Technician - pregnancy test

Product Description

The Midstream HCG Rapid Pregnancy Test (Urine) is a one-step lateral flow immunochromatographic test for the qualitative determination of human chorionic gonadotropin (hCG).

Indications

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 hCG monoclonal antibody, for the selective detection of elevated levels of hCG. The test is performed by applying urine to the hydrophilic dipstick and verifying the result based on the colored lines.

The test contains anti-hcg and anti-hcg particles deposited on the membrane.

Directions for Use and Dosage

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 the day can be used. Urine samples with visible particles should be centrifuged, filtered, or allowed to settle to obtain a clear sample for analysis.

If the urine sample cannot be collected, the test should be discarded. To be detected immediately, it must be stored at 2-8°C for up to 48 hours before testing. For extended storage, samples can be frozen and stored below -20°C. Frozen samples must be thawed and mixed before testing.

• Remove the test from the pouch and perform the test within one hour.
• Remove the cap from the test stick; hold and position the test stick so that the absorbent tip is wet with your urine stream, or urinate into a clean urine container and immerse the absorbent tip (= 2/3) in the collected urine for at least 15 seconds.
• Replace the cap on the test stick; place the test stick flat on a clean, stable surface and start the timer immediately.
• Read the first result in 3 minutes; but do not interpret the results after 10 minutes

Positive: Two distinct lines appear. One line in the test control window (C) and another in the test window (T). One line may be lighter than the other; they do not have to be the same. This indicates that you are most likely pregnant.

Negative: A 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.

Interactions

Medications containing hCG (such as Pregnyl, Profasi, Pergonal, Apl) may produce false positives. Test results are not expected to be affected by alcohol, oral contraceptives, analgesics, antibiotics, or hormone therapies without hCG.

Warnings

Read the information in this package insert 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 still open. opened or damaged.
• Keep out of 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 according to local regulations.

The test may produce unreliable results. Consult a doctor before making any health-related decisions.

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.

Very low levels of hcg (less than 50 miu/ml) are present in urine samples immediately after implantation. However, given the high number of pregnancies ending within the first trimester for natural reasons, weak positive results should be confirmed by repeating the test after 48 hours, with a first morning urine sample.

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 cancer 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.

The test may produce false negatives. False negatives may be observed if hcg levels are below the sensitivity threshold of the test. If you continue to suspect pregnancy, it will be necessary to collect a urine sample first thing in the morning, after 48 hours, and perform the test. If you suspect pregnancy, but the test continues to give negative results, please consult a doctor to confirm the diagnosis.

The test provides a presumptive diagnosis of pregnancy only. The actual diagnosis of pregnancy must be made by a doctor after evaluating all the results of clinical and laboratory tests.

Storage

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

Format

Package containing: Midstream test, method sheet.