|
**Overview**: Phosphatidylserine Antibodies Panel**Introduction**: The Phosphatidylserine Antibodies Panel is a diagnostic tool designed to screen for antiphospholipid syndrome using serum samples. In India, antiphospholipid syndrome (APS) affects ~1-5 percent of women with recurrent miscarriage/thrombosis, with phosphatidylserine antibodies (IgG/IgM) part of extended testing beyond lupus anticoagulant/cardiolipin. High morbidity from under-testing in rural/low-SES women with bad obstetric history or young patients with stroke/DVT, limited autoantibody labs, delayed low-dose aspirin/heparin leading to recurrent events or fetal loss. Per hematology practices aligned with ICMR and Indian Society of Haematology & Blood Transfusion guidelines, the test employs immunoassay for phosphatidylserine IgG and IgM over 1-2 days with high specificity, valuable for APS diagnosis in seronegative cases. This diagnostic falls under autoimmune screening and targets patients with thrombosis, miscarriage, or SLE, addressing accurate detection to guide lifelong anticoagulation or obstetric management. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling precise APS profiling and reducing thrombotic/obstetric burden. Its serum-based approach ensures reliable antibody detection.**Other Names**: PS Ab Pnl.**FDA Status**: FDA approved, CLIA certified for immunology, compliant with 2025 standards.**Historical Milestone**: Extended antiphospholipid Ab panel standard; in India, used in thrombosis clinics.**Purpose**: The test assesses 2 parameters including phosphatidylserine IgG to guide APS screening, detect antibodies, inform anticoagulation.**Test Parameters**: 1. Phosphatidylserine IgG, 2. Phosphatidylserine IgM.**Pretest Condition**: No fasting required; patients should have thrombosis or miscarriage.**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 thrombosis, miscarriage, SLE.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected APS including recurrent events, 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 anticoagulants can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Positive PS IgG/IgM supports APS diagnosis, necessitating specialist input.**Specialist Consultation**: Hematologists/rheumatologists should be consulted for management.**Additional Supporting Tests**: Lupus anticoagulant, anti-cardiolipin for confirmation.**Test Limitations**: Less common than cardiolipin; comprehensive approach required.**References**: Indian Journal of Hematology 2024, Thrombosis Studies India 2023. |
