Uncut sheet for Anti-Mullerian AMH Rapid test

The Anti-Müllerian Hormone (AMH) Rapid Test Device (the "Uncut Sheet" format for manufacturing use) is a fluorescence immunochromatographic assay intended for the quantitative determination of anti-Müllerian hormone (AMH) 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 ovarian reserve function and ovarian responsiveness, as part of an evaluation for infertility and assisted reproductive therapy protocols

Clinically, AMH measurement is useful in the following contexts :

1)Assessment of ovarian reserve function: AMH is a sensitive and specific marker for evaluating ovarian reserve

2)Diagnosis of polycystic ovary syndrome (PCOS): AMH levels in PCOS patients are typically 2–3 times higher than normal

3)Prediction of ovarian responsiveness in assisted reproductive technology (ART): AMH levels can predict ovarian hypo-responsiveness and hyper-stimulation, helping to develop individualized stimulation protocols

4)Diagnosis and monitoring of ovarian granulosa cell tumors: AMH is significantly elevated in patients with granulosa cell tumors and is used for follow-up monitorin

5)Diagnosis of premature ovarian failure (POF): AMH levels are reduced in patients with hypoovarianism and are almost undetectable in POF patients

6)Evaluation of disorders of sexual development: In males, AMH is used in the evaluation of disorders of sexual development (DSD) and male fertility

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., FSH, antral follicle count) 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.