Screen TestPregnancy 2

Description
The rapid hCG pregnancy test is a quick lateral flow immunoassay test, in midstream format, for the 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 identify elevated hCG levels.
The test is performed by pouring urine onto the absorbent tip and obtaining the result based on the colored lines.

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

Usage instructions
1. Remove the test from the sealed pouch and perform immediately within one hour.
2. Remove the cap from 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 more than 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 do not have to match. This indicates probable pregnancy.
NEGATIVE: one line appears in the control zone (C). No line appears in the test zone (T). This indicates probable no pregnancy.
INVALID: the result is invalid if no lines appear 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 decisions.
1. Medications containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may produce a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics, or hormone therapies that do not contain hCG should not affect the test.
2. Highly diluted urine samples, indicated by a low specific gravity, may not contain detectable levels of hCG. If pregnancy is still suspected, a new urine sample collected first thing in the morning after 48 hours should be collected and tested.
3. Immediately after fertilization, urine samples contain very low hCG levels (less than 50 mIU/ml). However, since many pregnancies end naturally in the first trimester, a borderline positive result should be confirmed by testing a new first morning urine sample after 48 hours.
4. This test can give false positive results. Several conditions other than pregnancy, including gestational trophoblastic disease and some non-trophoblastic tumors such as testicular cancer, prostate cancer, breast, and lung cancers, can cause elevated hCG levels2,3. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions are ruled out.
5. This test can also produce false negative results. False negatives can occur when hCG levels are below the test's sensitivity level. If pregnancy is still suspected, a new first morning urine sample should be collected after 48 hours and tested. If pregnancy is suspected but the test continues to be negative, consult a healthcare provider for further diagnostics.
6. This test provides a presumptive diagnosis of pregnancy. A definitive diagnosis should be made solely by a healthcare professional after evaluating all clinical and laboratory data.

Format
Pack containing 2 pieces.

REFERENCES
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