SPECIMEN: Whole Blood/ Serum/ Plasma
The One Step CMV IgG/IgM Rapid Test Device is a rapid qualitative
lateral flow test designed for the quantitive detection of IgG and
IgM antibodies to Cytomegalovirus (CMV) in human Whole blood, serum
or plasma samples.
Cytomegalovirus is a herpes virus and a leading biological factor
causing congenital abnormalities and complications among those who
receive massive blood transfusions and immunosuppressive therapy.
About half of the number of pregnant women who contract a primary
infection, spread the disease to their fetus. When acquired
in-utero, the infection may cause mental retardation, blindness,
and/or deafness. Serological tests for detecting the presence of
antibody to CMV can provide valuable information regarding the
history of previous infection, diagnosis or active or recent
infection, as well as in screening blood for transfusions in
newborns and immuno-compromised recipients.
The One Step CMV IgG/IgM Rapid Test Device is a rapid
chromatographic immunoassay for the qualitative detection of
antibodies (IgG and IgM) to CMV in Whole blood, Serum or Plasma.
Each test consists of: 1) a burgundy colored conjugate pad
containing CMV recombinant envelope antigens conjugated with
Colloid gold (CMV 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-CMV, T2 band is coated
with antibody for the detection of IgG anti-CMV, 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-CMV, if present in the specimen, will bind to
the CMV conjugates. The immunocomplex is then captured by the
reagent pre-coated on the T2 band, forming a burgundy colored T2
band, indicating a CMV IgG positive test result and suggesting a
recent or repeat infection. IgM anti-CMV if present in the specimen
will bind to the CMV conjugates. The immunocomplex is then captured
by the reagent coated on the T1 band, forming a burgundy colored T1
band, indicating a CMV 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.
Individually packed test devices
Each device contains a strip of CMV with colored conjugates and
reactive reagents pre-spreaded at the corresponding regions.
For adding specimens use.
Phosphate buffered saline and preservative.
For operation instruction.
MATERIALS REQUIRED BUT NOT PROVIDED
Specimen collection container
For specimens collection use.
For timing use.
For preparation of clear specimens
· 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.
STORAGE AND STABILITY
· The kit should be stored at 2-30°C until the expiry date printed
on the sealed pouch.
· The test must remain in the sealed pouch until use.
· Do not freeze.
· Cares should be taken to protect components in this kit from
contamination. Do not use if there is evidence of microbial
contamination or precipitation. Biological contamination of
dispensing equipments, containers or reagents can lead to false
SPECIMEN COLLECTION AND STORAGE
· The One Step CMV IgG/IgM Rapid Test Device (Whole
Blood/Serum/Plasma) is intended only for use with human whole
blood, serum or plasma specimens.
· Only clear, non-hemolyzed specimens are recommended for use with
this test. To collect whole blood, serum or plasma specimens
following regular clinical laboratory procedures.
· 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
· 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.
· Pack the specimens in compliance with applicable regulations for
transportation of etiological agents, in case they need to be
· Icteric, lipemic, hemolysed, heat treated and contaminated sera
may cause erroneous results.
Contact Rebecca Yan