Toxoplasma Toxo IgG/IgM Test Cassette

Toxo IgG/IgM Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (T. gondii) and IgG anti- T. gondii in human serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with the Toxo IgG/IgM Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.

Features

• Quick result read in 10 minutes
• High accuracy over 98.6%
• Relative sensitivity 96.5%
• Relative specificity 99.0%

One Step Cassette Style TOXO IgG/IgM TEST (Colloid Gold) 

INTRODUCTION

The one step cassette style TOXO IgG/IgM test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The TOXO test is a diagnostic device for qualitative detection of  the  total antibodies of TOXO in human serum (or plasma) specimen.

SUMMARY

Purified recombinant antigens of TOXO are precoated onto membrane as a capture reagent on the test band region . During testing, the specimen reacts with the colored conjugate (TOXO antigen colloidal gold conjugate) which has been pre-coated on the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action to react with TOXO antigen on the membrane and generate a red band. Presence of the red band indicates a positive result. The color intensity will depend on the concentration of the antibody of TOXO present in the sample. This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.

SPECIMEN COLLECTION

For serum（or plasma）, collect blood into a container without anticoagulant. If the specimen cannot be tested on the day of collection, store the serum (or plasma) specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing.

TEST PROCEDURE

1. Open a pouch containing a cassette, remove the test kit from the pouch and place it horizontally on the desk.
2. Pipette 2 or 3 drops of diluted specimen into the sample well of the cassette.
3. Read results within 10-15 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Negative: Only one pink band appears on test region of the cassette. This indicates that there is no detectable antibody of TOXO (IgM & IgG) in the specimen.

Positive: Two pink bands appear on test region of the cassette. This indicates that the specimen contains detectable amount of antibody of TOXO (IgM or IgG).

Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

PRECAUTION

1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2. Use it before expiry date.
3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator. Use the test kit as soon as possible but within 1 hour after removal from pouch specially if the room temperature is more than 30℃ and in high humidity environment.
4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.

LIMITATIONS

1. The test is for in-vitro diagnostic use only.
2. The test is qualitative filter detection，it can not be used as the final test for blood donor.

STORAGE AND STABILITY

The test kit can be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.