URINE
Optimal Sample: While any time of day is acceptable, the first morning urine specimen is preferred because it generally contains the highest concentration of hCG.
Storage:
Test the specimen immediately after collection for best results.
If immediate testing is not possible, the specimen may be stored refrigerated at 2-8°C (36-46°F) for up to 48 hours.
For prolonged storage, freeze the specimens below -20°C (-4°F).
Before Testing:
Frozen specimens must be completely thawed and mixed well before testing.
Bring refrigerated or frozen specimens to room temperature (15-30°C or 59-86°F) before performing the test.
If the sample is turbid (cloudy) or has precipitates, it should be allowed to settle, and only the clear supernatant should be used, or it can be centrifuged or filtered.
qPCR
(RML)
Cross-Reactivity: The test is designed to specifically detect hCG and generally does not show cross-reactivity with other hormones like LH, FSH, and TSH at normal physiological levels.
Medications/Conditions: Certain conditions, including some non-trophoblastic neoplasms (e.g., testicular, prostate, breast, or lung cancer), can cause elevated hCG levels. A medical professional should evaluate all clinical and laboratory findings for a confirmed diagnosis.
Procedural Errors: Incorrect procedural techniques or insufficient specimen volume are the most likely reasons for an invalid result (e.g., no control line appears).
Expired Tests: Using an expired test can lead to false negatives due to degraded antibodies
Single Use: The test cassette is for single use only. Do not reuse.
Handling the Cassette: Do not open the foil pouch until you are ready to perform the test. Place the cassette on a clean, level surface for testing.
Adding Sample: Use the provided dropper and add the exact number of drops (usually 3 drops, about 120µL) to the specimen well (S), avoiding air bubbles.
Reading Results: Read results within the specified timeframe (commonly 3-10 minutes, depending on the manufacturer’s instructions), but not after the maximum read time (e.g., after 10 minutes), as a weak line might appear which is not definitive for a positive result.
Disposal: The used test cassette and urine container should be discarded according to local regulations for biohazardous waste.
