Item Brochure

INTENDED USE
The OSOM
®
hCG Combo Test is a rapid immunoassay for the qualitative detection of human chorionic
gonadotropin (hCG) in urine or serum as an aid in the early determination of pregnancy. This test is for
professional use in physicians’ offices and clinical laboratories.
SUMMARY AND EXPLANATION
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing
placenta.
(1)
After fertilization, the concentration of hCG rapidly rises in both the urine and serum
of pregnant women. The detection of hCG in these fluids is an excellent marker for confirming
pregnancy. The OSOM hCG Combo Test is a rapid test which can detect the presence of hCG
in urine or serum. The test utilizes monoclonal and polyclonal antibodies to hCG.
PRINCIPLE OF THE TEST
OSOM hCG Combo Test is a solid phase, sandwich-format immunochromatographic assay for the qualitative
detection of hCG. Urine or serum is added to the sample well of the Test Device using the pipette provided.
The sample migrates through reaction pads where hCG, if present in the sample, binds to a monoclonal
anti-hCG dye conjugate. The sample then migrates across a membrane toward the results window,
where the labeled hCG complex is captured at a test line region containing immobilized rabbit anti-hCG.
Excess conjugate will flow past the test line region and be captured at a control line region containing an
immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it).
The appearance of 2 black bands in the results window — one at “T: Test” and the other at “C: Control” —
indicates the presence of hCG in the sample. If a detectable level of hCG is not present, only the control
band will appear in the result window.
REAGENTS AND MATERIALS PROVIDED
25 OSOM hCG Combo Tests Devices individually pouched, each containing a disposable pipette.
• Membrane coated with rabbit polyclonal anti-alpha hCG
• Conjugate pad containing mouse monoclonal anti-beta hCG
Directional Insert
MATERIALS REQUIRED BUT NOT PROVIDED
• Clock or timer
• Sample collection cups or tubes
• Positive and Negative Controls (Sekisui Diagnostics recommends the OSOM hCG Urine Control
(Catalog number 134) and the OSOM hCG Serum Control (Catalog Number 138)).
WARNINGS AND PRECAUTIONS
• For in vitro diagnostic use. Federal law restricts this device to sale by or on the order of a physician.
• Do not use beyond the expiration date printed on the kit or foil pouch.
• The lot numbers may be different on the foil pouch and the kit.
• 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
using appropriate precautions recommended in the Centers for Disease Control / National Institutes
of Health Manual, “Biosafety in Microbiological and Biomedical Laboratories,” 1993.
• Dispose of all used Test Devices, pipettes and specimens in suitable biohazardous waste containers.
• Test Devices are stable in the unopened foil pouches until the expiration date. Do not remove the
Test Device from the pouch until needed.
STORAGE
Store OSOM hCG Combo Tests at room temperature, 15° – 30°C (59° – 86 °F), out of direct sunlight.
Test Devices are stable until the expiration date printed on the kit or foil pouch. DO NOT FREEZE.
If the control band does not appear when running the test, the Test Cassette or kit may have been
stored or handled improperly or the foil pouch may not have been intact.
SPECIMEN COLLECTION AND PREPARATION
No filtration or centrifugation of urine or serum specimens is required for testing with the OSOM hCG
Combo Test.
Urine
Urine specimens may be collected in any clean, dry, plastic or glass container. For early determination
of pregnancy, the first morning specimen of urine is recommended since it usually contains the highest
concentration of hCG. Urine specimens may be stored at room temperature 15° – 30°C (59° – 86°F) for
up to 8 hours, or refrigerated at 2° – 8°C (35° – 46°F) for up to 72 hours.
®
CLIA Complexity: Waived for Urine
Non-Waived for Serum
hCG Combo Test