Evidence map›Paper›PMID 35418241›Full record

ArticleJournal of clinical microbiology2022

Multicenter Clinical Evaluation of Modified Two-Tiered Testing Algorithms for Lyme Disease Using Zeus Scientific Commercial Assays.

Maroun M Sfeir, Jennifer K Meece, Elitza S Theel, Dane Granger, Thomas R Fritsche, Allen C Steere, John A Branda

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical microbiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Lyme borreliosis.Nature reviews. Disease primers · 2026
    Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Evaluation of different standard and modified two-tier testing strategies for the laboratory diagnosis of lyme borreliosis in a European setting.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2024
    Article
  10. Article
  11. Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Maroun M Sfeir *UConn Health, Farmington, Connecticut, USA.
Jennifer K Meece *Marshfield Clinicgrid.280718.4 Health System, Marshfield, Wisconsin, USA.
Elitza S TheelDivision of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinicgrid.66875.3a, Rochester, Minnesota, USA.ORCID 0000-0002-6886-2294
Dane GrangerDivision of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinicgrid.66875.3a, Rochester, Minnesota, USA.
Thomas R FritscheMarshfield Clinicgrid.280718.4 Health System, Marshfield, Wisconsin, USA.
Allen C SteereMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
John A BrandaMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-6929-1219
Harvard University · USMarshfield Clinic · USMayo Clinic · USUConn Health · US

Funding

Zeus Scientific
6 · The paper itself

Abstract

Modified two-tiered testing (MTTT) algorithms for Lyme disease (LD), which involve the sequential use of orthogonal enzyme immunoassays (EIAs) without immunoblotting, are acceptable alternatives to standard two-tiered testing (STTT; EIA followed by immunoblots) provided the EIAs have been FDA-cleared for this intended use. We evaluated four Zeus Scientific LD EIAs used in two distinct MTTT algorithms for FDA review. MTTT 1 used a VlsE1/pepC10 polyvalent EIA followed by a whole-cell sonicate (WCS) polyvalent EIA. MTTT 2 used the same first-tier EIA followed by separate IgM and IgG WCS EIAs. In a retrospective phase, we compared each MTTT algorithm to STTT using archived samples from LD patients or control subjects. In a prospective phase, we used the same algorithms to analyze consecutive excess samples submitted for routine LD serology to three clinical laboratories. For the retrospective phase, MTTTs 1 and 2 were more sensitive (56% and 74%) than STTT (41%;

Indexed as

Borrelia burgdorferiLyme DiseaseAlgorithmsAnimalsAntibodies, BacterialFishesHumansImmunoglobulin MProspective StudiesRetrospective StudiesSensitivity and SpecificitySerologic TestsAntibodies, BacterialImmunoglobulin MBorreliaBorrelia burgdorferidiagnosticsimmunodiagnosticsLyme diseaseserology

Identifiers

PMID35418241
PMCPMC9116174
OpenAlexW4223903085

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.