SPECIMEN: Whole Blood/ Serum/ Plasma
The One Step RV IgG/IgM Test is a rapid chromatographic immunoassay
for the qualitative detection of antibodies (IgG and IgM) to Rubella (Virus) in Whole Blood /Serum / Plasma to aid in the diagnosis of RV
infection. The test is based on immunochromatography and can give a
result within 15 minutes.
The One Step RV IgG/IgM Test is a qualitative membrane strip based
immunoassay for the detection of RV antibodies (IgG and IgM) in
Whole Blood /Serum / Plasma. The test device consists of: 1) a
burgundy colored conjugate pad containing RV recombinant envelope
antigens conjugated with Colloid gold (RV 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-RV, T2 band is coated with antibody for the detection of IgG
anti-RV, 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-RV, if present in
the specimen, will bind to the RV conjugates. The immunocomplex is
then captured by the reagent pre-coated on the T2 band, forming a
burgundy colored T2 band, indicating a RV IgG positive test result
and suggesting a recent or repeat infection. IgM anti-RV if present
in the specimen will bind to the RV conjugates. The immunocomplex
is then captured by the reagent coated on the T1 band, forming a
burgundy colored T1 band, indicating a RV 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 RV 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