Instatest Toxoplasma Igg, M

InstaTest Toxo IgG,M 171102-50 (50 Tests)

4. Avoid microbial contamination of reagents when opening Atlas Link and dispensing liquids from vials & bottles. 5. Do not smoke, eat or drink in areas in which specimens or InstaTest Toxoplasma IgG, M kit reagents are handled. 6. Wipe spills quickly and thoroughly with sodium Cat. No. 171102-50 (50 Tests) hypoclorite solution. 7. Devices should be kept dry in the reclosable foil pouch INTRODUCTION with desiccant. Allow the strips and pouch to equilibrate Toxoplasmosis is caused by the intracellular parasite to room temperature before opening the pouch to avoid Toxoplasma gondii and may be contracted by consuming condensation of moisture onto the strips. Always reseal contaminated meat or by contact with cat feces containing the foil pouch after use. oocysts. In adolescence and adulthood, most infections are 8. Autoclave used and contaminated materials at 121 subclinical. However, if a pregnant woman contracts degrees C at 15 p.s.i. for 30 minutes before disposal toxoplasmosis, it may be passed through the placenta to the 9. Do not use after expiration date fetus, resulting in congenital toxoplasmosis, which is a cause 10. Once the assay has been started, all subsequent steps of mortality and malformation. Asymptomatic infants may should be complete without interruption and within the develop anomalies later in life. The Atlas Link Toxo IgM Insta recommended time limits. Test (Two Spot) is a rapid serological method to detect 11. Do not use reagents from different kits. The solutions Toxoplasma antibody for clinical identification of contain sodium azide as a preservative. If these materials, toxoplasmosis. either concentrated or diluted, are to be disposed of through a sink or other common plumbing systems, flush PRINCIPLES OF THE TEST with generous amounts of water to prevent accumulation The test involves capturing of antibodies to Toxoplasma of potentially explosive compounds. gondii by purified proteins of the organism immobilized onto a porous membrane. After washing, the presence of antibodies SPECIMEN COLLECTION AND PREPARATION is revealed by reaction with colloidal gold conjugate, which This test can be performed on either serum or plasma. It is will bind to absorbed Toxoplasma antibodies, forming a red recommended that fresh samples be used if possible. If this is spot on the membrane. not possible, samples should be stored in a refrigerator (2-8C) before being analyzed. For long term storage, specimens Specific anti-human IgM conjugate is used. An additional should be frozen at – 20C. reagent control spot has been applied onto the membrane to check for the reactivity of the reagents of the kit. In practice Frozen Specimen therefore, the test has been designed so that one red spot The test works best when used with fresh samples that have appears (the control spot) if the sample is non-reactive, and never been frozen and thawed. However most frozen samples two red spots appear if the sample is reactive and contains will work well if the suggested procedure below is followed. Toxoplasma antibodies. 1. Allow the sample to thaw in a vertical position in a rack. MATERIALS PROVIDED Do not agitate the sample. This allows particles to settle to 1. Test devices: 50 the bottom of the tube/vial. Alternatively centrifuge the 2. Buffer solution in dropper bottle with blue tip and cap. sample. 3. Wash solution in dropper bottle with red tip and cap. 2. Insert a pipette just below the surface of the sample to 4. Colloidal gold conjugate (Anti-human IgM gold) in obtain one drop of the sample for the test, being careful dropper bottle with white cap and tip. not to take any particulate into the pipette. 5. Dropper pipettes: 50 3. If this procedure still results in a very slow and/or high background, make a dilution of 1 part of sample with 3 STORAGE OF KIT AND REAGENTS parts of the buffer solution (blue cap bottle). Use only 1 Store refrigerated at 4-8 degrees C. Do not freeze. If drop of this diluted sample for the test. refrigerated storage space is limited, the test device can be stored in its original container with desiccant in a cool, dry TEST PROCEDURE area. Solutions must be stored refrigerated at 4-8 degrees, but 1. Dispense 3 drops of buffer solution for the blue top do not freeze. It is important to always reseal the test device dropper bottle into the device. container containing the desiccant immediately after use. 2. Add 1 drop of sample using the pipette provided. Incubate for 1 minute. PRECAUTIONS TO USERS 3. Dispense 2 drops of anti-human IgG & M secondary 1. For in vitro investigative use only. antibody solution from the red top dropper bottle into the 2. Handle assay specimens as if capable of transmitting device. Incubate for 1 minute. infectious agents. 4. Dispense 3 drops of buffer solution from the blue top 3. Do not mouth pipette. Wear disposable gloves and dropper into the device. protective clothing and eye wear throughout the test 5. Dispense 3 drops of Protein-A-Gold conjugate from the procedure. Dispose of gloves in the biohazard waste. white top dropper bottle into the device. Wash hands afterwards. Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected] InstaTest Toxo IgG,M 171102-50 (50 Tests)

6. Dispense 3 drops of buffer solution from the blue top 3. Wilson, M., D.A. Ware, and D.D. Juranek. 1990. Serological aspects of toxoplasmosis. J. Am. Yet. Med. Assoc. 196:277-281. dropper bottle into the device. Rev. 3.31.99 CL 7. Read results within 10 minutes for easiest interpretation.

INTERPRETATION OF RESULTS Two red spots appearing in the inner circle one adjacent to the T, one next to the C indicates a positive reaction. Any degree of redness should be considered as positive. Only one red spot appearing next to the C indicates a negative reaction. No red spot at all or a totally red membrane indicates an invalid result. If a slight pink color develops on the entire surface of the membrane, this may be the result of a lipemic sample or particulate in the sample, and the sample should be diluted one part sample with two part buffer blue top bottle) and retested.

C T C T

Positive Result Negative Result

C T C T

Invalid Result Negative Result

LIMITATIONS OF THE PROCEDURE 1. Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particulate, which can block the membrane. This slows the flow of reagents and can lead to high background color, making the interpretation of results difficult. (See remarks on Frozen Specimens) 2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Deviations may lead to aberrant results. 3. Lipemic, hemolyzed, icteric or heat inactivated sera may cause erroneous results. 4. As with other serological assays, the results of these assays should be used in conjunction with information available from clinical evaluation and other diagnostic procedures.

REFERENCES 1. Frenkel, J.K. 1990. Toxoplasmosis in human beings. J. Am. Vet. Med. Assoc. 196:240-248. 2. Naot, Y., D.R. Guptill, and J.S. Remington. 1982. Duration of IgM antibodies to Toxoplasma gondii after acute acquired toxoplasmosis. J. Infect. Dis. 145:770.

Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected]