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Diseases

Improved Lyme Disease Diagnosis through Enhanced Molecular Testing

Strategic Insights

— 2 min read

The Milford Molecular Diagnostics Laboratory, led by Dr. Sin Hang Lee, has announced a significant breakthrough in the diagnosis of Lyme disease. The laboratory's research has shown that the flaB gene, with its paralogs, is a more sensitive target for Sanger sequencing-based diagnosis of Lyme disease spirochetemia than the 16S rRNA gene. This discovery has critical implications for the early detection and treatment of the disease. To achieve accurate results, the study emphasizes the importance of timely differential centrifugation of whole blood specimens to isolate the platelet fraction, which contains the spirochetes.

Key Takeaways:

  • The flaB gene, with its paralogs, is a more sensitive chromosomal target for Sanger sequencing-based diagnosis of Lyme disease spirochetemia than the 16S rRNA gene.
  • Timely differential centrifugation of whole blood specimens is crucial for isolating the platelet fraction, which contains the spirochetes, to prevent false-negative results.
  • The study, which analyzed platelet-rich plasma specimens from 145 people, including 98 symptomatic patients, emphasizes the need for early detection and timely treatment of Borrelia burgdorferi infections.
  • The research was based on a study conducted in Lyme disease-endemic areas in the United States during a Lyme disease season in 2023.
  • Dr. Lee has sent an open letter to the director of the Centers for Disease Control and Prevention (CDC) urging the CDC to assist hospital laboratories in Lyme disease-endemic areas to implement methods to detect spirochetemia for early diagnosis and timely treatment.
  • The Milford Molecular Diagnostics Laboratory is CLIA-certified and has an approved method for qualitative detection/identification of Borrelia burgdorferi (Lyme disease) and Borrelia miyamotoi in whole blood specimens, which also includes a nested PCR and direct automated DNA sequencing method.

Statistics:

  • 145 people were included in the study, including 98 symptomatic patients residing in Lyme disease-endemic areas in the United States during a Lyme disease season in 2023.
  • 16S rRNA gene was used as a benchmark for comparison with the flaB gene and its paralogs in the Sanger sequencing-based diagnosis of Lyme disease spirochetemia.
  • The laboratory's method for detecting Borrelia burgdorferi and Borrelia miyamotoi in whole blood specimens has a specific approval from the New York State Department of Health for residents of the State of New York.

Sources:

  • " Nested PCR and Direct Automated DNA Sequencing-Based Method for Qualitative Detection/Identification of Borrelia burgdorferi (Lyme Disease) and Borrelia miyamotoi in Whole Blood Specimens" - [Source: http://www.dnalymetest.com/images/Urges_CDC_to_implement_Sanger_sequencing_for_Lyme_disease_diagnosis.pdf]
  • "Article Published in Frontier in Bioscience-Scholar" - [Source: https://www.imrpress.com/journal/FBS/17/2/10.31083/FBS31280/htm]

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