* 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
Expiry Check: Verify the pouch expiry date before opening the pouch; do not use expired kits.
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
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
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
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
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
STOP / STRICT CUTOFFMaximum 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
Two distinct red/pink bands (C and T lines visible)
FAINT POSITIVE
Any visible T line, even faint, indicates hCG ≥ 25 mIU/mL
NEGATIVE
Control line C only; T zone completely clear white
INVALID
No C line. Test VOID. Discard and repeat with new cassette.
Clinical Cautions & Quality Control (SOP 5.7 & 5.8)
Internal Control (C): A distinct colored C line must appear on every cassette. Never report an invalid test as negative.
External QC: Run kit positive/negative controls with each new lot/shipment or at the SOP-defined frequency; log lot number and expiry (ISO 15189:2022 §7.3.7).
Very Early Gestation: In early pregnancy, hCG may be < 25 mIU/mL. If clinically suspected, repeat with first-morning urine in 48–72 hours or test serum per SOP-S-005.
Dilute Urine: Low specific gravity (< 1.005) may yield false negatives; request a concentrated first-morning collection.
Hook Effect (Molar Pregnancy): Extreme hCG (> 500,000 mIU/mL) causes false negative. If gestational trophoblastic disease suspected, dilute urine 1:10 and 1:100 in saline.
Prepared by: Chief Medical Technologist Signature / Date: ____________________