total specimens
(n=324)
25
299
Reference IgG ELISA
Positive Negative
24
300
Relative Sensitivity: 91.6%, Relative Specificity: 99.0%, Overall Agreement: 98.5%
All three OnSite Toxo Rapid Test Kits
the Leading Products on the Market
• Launched in 2007
• Major market shares in almost every market
• Million tests to be distributed annually
• Distributed to more than 90 countries
2010
2011
2012
2013
Annual Sales of Toxo Rapid Test Kits
OnSite Toxo IgG/IgM Rapid Test Kits
The Right Choice for You
• An ideal screening test
o Simple procedure
o Fast result
o High sensitivity and specificity
o Low cost
o Minimal training requirement
• More products available
o Toxo IgM ELISA Kit E0230
o Toxo IgG ELISA Kit E0231
Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739
QUALITY . INNOVATION . SIMPLICITY