SPECIMEN: Whole Blood/ Serum/ Plasma
The One Step TOXO IgG/IgM Test is a rapid chromatographic
immunoassay for the qualitative detection of antibodies (IgG and
IgM) to Toxoplasma gondii in Whole Blood /Serum / Plasma to aid in the diagnosis of TOXO
infection. Toxoplasma gondii is an obligate intracellular protozoan parasite with a worldwide
distribution. Serological data indicates that approximately 30% of
the population of most industrialized nations is chronically
infected with the organism. A variety of serologic tests for
antibodies to Toxoplasma 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 ELISA. Recently, lateral flow chromatographic immunoassay, such
as The Toxo IgM/IgG Rapid Test (Whole Blood/Serum/Plasma) was
introduced into the clinic for the serodiagnosis of Toxoplasma gondii infection. One step TOXO IgG/IgM Test is a simple, visual
qualitative test that detects TOXO antibodies in human Whole
Blood/serum/plasma. The test is based on immunochromatography and
can give a result within 15 minutes.
The One Step TOXO IgG/IgM Test is a qualitative membrane strip
based immunoassay for the detection of TOXO antibodies (IgG and
IgM) in Whole Blood /Serum / Plasma. The test device consists of:
1) a burgundy colored conjugate pad containing TOXO recombinant
envelope antigens conjugated with Colloid gold (TOXO conjugates)
and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip
containing two test bands (T1 and T2 bands) and a control band (C
band). The T1 band is pre-coated with the antibody for the
detection of IgM anti-TOXO, T2 band is coated with antibody for the
detection of IgG anti-TOXO, and the C band is pre-coated with goat
anti rabbit IgG. When an adequate volume of test specimen is
dispensed into the sample well of the test cassette, the specimen
migrates by capillary action across the cassette. IgG anti-TOXO, if
present in the specimen, will bind to the TOXO conjugates. The
immunocomplex is then captured by the reagent pre-coated on the T2
band, forming a burgundy colored T2 band, indicating a TOXO IgG
positive test result and suggesting a recent or repeat infection.
IgM anti-TOXO if present in the specimen will bind to the TOXO
conjugates. The immunocomplex is then captured by the reagent
coated on the T1 band, forming a burgundy colored T1 band,
indicating a TOXO IgM positive test result and suggesting a fresh
infection. Absence of any T bands (T1 and T2) suggests a negative
result. The test contains an internal control (C band) which should
exhibit a burgundy colored band of the immunocomplex of goat anti
rabbit IgG/rabbit IgG-gold conjugate regardless of the color
development on any of the T bands. Otherwise, the test result is
invalid and the specimen must be retested with another device.
Storage and Stability
· Store as packaged in the sealed pouch at room temperature or
refrigerated (4-30℃ or 40-86℉). The test device is stable through
the expiration date printed on the sealed pouch.
· The test must remain in the sealed pouch until use.
Additional Special Equipment
Test devices Disposable specimen droppers
Buffer Package insert
Materials Required But Not Provided
Specimen collection containers
· For professional in vitro diagnostic use only. Do not use after
· Do not eat, drink or smoke in the area where the specimens and
kits are handled.
· Handle all specimens as if they contain infectious agents.
· Observe established precautions against microbiological hazards
throughout all procedures and follow the standard procedures for
proper disposal of specimens.
· Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
· Follow standard biosafety guidelines for handling and disposal of
potential infective material.
· Humidity and temperature can adversely affect results.
Specimen Collection and Preparation
1. The One Step TOXO IgG/IgM Test can be performed used on Whole
Blood /Serum / Plasma.
2. To collect whole blood, serum or plasma specimens following
regular clinical laboratory procedures.
3. Testing should be performed immediately after specimen
collection. Do not leave the specimens at room temperature for
prolonged periods. For long term storage, specimens should be kept
below -20℃. Whole blood should be stored at 2-8℃ if the test is to
be run within 2 days of collection. Do not freeze whole blood
4. Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to
testing. Specimens should not be frozen and thawed repeatedly.
Allow the test, specimen, buffer and/or controls to reach room
temperature 15-30℃ (59-86℉) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test device from the sealed pouch and use it as soon as
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 1 drop of specimen
(approximately 10μl) to the specimen well(S) of the test device,
then add 2 drops of buffer (approximately 80μl) and start the
timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15
minutes. Do not interpret the result after 20 minutes.
Applying sufficient amount of specimen is essential for a valid
test result. If migration (the wetting of membrane) is not observed
in the test window after one minute, add one more drop of buffer to
the specimen well.
Contact Rebecca Yan