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**Overview**: Infertility Screening 1 Panel**Introduction**: The Infertility Screening 1 Panel is a diagnostic tool designed to screen for infertility causes using serum samples. In India, initial hormonal screening is recommended for couples with infertility >1 year, with ~15-20 percent of couples affected and ovulatory/hormonal issues common in women. High morbidity from under-screening in rural/low-SES couples, limited labs, delayed basic evaluation leading to prolonged infertility or unnecessary ART. Per endocrinology practices aligned with ICMR, FOGSI, and Indian Society for Assisted Reproduction guidelines, the test employs immunoassay for FSH, LH, and prolactin over 1-2 days with high accuracy, valuable as first-line screening for anovulation or hyperprolactinemia. This diagnostic falls under reproductive screening and targets women (or couples) with infertility history, addressing accurate detection to guide further workup (ultrasound, semen analysis) or clomiphene trial. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling early hormonal assessment and reducing infertility burden. Its serum-based approach ensures reliable gonadotropin/prolactin measurement.**Other Names**: Infert Scr 1 Pnl.**FDA Status**: FDA approved, CLIA certified for endocrinology/immunology, compliant with 2025 standards.**Historical Milestone**: Basic infertility screen standard; in India, used in gynecology clinics.**Purpose**: The test assesses 3 parameters including FSH to guide infertility screening, detect ovulatory/hyperprolactinemic causes, inform next steps.**Test Parameters**: 1. FSH, 2. LH, 3. Prolactin.**Pretest Condition**: Fasting 10-12 hours recommended (day 2-5 of cycle for women); patients should report infertility.**Specimen**: 3 mL serum in 1 SST, transported within specified times to maintain sample viability.**Sample Stability at Room Temperature**: 8 hours with proper handling to preserve analyte integrity, ensuring reliable test performance.**Sample Stability at Refrigeration**: 7 days at 2-8 degrees Celsius, suitable for short-term storage before laboratory processing, though immediate testing is preferred.**Sample Stability at Frozen**: 6 months at -20 degrees Celsius, allowing long-term storage for retesting, though freezing may affect some analytes.**Medical History**: Patients should provide details on infertility duration, menstrual regularity.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of untreated infertility including prolonged distress, benefits of screening, and minimal discomfort from venipuncture.**Procedural Considerations**: The test involves sample processing using immunoassay by trained personnel to ensure sterile technique, avoid hemolysis, and interpret results within 1-2 days using provided controls. Laboratories must maintain a controlled environment, adhere to quality assurance protocols.**Factors Affecting Result Accuracy**: Delays beyond stability periods, improper storage conditions, hemolysis, or cycle day can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Abnormal FSH/LH/prolactin indicate ovulatory or pituitary issues, necessitating specialist input.**Specialist Consultation**: Reproductive endocrinologists or gynecologists should be consulted for management.**Additional Supporting Tests**: AMH, ultrasound, semen analysis for confirmation.**Test Limitations**: Basic screen only; comprehensive approach required.**References**: Indian Journal of Obstetrics and Gynaecology 2024, Infertility Studies India 2023. |
