Test kit for detection of antibodies IgG/IgM to Canine and Feline Toxoplasma

BIOPLACEFLOW TOXO Ab

INTENDED USE
BIOPLACEFLOW TOXO Ab is a one-step qualitative immunochromatographic assay for the
detection antibodies to Toxoplasma gondii in dog’s and cat’s whole blood, serum or
plasma.
Assay time: 10-15 min
PRINCIPLE OF THE ASSAY
The BIOPLACEFLOW TOXO Ab kit is based on sandwich lateral flow
immunochromatographic assay. The test device has a testing window for the observation
of assay running and result reading. The testing window has an invisible tests (1 and 2)
zone and a control (C) zone before running the assay. When the treated sample was
applied into the sample hole on the device, the liquid will laterally flow through the
surface of the test strip and react with the pre-coated anti-antibodies. If there are specific
antibodies to antigen in the specimen, a visible T lines will appear (1 – IgG; 2 – IgM). The
C line should always appear after a sample is applied, which indicates a valid result. By
this means, the device can accurately indicate the presence of antibodies to Toxoplasma
gondii in the specimen.
KIT COMPONENTS
1. Test device with disposable dropper
2. Assay buffer tube
3. Product Manual
STORAGE AND STABILITY
The kit can be stored at room temperature (8-25°C). The test kit is stable through the
expiration date (12 months) marked on the package label. DO NOT FREEZE. Do not store
the test kit in direct sunlight.
TEST PROCEDURE
1. When sample and test kits are stored at cold circum stances (2-8 °C), put them at
room temperature for 15-30 minutes before use.
2. Take out a device from a pouch and place it on a horizontal surface.
3. 3. Holding the disposable pipette strictly vertically, add 2 drops of the test sample into
the hole (S) of the test cassette.

4. Free the disposable pipette from sample residues and, holding it strictly vertically,
immediately add 5 drops of analysis buffer.
5. Read the test results between 5-10 minutes. A result obtained after 10 minutes is
invalid.

INTERPRETATION OF RESULTS
- IgM Positive (+): The presence of “C” line and “2” line, no matter 2 line is clear or
vague.
- IgG Positive (+): The presence of “C” line and “1” line, no matter 1 line is clear or
vague.
- IgM/IgG Positive (+): The presence of “C” line and “1” and “2” line, no matter T lines
are clear or vague.
- Negative: Only clear C line appear. No Test line (1,2).
- Invalid: No colored line appears in C zone. No matter if T line appears.
PRECAUTIONS
- All reagents must be at room temperature before running the assay.
- Do not remove test cassette from its pouch until immediately before use.
- Do not use the test beyond its expiration date.
- The components in this kit have been quality control tested as standard batch unit. Do
not mix components from different lot numbers.
- All specimens are of potential infection. It must be strictly treated according to the
rules and regulations by local states.
LIMITATION
Test kit for detection antibodies to Toxoplasma gondii BIOPLACEFLOW TOXO Ab is for in
vitro veterinary diagnosis use only. All result should be considered with other clinical
information available with veterinarian. It is suggested to apply a further confirmative
method such as PCR when positive result was observed.