Product Manual

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EN
OSOM
®
Mono Test
Catalog number 145
CLIA Complexity: Non-Waived for Serum and Plasma
C
LIA Complexity: Waived for Whole Blood
FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
INTENDED USE
The OSOM
®
Mono Test is intended for the qualitative detection of infectious
mononucleosis heterophile antibodies in serum, plasma or whole blood as an
aid in the diagnosis of infectious mononucleosis.
S
UMMARY AND EXPLANATION OF TEST
T
he diagnosis of infectious mononucleosis (IM) is suggested on the basis of the
c
linical symptoms of fever, sore throat and swollen lymph glands. The highest
incidence of symptomatic IM occurs during late adolescence (15-24 years of age).
Infectious mononucleosis is caused by the Epstein-Barr Virus (EBV)
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,2
. The laboratory
diagnosis of IM is based on the detection of IM heterophile antibodies. These
heterophile antibodies are directed against antigens found in bovine, sheep
and horse erythrocytes.The OSOM Mono Test utilizes an extract of bovine
erythrocytes to give the required sensitivity and specificity.
PRINCIPLES OF TEST
The OSOM Mono Test uses color immunochromatographic dipstick technology with
bovine erythrocyte extract coated on the membrane. In the test procedure, serum,
plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the
mixture and the mixture migrates along the membrane. If the specific IM heterophile
antibody is present in the sample, it will form a complex with the bovine erythrocyte
extract conjugated color particles. The complex will then be bound by bovine
erythrocyte extract immobilized on the membrane and a visible blue Test Line will
appear to indicate a positive result.
KIT CONTENTS AND STORAGE
25 Test Sticks in a container
25 Test Tubes
25 Transfer Pipettes
25 Capillary Tubes with 1 Capillary Bulb
1 Diluent (contains buffer with 0.2% sodium azide)
1 Mono Positive Control (contains rabbit anti-beef stroma in tris buffer with 0.2% sodium
azide and 0.05% gentamycin sulfate preservatives)
1 Mono Negative Control (contains goat albumin in tris buffer with 0.2% sodium azide)
1 Work Station
1 Directional Insert
2 Additional test sticks have been included in the kit for external QC testing
Note: Extra components (tubes, pipettes, capillary tubes, capillary bulb) have been
provided for your convenience.
Store the Test Sticks and reagents tightly capped at 15°-30°C (59°-86°F).
Do not use the Test Sticks or reagents after their expiration dates.
MATERIALS REQUIRED BUT NOT PROVIDED
Specimen collection containers.
A timer or watch.
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