AffiGEN AFG-VGS-19 Rapid Test Kit Instruction Manual

: June 1, 2024
: AffiGEN

Table of Contents

Material Required
Storage
Principle
Precautions
Sample Collection & Preparation
Result Interpretation
Limitations
Sensitivity & Specificity
References
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**AffiGEN AFG-VGS-19 Rapid Test Kit Instruction Manual

**

Material Required

(15) Rapid Toxoplasma Antibody Test Device
(15) Sample Buffer
(15) Disposable Pipette
(01) Instruction of Use

Storage

Store the test kit at 4~30℃ in dry place. DO NOT FREEZE.
Do not store the test kit in the direct sunlight.
The expiry date is 12 months from the production date, which is indicated on the box.

Principle

The AffiVET® Canine & Feline Toxoplasma IgG/IgM Antibodies Rapid Test Kit is a
Chromatographic Immunoassay method, used to qualitatively identify canine or feline
Toxoplasma gondii antibodies in plasma, serum and whole blood.
Highly specific Toxoplasma gondii antigens serve as both capture and detector elements in this assay. These antigens have a remarkable capability to directly detect antibodies against Toxoplasma gondii, ensuring an exceptionally accurate outcome.

Precautions

This kit is for detecting toxoplasma IgG/IgM antibodies in serum, plasma and whole blood. Make sure you understand how to use it properly.
Check the kit package and read these instructions to make sure everything looks good before using it. Only use a kit that’s in good condition.
If you find any damage or leaks, contact your vendor for a replacement. Don’t use a damaged kit unless you’ve talked to the vendor first.
Handle all samples carefully because they might be contagious. Follow local laws about handling them And be careful not to contaminate the kit or other samples.
Use the test cassette, buffer, and swab within 5 minutes of opening them. Don’t open them if you’re not ready to use them.
Don’t use parts from other kits. Stick to what’s in this one for accurate results.
This kit is for one-time use only. Don’t try to use it again.

Sample Collection & Preparation

Canine & Feline whole blood, serum, or plasma should be used with this test.
Whole blood
Collect the whole blood into the anti-coagulant tube (Max. vol. 1.5 mL) provided. If anticoagulated whole blood is not immediately tested, they should be refrigerated at 2~8°C and used within 24 hours.
Serum
Collect the whole blood into the collection tube (NOT containing anticoagulants such as heparin, EDTA and sodium citrate), leave to settle for 30 minutes for blood coagulation and then centrifuge to get serum supernatant.
Plasma
Collect the whole blood into the collection tube (containing anticoagulants such as heparin, EDTA and sodium citrate) and then centrifuge to get plasma.
If serum or plasma samples are not tested immediately, they should be refrigerated at 2~8°C.
For longer storage, freezing is recommended. Frozen samples should be brought to room temperature (15~30°C) prior to use.
Samples containing precipitate may yield inconsistent test results. Such samples must be clarified prior to assaying.
The use of thrombolytic or bacterial contaminated samples should be avoided. Erroneous result may occur.

Test Procedure

All reagents and samples must be at room temperature (15~30°C) before use.
Remove the test device from the foil pouch, and place it on a flat and dry surface.
Utilize the provided plastic pipette to collect the supernatant.
Dispense 1 drop (10µL) of serum /plasma/whole blood into the sample well.
Add 3 drops (approx.) of the sample buffer into the sample well on the test card.
Allow 5 to 10 minutes for the reaction, then proceed to observe the results. Do not interpret over 10 minutes.

Result Interpretation

Negative Result
- Presence of C-Line
- Absence of T1-Line – IgG (-)
- Absence of T2-Line – IgM (-)
Positive Result
- Presence of C-Line
- Presence of T1-Line – IgG (+)
- Absence of T2-Line – IgM (-)
  
  IgG (+) indicates that the animal has been exposed to Toxoplasma gondii
- Presence of C-Line
- Presence of T1-Line – IgG (+)
- Presence of T2-Line – IgM (+)
  
  IgM (+) indicates current infection
Invalid Result
- Absence of C-Line
- Presence of T1-Line
- Presence of T2-Line
- Absence of C-Line
- Absence of T1-Line
- Absence of T2-Line

Limitations

This kit is for screening and on-site testing. A positive result should be confirmed further using PCR or other official methods. Diagnosis of toxoplasma should be made by a veterinarian, based on clinical symptoms and lab tests.

A negative result means no toxoplasma antibodies were found, but if acute symptoms are present, toxoplasma infection cannot be ruled out.

Sensitivity & Specificity

This kit has a sensitivity of 95% for detecting toxoplasma antibodies, with a specificity of 100%.
It’s important to note that this kit does not detect antibodies for CDV, CPV, CCV, or toxoplasma antigens.

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