Alere TestPack+Plus hCG Urine Manual Del Usuario página 4

EN
INTENDED USE
Alere TM TestPack Plus hCG Urine with On Board Controls (OBC) (Alere
TestPack hCG Urine) is a rapid immunoassay for the qualitative detection of
human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
For professional in vitro diagnostic use only.
INTRODUCTION
Human chorionic gonadotropin (hCG) is a glycoprotein hormone that is
produced by the blastocyst.
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The background concentration of hCG in urine increases with age, but is
normally <5mlU/ml in women of childbearing age . This rapidly increases
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after conception, reaching 50-250mlU/ml by the day of the expected period
and peaks at approximately 100,000 to 200,000mlU/ml during
the first trimester 3,4 . The sudden rapid rise in concentration of hCG in urine
following conception makes it an excellent marker for pregnancy.
TEST PRINCIPLE
Urine is added to the Sample Well of the reaction disc with the aid of a
transfer pipette, and allowed to migrate through the membrane until it
reaches the End of Assay Window. As the urine proceeds through the
membrane, it mobilises the anti-hCG monoclonal antibody-colloid. If hCG
is present in the specimen, it will form a complex with the antibody-colloid.
The antibody-colloid complex migrates through the membrane and is
captured by the immobilised anti-hCG monoclonal antibody in the result
window, providing a visual indication of the presence of hCG.
The result must be read when the End of Assay Window has turned pink/
red. If hCG is present in the urine at levels of 25mlU/ml or greater, a Plus
Sign "+" appears in the Result Window. A Minus Sign "-" indicates no hCG
was detected.
EN
KIT CONTENTS AND STORAGE
• 20 reaction discs
TM
• Pack of 20 transfer pipettes
• One package insert
Store at 2-30°C. Do not use after the expiry date.
Safety data sheet available for professional user on request.
Result Window
Sample Well
PRECAUTIONS
Standard guidelines for handling infectious agents should be observed
throughout all procedures.
1. Do not use reaction discs that have become wet or if the foil pouch has
been opened or damaged.
2. Properly dispose of all contaminated waste such as reaction discs and
transfer pipettes.
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SPECIMEN COLLECTION & STORAGE
A urine specimen collected at any time of the day is suitable, but a first
morning specimen is recommended for early detection of pregnancy, as it
should contain the highest concentration of hCG
Urine specimens must be collected in clean, dry, plastic or glass containers.
Specimens may be stored in the refrigerator (2-8°C) for up to 48 hours, or
frozen once (-20°C) for up to 3 months. Specimens should not be repeatedly
frozen and thawed.
Alere TestPack hCG Urine has not been validated for use with specimens
TM
containing preservatives other than sodium azide (0.1%).
End of Assay
Window
No centrifugation or filtration of specimens is required prior to testing.
However, particulate matter in specimens should be allowed to settle before
removing a sediment-free aliquot for testing.
TEST PROCEDURE
Allow the reaction disc and patient specimen to equilibrate to room
temperature (18-30°C) for a minimum of 30 minutes before beginning the
assay. Do not open foil pouches until ready to perform the assay.
1. Remove the reaction disc from its foil pouch. Label with patient or control
identifications. Place on a clean, flat, dry surface.
2. Draw specimen to the line marked on the transfer pipette. Dispense the
entire contents drop wise into the Sample Well on the reaction disc.
3. Wait for a pink/red colour in the End of Assay Window to appear
(approximately 5 minutes). Read results. Ignore any results after this
time.
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