Valfast Ovulation Kit

Overview & Mechanism of Action

• Valfast Ovulation Kit (diagnostic kit containing test devices, disposable droppers, and instructional inserts) provides reliable home-use tracking of female reproductive hormones:
• LH Surge Detection: Employs a combination of monoclonal and polyclonal antibodies immobilized on a nitrocellulose membrane to selectively bind elevated concentrations of human Luteinizing Hormone ($\text{hLH}$) in urine.
• Calibrated Threshold Sensitivity: Calibrated to detect $\text{LH}$ levels at or above $25\text{ mIU/mL}$, marking the pre-ovulatory surge that typically occurs $24$ to $36$ hours prior to egg release from the ovary.
• Rapid Visual Interpretation: Features dual-line lateral flow technology displaying a control line ($\text{C}$) to verify test validity and a test line ($\text{T}$) that matches or exceeds the intensity of the control line during an active $\text{LH}$ surge.

Clinical Indications & Uses

• Valfast Ovulation Kit is indicated for:
• Predicting the 2 to 3 days of peak fertility during a woman's menstrual cycle to maximize chances of natural conception
• Monitoring menstrual cycle regularity and verifying the occurrence of physiological ovulation
• Baseline home tracking prior to undergoing clinical fertility evaluations or assisted reproductive consultations

Usage Guidance & Safety Precautions

Administration:

• Collect a urine sample in a clean, dry container (preferably between 10:00 AM and 8:00 PM; avoid first morning urine as it may yield false surges). Using the transfer pipette, place 3 drops of urine into the sample well ($\text{S}$) of the device, or submerge the absorbent tip if using a midstream format. Read visual results strictly between 3 and 5 minutes.

Recommended Dosage:

• Testing Protocol: Begin testing 3 to 4 days prior to expected ovulation based on average cycle length (e.g., for a 28-day cycle, start testing on day 11). Test once daily at approximately the same time until a positive $\text{LH}$ surge is detected.

Precautions & Warnings:

• For in vitro diagnostic self-testing only. Do not interpret results after 10 minutes. Conditions such as Polycystic Ovary Syndrome (PCOS), pregnancy, early menopause, or medications containing $\text{hCG}$ or $\text{LH}$ may produce false-positive or inconclusive results. Store between $2^\circ\text{C}$ and $30^\circ\text{C}$ away from direct heat, sunlight, and moisture. Keep out of reach of children