Screen TestPregnancy 1

Description
The hCG rapid pregnancy test is a quick lateral flow immunoassay, in midstream format for qualitative detection of human chorionic gonadotropin (hCG) in urine to assist in diagnosing pregnancy.
The test uses a combination of antibodies including monoclonal hCG to selectively detect elevated hCG levels.
The test is performed by pouring urine onto the hydrophilic stick and obtaining the result based on the colored lines.

Precautions
Please read all information before performing the test.
1. Do not use after the expiration date printed on the sealed packaging.
2. Store in a dry place at 2-30°C or 35.6-86°F. Do not freeze.
3. Do not use if the package is open or damaged.
4. Keep out of reach of children.
5. For in vitro diagnostic use only. Not for internal consumption.
6. Do not open the sealed test packaging until ready to perform.
7. The used test should be disposed of according to local regulations.

Instructions for Use
1. Remove the test from the sealed package and perform immediately within one hour.
2. Remove the cap of the test, then urinate directly on it or immerse it in a collected urine sample in a clean container for at least 15 seconds.
3. Replace the cap on the test, then place everything on a flat, clean surface, and start the timer immediately.
4. Wait 3 minutes to read the result; do not wait beyond 10 minutes.

Result Interpretation
POSITIVE: two distinct colored lines appear. One should be in the control zone (C) and the other in the test zone (T). One line may be lighter than the other; they should not match. This means probable pregnancy.
NEGATIVE: one line appears in the control zone (C). No line appears in the test zone (T). This indicates likely non-pregnancy.
INVALID: the result is invalid if no line appears in the control zone (C), even if a faint line appears in the test zone (T). The test should be repeated with a new device.

Limitations
There is a possibility that this midstream test may produce false results. Consult your healthcare provider before making any medical decision.
1. Drugs containing hCG (such as Pregnyl, Profasi, Pergonal, APL) can cause false-positive results. Alcohol, oral contraceptives, painkillers, antibiotics, or hormonal therapies not containing hCG should not affect the test.
2. Highly diluted urine samples, indicated by low specific gravity, may not contain detectable hCG levels. If pregnancy is still suspected, a new early morning urine sample should be collected 48 hours later and tested.
3. Urine samples immediately after fertilization contain very low levels of hCG (less than 50 mU/ml). However, since many pregnancies end naturally in the first trimester, a weakly positive test result should be confirmed by testing a new early morning urine sample collected 48 hours later.
4. This test can produce false-positive results. Conditions other than pregnancy, including gestational trophoblastic disease and some non-trophoblastic neoplasms such as testicular tumors, prostate cancer, and breast and lung cancers, can elevate hCG levels. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions are ruled out.
5. False-negative results may occur when hCG levels are below the test's sensitivity level. If pregnancy is still suspected, collect a new early morning urine sample 48 hours later and test. If pregnancy is suspected but the test remains negative, consult a doctor for further diagnosis.
6. This test provides a presumptive diagnosis of pregnancy. Confirmatory diagnosis should be made solely by a healthcare professional after evaluating all clinical and laboratory findings.

Format
Box containing 1 piece.

Bibliography
1. Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion and removed ectopic pregnancy, Obstet. Gynecol. 1984; 64(3): 391-394
2. Dawood MY, BB Saxena, R Landesman Human chorionic gonadotropin and its subunits in hydatidiform mole and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181
3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopic production of human chorionic gonadotropin by neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45