Uncut sheet for Progesterone Prog Rapid test

The Progesterone (Prog) Rapid Test Device (the Uncut Sheet  format for manufacturing use) is a rapid immunochromatographic assay intended for the quantitativedetermination of progesterone concentration in human serum, plasma, or whole blood specimens.

This test is intended for in vitro diagnostic professional use and serves as an aid in the assessment of female reproductive health, including the evaluation of ovulation status, luteal phase function, and the monitoring of pregnancy-related conditions such as ectopic pregnancy or threatened miscarriage.

Progesterone is a steroid hormone produced by the ovaries, placenta, and adrenal cortex. It plays a crucial role in the menstrual cycle and in maintaining early pregnancy . Progesterone measurement is clinically useful in the following contexts:

• Ovulation confirmation: Detection of progesterone rise during the luteal phase confirms ovulation has occurred .
• Luteal phase assessment: Monitoring progesterone levels helps evaluate corpus luteum function and diagnose luteal phase deficiency .
• Pregnancy monitoring: Serial progesterone measurements, in conjunction with β-hCG, aid in the early detection of pregnancy-related complications such as ectopic pregnancy .
• Menstrual cycle evaluation: Helps differentiate between ovulatory and anovulatory cycles .

The device provides quantitative screening results. The test results are intended for clinical reference only. Definitive diagnosis should be based on a comprehensive assessment of clinical presentation and other laboratory findings . Results should be interpreted in conjunction with other relevant markers (e.g., β-hCG, LH) and patient history. Positive/abnormal results do not by themselves constitute a diagnosis of a specific condition and require further clinical evaluation.

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.