Toxoplasmosis is a kind of zoonosis caused by Toxoplasma gondii (TOXO) infection and it mainly causes the latent infection in the human body with non-specific signs and symptoms that may easily lead to misdiagnosis. TOXO infection mainly affects the eyes, brain, heart, liver, and lymph nodes, etc; it has a close association with Acquired Immune Deficiency Syndrome (AIDS) as well.
Toxoplasma gondii infection in pregnant women can directly affect the fetal development and result in severe malformation and reverse the effects on aristogenesis as the pathogen can pass through the placental barriers. Its teratogenic risk is 10 times higher than the pregnant women without the infection that has attracted extensive attention as it has become one of the sorts of human congenital infection. Therefore, it is necessary for its early diagnosis, treatment and prevention.
This test uses a sandwich lateral flow Immunochromatography assay. The testing window on the test device contains invisible T (test) zone and C (control) zone. When the sample is applied to the sample window on the device, the liquid laterally flows on the surface of the test strip. If there are enough Toxoplasma antigens in the sample present, a visible T band will appear. The C band should always appear after the sample is applied, this indicates a valid result. By this it means, the device can accurately indicate the presence of Toxoplasma antigen in the sample.
Allow the test device, serum specimen and/or controls to equilibrate to room temperature between 15 to 30Â°C prior to testing.
Remove the test kit from the pouch and use it as soon as possible.
With arrows pointing toward the serum specimen, immerse the strip test vertically in the specimen. Do not pass the maximum line (MAX) on the strip test while immersing the strip.
Lay the strip flatly on a non-absorbent clean surface and start the timer and wait for the red line(s) to appear. Read the result within 5 minutes but not longer than 15 minutes.
INTERPRETATION OF RESULTS
Negative: Only 1 colored line appears on the control (C) region and no apparent band on the test (T) region.
Positive: In addition to a pink control (C) line, a distinct pink band also appears in the test (T) region. Invalid: Absence of color in both regions indicates a procedural error and/or the test reagent has deteriorated.
STORAGE AND STABILITY
The test kit should be stored at room temperature 4 to 30â in the sealed pouch till the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.