INTENDED USE

Toxoplasma is one kind of protozoans, is a kind parasite in cells and is constituted by trophozoites and cysts. The average size of trophozoites is 1.5×5cm, and the shape of it is like crescent. Therefore, this kind protozoan is called toxoplasma. Worldwide toxoplasmosis is caused by toxoplasma, and can attack both human and livestock. Maternal and infant are easily infected by toxoplasma. Pregnant women whose endocrine is changed and immunity decreases are prone to primary infection. Latent viruses in the body of past infected pregnant woman are easily activated and infect the body again.

The agent is based on the principle of Gold Immunochromatography Assay (GIA) to qualitatively detect TOX-IgM/G antibody in human serum by capture method which is very sensitive and specific.

PRINCIPLE

TOX IgM:

When the specimen contains TOX IgM antibody, the antibody is forming complex concentrate with antibo colloidal-gold monoclonal dy firstly, moving forward under the action of colloidal-gold chromatography, and then react with coating antigen, appearing a red line (Test Line) with naked eye,showing positive. unbound form marker is moving forward sequentially, combining with antimous antibody, and forming a red line(Control Line).If the red test line not appears, showing negative.

TOX IgG:

When the specimen contains TOX IgG antibody, the antibody is forming complex concentrate with colloidal-gold monoclonal antibody firstly, moving forward under the action of colloidal-gold chromatography, and then react with coating antigen, appearing a red line (Test Line) with naked eye,showing positive. unbound form marker is moving forward sequentially, combining with antimous antibody, and forming a red line(Control Line).If the red test line not appears, showing negative.

INTERPRETATION OF RESULTS

Negative:  Only one red line appears on the control region(C).No red line appears on the test region. (T)

Positive: One red line appears on the control region(C) and meanwhile red line appears on the test region. (T)

Invalid:  The test is invalid if the control line is not visible on the control region(C)The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device.

PRECAUTIONS

1. The serum must be fresh for test, avoiding freezing repeatedly.

2. Read result after 30minutes may give erroneous results.

3. Do not use after the expiration date.

4. If the patient, for the first time, is infected in less than 5 days, with no detected specific antibody, the result will be negative when testing.

5. The parent antibody can be detected from the specimens of a yearling baby, therefore, it is not appropriate to take this test to evaluate the baby's history of infection and immunization .

LIMITATION

1. For IN VITRO diagnostic use only.

2.There are differences between the antibody reaction of the immunosuppressant individual and immune hyperfunction individual.

STORAGE AND STABILITY

1. The test kit is to be stored at room temperature 4～30℃in the sealed pouch,Avoid sunlight,heat and freezing. Stored at a dry place. Its period of validity is 24 months.

2. This test kit can be transported in a short period at a normal temperature. Some preventive measures should be taken in summer or winter.