FSH Rapid Test Device (Urine)

Follicle-stimulating hormone (FSH) is a hormone involved in reproductive health. In women, FSH helps regulate the menstrual cycle and supports ovarian follicle development. When ovarian function changes, especially around perimenopause or menopause, FSH levels may rise because the body produces more FSH in response to lower estrogen activity. Because of this hormonal change, the FSH Rapid Test Device can be useful as a screening aid for women who want to understand whether elevated FSH may be present in urine.

The FSH Rapid Test Device (Urine) is intended for the qualitative detection of human FSH in urine specimens. The FSH Rapid Test Device by LARKSOIS Pharma may help healthcare professionals identify whether FSH levels are elevated above the device’s detection threshold.

Applications

• Fertility-related hormone screening
• Menopause and perimenopause assessment support
• Women’s health diagnostic evaluation
• Gynecology clinic testing
• Laboratory-based rapid hormone screening
• International diagnostic product distribution

The FSH Rapid Test Device works on the principle of colloidal gold immunochromatography. In this method, antibodies are used to identify FSH in the urine sample. If FSH is present at or above the test cut-off, a visible test line appears on the device along with the control line.

Benefits

• Fast visual result
• Simple urine sample testing
• No complex instrument required
• Easy-to-read test and control lines
• Suitable for clinics and laboratories
• Practical format for global healthcare use
• Useful for point-of-care fertility screening

The FSH Rapid Test Device uses urine as the specimen. Urine-based hormone testing is convenient because it is non-invasive, simple to collect, and easy to process.

Guidance

• Collect urine in a clean and dry container
• Test at a consistent time when recommended
• First morning urine may be preferred if instructed by the product insert
• Bring the test device and urine sample to room temperature before use
• Follow the official LARKSOIS Pharma product insert carefully
• Read results only within the approved time window

Note

The exact collection procedure should follow the LARKSOIS Pharma product insert.

Steps

• Bring the test device and urine sample to room temperature
• Open the sealed pouch only when ready to test
• Place the test device on a clean, flat surface
• Add the recommended number of urine drops into the sample well
• Wait for the colored lines to appear
• Read the result within the time mentioned in the IFU
• Do not interpret results after the approved reading window

Note

The FSH Rapid Test Device (Urine) should be used according to the official product instructions.

Positive

A positive result generally means FSH is detected at or above the test cut-off. Because FSH levels can vary during the month, repeat testing may be recommended according to the product insert or healthcare professional guidance.

Negative

A negative result means FSH is below the device cut-off or not detected at a positive level.

Invalid

If the control line does not appear, the result is invalid. The test should be repeated with a new device and new urine sample.

• The FSH Rapid Test Device (Urine) can support women’s health screening by identifying elevated FSH levels. Elevated FSH may be associated with perimenopause, menopause, or changes in ovarian function.
• The test may be useful for women experiencing symptoms such as irregular menstrual cycles, hot flashes, sleep irregularities, mood changes, or other hormone-related changes.
• FSH levels may fluctuate, so a single test result should not be used as a final diagnosis. The FSH Rapid Test Device result should be reviewed with a healthcare professional, especially if the user has irregular periods, fertility concerns, menopause symptoms, pregnancy possibility, hormonal therapy use, or any ongoing medical condition.

Instructions

• Store in a dry place
• Keep away from direct sunlight
• Do not freeze
• Keep sealed until use
• Use before expiry date
• Do not use damaged pouches
• Follow the storage temperature printed on the pack

Note

Proper storage helps maintain the performance, sensitivity, and reliability of the FSH Rapid Test Device (Urine) during local and international supply.

Instructions

• For in vitro diagnostic screening support only
• Use urine specimen only as validated by the product insert
• Do not use as the only basis for fertility, menopause, or hormone-related diagnosis
• Do not use expired or damaged devices
• Do not reuse the test device
• Read results only within the approved time window
• Consult a healthcare professional for symptoms, fertility concerns, irregular menstrual cycles, or ongoing medical conditions

LARKSOIS Pharma focuses on reliable diagnostic and healthcare products for international markets. The FSH Rapid Test Device (Urine) is designed to support fertility screening, women’s health testing, and menopause-related hormone evaluation.

Advantages

• Urine-based rapid test format
• Colloidal gold method
• Easy visual result interpretation
• Fertility and women’s health category product
• Suitable for clinics, laboratories, and distributors
• International market-ready product positioning
• Professional diagnostic support from LARKSOIS Pharma