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GS Mamatest is a rapid pregnancy test that you can perform yourself. Based on a qualitative chromatographic immunoassay, it detects the presence of human chorionic gonadotropin (hCG), which appears in urine in the very early stages of pregnancy. You can use your urine from the first day of your missed period. The test can be performed at any time of the day. However, the first morning urine is the most suitable as it contains the highest concentration of the pregnancy hormone if you are pregnant.
Chorionic Gonadotropin (hCG)
hCG is a glycoprotein hormone produced by the developing placenta shortly after fertilisation. In a normal pregnancy, hCG can be detected in urine, blood serum or plasma as early as 7 to 10 days after conception.1, 2, 3, 4 The hCG level rises very rapidly. It often exceeds 100 mIU/ml on the first day of the expected period2, 3, 4 and peaks in the range of 100,000–200,000 mIU/ml between the 10th and 12th week of pregnancy. Because hCG appears in both urine and blood serum or plasma shortly after conception and its concentration rises rapidly during the early growth of embryonic tissues, its presence is an excellent indicator for the early detection of pregnancy.
Benefits of the GS Mamatest Pregnancy Test
Guaranteed accuracy – over 99% precision, tested in a consumer clinical study on 413 urine samples
High sensitivity – 10 mIU/ml
Fast – the result can be read after 3 minutes
2 tests in one pack for double the certainty
How does GS Mamatest work?
GS Mamatest is a one-step test that works on the principle of a lateral flow immunoassay format for the qualitative detection of hCG in urine, thereby helping to detect pregnancy. It uses a combination of monoclonal and polyclonal antibodies to selectively capture elevated levels of hCG. The test is performed on a urine sample. The result is displayed as distinct coloured lines.
Urine Sample Collection and Preparation: Collect a urine sample in a clean, dry container. The first morning urine is the most suitable as it generally contains the highest concentration of hCG. However, urine collected at any time of the day can also be used. If the urine sample is cloudy (contains sediment), wait for the sediment to settle and the sample to clear. Alternatively, the cloudiness can be removed by centrifugation and filtration before testing. Urine samples can be collected in any clean, dry plastic or glass container.
Sample Storage: If the urine sample is not used for testing immediately after collection, it can be stored for up to 48 hours at a temperature of 2–8°C. For long-term storage, samples can be frozen at −20°C. Allow frozen samples to thaw and then mix them before use.
What else you need: A clean, dry container to collect the urine, and a timer (clock or watch) - these items are not included in the test kit.
Performing the Test
Urinate into a clean, dry container.
Keep the test at room temperature before opening the pouch. Remove the test strip from the pouch and use it within one hour of opening.
Immerse the strip in the direction of the arrow into the urine sample. Important: do not immerse the strip beyond the marked maximum immersion line, otherwise the test will not perform correctly!
Start timing. After 15 seconds, you can remove the strip from the sample or you can leave it in the sample.
You can read the test after three minutes. Do not read the result after 10 minutes have passed.
Reading the Results
Positive result (you are pregnant): Two distinct coloured lines have appeared, one in the control (C) region and one in the test (T) region. The intensity of the lines' colour may vary. One line may be lighter than the other. This means you are probably pregnant.
Negative result (you are not pregnant): Only one coloured line has appeared, in the control region (C). No coloured line is visible in the test region (T). This means that pregnancy has not been confirmed by the test.
Invalid result: If the test was not performed correctly, no coloured line appeared, or a line appeared only in the test region but not in the control region. Repeat the test with a new kit. If the test result is repeatedly invalid, please contact the manufacturer or seller. Do not forget to state the batch number.
Limitations
GS Mamatest is a preliminary qualitative test. This means that it is not possible to quantitatively determine the concentration of hCG or to detect the rate of its increase.
Very dilute samples, characterised by a low specific gravity, may not contain a representative amount of hCG to show a positive result. If you still suspect you are pregnant, repeat the test with your first morning urine at least 48 hours after the last test.
Very low levels of hCG (less than 50 mIU/ml) can be detected shortly after the embryo has implanted in the uterus. However, as a significant number of pregnancies naturally end during the first trimester,5 a result that appears weakly positive should be confirmed with a new test, performed with first morning urine at least 48 hours after the last test.
The test may, under certain circumstances, show a false positive result. In addition to pregnancy, a number of diseases also cause elevated levels of hCG, such as trophoblastic disease and some non-trophoblastic neoplasms including testicular, prostate, breast, and lung tumours.6, 7 Therefore, the presence of hCG should not be used alone to diagnose pregnancy without also ruling out the aforementioned conditions.
The test may, under certain circumstances, show a false negative result. This can happen if the hCG level is too low, i.e., below the stated sensitivity limit. If you still suspect you are pregnant, repeat the test with your first morning urine at least 48 hours after the last test. If you still get a negative result, visit a doctor who will perform a more detailed examination. 6 This test provides a preliminary diagnosis of pregnancy. Your pregnancy can only be definitively confirmed by a doctor based on further examinations.
Warning
Do not use after the expiry date found on the packaging. Do not use if the protective pouch is torn or damaged. For in vitro diagnostic use with a urine sample in a container only. Do not use internally. Open the pouch just before use. Dispose of the used test with household waste. The test kit may only be used once. In vitro diagnostic medical device. Carefully read the instructions for use and information about safe use.
Storage
Store in a dry place at 2–30°C. Do not freeze. Keep out of reach of children.
Warning: Use the medical device in accordance with the instructions for use. Carefully read the information on safe use of the device. Keep out of reach of children.
Specifications
Designed for
Adults
From age
18 years (216 months)
Zaměření testu na
Pregnancy
Evaluation method
Instant results (self-diagnosis)
Method of test performance
Urine
Usage
Designed for
Adults
From age
18 years (216 months)
Use
Zaměření testu na
Pregnancy
Basic information
Evaluation method
Instant results (self-diagnosis)
Method of test performance
Urine
Collection point
Home
Evaluation time
1 min
Usability
Disposable
Brand
GS
Accuracy
99 %
Number of pieces in package
Number of pieces in package
2 pc(s)
Medical device
Type of medical device
In vitro diagnostic medical device (IVD)
Intended purpose
Birth control
Product characteristics
Product characteristics
Medical device
More Specifications
UPOZORNĚNÍ - Zdravotnický prostředek: Čtěte pečlivě návod k použití a informaci o bezpečném používání. Zdravotnické prostředky jsou určeny pouze pro koncové uživatele, jejich další distribuce není možná.
Produkt: GS Mamatest Těhotenský test, 2 kusy
Druh: Diagnostický zdravotnický prostředek in vitro (ZP IVD)
Určený účel použití: Kontrola početí
Green–Swan Pharmaceuticals CR a. s. Tomíčkova 2144/1, 148 00 Praha 4, Česko, +420 225 341 600, [email protected]
Note:
Specifications can be changed without notice. Images are for illustrative purposes only.
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