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1 ABBOTT Diagnostics Division1enToxo IgG 9K08-2049-5758/R5B9K080 Read Highlighted ChangesRevised July, 2010 toxo IgGCustomer Service For additional product information, please contact your local customer service to symbols usedList NumberIn Vitro Diagnostic Medical DeviceLot NumberExpiration DateStore at 2-8 CStore at 15-30 CCAUTION: Consult accompanying (A-F)Control Negative, Positive (NEG, POS)Reagent PackReaction VesselsMatrix CellsSample CupsSee REAGENTS section for a full explanation of symbols used in reagent component package insert must be read carefully prior to use.

2 Package insert instructions must be followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package toxo IgGINTENDED USEThe AxSYM toxo IgG assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of IgG antibodies to Toxoplasma gondii in human serum or plasma (EDTA, heparin or sodium citrate) and is used as an aid in the determination of immune status and recommended as a screening test during AND EXPLANATION OF THE TESTT oxoplasma gondii is an obligate intracellular parasite capable of infecting a wide variety of intermediate hosts including man (see reference 1 for a comprehensive review of toxoplasmosis.)

3 Infected definitive hosts (cats) shed oocysts in feces which rapidly mature in soil and become infectious. When ingested by intermediate hosts, tachyzoites form and multiply rapidly with eventual development of cysts containing the slower growing, but infectious bradyzoites. Thus, toxoplasmosis is acquired by man via ingestion of cat feces or undercooked meats infested with ,3 Infection of the normal adult is commonly asymptomatic. In those cases with clinical manifestations, the most common of the symptoms is lymphadenopathy which may be accompanied by an array of other symptoms making differential diagnosis ,5 On the other hand, severe to fatal infections do occur in adults immunocompromised by cancer chemotherapy or immunosuppressive treatment and in patients with AIDS.

4 Infections in immunocompromised adults are thought to be a reactivation of latent acquired infections and usually involve the central nervous system although involvement of other sites has been Transplacental transmission of the parasite resulting in congenital toxoplasmosis can occur during the acute acquired maternal infection. The risk of fetal infection is a function of time at which acute maternal infection occurs during gestation. Maternal infections acquired before conception present very little, if any, risk to the fetus.

5 However, the incidence of congenital toxoplasmosis increases as pregnancy progresses; conversely, the severity of congenital toxoplasmosis is greatest when maternal infection is acquired early during pregnancy. A majority of infants infected in utero are asymptomatic at birth, particularly if maternal infection occurs during the third trimester, with sequelae appearing later in ,11 Congenital toxoplasmosis results in severe generalized or neurologic disease in about 20-30% of the infants infected in utero.

6 Approximately 10% exhibit ocular involvement only, and the remainder (about 70%) are asymptomatic at ,12 Subclinical infection may result in premature delivery and subsequent neurologic, intellectual, and audiologic ,13 Prospective studies of pregnancies have shown that prenatal diagnosis of infection followed by prenatal therapy reduces the frequency and the severity of congenital ,14 Serologic tests can be used to identify those pregnancies at risk; women who are seronegative at the time of diagnosis of pregnancy can be monitored during pregnancy.

7 Seroconversion is indicative of T. gondii infection and establishes gestational age when maternal infection ,14,15 The AxSYM toxo IgG assay is a quantitative method for the measurement of T. gondii IgG antibodies in human serum and plasma (EDTA, heparin or sodium citrate). The presence of at least 3 International Units of antibody per mL of sample is indicative of acute or past PRINCIPLES OF THE PROCEDUREThe AxSYM toxo IgG assay is based on the microparticle enzyme immunoassay (MEIA) and all AxSYM toxo IgG reagents required for one test are pipetted by the Sampling Probe into various wells of a reaction vessel (RV) in the Sampling Center.

8 The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing reactions occur in the following sequence:Sampling CenterThe Sampling Probe dilutes the sample in Solution 4 (Line Diluent) and delivers an aliquot of diluted sample and T. gondii coated microparticles to an incubation well of the T. gondii antibody binds to the T. gondii coated microparticles forming an antigen-antibody CenterAssay Diluent is added to the reaction mixture and an aliquot of the antigen-antibody complex is transferred to the matrix cell.

9 The microparticles bind irreversibly to the glass fiber matrix cell is washed to remove unbound materials. The anti- human IgG: alkaline phosphatase conjugate is dispensed onto the matrix cell and binds to the antigen-antibody matrix cell is washed to remove unbound materials. The substrate, 4-Methylumbelliferyl phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical further information refer to the AxSYM System Operations Manual, Section Pack, 100 TestsAxSYM toxo IgG Reagent Pack (9K08-20)1 Bottle ( mL) T.

10 Gondii coated microparticles in TRIS buffer with protein stabilizers. Preservatives: antimicrobial agents. (Reagent Bottle 1)1 Bottle ( mL) anti- human IgG (goat): alkaline phosphatase conjugate in TRIS buffer with protein stabilizers. Minimum concentration: g/mL. Preservative: sodium azide. (Reagent Bottle 2)1 Bottle ( mL) Assay Diluent in TRIS buffer with protein stabilizers. Preservatives: antimicrobial agents. (Reagent Bottle 3)CalibratorsAxSYM toxo IgG Calibrators (9K08-01)The calibrators are manufactured by dilution and referenced to the World Health Organization (WHO) 2nd International Standard for Anti-T.