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**Overview**: Lyme Disease Antibodies Panel**Introduction**: The Lyme Disease Antibodies Panel is a diagnostic tool designed to screen for Lyme disease using serum samples. In India, Lyme borreliosis (Borrelia burgdorferi infection) is emerging in northern hilly regions (Himachal, Uttarakhand, Jammu & Kashmir) with tick exposure, though underreported (~few hundred confirmed cases annually), often misdiagnosed as rheumatoid arthritis or viral fever. High morbidity from under-testing in rural/low-SES populations with outdoor occupations (farmers, shepherds), limited serology labs, delayed doxycycline leading to chronic arthritis, neurological/cardiac complications. Per microbiology practices aligned with ICMR and National Centre for Disease Control guidelines, the test employs immunoassay for Borrelia IgG and IgM over 1-2 days with high specificity (two-tier testing recommended: ELISA + Western blot confirmation), valuable for acute and late-stage diagnosis. This diagnostic falls under infection screening and targets patients with erythema migrans, arthritis, or tick bite history plus fever/myalgia, addressing accurate detection to guide antibiotics and prevent disseminated disease. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling precise Lyme identification and reducing chronic sequelae. Its serum-based approach ensures reliable antibody detection.**Other Names**: Lyme Ab Pnl.**FDA Status**: FDA approved, CLIA certified for microbiology/immunology, compliant with 2025 standards.**Historical Milestone**: Two-tier serology standard; in India, increasing awareness in tick-endemic areas.**Purpose**: The test assesses 2 parameters including Borrelia IgG to guide Lyme disease screening, detect acute/past infection, inform antibiotic therapy.**Test Parameters**: 1. Borrelia IgG, 2. Borrelia IgM.**Pretest Condition**: No fasting required; patients should report tick exposure or arthritis.**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 tick bite, rash, joint pain, neurological symptoms.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of untreated Lyme including chronic arthritis, 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 early sampling can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Positive IgM indicates acute infection; IgG positive past/chronic exposure, necessitating specialist input.**Specialist Consultation**: Infectious disease specialists or rheumatologists should be consulted for management.**Additional Supporting Tests**: Western blot, PCR for confirmation.**Test Limitations**: Cross-reactivity possible; comprehensive approach required.**References**: Indian Journal of Medical Microbiology 2024, Tick-borne Studies India 2023. |
