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

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) 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” 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 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. MethodSerologic Test Histologic Diagnosis T. Gondii Isolation PCR Advantage High sensitivity & specificity 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) EquipmentModerateExpensive SkillModerateSignificant ShortageA screening testDifficult to obtain sample Difficult to obtain sample, Time consuming Costly

Serologic Tests For Toxoplasmosis MethodRapid TestELISAAgglutination Advantage Simple procedure, Results in 15 min, Easy to read results Multiple procedure, 2-3 hours Multiple procedure Sensitivity &specificity VariantHighModerate EquipmentNoModerateNo SkillMinimal trainingModerate Shortage Good product is not common Time consuming, IgG &IgM separately tested Difficult to read result, Unable to detect IgM alone StorageRoom temperature 4℃4℃ 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 device 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 ℃

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 IgMIgGIndicationRisk to Pregnancy + -Acute infectionHigh 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 infectionRisk 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 IgMReference IgM ELISA PositiveNegativePositiveNegative Total specimens (n=302)

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 IgGReference IgG ELISA PositiveNegativePositiveNegative Total specimens (n=324)

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

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.: Mesa Rim Rd. San Diego, CA USA Address: Telephone: 1 (858) Fax: 1 (858)

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