Toxo IgG IgM Combo Rapid Test Cassette IgM Anti Toxoplasma Gondii IgG Anti T Gondii
Brand Name:Citest
Certification:CE0123
Model Number:ITG-302/ITG-402/ITM-302/ITM-402/ITGM-302
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
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Hangzhou Zhejiang
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170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
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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 |
Toxo IgG IgM Combo Rapid Test Cassette IgM Anti Toxoplasma Gondii IgG Anti T Gondii
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