Description
Description
The ClearSign Midstream Pregnancy Test is a HCG midstream test that is over 99% accurate and can display a positive result in as soon as 1 minute. The test is easy to read, and can be used for self-testing, or can also be used by medical professionals.
The ClearSign Midstream Pregnancy Test is a rapid one-step test based on immunochromatographic technology. A membrane with an absorbent pad over a strip of fiber glass is impregnated with a colloidal conjugate of gold particles and monoclonal antibodies to HCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into a chromatographic membrane, and as it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the HCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-HCG monoclonal antibodies affixed on the test zone (“T”) will bind the HCG-gold conjugate complex, forming a pink line (“T”). Any sample will cause a pink coloured line to appear in the control zone (“C”) – this line is formed by the binding of polyclonal antibodies (Anti-mouse lgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly.
The pack contains:
- One individually foiled test (sensitive to 20mlU/ml)
- One instruction for use leaflet
Uses
The ClearSign Midstream Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in urine samples to aid in the early detection of pregnancy by home users. The ClearSign Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotropin (HCG) in human urine for the early detection of pregnancy. During pregnancy, the placenta produces HCG after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after missed a period. As pregnancy progress, urine contains higher levels of HCG at concentrations of 20mIU/ml (Mili-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mIU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mIU/ml with peak levels of 100.000 to 200.000mIU/ml.
Application
Storage and Stability:
• The test kit can be stored at room temperature (4°C – 30°C) in the sealed pouch to the date of expiration.
• The test kits should be kept away from direct sunlight, moisture and heat. Do not freeze.
Precautions:
• For in-vitro diagnostic use only (IVD), not for internal use
• Read directions for use carefully before performing this test. Perform each step exactly as described
• Do not use beyond the expiration date marked on the foil pouch
• Each Midstream Test can only be used once, do not re-use the Midstream Test
• Do not use the Midstream Test if the foil pouch is damaged
• Once the foil pouch has been opened, the Midstream Test should be used immediately.
• Discard each one step HCG pregnancy Test Midstream after use. Treat urine samples and used test devices as if they were potentially infectious. Avoid contact with skin
• Keep out of reach of children
Test Procedure:
• Please read the instruction leaflet before use
• To perform this test, hold the Midstream Test’s absorbent tip directly into the urine stream. The first urine sample in the morning is ideal because it generally contains higher concentration of HCG. However, urine samples may be tested at any time of the day.
Using the Test:
• Bring the sealed pouch to room temperature
• Carefully remove the Midstream Test from the sealed pouch
• Hold the Midstream Test and remove the cap to expose the absorbent tip
• Point the absorbent tip downward; place the absorbent tip into the urine stream at least 10 seconds or in your collected urine sample for 20 seconds to ensure it is thoroughly wet
• Re-cap the device and wait for the colour bands to appear
• Read results in 5 minutes
• Depending on the concentration of HCG in the urine sample, positive results may be seen within 40 seconds. Wait the full five minutes to confirm the result. Do not read the Midstream Test after 5 minutes as this may also give an incorrect test result
• This is a single use test. Please safely dispose of the Midstream Test; regard this as infectious material and dispose of the test appropriately after use
Reading the Results:
• Positive: If two pink/purple coloured lines appear on the one step HCG pregnancy Test, one in the control area and one in the test area, then this means HCG has been detected in the urine and there is a strong possibility of pregnancy. The lines seen may be faint and one line might be lighter than the other; however, this is still a positive result. The lines do not have to match in strength or colour.
• Negative: If one coloured pink/purple line appears in the control area on the Midstream Test and there is no line in the test area, then this indicates a negative result. This means no HCG has been detected in the urine. This indicates you are either not pregnant or you have tested too early. If you are not sure, repeat the test in 48 hours.
• Invalid: If no lines appear anywhere in the control zone, the test is invalid and repeat the test using another Midstream Test.
Invalid Test Results can be caused by:
• The absorbent tip not being wetted thoroughly
• Reading the test result too early or too late – A 5 minute reaction time is required
• For further information, see limitations of the procedure
