Luteinizing Hormone Test
INTENDED USE
The LH Test is a rapid visual immunoassay for the semiquantitative detection of luteinizing hormone (LH) in human urine specimens. This kit is intended for use as an aid in the prediction of ovulation.
INTRODUCTION
While a woman’s body always produces a small amount of human luteinizing hormone (LH), there is a sudden increase of this hormone during the middle of the menstrual cycle. This increase of the LH level, called the LH surge, promotes the release of a mature egg from the ovaries (ovulation). For most women, ovulation will occur within 24-36 hours after the peak of the LH surge. Immediately after ovulation, the egg is capable of being fertilized for a short time (approx. 12 hours).
It is recommended to determine the LH concentration for a time period of approximately 6 days. The starting day of the testing period depends on the length of the menstrual cycle and is individually calculated. During this time period the DIMA®LH Test will detect the LH surge thus allowing the prediction of the fertile days of the cycle.
PRINCIPLE
The DIMA®LH test is a semiquantitative immunoassay that is visually interpreted by the comparison of line intensities that appear on the membrane in the presence of LH in the urine sample.
LH is detected with the aid of specific antibodies against the hormone. After the addition of the sample, a color-labelled antibody specifically binds to LH if it is present in the sample. When the LH-antibody-complexes migrate upward on the membrane by capillary action, they are captured with the aid of another specific antibody at the test result line region (T) of the test. A red test result line is generated the color intensity of which is dependent on the concentration of LH.
In contrast to the test result line (T) the color intensity of the control line (C) is the same in all assays. By comparing the color intensity of the test result line (T) to the control line (C) the user can estimate the concentration of LH present in the sample and can predict if the LH peak has been reached and when ovulation takes place. If no LH is present the color labelled antibody cannot bind at the test result line region. No red test result line is formed.
The control line (C) that will always appear in the control line region also serves as an internal control and indicates that proper volume of specimen has been added and membrane wicking has occurred.
MATERIALS SUPPLIED
• 40 individually pouched test devices
• 40 disposable pipettes included in the pouch
• 1 package insert
MATERIALS REQUIRED
• Clean, dry containers for the collection urine samples
• Stop watch or timer
STORAGE AND STABILITY
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
PRECAUTIONS
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests or pipettes.
• Read the entire procedure carefully prior to any testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for proper disposal of specimens and used testing materials in accordance with local regulations. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• The components of the test (e.g. antibodies/chemicals) do not cause any danger if the test is used according to the instructions.
SPECIMEN COLLECTION AND STORAGE
Calculation of the initial testing date
The initial testing date for a complete 6 day testing period depends on the average length of the last normal menstrual cycles. The first day when bleeding begins in the menstrual period is counted as day 1.
The chart below demonstrates the correlation between the starting day and the length of the menstrual cycle. Beginning with the starting day and on the following 5 days the LH concentration is determined by using 1 test per day.
If the menstrual cycle is shorter or longer than in the chart above, the initial testing date must be calculated by the physician. If the cycles are irregular it might be necessary to prolong the 6 day testing period for several days.
