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Product specifications

Intended Use
The Feline/Canine Toxoplasma IgG/IgM Antibody Rapid Test is a test cassette to diagnose the presence of anti-Toxoplasma antibodies IgG and IgM in dog’s or cat’s whole blood, serum or plasma.
Assay Time
5-10 minutes
Principle

The Feline/Canine Toxoplasma IgG/IgM AntibodyRapid Test is based on sandwich lateral flowimmuno-chromatographic assay, which displays ifthe tested animal had previous contact withToxoplasma gondii.

Reagents and Materials

- Test devices, in foil pouches with desiccant

- Disposable droppers

- Assay buffer

- Product Manual

Storage and Stability
The kit can be stored at room temperature (4-30°C). The test kit is stable through the expiration date marked on the package label. DO NOT FREEZE. Do not store the test kit in direct sunlight.
Test Procedure

Specimen preparation: Collect the cat’s or dog’s whole blood and centrifugeit to get the serum or place the whole blood into atube which contains anticoagulants and thencentrifuge to get plasma.Whole blood: directly use in the assay.All specimens should be tested immediately. If notfor testing right now, they should be stored at 2-8°C

1. Allow all materials, including the specimen and testdevice, to recover at 15-25°C before running.

2. Take out the test device from the foil pouch andplace it horizontally.

3. Use the dropper to place 1 drop of the preparedspecimen into the sample hole “S” of the test device.

4. Immediately drop 3 drops (approx. 90μL) of theassay buffer into the sample hole.

5. Interpret the result in 5-10 minutes. Result after 10minutes is considered as invalid.

Results Interpretation
- IgG Positive (+): The presence of both “C” line andzone “G” (IgG) line (clear or vague), which indicatesthat the animal has been contracted to Toxoplasmagondii.- IgM Positive (+): The presence of both “C” line andzone “M” (IgM) line (clear or vague), which indicatesa possible current contract of Toxoplasma gondii.- Negative (-): Only clear “C” line appears.- Invalid: No colored line appears in “C” zone. Nomatter if “G” (IgG) or “M” (IgM) lines appear.
Precautions

- All reagents must be at room temperature beforerunning the assay.

- Do not remove test cassette from its pouch untilimmediately before use.

- Do not use the test beyond its expiration date.

- The components in this kit have been qualitycontrol tested as standard batch unit. Do not mixcomponents from different lot numbers.

- All specimens are of potential infection. It must betreated according to the local rules and regulations.

Limitations
The Feline/Canine Toxoplasma IgG/IgM Antibody Rapid Test is for in vitro veterinary diagnosis use only. All results should be considered with other clinical information available from veterinarians. It is suggested to apply a further confirmative method when positive results are observed.

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