ArticleMMWR. Morbidity and mortality weekly report2014
Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnosis of Lyme disease.
Article in MMWR. Morbidity and mortality weekly report, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Accuracy of Diagnostic Tests for Lyme Disease in Humans, A Systematic Review and Meta-Analysis of North American Research.PloS one · 2016Pooled it
- Advances in Serodiagnostic Testing for Lyme Disease Are at Hand.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Article
- A Review of the Centers for Disease Control and Prevention's Guidelines for the Clinical Laboratory Diagnosis of Lyme Disease.Journal of chiropractic medicine · 2016Review
- Lyme Borreliosis Serology: Performance of Several Commonly Used Laboratory Diagnostic Tests and a Large Resource Panel of Well-Characterized Patient Samples.Journal of clinical microbiology · 2016Article
- Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease, United States.Emerging infectious diseases · 2016Review
- Lyme Disease Serology.JAMA · 2016Article
- Precision medicine and the FDA's draft guidance on laboratory-developed tests.Nature biotechnology · 2015Article
- Update on persistent symptoms associated with Lyme disease.Current opinion in pediatrics · 2015Review
- A concise critical analysis of serologic testing for the diagnosis of lyme disease.Current infectious disease reports · 2014Article
- Review: unraveling Lyme disease.Arthritis & rheumatology (Hoboken, N.J.) · 2014Review
- Relevance of chronic lyme disease to family medicine as a complex multidimensional chronic disease construct: a systematic review.International journal of family medicine · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In 2005, CDC and the Food and Drug Administration (FDA) issued a warning regarding the use of Lyme disease tests whose accuracy and clinical usefulness have not been adequately established. Often these are laboratory-developed tests (also known as "home brew" tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. Recently, CDC has received inquiries regarding a laboratory-developed test that uses a novel culture method to identify Borrelia burgdorferi, the spirochete that causes Lyme disease. Patient specimens reportedly are incubated using a two-step pre-enrichment process, followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Specimens that test positive by immunostaining or PCR are deemed "culture positive". Published methods and results for this laboratory-developed test have been reviewed by CDC. The review raised serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis.
Indexed as
Identifiers
24739342PMC5779394What OpenQuestion holds
Registered trials
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.