A modified two-tiered testing algorithm (MTTT; ZEUS Scientific) for Borrelia burgdorferi was recently FDA-cleared. We evaluated the MTTT algorithm to confirm Lyme disease and compared the findings in parallel with those obtained using standard two-tiered testing (STTT). Medical records from patients who submitted sera for laboratory confirmation of Lyme-like disease were reviewed. Three hundred twenty patient samples were run by the STTT and MTTT approaches and the results compared. Positive STTT samples were also positive by MTTT (94%). The MTTT confirmed the illness in 116 subjects (36%, P = 0.007), and 30 (26%) were negative by the STTT. Increased MTTT sensitivity was seen (P = 0.0005) during early infection. MTTT was insufficiently sensitive to identify other non-Borrelia spp. infections. Routine adoption of MTTT would improve sensitivity for early Lyme disease attributable to B. burgdorferi, but may not capture illness attributed to B. mayonii and B. miyamotoi.

Lyme disease

Borrelia burgdorferi

Antibodies

Standard two-tiered testing (STTT)

Modified two-tiered testing (MTTT)

© 2022 Elsevier Inc. All rights reserved.