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3/19/12
ETIOLOGY
The name rubella is derived
first described as a separate disease in the German medical literature, hence the common name German measles.
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confirmed the viral etiology by passing the disease to children using filtered nasal washings from persons with acute cases.
The first rubella vaccines were
licensed in 1969.
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RUBELLA VIRUS
Rubella virus is classified as a
with a single antigenic type that does not cross-react with other members of the togavirus group.
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Rubella virus is
relatively unstable and is inactivated by lipid solvents, trypsin, formalin, ultraviolet light, low pH, heat, and
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EPIDEMIOLOGY
Rubella infections occurred
cases of congenital rubella syndrome and an unknown number of stillbirths occurred in the United 3/19/12
In countries where
vaccination is uncommon, the incidence of rubella infection is high and epidemic are frequent
Individuals who have not
children
All females at or just before
person and may not be recognized in some cases especially if the characteristic rash is light or absent, as may occur in substantial number of cases
Rubella infection also resemble
ACQUIRED INFECTION
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Incubation Period
Varies from 10-21 days, and
12 to 14 days is typical
Infected person usually
contagious for 12-15 days, beginning 5 to 7 days before the appearance of rash
Last from 3 to 5 days and
CLINICAL PRESENTATION
Usually mild Begins with prodromal period of
catarrhal symptoms
Followed by involvement of
maculopapular rash on the face and then on the neck and trunk
Temperature less than 34.4 C is
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CONGENITAL INFECTION
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those infected in the first trimester have devastating effects on the fetus
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rubella infection may not be recognized for months or even years after birth
Rubella immunity develops in
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IMMUNOLOGICAL MANIFESTATION
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ACQUIRED INFECTION
appearance of both
immunoglobulin G (IgG) and immunoglobulin M ( IgM) antibodies is associated with the appearance of clinical signs and symptoms
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IgM
IgM antibodies become detectable
a few days after the onset signs and symptoms and reach peak levels at 7 to 10 days
these antibodies persist but
rapidly diminish in concentration over the next 4 to 5 weeks until antibody is no longer clinically detectable 3/19/12
IgG
production of IgG also associated
useful indicator of rubella infection only when acute and convalescent blood are drawn 3/19/12 several weeks apart
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passive latex agglutination test for the qualitative detection of rubella IgG and IgM antibodies in human serum or as an aid in the determination of immune status.
The RUBAscanCard Test can
also be used to give semiquantitative results when serial dilutions of properly paired 3/19/12 specimens are tested to
PRINCIPLE
Latex is sensitized according to
a patented process using solubilized rubella virus antigens from disrupted virions.
This latex reagent, when mixed
with serum containing rubella antibodies on a card surface, will agglutinate forming visible clumps. 3/19/12
PRINCIPLE
In the absence of antibody, or if
the concentration is insufficient to react, the latex will remain smooth and evenly dispersed.
In a qualitative sense, the
presence of rubella antibodies is an indication of previous infection and presumptive of immunity. 3/19/12
PRINCIPLE
An interpretation of the test
results can be used to evaluate the immune status of the individual with regard to resistance or susceptibility to primary rubella infection.
The test is configured to give
within three days of the onset of rash or at the time of exposure and tested upon arrival at the laboratory.
This specimen should then be
stored frozen until the second specimen is collected 7-21 days after the onset of rash or at least 30 days after exposure if no clinical symptoms occur.3/19/12 Both
serum is separated. Specimens may be stored up to 48 hours at 2 - 8C. Specimens should be frozen if longer storage is required.
Do not heat inactivate serum.
Serum that displays excessive particulate matter, lipemia, or hemolysis could affect the test. patient is required prior to
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QUALITY CONTROL
Reagent B, RUBAscan Card Dilution
Buffer, Phosphate buffered saline solution, containing bovine serum albumin, with 0.02% sodium azide (preservative).
Control (human serum), with 0.1% sodium azide (preservative). Control (human serum), with 0.1% sodium azide (preservative).3/19/12
PROCEDURE
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UNDILUTED SPECIMENS
1.Mark the card to identify Control +, Control -, or all samples being tested. 2. With a micropipettor, place 25 L of Control +, Control -, or patient sample onto the appropriate circle. 3. Using a new plastic stirrer for 3/19/12 each circle, spread the serum to
4.
Gently invert the dispensing bottle several times to thoroughly mix Reagent A. 5. Before uncapping the bottle, gently tap base on counter top to assure no latex reagent remains in the tip. Dispense one freefalling drop of Reagent A (approx. 15L) onto each circle containing the serum. 6. Place the card on a rotator and
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ALTERNATE PROCEDURE
This procedure will approximate a 10 IU/mL sensitivity level. 1. Mark the card to identify Control +, Control -, or all samples being tested. 2. With a micropipettor, add 100 L of Reagent B to the appropriate squares for each control and sample being tested. 3. With a micropipettor, add 25 L of
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4.
Using the same micropipettor with a new tip, place 25 L of Control + directly into the buffer in the appropriate square and mix the serum and buffer by drawing up-and-down with the micropipettor 12 times. Avoid the formation of bubbles. The serum in this square is now a 1:5 dilution. 5. Using the same micropipettor 3/19/12
6.
Repeat the procedures in step 3 (with a new tip each time) for the Control - or for each patient sample being tested. 7. Using a new plastic stirrer for each circle, spread the serum to fill the entire circle. 8. Gently invert the dispensing bottle several times to thoroughly mix Reagent3/19/12 A.
base on counter top to assure no latex reagent remains in the tip. Dispense one free-falling drop of Reagent A (approx. 15L) onto each circle containing the serum.
10. Place the card on a rotator and rotate for 8 min under a moistened humidifying cover. 11. Immediately following mechanical rotation, read the card macroscopically in the wet state under a high intensity incandescent lamp. Gently tilt the card 3/19/12 (three or four back-and-forth motions) to
INTERPRETATION of RESULT
The Control + should show
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