PREGNANCY TEST

Description
The HCG (urine) Midstream Rapid Pregnancy Test 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 based on the colored lines.
The test contains anti-hCG and anti-hCG particles deposited on the membrane.

Instructions for use
The urine sample must be collected in a clean, dry container. A first-morning urine sample is preferred as it generally contains the highest concentration of hCG; however, urine samples collected at any time of day can be used. Urine samples with visible particles must be centrifuged, filtered, or allowed to settle to obtain a clear sample for analysis.
If the urine sample cannot be tested immediately, it should be stored at 2-8°C for up to 48 hours before testing. For prolonged storage, samples can be frozen and stored at temperatures 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 and position the stick so that the absorbent tip is wet with the urine stream, or urinate into a clean, dedicated container and immerse the absorbent tip (= 2/3) in the collected urine for at least 15 seconds.
3. Replace the cap on the stick; place the stick flat on a clean, stable surface and start the timer immediately.
4. Read the first result at 3 minutes; but 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 necessarily have to be identical. This indicates that you are most likely pregnant.
NEGATIVE: One colored line appears in the control window (C). No line appears in the test window (T). This indicates that you are most likely not pregnant.
INVALID: The result is considered 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 this method carefully before performing the test.
- Do not use after the expiration date printed on the pouch.
- Do not freeze.
- Do not use if the pouch is open or damaged.
- Keep out of reach of children.
- For in vitro diagnostic use only. Not for internal use.
- Do not open the aluminum pouch until you are ready to perform the test.
- The used midstream test must be disposed of according to local regulations.
The test may produce unreliable results. Consult a doctor before making any health-related decisions.
1. Medicines containing hCG (such as Pregnyl, Profasi, Pergonal, APL) can produce false positives. Alcohol, oral contraceptives, analgesics, antibiotics, or hormone therapies without hCG content are not expected to affect the test result.
2. Very dilute urine samples (indicating 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 perform the test.
3. Very low levels of hCG (less than 50mIU/ml) are present in urine samples immediately after implantation. However, given the high number of pregnancies ending 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. There are several other conditions, besides pregnancy, that can cause elevated hCG levels (including trophoblastic diseases and some non-trophoblastic neoplasms such as breast carcinoma and lung cancer)2,3. For this reason, the presence of hCG in urine should not be considered functional for the diagnosis of pregnancy if the aforementioned conditions have not been excluded.
5. The test may produce false negatives. False negatives can be observed if hCG levels are below the test's sensitivity threshold. If pregnancy is still suspected, it will be necessary to collect a urine sample first thing in the morning, 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. The actual diagnosis of pregnancy must be made by a doctor, after evaluating all clinical and laboratory test results.

Storage
Store in a dry place at 2-30°C.
Shelf life of intact packaging: 36 months.

Format
Pack containing:
- Midstream test;
- Method.

Code 7541151