ico
Tecnico
Test
PREGNANCY TEST
Description
The Midstream HCG rapid pregnancy test (urine) is a rapid, one-step, lateral flow immunochromatographic test in midstream format for the qualitative determination of human chorionic gonadotropin (hCG), to selectively detect elevated levels of hCG. The test uses a combination of antibodies including a monoclonal hCG antibody for the selective detection of elevated hCG levels. The test is performed by applying urine to the hydrophilic stick and checking the result obtained from the coloured lines.
The test contains anti-hCG particles and anti-hCG deposited on the membrane.
Directions for use
The urine sample must be collected in a clean, dry container. A first-morning urine sample is preferable as it generally contains the highest concentration of hCG; however, urine samples collected at any time of day may be used. Urine samples with visible particles should be centrifuged, filtered or allowed to settle to obtain a clear sample for testing.
If the urine sample cannot be tested immediately, it should be stored at 2-8°C for up to 48 hours before testing. For longer storage, samples may be frozen and stored below -20°C. Frozen samples must be thawed and mixed before testing.
1. Remove the test from the pouch and perform the test within one hour.
2. Remove the cap from the stick; hold the stick so that the absorbent tip is wetted by the urine stream, or urinate into a clean container and immerse the absorbent tip (= 2/3) in the collected urine for at least 15 seconds.
3. Replace the cap on the stick; lay the stick flat on a clean, stable surface and start the timer immediately.
4. Read the first result at 3 minutes; do not interpret results after 10 minutes have passed
POSITIVE: Two distinct lines appear. One line in the control window (C) and another in the test window (T).
One line may be lighter than the other; they do not need to be identical. This indicates that you are most probably pregnant.
NEGATIVE: One coloured line appears in the control window (C). No line appears in the test window (T). This indicates that you are most probably not pregnant.
INVALID: The result is invalid if no line appears in the control window (C), even if a line appears in the test window (T). The test must be repeated with another midstream test.
Warnings
Read the information in these instructions carefully before performing the test.
- Do not use after the expiry date printed on the pouch.
- Do not freeze.
- Do not use if the pouch is open or damaged.
- Keep out of the reach of children.
- For in vitro diagnostic use only. Not for internal use.
- Do not open the foil pouch until you are ready to perform the test.
- The used midstream test must be disposed of in accordance with local regulations.
The test may produce unreliable results. Consult a doctor before making any health-related decision.
1. Medicines containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce false positives. Alcohol, oral contraceptives, painkillers, antibiotics or hormone therapies not containing hCG are not expected to affect the test result.
2. Very dilute urine samples (indicated by low specific gravity) may not contain sufficient levels of hCG. If pregnancy is still suspected, collect a first-morning urine sample after 48 hours and repeat the test.
3. Very low levels of hCG (less than 50mIU/ml) are present in urine samples shortly after implantation. However, given the high number of pregnancies that end within the first trimester for natural reasons, weakly positive results should be confirmed by repeating the test after 48 hours with a first-morning urine sample.
4. The test may produce false positives. Several conditions other than pregnancy can cause elevated hCG levels (including trophoblastic disease and certain non-trophoblastic neoplasms such as breast cancer and lung cancer)2,3. For this reason, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.
5. The test may produce false negatives. False negatives may occur when hCG levels are below the sensitivity threshold of the test. If pregnancy is still suspected, collect a first-morning urine sample after 48 hours and perform the test. If pregnancy is suspected but the test continues to give negative results, please consult a doctor to confirm the diagnosis.
6. The test provides only a presumptive diagnosis of pregnancy. A definitive diagnosis of pregnancy must be made by a doctor after evaluating all clinical and laboratory findings.
Storage
Store in a dry place at 2-30°C.
Shelf life in unopened packaging: 36 months.
Pack size
Pack containing:
- Midstream test;
- instructions.
Code 7541151
