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A First-Tier Rapid Assay for the Serodiagnosis of Borrelia burgdorferi Infection
Maria J. C. Gomes-Solecki, DVM;
Gary P. Wormser, MD;
David H. Persing, MD;
Bernard W. Berger, MD;
John D. Glass, PhD;
Xiaohua Yang, MS;
Raymond J. Dattwyler, MD
Arch Intern Med. 2001;161:2015-2020.
Background The present recommendation for the serologic diagnosis of Lyme disease
is a 2-tier process in which a serum sample with a positive or equivocal result
by an enzyme-linked immunosorbent assay (ELISA) or immunofluorescent assay
is then followed by supplemental testing by Western blot. Our laboratory has
developed recombinant chimeric proteins composed of key Borrelia epitopes. These novel antigens are consistent and are easily
standardized.
Methods We adapted these recombinant proteins into a new immunochromatographic
format that can be used as a highly sensitive and specific first-tier assay
that can be used to replace the ELISA or immunofluorescent assay.
Results This rapid test was equally sensitive (P>.05)
and more specific (P<.05) than a frequently used
commercial whole cell ELISA. The overall clinical accuracy achieved on agreement
studies among 3 Lyme research laboratories on clinically defined serum panels
was shown to be statistically equivalent to the commercial ELISA. The assay
can detect anti–Borrelia burgdorferi antibodies
in either serum or whole blood.
Conclusion This sensitive and specific rapid assay, which is suited for the physician's
office, streamlines the 2-tier system by allowing the physician to determine
if a Western blot is necessary at the time of the initial office visit.
From Brook Biotechnologies, Inc, Stony Brook, NY (Drs Gomes-Solecki
and Glass); the Departments of Medicine (Ms Yang and Dr Dattwyler) and Dermatology
(Dr Berger), State University of New York at Stony Brook; Westchester Medical
Center, New York Medical College, Valhalla, NY (Dr Wormser); and Division
of Clinical Microbiology, Mayo Clinic, Rochester, Minn (Dr Persing). Dr Persing
is now with Corixa Corporation, Seattle, Wash. Dr Dattwyler has financial
interests in Brook Biotechnologies, Inc.
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