One Step Toxoplasma Rapid Test for detection of IgM antibodies to
Toxoplasma gondii in serum/plasma
INTENDED USE:
The Toxoplasma Rapid Test is a rapid qualitative lateral flow test
designed for the quantitive detection of IgM antibodies to
Toxoplasma gondii (TOXO) in human serum/plasma samples.
INTRODUCTION
T. gondii is an obligate intracellular protozoan parasite with a
worldwide distribution (5, 6). Serological data indicate that
approximately 30% of the population of most industrialized nations
is chronically infected with the organism (7). When a seronegative
woman becomes infected with T. gondii during pregnancy, the
organism is often transmitted across the placenta to the fetus (5,
8). The severity of the infection in the fetus varies with the
trimester during which the infection was acquired. Infection during
pregnancy may lead to spontaneous abortion, stillbirth or overt
diseases in the neonate. Approximately 75% of congenitally infected
newborns are symptomatic. However, nearly all children born with
subclinical toxoplasmosis will develop adverse ocular or neurologic
sequelae later in life (8, 11). Approximately 80-85% develops
chorioretinitis and some may also experience blindness or mental
retardation.
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. The more widely used tests
include the Sabin-Feldman dye test, direct agglutination, indirect
hemagglutination, latex agglutination, indirect immunofluorescence,
and ELISA (9, 10).
TEST PRINCIPLE
The Toxoplasma Rapid Test Device (Serum/Plasma) has been designed
to detect IgM antibodies to TOXO through visual interpretation of
color development in the internal strip. The membrane was
immobilized with antigens of TOXO on the test region. During the
test, the specimen is allowed to react with colored recombinant
mouse anti-human IgM latex conjugates, which were precoated on the
sample pad of the test. The mixture then moves on the membrane by a
capillary action, and interacts with reagents on the membrane. If
there were enough TOXO antibodies in specimens, a colored band will
from at the test region of the membrane. Presence of this colored
band indicates a positive result, while its absence indicates a
negative result. Appearance of a colored band at the control region
serves as a procedural control. This indicates that proper volume
of specimen has been added and membrane wicking has occurred.
TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior
to testing. Do not open the pouch until ready
to begin testing.
2. Remove the device from the sealed pouch and lay it on a flat and
dry surface.
3. Using the provided pipette, add one drop of fresh specimen to
the sample well.
4. Hold the buffer bottle vertically and add 1 drop to the sample
well. /If using a pipette, change a new one to avoid
cross-contamination. Draw and transfer 2-3 drops of buffer to the
sample well.
5. Read the result between 15-20minutes. Do not read results after
20 minutes.
INTERPRETATION OF RESULTS
Positive:
Two pink lines appear in the result window.
Negative:
Only one pink line appears in the control region (C).
Invalid:
No colored line appears in the control region regardless of the
presence or absence of the test line.
PERFORMANCE STUDY
Table: TOXO Rapid Test vs. EIA Test
Relative Sensitivity: 98.21% (90.45%-99.95%)* Relative Specificity: 98.33% (91.06%-99.96%)* Overall Agreement: 98.28% (93.91%-99.79%)* *95% Confidence Interval | | TOXO Rapid Test | |
| + | - | Total |
| EIA Test | + | 55 | 1 | 56 |
| - | 1 | 59 | 60 |
| 56 | 60 | 116 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
