Specifications and Product Details:

Accurate midstream LH rapid test

Accurate midstream LH rapid test is to detect Luteinizing Hormone in Urine, help predict the time of ovulation, and peak fertility.
General Information
Analytical sensitivity : 30mIU/ml of LH , 10 mIU/ml
Sensitivity : 99.9% , Specificity : 99.9%
Specimen : Urine
Reading Time : 5 min
No cross-reactivity : hCG (1000 mIU/mL), hFSH (1,000 mIU/mL) and hTSH (1,000 μIU/mL)

SUMMARY AND EXPLANATION OF PROCEDURE

Human luteinizing hormone (hLH) is a glycoprotein secreted by anterior pituitary. This hormone has a
molecular weight of 30,000 daltons and is composed of alpha- and beta- subunits. The alpha subunit of
hLH is essentially identical to that of other glycoprotein hormones including FSH, TSH, and hCG. It is
the beta subunit of hLH which confers the biological and immunological specificity of the hormone(1).
LH, FSH and steroid hormones are known to be involved in regulating the ovulation and ovarian function
during the menstrual cycle. The maturation of ovarian follicles and the oocytes begins at the end of the
preceding menstrual cycle. As follicles develop through the stimulation by FSH, estradiol secretion
begins to rise slowly and ends with a rapid increase. The rapid rise of estradiol level is generally believed
to trigger a rapid rise and peaking of LH secretion at the midcycle (LH surge). Approximately 12 to 24
hours after the LH surge, the rupture of the enlarged follicle will take place to release the mature ovum
(ova). Following ovulation, LH returns to its basal level in two days with a concomitant increase of the
progesterone level to initiate a luteal phase in the next 14 days. If no pregnancy occurs, a new follicle
begins with the same procedure for maturation in the next menstrual cycle. In view of the characteristic
changes of LH levels during the menstrual cycle, rapid and sensitive measurement of LH is essential in
the diagnosis and management of infertility in woman(2,3). Detection of hLH surge offers a great help in
predicting the timing of ovulation. The onset of hLH surge precedes the ovulation by about 12 to 24
hours(4). The assay of hLH has been successfully used to time oocyte retrieval for the in vitro
fertilization(5,6) and to assist the timing of artificial insemination.

PRINCIPLE

The LH One Step Test is a colloidal gold enhanced immunoassay for qualitative or semi-quantitative
determination of hLH in urine. The nitrocellulose membrane used as solid phase was precoated with
sheep anti-hLH on the test region. During the test, the urine sample is allowed to react with a colored
conjugate (mouse anti-hLH monoclonal antibody-colloidal conjugate) which was pre-dried on the test
strip. Upon the dropping of the urine sample, the mixture will move along the strip through a capillary
action. If hLH is present in the sample, a red color band with a specific antibody-hLH colored
immunogold conjugate complex will form on the test band region. On the other hand, a light color band
will always appear at the control region. This control band serves as a reference of the color intensity of
about 25 mIU/ml hLH. When the intensity of the test band is equal to or stronger than that of the
control/reference band, the test result is positive, indicating that the LH surge is likely in progress.

SPECIMEN COLLECTION

The sample must be collected once each day in one of the urine cups in the kit. Use a new cup each day.
For best results, try to collect urine at about the same time each day when conducting the tests. The liquid
intake should be reduced for two hours before collecting the urine. The urine can be stored at room temperature for up to 8 hours or in the refrigerator for up to 24 hours. Do not freeze. If sample was refrigerated, it must be equilibrated to room temperature before testing

BEFORE TESTING

1. Bring all materials and specimens to room temperature.

2. Remove test device from the sealed foil pouch.

FOR MIDSTREAM TEST:

1. Remove the test stick from the foil pouch

2. Remove the cap to expose the absorbent tip.

3. Hold the stick by the thumb grip with the exposed absorbent tip pointing downward.

Urinate on the absorbent tip only until it is thoroughly wet.

4.Lay the test stick down on a flat surface with the windows on top while you wait for the test result.

5.Read the result within five minutes.

6. Discard the test device after single use in a dustbin.

READING THE TEST RESULTS

Read results between 3 and 10 minutes. Do NOT interpret results after 10 minutes.

Negative:: One (1Lineimumk/purple band forms in the control region; no band is found in the test region, or the color of the test band is less intense than that of the control/reference band. The result indicates basal LH level of the tested specimen.

Positive: Two (2) pink/purple bands form, and the color of the test band is equal to or more intense than that of the control/reference band. This result indicates an LH surge level of the tested specimen.

Invalid: If there is no pink/purple band in the control region, the test result is invalid. Retest the sample using a new device.