Abstract
There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme disease agent (Borrelia burgdorferi sensu stricto). There are many diagnostic tests for LD available in North America, all of which have some performance issues, and physicians are concerned about the appropriate use and interpretation of these tests. The objective of this systematic review is to summarize the North American evidence on the accuracy of diagnostic tests and test regimes at various stages of LD. Included in the review are 48 studies on diagnostic tests used in North America published since 1995. Thirteen studies examined a two-tier serological test protocol vs. clinical diagnosis, 24 studies examined single assays vs. clinical diagnosis, 9 studies examined single immunoblot vs. clinical diagnosis, 7 studies compared culture or PCR direct detection methods vs. clinical diagnosis, 22 studies compared two or more tests with each other and 8 studies compared a two-tiered serological test protocol to another test. Recent studies examining the sensitivity and specificity of various test protocols noted that the Immunetics® C6 B. burgdorferi ELISA™ and the two tier approach have superior specificity compared to proposed replacements, and the CDC recommended western blot algorithm has equivalent or superior specificity over other proposed test algorithms. There is a dramatic increase in test sensitivity with progression of B. burgdorferi infection from early to late LD. Direct detection methods, culture and PCR of tissue or blood samples were not as sensitive or timely compared to serological testing. It was also noted that there are a large number of both commercial (n = 42) and in-house developed tests used by private laboratories which have not been evaluated in the primary literature.
Highlights
Lyme disease (LD) is the most common tick-borne infection in North America [1,2]
Lyme disease in North America is caused by Borrelia burgdorferi sensu stricto and recently Borrelia mayonii was identified and may be responsible for a proportion of cases, the performance of LD diagnostic tests to identify B. mayonii infection is not available [8]
This systematic review was preceded by a scoping review conducted by Greig et al (2016) to identify, classify and characterise what is the current state of scientific knowledge on surveillance methods, prevention and control strategies, diagnostic tests, risk factors, and societal attitudes and perceptions towards LD in humans and B. burgdorferi in tick vectors and vertebrate reservoirs [26]
Summary
Lyme disease (LD) is the most common tick-borne infection in North America [1,2]. It was first publically recognized in the United States in 1975 in the towns of Lyme and Old Lyme Connecticut as a result of an investigation into 51 cases (39 children) with a similar form of arthritis, the first case was describe five years earlier by a dermatologist in Wisconsin [3,4]. Lyme disease in North America is caused by Borrelia burgdorferi sensu stricto (hereafter called B. burgdorferi) and recently Borrelia mayonii was identified and may be responsible for a proportion of cases, the performance of LD diagnostic tests to identify B. mayonii infection is not available [8]. In Europe B. afzelii, B. garinii, B. burgdorferi, B. spielmanii, B. bissettii and B. bavariensis cause disease with a wider variety of symptoms than reported in North America; a number of genospecies including B garinii occur in Asia
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