About the Test
Saliva is a complex fluid which contains markers for several diseases and variety of hormones. The level of those hormones is significantly lower than in serum/- blood or urine. Therefore, only a sensitive test will allow their detection.1,2,3,4
When you are pregnant, your body produces the pregnancy hormone, hCG (human chorionic gonadotropin). A portion of this hormone travels from the blood to the saliva. Levels of hCG continue to increase rapidly during the first 3 months of pregnancy. Salignostics has developed the unique SaliStick™ pregnancy test. The SaliStick kit can detect even the low levels of hCG in saliva. The kit is based on a lateral flow immunoassay (LFIA). This is the same principle used by other pregnancy tests that you can find on the market.
When to use the SaliStick™ Test Kit?
The SaliStick™ Test can detect hCG (human chorionic gonado- tropin) in saliva starting after 2 day after your missed period. You can use the test at any time of the day (30 minutes after drinking or eating).
Intended Use
The Salignostics SaliStick™ Test Kit is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in saliva. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use.
How does the test work?
The Collection foam absorbs saliva from your mouth. When you connect the Collection handle to the Analytical unit, the saliva is squeezed and migrates along a special membrane until it reaches the test zone. In the presence of the hCG pregnancy hormone, a pink line will appear. Absence of this test line suggests a negative result. A pink control line will appear if the test was performed properly.
Questions and answers
Q: How does the test work?
A: When you are pregnant, your body produces the pregnancy hormone hCG. The amount of hCG in your body increases in the early stages of pregnancy. The SaliStick™ test detects the amounts of this hormone in saliva.
Q: When can I test with the SaliStick™ test?
A: The SaliStick™ test is designed to detect the hCG pregnancy hormone levels after the second day of your missed period. The amount of this hormone increases as pregnancy progresses.
Q: How accurate is the test?
A: In laboratory testing with saliva samples of pregnant women after 2 day after their missed period, SaliStick™ test gave 95% positive results.
Q: What do I do if the result is positive (pregnant)?
A: A positive (pregnant) test result shows that the pregnancy hormone (hCG) was detected, which normally indicates pregnancy. You must see your doctor to confirm that you are pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
Q: What do I do if the result is negative (not pregnant)?
A: You may not be pregnant, or it may be too early to detect it. If you do not get your period within two days, you should retest with another SaliStick™ test. It is possible that you miscalculated the length of your cycle, or your saliva may not have had enough pregnancy hormone for the test to give a positive result. If upon retesting you get another negative result and your period has still not started, you should call your doctor.
Q: I have waited longer than 10 minutes and still there is no line in the Result Window. Is there anything wrong?
A: Your result should appear within 5-10 minutes. The control line should appear in the Result Window, to indicate that the test is completed, and you have done it correctly. If not, the test is not valid. This could be due to insufficient saliva that was collected, or not placing the device horizontally after connecting the Collection handle to the Analytical unit. You should retest with another device, carefully following all instructions.
Q: Will the result change if left standing for additional time?
A: The test result should be read within 10 minutes. In particular, a negative result should not be read after 10 minutes.
Q: Do any drugs or medications affect the test?
A: Only medications containing the pregnancy hormone, human chorionic gonadotropin (hCG), can affect the result (for example, A.P.L., Pregnyl, and Profasi). The test should not be affected by hormone therapies containing Clomiphene citrate (for example, Clomid and Seraphine), alcohol, pain killers, antibiotics, or the contraceptive pill.
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