Resources

Sofia 2 Lyme FIA

CLIA-waived Sofia 2 Lyme Fluorescent Immunoassay (FIA) with Sofia 2 uses advanced immunofluorescence-based lateral-flow technology to provide rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection.

Sofia 2 Lyme FIA offers:

  • Automated, objective, accurate results in just 3-15 minutes
  • A simple, CLIA-waived workflow
  • Finger-stick whole blood sample type
  • Differentiated IgM and IgG results on a single test cassette
  • Room temperature storage
  • 18-month shelf life

Suggested CPT codes* and Medicare National Limit:

  • IgM: 86618QW; $18.92
  • IgG: 86618QW-59; $18.92

Sofia 2 User Manual

Sofia 2 Sales Sheet

Sofia 2 Lyme Package Insert

Sofia 2 Lyme FIA Package Insert (Canadian French)

Sofia 2 Lyme FIA Package Insert (Latin American Spanish)

Sofia 2 Lyme FIA Sales Sheet

Sofia 2 Demo Video

Sofia 2 Lyme FIA Training Video

Sofia Lyme FIA

The Sofia Lyme Fluorescent Immunoassay (FIA) with Sofia 2 or Sofia uses advanced immunofluorescence-based lateral-flow technology to provide rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection.

Sofia Lyme FIA offers:

  • Automated, objective, accurate results in just 10 minutes, or as few as three when used with Sofia 2
  • A simple workflow
  • Serum/plasma sample type
  • Differentiated IgM and IgG results on a single test cassette
  • Room temperature storage
  • 18-month shelf life

Suggested CPT codes* and Medicare National Limit:

  • IgM: 86618QW; $18.92
  • IgG: 86618QW-59; $18.92

Sofia User Manual

Sofia Sales Sheet

Sofia Lyme Package Insert

Sofia Lyme Sales Sheet (with Sofia Analyzer)

Sofia Lyme Sales Sheet (with Sofia 2 Analyzer)

*Under Federal and State law, it is the individual provider’s responsibility to determine appropriate coding, charges and claims for a particular service. Policies regarding appropriate coding and payment levels can vary greatly from payer to payer and change over time. Quidel Corporation strongly recommends that providers contact their own regional payers to determine appropriate coding and charge or payment levels prior to submitting claims.

CDC

The CDC’s website is an excellent resource for all things Lyme disease.  Find information, graphics, educational resources and more.

The CDC recommends a two-tiered algorithm for testing for Lyme disease and warns that “Some laboratories offer Lyme disease testing using assays whose accuracy and clinical usefulness have not been adequately established.”

FDA

The FDA website lets you research FDA-cleared assays, as well as learn more about non-FDA-cleared laboratory developed tests (LDTs).

Quest Diagnostics’ Health Trends Lyme Disease Report, July 2018

Read the FDA’s discussion paper on LDTs.

In this report, Quest Diagnostics analyzes six million results of its own Lyme testing conducted between 2010 and 2017 to reveal confirmed Lyme disease cases in all 50 states and that positive Lyme diagnoses are both growing and spreading.

A Window Into Lyme Disease Using Private Claims Data, July 2017

In this article published by the American Journal of Managed Care, president of FAIR Health Robin Gelburd analyzes more than 23 billion private insurance claims from 2007 to 2016 to determine claims with a Lyme disease diagnosis are growing both in number and percentage and are spreading geographically.