TCH Logo Tarangnan Community Hospital Clinical Laboratory • Clinical Microscopy & Serology Document No.: WI-CM-004-A-V0 CONTROLLED COPY
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Parent document: SOP-CM-004, Sections 5.3–5.5 (and SOP-S-005)  |  Version: V0
Applies to: Medical Technologists and Laboratory Aides  |  Effective date: MM-DD-YYYY  |  Supersedes: None

Abbott Bioline hCG Urine & Serum Pregnancy Test Rapid Bench Card

Cat. No. 30FK10 • Analytical Sensitivity: 25 mIU/mL • Specimen: Urine (preferred) or Serum*

* Confirm serum use against the Cat. 30FK10 insert in the laboratory.

BIOSAFETY: Wear gloves; discard used cassettes and droppers into biohazard/sharps waste; decontaminate spills per waste SOP.
  1. 1
    Expiry Check: Verify the pouch expiry date before opening the pouch; do not use expired kits.
  2. 2
    Equilibration: Allow sealed foil pouch and urine or serum specimen to reach room temperature (15–30 °C) for 15–30 minutes before opening. First-morning urine is preferred for peak β-hCG concentration. SOP 5.4
    15–30 min
  3. 3
    Pouch Check & Labeling: Tear open foil pouch; inspect desiccant (discard). Place cassette flat on a clean, horizontal surface. Label plastic frame with 2 unique patient identifiers. Do not touch membrane. SOP 5.5.2–3
  4. 4
    Specimen Inoculation: Draw clear urine or serum into the supplied disposable dropper. Hold dropper strictly vertical (90°) and dispense exactly 3 drops (approximately 100 µL) into round sample well (S). Avoid bubbles. SOP 5.5.4
    3 drops (100 µL)
  5. 5
    Timer Activation: Start digital stopwatch immediately after dispensing the 3rd drop. Keep cassette flat and undisturbed. Observe purple chromatographic dye front migrating across the reading window. SOP 5.5.5–6
  6. 6
    Analytical Result Reading: Read and interpret visual band patterns at exactly 3 minutes under bright, direct white illumination. SOP 5.5.7
    3 min
  7. 7
    STOP / STRICT CUTOFF Maximum Reading Window: DO NOT read or interpret results after 10 minutes. As the nitrocellulose membrane dries, non-specific protein binding and evaporation lines cause false-positive artifacts. SOP 5.5.8
    STOP > 10 min
POSITIVE
S T C
Two distinct red/pink bands (C and T lines visible)
FAINT POSITIVE
S T C
Any visible T line, even faint, indicates hCG ≥ 25 mIU/mL
NEGATIVE
S T C
Control line C only; T zone completely clear white
INVALID
S T NO C
No C line. Test VOID. Discard and repeat with new cassette.

Clinical Cautions & Quality Control (SOP 5.7 & 5.8)

Prepared by: Chief Medical Technologist
Signature / Date: ____________________
Reviewed by: Pathologist
Signature / Date: ____________________
Approved by: Hospital Director
Signature / Date: ____________________