Product Manual
THIS TEST IS FOR PROFESSIONAL USE IN PHYSICIANS’ OFFICES AND CLINICAL LABORATORIES.
INTENDED USE
OSOM Ultra hCG Combo Test is a simple immunoassay for the qualitative detection of human chorionic
gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.
SUMMARY AND PRINCIPLE
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the placental
trophoblastic cells shortly after the fertilized ovum is implanted in the uterine wall.
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The primary
function of hCG is to maintain the corpus luteum during early pregnancy. The appearance of hCG in
both the urine and serum soon after conception and its rapid rise in concentration make it an
excellent marker for confirmation of pregnancy. The hormone may become detectable in both urine
and serum as early as 7 to 10 days after conception.
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The concentration of hCG continues to rise
rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period and peaking in the
30,000–100,000 mIU range by 10 to 12 weeks into pregnancy. The hormone is comprised of two
non-covalently bound dissimilar subunits containing approximately 30% carbohydrate by weight.
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The alpha subunit is structurally similar to other human pituitary glycoprotein hormones, whereas
the beta (ß) subunit confers unique biological and immunological specificity to the molecule.
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The OSOM Ultra hCG Combo Test is a rapid serum or urine test for detecting hCG. The test is a
solid-phase, two-site immunometric assay in which a combination of monoclonal and
polyclonal antibodies is used to selectively detect elevated levels of hCG in serum or urine with a
high degree of sensitivity. In the test procedure, sample is added to the sample well with the aid of a
transfer pipette and sample is allowed to soak in. If hCG is present in the specimen, it will react
with the conjugate dye, which binds to the antibody on the membrane to generate a colored line.
Presence of two colored lines, one in the Test position (T) and the other in the Control position (C),
indicates a positive result, while the absence of the line in the Test position indicates a negative result.
REAGENTS AND MATERIALS PROVIDED
OSOM Ultra hCG Combo Test kit contains enough reagents and materials to perform all the tests.
• 25 OSOM Ultra hCG devices (Test device containing the polyclonal anti-hCG coated
membrane and a pad with the mouse monoclonal IgG (anti-hCG) -dye conjugate in a protein
matrix containing 0.1%sodium azide)
• Disposable dropper
• Package insert
NOTE: Two extra devices have been included in the kit for external QC testing.
MATERIALS MAYBE REQUIRED BUT NOT PROVIDED
• Timer
• Specimen cup
• Latex gloves
• Positive and Negative Controls (Sekisui Diagnostics recommends the OSOM hCG Urine Control
(Catalog number 134) and the OSOM hCG Serum Control (Catalog Number 138)).
WARNING AND PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use beyond the expiration date.
• The OSOM Ultra hCG Combo Test device should remain in its sealed pouch until ready for use.
• Use appropriate precautions for the collection, handling, and storage of specimens. All human blood
products should be treated as potentially infectious and handled with good laboratory practices.
STORAGE AND STABILITY
OSOM Ultra hCG Combo Test kit should be stored at 2–30°C (36–86°F) in the sealed pouch.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
• For optimal early detection of pregnancy, a first morning urine specimen is preferred since it generally
contains the highest concentration of hCG. However, randomly collected urine specimens may be
used.
• Collect the urine specimen in a clean glass or plastic cup.
• Urine containing excessive bacterial contamination should not be used since spurious results may
occur with such specimens.
Serum Assay
• Remove the serum from the clot as soon as possible to avoid hemolysis. When possible, clear,
non-hemolyzed specimens should be used. Specimens containing particulate matter may give
CLIA Complexity: Waived for Urine
Non-Waived for Serum
®
Ultra hCG Combo Test