URINE
Testing Time: For best results, test the specimen as soon as possible, ideally within one hour of collection.
Short-Term Storage: If immediate testing is not possible, the specimen can be refrigerated at 2–8°C (36–46°F) for up to 48-72 hours.
Long-Term Storage: For longer storage, specimens can be frozen at or below -20°C (-4°F).
Preparation for Testing: Frozen specimens must be completely thawed and mixed thoroughly before testing. Refrigerated samples must be brought to room temperature (15–30°C) prior to use.
Specimen Clarity: If the specimen has visible precipitates or is turbid, it should be allowed to settle, centrifuged, or filtered to obtain a clear specimen for testing.
qPCR
(RML)
Diluted Urine: Very dilute urine, indicated by a low specific gravity (e.g., from drinking large amounts of fluid), may have hCG levels below the test’s sensitivity threshold, potentially leading to false negative results.
Medications: Certain medications, especially fertility drugs that contain hCG (e.g., Pregnyl, Profasi), can cause false positive results. Other drugs like alcohol, oral contraceptives, painkillers, or antibiotics generally do not affect the test result.
Medical Conditions: Certain non-pregnancy conditions, such as some trophoblastic diseases or certain cancers (testicular, prostate, breast, lung), can produce elevated hCG levels and cause false positives.
Sample Contamination: Blood in the urine or contamination with cleaning solutions/detergents may interfere with the test results.
Improper Timing: Testing too early in the pregnancy (before hCG levels are high enough) can result in a false negative.
Handle as Biohazard: All specimens should be considered potentially infectious and handled according to local biohazard regulations.
Read Instructions: The collector should carefully read and adhere to the specific manufacturer’s instructions for the test kit being used, including the exact waiting time for reading results (typically 3-5 minutes, but no later than 10 minutes).
First Morning Urine Preferred: While any time of day is acceptable, the first morning urine generally contains the highest concentration of hCG and is the optimal specimen for early pregnancy detection.
Single Use Only: The test device is for single use only and must not be reused.
Expiration Date: Do not use the test beyond its expiration date.
Repeat Testing: If the result is weak or inconclusive, or if pregnancy is still suspected despite a negative result, it is recommended to repeat the test with a new first morning urine specimen collected 48 hours later, or consult a physician for further testing (e.g., a quantitative blood test.
