Toxo IgG/IgM Combo Rapid Test Cassette, IgM anti-Toxoplasma Gondii (T. gondii) and IgG anti-T. gondii
| Principle |
Chromatographic Immunoassay |
| Format |
Cassette |
| Specimen |
S / P |
| Certificate |
CE0123 |
| Reading Time |
15 minutes |
| Pack |
25 T/40 T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
96.70% |
| Specificity |
98.30% |
| Accuracy |
98.20% |
A rapid test for the qualitative detection of IgG and IgM antibodies to Toxoplasma Gondii(T.gondii) in human serum or plasma.
For professional in vitro diagnostic use only
INTENDED USE
The Toxo IgG/IgM Rapid 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 two screening tests and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with the Toxo IgG/IgM Combo Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.
SUMMARY
T. gondii is an obligate intracellular protozoan parasite with a worldwide distribution1,2 . Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism3 . A variety of serologic tests for antibodies to T. gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are the Sabin-Feldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA4-7 .
Recently, lateral flow chromatographic immunoassay, such as The Toxo IgG/IgM Combo Rapid Test Cassette was introduced into the clinic for the serodiagnosis of T. gondii infection.
PRINCIPLE
The Toxo IgG/IgM Combo Rapid Test Cassette (Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of IgG and IgM antibodies to Toxoplasma in serum or plasma specimens. In this test, mouse anti-human IgG and mouse anti-human IgM are coated in the test line regions of the test. During testing, the specimen reacts with T.gondii antigen coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-human IgG and mouse anti-human IgM on the membrane in the test line region respectively. The presence of a colored line in the test line region indicates a positive result for T.gondii infection, while its
absence indicates a negative result for that infection.
To serve as a procedural control, a colored line will always appear in the respective control line regions of all the two strips indicating that proper volume of specimen has been added and membrane wicking has occurred.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room temperature (15- 30°C) prior to testing.
a. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
b. Place the test cassette on a clean and level surface. Hold the dropper vertically; draw the specimen about 1cm above the upper end of the nozzle as shown in illustration below. Transfer 1 full drop (approx. 20μL) of specimen to each sample well, then add 2 drops of buffer (approximately 80μL) to each sample well and start the timer. See the illustration below.
c. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the test line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of T.gondii IgG or IgM antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line regions.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Sensitivity and Specificity
A clinical evaluation was conducted comparing the results obtained using the Toxo IgG/IgM Combo Rapid Test Cassette to Toxo IgG/IgM ELISA Testing. The study included 380 IgG specimens and 380 IgM specimens, and about the IgM specimen both assays identified 345 negative and 28 positive results, about the IgG specimen both assays identified 344 negative and 29 positive results
Order Information
| Cat. No. |
Product |
Specimen |
Pack |
| ITG-302 |
Toxo IgG Rapid Test Cassette |
S / P |
40 T |
| ITG-402 |
Toxo IgG Rapid Test Cassette |
WB/S/P |
40 T |
| ITM-302 |
Toxo IgM Rapid Test Cassette |
S / P |
40 T |
| ITM-402 |
Toxo IgM Rapid Test Cassette |
WB/S/P |
40 T |
| ITGM-302 |
Toxo IgG/IgM Rapid Test Cassette |
S / P |
40 T |
| ITGM-325 |
Toxo IgG/IgM Combo Rapid Test Cassette |
S / P |
25 T |
| ITGM-402 |
Toxo IgG/IgM Rapid Test Cassette |
WB/S/P |
40 T |
| ITGM-425 |
Toxo IgG/IgM Combo Rapid Test Cassette |
WB/S/P |
25 T |
