Lifesign 135-100A - StatusFirst hCG Urine Controls, 2 x 2.5 mL
StatusFirst hCG Urine Controls, 2 x 2.5 mL
Rapid immunassay for the qualitative detection of human chronic gonadotropin in serum and urine.
For the Detection of hCG in Urine.
- CLIA WAIVED
- Simple "dip and read" procedure
- Results in 3-5 minutes
- Minimal susceptibility to the Hook effect by hCG Beta core fragment
Status hCG Strip - One Step Pregnancy Test Strip is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
StatusFirst hCG Urine Controls Summary and Principle of Procedure
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the placental trophoblastic cells shortly after the fertilized ovum is implanted in the uterine wall.1-4 The primary function of hCG is to maintain the corpus luteum during early pregnancy. The appearance of hCG in both the urine and serum soon after conception and its rapid rise in concentration make it an excellent marker for confirmation of pregnancy.
The hormone may become detectable in both urine and serum as early as 7 to 10 days after conception.1-4 The concentration of hCG continues to rise rapidly, frequently exceeding 100 mIU/mL by the first missed menses and peaking in the range of 30,000-100,000 mIU/mL by 10 to 12 weeks into pregnancy.
The hormone is comprised of two non-covalently bound dissimilar subunits containing approximately 30% carbohydrate by weight.5 The alpha subunit is structurally similar to other human pituitary glycoprotein hormones, whereas the beta () subunit confers unique biological and immunological specificity to the molecule.
The Status hCG Strip - One Step Pregnancy Test Strip is a rapid urine test for detecting hCG. The test is a solid phase, immunochromatographic assay in which a combination of monoclonal and polyclonal antibodies is used to selectively detect elevated levels of hCG in urine with a high degree of sensitivity. In the test procedure, urine is added to the tube with an aid of a transfer pipette and a Status hCG Strip is inserted into the test tube.
If hCG is present in the specimen, it will react with the conjugated dye, which binds to the antibody on the membrane and generate a colored line. Presence of two colored lines indicates a positive result, while one line at Control position indicates a negative result.
Reagents
The Status hCG Strip kit contains enough reagents to perform all the tests.
Status hCG Strip with a polyclonal anti-hCG antibody coated membrane and a pad containing mouse monoclonal anti-hCG antibodydye conjugate in a protein matrix containing 0.1% sodium azide.
StatusFirst hCG Urine Controls Precautions
- For in vitro diagnostic use only.
- Do not use beyond the expiration date which appears on the package.
- The Status hCG Strip should remain in the original sealed pouch until ready for use.
Specimen Collection and Preparation of StatusFirst hCG Urine Controls
- Approximately 1 mL of urine is required for each test.
- For optimal detection of early pregnancy, a first-morning specimen is preferred since it generally contains the highest concentration of hCG. However, urine collected at any time in a day may be used.
- Collect the urine specimen in a clean glass, plastic, or waxcoated container without preservatives.
- Urine containing excessive bacterial contamination should not be used since spurious results may occur with such specimens.
Procedural Notes
The instructions below must be followed in order to achieve optimal test reactivity with urine specimens. Follow the assay procedure and always perform the test under carefully standardized conditions.
- A test tube or any other sample container can be used for testing as long as the container will hold the required amount of urine sample and is free of contaminating substances.
- To avoid cross-contamination, use a new dropper or pipette tip and a test tube for each specimen.
- Use a test tube rack to hold the test tubes.
- Several tests may be run at one time.
- Keep the Status hCG Strip in the sealed pouch until the test is ready to be performed.
- Handle all specimens as if capable of transmitting disease.
- After testing, dispose of the test tubes, the Status hCG Strip, and the specimen dispenser following good laboratory practices. Consider each material that comes in contact with specimen to be potentially infectious
Test Protocol 1
- For each test, set up one test tube in a test tube rack.
- Dispense 1 mL of the urine into the test tube, label thetube and insert a new Status hCG Strip. Make sure the urine reaches the dotted area on the strip (Dipping Zone).
- Read the result after 3 minutes, but within 5 minutes.
Test Protocol 2
- Collect the urine in a urine cup.
- Dip the Status hCG Strip in the urine up to the dotted area (Dipping Zone), and keep it there for at least 10 seconds. The strip can then be removed and placed on a flat surface, or left in the sample.
- Read the result after 3 minutes, but within 5 minutes.
Results
- If there is one pinkish-purple line each in the Test line area and in the Control line area, the test result is positive (pregnancy hormone has been detected).
- If there is no distinct pinkish-purple line in the Test line area other than the normal faint background color, and there is a pinkish-purple line in the Control line area, the test result is negative.
Positive
A specimen containing a detectable level of hCG will generate two pinkish-purple lines within 3 minutes. The time required to generate the line is dependent on the hCG concentration in the sample. Some positive results can be read as early as one minute. To be interpreted as positive, the pinkish-purple lines should be clearly distinguishable from the background color of the membrane.
Negative
In the absence of hCG, or in the case that the hCG concentration is below the detection limit of the test, there will be the Control line only with no apparent pinkish-purple line in the Test line area of the membrane.
