Suggested Reporting Language, Interpretation and Guidance Regarding Lyme Disease Serologic Test Results

Details

• Alternative Title:
  APHL Suggested Reporting Language, Interpretation and Guidance for Lyme Disease Serologic Testing Results
• Corporate Authors:
  Association of Public Health Laboratories (U.S.) ; Centers for Disease Control and Prevention (U.S.)
• Description:
  Lyme disease, predominantly caused by the bacterial spirochete Borrelia burgdorferi (also referred to as Borrelia burgdorferi), is the most common tick-borne illness in the United States. In recent years, approximately 40,000 Lyme disease cases have been reported annually to the US Centers for Disease Control and Prevention (CDC). The true incidence of this disease, however, is likely much higher as millions of diagnostic tests are performed annually. Diagnosis of Lyme disease is reliant on both a clinical suspicion of disease and appropriate utilization of diagnostic tests, including serologic assays for detection of an immune response against B. burgdorferi. The recommended serologic testing algorithms involve multiple tests, and correct interpretation of results depends on the timing of testing relative to symptom onset.
  
  Differences in language and formatting of diagnostic test reports used by clinical laboratories can lead to misinterpretation of results and confusion by both healthcare providers and patients, which may lead to misdiagnosis and poor patient health outcome. This document was created by the Association for Public Health Laboratories (APHL) and an associated workgroup comprised of subject matter experts from public health agencies, and public health and clinical laboratories, to address the proper interpretation of serologic testing for B. burgdorferi, as well as to identify best practices for reporting of results to clinicians, public health agencies and patients.
  
  The intent of this document is to clearly outline scenarios when Lyme disease serologic testing is indicated and to outline proper application of the standard two-tier testing (STTT) or modified two-tier testing (MTTT) algorithms for testing of human samples. These serologic approaches for the diagnosis of Lyme disease, including recommended result reporting and interpretative guidance are summarized below. Additionally, recommended standard reporting language for the STTT and MTTT are provided, with an emphasis on clear and concise interpretations to provide clarity for clinicians, laboratorians and patients. The reporting guidance outlined in this document is only suggestive and may need to be adapted or modified depending on local factors or advances in diagnostic testing technology.
  
  This project was 100% funded with federal funds from a federal program of $785,926. This publication was supported by Cooperative Agreement #NU60OE000104 from the US Centers for Disease Control and Prevention (CDC). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC, the Department of Health and Human Services or the US Government.
  
  ID-2024-Lyme-Disease-Serologic-Testing-Reporting.pdf
  
  
• Subjects:
  Clinical Laboratory Techniques/methods Disease Notification Laboratories/standards Lyme Disease/diagnosis Serologic Tests
• Document Type:
  Pamphlet (or booklet)
• Funding:
  Cooperative Agreement #NU60OE000104
• Place as Subject:
  United States
• Pages in Document:
  17 numbered pages
• Collection(s):
  Stephen B. Thacker CDC Library
• Main Document Checksum:
  urn:sha256:d76984b4929903d8194dd3a77a6cea3ae6283b5c7841c5ccfa41f09d8a28112e
• Download URL:
  https://stacks.cdc.gov/view/cdc/156015/cdc_156015_DS1.pdf
• File Type:
  [PDF - 1.48 MB ]