PRINCIPLE
The test is based on chromatographic immunoassay technology. The membrane is pre-coated with anti-alpha HCG capture antibodies in the test line region (T) and goat anti-mouse antibodies in the control line region (C).
When the urine specimen is applied, it reacts with a pre-dried conjugate (mouse anti-beta HCG monoclonal antibodies linked to colloidal gold). The mixture migrates upward by capillary action.
Positive result: a pink line appears in both T and C regions.
Negative result: a pink line appears only in the C region.
Invalid result: no line appears in the C region.
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KIT COMPONENTS
Individually sealed test strips.
Instruction leaflet.
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STORAGE AND STABILITY
Store at 2–30°C in the sealed pouch. Do not freeze. The test device is stable until the expiration date printed on the pouch.
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SPECIMEN COLLECTION
Collect urine in a clean, dry container. First morning urine is preferred, as it usually contains the highest concentration of HCG.
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TEST PROCEDURE
- Bring the test strip and urine specimen to room temperature (15–30°C).
- Remove the test strip from the sealed pouch.
- Dip the strip’s end into the urine for 5 seconds.
- Lay the strip flat on a clean, non-absorbent surface.
- Wait for pink-colored lines to appear. Read results within 5–8 minutes. Do not read after 10 minutes.
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INTERPRETATION OF RESULTS
Positive: Two pink lines appear (one in T, one in C).
Negative: One pink line appears in C only.
Invalid: No pink line in C.
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QUALITY CONTROL
A pink line in the control region (C) confirms that sufficient specimen volume has been added, proper flow has occurred, and reagents are functional.
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EXPECTED VALUES
Negative results are expected in healthy men and non-pregnant women. Pregnant women will have varying levels of HCG depending on gestational age. The test has an analytical sensitivity of 10 mIU/mL and can detect pregnancy as early as 1 day after the first missed period.
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LIMITATIONS
- Very early pregnancy or diluted urine may give false-negative results.
- Fertility drugs containing HCG may cause false-positive results.
- HCG may remain detectable for several days to weeks postpartum, after miscarriage, or after HCG injections.
- Certain medical conditions (e.g., ectopic pregnancy, trophoblastic disease, ovarian cysts, menopause, or certain tumors) may cause misleading results.
- Confirm all results clinically before diagnosis.
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PERFORMANCE CHARACTERISTICS
Analytical Sensitivity: ≥ 10 mIU/mL.
Diagnostic Sensitivity: 100% (450/450).
Diagnostic Specificity: 100% (450/450).
No cross-reactivity with hLH (500 mIU/mL), hFSH (1000 mIU/mL), or hTSH (1000 μIU/mL).
No interference observed with common substances such as acetaminophen, acetylsalicylic acid, ascorbic acid, caffeine, glucose, hemoglobin, or tetracycline at tested concentrations.
