OnSite Toxo IgG/IgM Rapid TestProviding the Full Spectrum of Infection with Toxoplasma

• Caused by Toxoplasma gondii (T. gondii)

• Principal transmissiono Foodborneo Animal-to-human o Mother-to-child (congenital)

• Worldwideo A third of population carry infectiono Up to 95% of some population in some

regions have been infected

• In U.S. o More than 60 million carry T. gondiio 10.8% overall seroprevalenceo 11% among women of childbearing age

(15 to 44 years)

Toxoplasmosis

T. gondii oocysts in a fecal floatation

• 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

Life Cycle of T. gondii

• Healthy people (nonpregnant)o Usually mild with “flu-like” symptomso The parasite can remain in the body in an inactive state

• Pregnant mother o Induce miscarriageo A stillborn child with potential eye and behavior problemo Can be treated and reduce the fetal effects during pregnancy

• Person with suppressed immune systems, such as AIDSo Develop a severe primary infection or a relapse

Clinical Feature of Toxoplasmosis

Pregnant women and HIV infected individual should be tested for T. gondii infection.

Current Diagnosis Methods and Feature

Serologic test for detection of IgG /IgM is the most common method.

Method Serologic Test Histologic Diagnosis

T. Gondii Isolation PCR

Advantage High sensitivity & specificity

Accurate Accurate Sensitive; Specific; Quantitative

Specimen Serum, Plasma, whole blood

Stained tissue, body fluid (CSF, amniotic fluid)

Blood, body fluid (CSF, amniotic fluid)

Blood, , body fluid (CSF, amniotic fluid)

Equipment Moderate Expensive Expensive Expensive

Skill Moderate Significant Significant Significant

Shortage A screening test Difficult to obtain sample

Difficult to obtain sample, Time consuming

Costly

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

Key Feature

Detects IgG/IgM in the same test deviceIn 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℃

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1 drop of specimen 1 drops of sample diluent 15 minutes （ S/P/WB)

Simple, Rapid Procedure

C line only

Clear, Easy-To-Read Result

Negative

Positive

C + M line: IgM (+)

C + G line: IgG (+)

C + G + M line: IgG(+)/IgM (+)

Provide Full Spectrum of Infection in 1 Test

IgM IgG Indication Risk to Pregnancy + - Acute infection High risk of fetus defect + + Current infection or past infection,

since IgM may persist for long time for Toxo

Further test to discriminate an acute infection from a past infection. IgG avidity testing or IgG titer may be determined

- + • Latent infection or past infection • Congenital transmission unlikely• Low risk of congential

toxoplasmosis

Remote risk of fetus detect

- - No infection Risk of Toxo infection, minimize exposures (raw meat, suspicious cats and so on)

• 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.

Relative Sensitivity: 100%, Relative Specificity: 99.3%, Overall Agreement: 99.3%

Clinical Performance - High Accuracy

OnSite Toxo IgM Reference IgM ELISA

Positive Negative Positive Negative

Total specimens (n=302) 4 298 2 300

• 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.

Relative Sensitivity: 91.6%, Relative Specificity: 99.0%, Overall Agreement: 98.5%

Clinical Performance - High Accuracy

OnSite Toxo IgG Reference IgG ELISA

Positive Negative Positive Negative

Total specimens (n=324) 25 299 24 300

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 2014

Annual Sales of Toxo Rapid Test Kits

OnSite Toxo IgG/IgM Rapid Test KitsThe Right Choice for You

• An ideal screening test o Simple procedureo Fast resulto High sensitivity and specificityo Low cost o Minimal training requirement

• More products availableo Toxo IgM ELISA Kit E0230o Toxo IgG ELISA Kit E0231

Technical Support

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

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