Testing for Lyme Disease

Lyme disease is a serious bacterial infection caused by a tick bite and affects humans and animals.

Links on this page labeled "MEDLINE" are links to citations of medical and scientific articles from the National Institutes of Health (NIH), National Library of Medicine (NLM) MEDLINE database.

Table of Contents

General Information on Testing for Lyme Disease
Lyme Disease and False Negative or False Positive (Unreliable) Blood Test Results
Laboratories on Testing for Lyme Disease
Antibody Tests for Lyme disease (IFA, ELISA, Western blot)
The "two test" criteria as recommended by CDC - EIA/IFA and Western blot
Antigen Tests for Lyme disease (PCR, LUAT)
Other Serologic Tests for Lyme disease
Bacteria Culture Tests for Lyme disease
Neurological/Psychological Tests for Lyme disease
SPECT scan test for Lyme disease
Other tests for Lyme disease, VCS, etc.
New Tests for Lyme disease
Miscellaneous Articles and Information on Testing for Lyme Disease
Miscellaneous Articles and Information on Testing
General Testing Resources
See also:

For more information on Lyme disease


Testing for Lyme Disease

General Information on Testing for Lyme Disease

An Understanding of Laboratory Testing for Lyme Disease, JSTD, Spring/Summer 1998
Laboratory Tests for Lyme Disease, Lyme Alliance
Laboratory Tests by Tom Grier - Part 1
Laboratory Tests by Tom Grier - Part 2 - Western Blot and ELISA
ELISA and Western Blot: Lies that can kill you?
Lyme Disease (Borrelia burgdorferi), ARUP's Guide to Clinical Laboratory Testing (CLT)
FDA: Microbiological Issues in Early Localized Lyme Disease - Slide Show - 11 charts, Jul 1998
Creating a solid foundation for Lyme disease testing, CAP Today, Oct 95
Pitfalls in Lyme Testing, John Drulle M.D., 1991
EUCALB Diagnosis Index
Image of a Western blot test results - EUCALB

MEDLINE - testing or laboratory/sero diagnosis [in Title] and human AND LD - 171 on 6 Mar 00
MEDLINE - testing or laboratory/sero diagnosis and human AND LD - 1530 on 6 Mar 00
Labodia: Immunoblots and Lyme disease



Lyme Disease and False Negative or False Positive (Unreliable) Blood Test Results

Seronegative or False Negative Lyme disease - An Annotated Bibliography
Lyme disease and false negative or false positive blood test results (Links Only)
Lyme disease and false negative or false positive blood test results (Text Version)
Introduction to unreliability of Lyme disease tests
MEDLINE - Lyme disease and false negative/seronegative/false positive blood tests
Doctors on Lyme disease and false negative/seronegative/false positive blood tests
Doctors on Lyme Disease and false positive blood tests
Laboratories on Lyme disease false negative/seronegative/false positive blood tests
Other information on Lyme disease false negative/seronegative/false positive blood tests
Media articles on Lyme disease and false negative/seronegative/false positive blood tests

Introduction to unreliability of Lyme disease tests

Lyme Disease Test Kits: Potential for Misdiagnosis, FDA Medical Bulletin, Summer 1999
Interlaboratory comparison of test results for detection of Lyme disease..., J Clin Microbiol, Mar 97
Performance of 45 labs participating in proficiency testing program for LD serology,JAMA,Aug 92

MEDLINE - testing unreliable AND Lyme disease - 2 on 27 Jun 01 [1998, 1992]

Letter to the editor, D.E. Papendick, M.D., Algoma, WI, Fall 1997
Study shows Lyme testing has long way to go, Wisconsin State Laboratory of Hygiene, 1997
CDC: Evaluating Diagnostic Test Kits for Lyme Disease [1990]

Medical Diagnostic Labs Services:  Tick-Borne Diseases
III. Lyme Disease: Diagnosis - SUNY, Stony Brook

MEDLINE - Lyme disease and false negative/seronegative/false positive blood tests

MEDLINE - False Negative Reactions AND Lyme disease - 27 on 28 Jun 01
MEDLINE - seronegativ* AND Lyme disease - 102 on 28 Jun 01

MEDLINE - false AND negative AND positive AND Lyme disease - 51 on 28 Jun 01

MEDLINE - False Positive Reactions AND Lyme disease - 105 on 28 Jun 01

Doctors on Lyme disease and false negative/seronegative/false positive blood tests

Lyme Disease: The Sensible Pursuit of Answers, Kenneth B. Liegner, JCM, Aug. 1993
Neuropsychiatric Manifestation of Lyme Borreliosis, Fallon, M.D. et al., Psyc Qtrly, 63/1, 1992
The Neuropsychiatric Assessment of Lyme Disease, Robert Bransfield, M.D.
Seronegative Lyme Disease, Robert Bransfield, M.D.
Lyme Disease by Dr Joseph Burrascano - Conn's Current Therapy - 1997 (7 pages)
Advanced Topics in Lyme Disease, Joseph J. Burrascano Jr., M.D., May 2000

Doctors on Lyme Disease and false positive blood tests

Recognition and Management of Lyme Disease, by Verdon and Sigal, AFP, August 1997
Lyme Disease, The Health Gazette, Tallahassee, Florida, Karl Hempel, M.D.

Laboratories on Lyme disease false negative/seronegative/false positive blood tests

Rheumatology Diagnostics Laboratory - Lyme [disease] Serology
Labodia Lyme G kit insert
Labodia Lyme M kit insert
Virus Alert, The Bulletin of The Irish National Virus Reference Laboratory, Issue 03/94

Other information on Lyme disease false negative/seronegative/false positive blood tests

LDF: Nine reasons for false negative Lyme disease test results
NIH NIAID: Diagnosis of Lyme Disease, Division of Microbiology and Infectious Diseases
NIH: Conference on the Laboratory Diagnosis of Lyme Disease, Aug 98
FDA Public Health Advisory: Assays for Antibodies to Borrelia burgdorferi
Knowing the Enemy - New Image of Lyme Disease, PNNL, ER News - April/May 1997
Joint Pain and Swelling: Could It Be Lyme Arthritis? David H. Wang, MD; Jesse L. Goodman, MD
LD Guidelines for MN Clinicians: Epidemiology, Microbiology, Diagnosis, Treatment, Prevention
Univ of Iowa Family Practice Handbook: Infectious Disease: Zoonoses Not Covered Elsewhere
NIH Guide: Neurological Aspects of Lyme Disease, Volume 22, Number 5, February 5, 1993
Seronegative LD. Dissociation of specific T- and B-lymphocyte responses to Bb, NEJM 1988

The Consequences of Overdiagnosis and Overtreatment of Lyme Disease..., Annals 1 Mar 98
CDC: Improved Serodiagnostic Testing for LD: ...a Multicenter Serologic Evaluation, Apr-Jun 96
CDC: Recom. for Test Perf. and Interpretation from Second Natl Conf. on Serologic Diag. of LD

Lyme Disease Update, Darrell T. Hulisz, Pharm.D., US Pharmacist, Sep 97
How to Diagnose and Treat Lyme Disease in Children - Canadian Paediatric Society - 1992

Media articles on Lyme disease and false negative/seronegative/false positive blood tests

Log Cabin Democrat Features: Medical community split on Lyme realities 6/22/97
Overdiagnosis of Lyme disease - Newspaper Article Synopsis, 3/19/98



Laboratories on Testing for Lyme Disease

Testing laboratories:
IgeneX, Inc., Palo Alto, California
BBI Clinical Laboratories, New Britain, Connecticut
Medical Diagnostic Laboratories (MDL), Mt. Laurel, New Jersey
Specialty Laboratories, Santa Monica, California
Laboratory Corporation of America, Burlington, North Carolina
IMUGEN, Inc. via Sunrise Medical Laboratories
Diagnostic (production) laboratories:
Chembio Diagnostics Systems Inc., Medford, New York
Hardy Diagnostics, Santa Maria, California
Immunetics, Inc., Cambridge, Massachusetts
Immuno-Biological Laboratories (IBL) - Hamburg, Germany
INOVA Diagnostics, Inc., San Diego, California
KMI Diagnostics, Inc.
MRL Diagnostics, Cypress, California
Wampole Laboratories, Cranbury, New Jersey
Zeus Scientific, Inc., Raritan, New Jersey
Testing laboratories:

IgeneX, Inc., Palo Alto, California

IGeneX Inc, Reference Laboratory
IGeneX Inc, Lyme Disease Overview
IGeneX Inc, Lyme Disease ELISA
IGeneX Inc, Western Blot - Lyme Disease
IGeneX Inc, Antigen Detection - Lyme Disease - Lyme Dot Blot Assay (LDA) and Reverse WB
IGeneX Inc, Lyme Disease PCR
IGeneX Inc, Neurological Lyme Disease Testing
IGeneX Inc, Lyme Disease - Which Tests To Perform?
Tick Test Request Form - Igenex

BBI Clinical Laboratories, New Britain, Connecticut

BBI Clinical Laboratories - Home
Specialty Laboratories Purchases Certain Assets of BBI Clinical Laboratories, PR, 20 Feb 01
New Lyme Disease Assay - C6 Lyme Peptide ELISA (VlsE), BBI, 23 Aug 00
Tick Testing for Lyme Disease - BBI Clinical Laboratories
Tick-Borne Diseases - BBI Clinical Laboratories
Clinical Progression of Lyme Disease - BBI Clinical Labs
Confirmatory Testing for Tick-Borne Diseases - BBI Clinical Labs - Western Blot

Medical Diagnostic Laboratories (MDL), Mt. Laurel, New Jersey

Medical Diagnostic Laboratories (MDL)
Medical Diagnostic Laboratories: Tick-Borne Diseases
Medical Diagnostic Laboratories: The Polymerase Chain Reaction (PCR)
Medical Diagnostic Laboratories: Diagnosis and Treatment of Lyme Disease
Medical Diagnostic Laboratories: Test Requisition Form
Medical Diagnostic Laboratories Service Fees: Tick-Borne Diseases
MDL: Search Our Site, manual - 7 for lyme, 15 for burgdorferi on 28 Jun 01

Specialty Laboratories, Santa Monica, California

Specialty Laboratories
Specialty Laboratories - Search for a test
Specialty Laboratories Search results for burgdorferi - 33 on 28 Jun 01
Specialty Laboratories - Test Methodology Guide
Specialty Laboratories - #8944: Borrelia burgdorferi C6 Peptide Antibody DetectR
Specialty Laboratories Purchases Certain Assets of BBI Clinical Laboratories, PR, 20 Feb 01

Laboratory Corporation of America, Burlington, North Carolina

Laboratory Corporation of America
LabCorp Directory of Services Search, manual for lyme - 12 tests found on 28 Jun 01

Diagnostic (production) laboratories:

Chembio Diagnostics Systems Inc., Medford, New York

Chembio Diagnostic Systems Inc.

Hardy Diagnostics, Santa Maria, California

HARDY DIAGNOSTICS - Manufacturers and distributors of microbiology culture media.
Hardy Diagnostics - Products dealing with Borellia burgdorferi (Lyme disease

Immunetics, Inc., Cambridge, Massachusetts

Immunetics, Inc. Homepage
Table of Contents
C6 B. burgdorferi (Lyme) ELISA Kit - Immunetics
QualiCodeTM B. burgdorferi IgG/IgM Western Blot Kits - Immunetics
Immunetics receives FDA approval for more accurate LD test w/o vaccine cross-reactivity,7 Jun 01
Company: Press Releases - Immunetics

Immuno-Biological Laboratories (IBL) - Hamburg, Germany

Immuno-Biological Laboratories (IBL)
IBL ONLINE CATALOGUE - Infectious diseases

INOVA Diagnostics, Inc., San Diego, California

INOVA Diagnostics, Inc.
INOVA Diagnostics, Inc. | Products

KMI Diagnostics, Inc.

KMI Diagnostics, importer/distributer of autoimmune, infectious disease/other diagnostic assays
Lyme Disease, ELISA and Western Blot technology, KMI Diagnostics, Inc.
Borrelia (Lyme)

MRL Diagnostics, Cypress, California

MRL Diagnostics
Lyme Disease Test Kits - MRL Diagnostics
Lyme Disease Enzyme-linked Immunosorbent Assay (ELISA) - MRL Diagnostics
Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test - MRL Diagnostics

Wampole Laboratories, Cranbury, New Jersey

Wampole Laboratories
Wampole Laboratories search for lyme - 24 on 28 Jun 01
Wampole Laboratories - Infectious Disease

Zeus Scientific, Inc., Raritan, New Jersey

Zeus Scientific, Inc. Homepage
Zeus Scientific, Inc.- IFA Assays Bacterial Diseases
Zeus Scientific, Inc.- ELISA Assays Bacterial Diseases

IMUGEN, Inc. via Sunrise Medical Laboratories

Sunrise Home Page
Imugen Lyme Testing via Sunrise Medical Laboratories
IMUGEN receives Lyme disease patent, 10 Jul 00
IMUGEN, Inc. Receives Patent for Exclusive LD Technology - [differentiates Lyme vaccine response from true Lyme infection], 6 Jul 00
Patent No. 6,045,804, Method for detecting B. burgdorferi infection, USPTO, 7 Mar 96



Antibody Tests for Lyme disease (IFA, ELISA, Western blot)

IFA testing for Lyme disease
ELISA testing for Lyme disease
Western blot testing for Lyme disease

IFA testing for Lyme disease

MEDLINE - Fluorescent Antibody [in Title] AND Lyme disease - 35 on 28 Jun 01
MEDLINE - Fluorescent Antibody Technique AND human AND Lyme disease -453 on 28 Jun 01
MEDLINE - Fluorescent Antibody Technique AND Lyme disease - 680 on 28 Jun 01

MEDLINE - Indirect Fluorescent Antibody (IFA) [in Title] AND Lyme disease - 5 on 28 Jun 01
MEDLINE - Indirect Fluorescent Antibody (IFA) AND human AND LD - 122 on 28 Jun 01
MEDLINE - Indirect Fluorescent Antibody (IFA) Technique AND Lyme disease-181 on 28Jun01

MEDLINE - indirect immunofluorescence [in Title] AND Lyme disease - 13 on 28 Jun 01
MEDLINE - indirect immunofluorescence AND Lyme disease - 244 on 28 Jun 01

MEDLINE - Direct Fluorescent Antibody Technique AND Lyme disease - 44 on 28 Jun 01

MEDLINE - surface immunofluorescence assay (SIFA) AND Lyme disease - 11 on 20 Sep 99
MEDLINE - Fluoroimmunoassay AND Lyme disease - 7 on 20 Sep 99
MEDLINE - solid-phase fluorescence immunoassays (FIA-L) AND LD - 2 on 20 Sep 99
MEDLINE - Fluorescence Polarization Immunoassay AND Lyme disease - 1 on 20 Sep 99

ELISA testing for Lyme disease

MEDLINE - Enzyme-Linked Immunosorbent Assay (ELISA) [in Title] AND human AND LD - 79 on 28 Jun 01
MEDLINE - Enzyme-Linked Immunosorbent Assay (ELISA) AND human AND LD - 916 on 28 Jun 01
MEDLINE - Enzyme-Linked Immunosorbent Assay (ELISA) AND LD - 1,139 on 28 Jun 01

MEDLINE - indirect enzyme immunoassay (IDEIA) AND Lyme disease - 87 on 20 Sep 99
MEDLINE - sonicate ELISA AND Lyme disease - 16 on 20 Sep 99
MEDLINE - flagellum ELISA AND Lyme disease - 9 on 20 Sep 99
MEDLINE - Antigen-Capture Enzyme-Linked Immunosorbent Assay AND LD - 8 on 20 Sep 99

Western blot testing for Lyme disease

MEDLINE - Western Immunoblotting/...blots [in Title] AND Lyme disease - 70 on 28 Jun 01
MEDLINE - Western Immunoblotting/...blots AND human AND LD - 533 on 28 Jun 01
MEDLINE - Western Immunoblotting/immunoblots/blottting/blots AND LD - 738 on 28 Jun 01

MEDLINE - immunodot AND Lyme disease - 5 on 20 Sep 99

"And the bands played on" - Western blot serological testing for Lyme disease
CDC: Western Blot diagnostic testing
CDC: Recommendations for Test Perf. and Interpr. ... Serologic Diag. of Lyme Disease
LymeNet Newsletter Volume 4 Issue 13 - Understanding the Western Blot
Explanation of the Lyme Disease Western Blot by Carl Brenner
Laboratory Tests by Tom Grier - Part 2 - Western Blot and ELISA
IGeneX Inc, - Western Blot - Lyme Disease
Simultaneous ELISA/Western Blot Testing in Evaluation of Patients for ...Lyme Disease
Western Blot - BBI Clinical Laboratories Inc
MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test
Immunoblot interpretation criteria for serodiagnosis of early Lyme disease, J Clin Microbiol 1995



The "two test" criteria as recommended by CDC - EIA/IFA and Western blot

CDC: Recommendations for Test Performance and Interpretation on Serologic Diagnosis of Lyme Disease, 11 Aug 95

CDC: Improved Serodiagnostic Testing for Lyme Disease: Results of a Multicenter Serologic Evaluation, 1996

ILADS' Position Paper on the CDC's Statement Regarding Lyme Diagnosis
Simultaneous ELISA/Western Blot Testing in Evaluation of Patients for ...Lyme Disease
ACP Recommendations Opposed by Laboratory Scientists
ELISA and Western Blot: Lies that can kill you?

Google Search: criteria CDC ELISA Western blot lyme disease two tier OR tiered-30 on 28 Jun 01
Google Search: criteria CDC ELISA Western blot lyme disease two-test - 25 on 28 Jun 01



Antigen Tests for Lyme disease (PCR)

MEDLINE - antigen test and human AND Lyme disease - 102 on 20 Sep 99
MEDLINE - antigen test AND Lyme disease - 132 on 20 Sep 99

PCR testing for Lyme disease

MEDLINE - Polymerase Chain Reaction (PCR) [in Title] and human AND LD - 87 on 20 Sep 99
MEDLINE - Polymerase Chain Reaction (PCR) [in Title] AND Lyme disease - 131 on 20 Sep 99
MEDLINE - Polymerase Chain Reaction (PCR) and human AND Lyme disease-349 on 20 Sep 99
MEDLINE - Polymerase Chain Reaction (PCR) AND Lyme disease - 522 on 20 Sep 99

MEDLINE - Nested Polymerase Chain Reaction (PCR) AND Lyme disease - 43 on 20 Sep 99

MEDLINE - Polymerase Chain Reaction (PCR) and false negative AND LD - 8 on 20 Sep 99
MEDLINE - Polymerase Chain Reaction (PCR) and false positive AND LD - 9 on 20 Sep 99
MEDLINE - Polymerase Chain Reaction (PCR) and cross-react* AND LD - 14 on 20 Sep 99

IGeneX Inc, - Polymerase Chain Reaction - Lyme Disease - Multiplex PCR
Polymerase chain reaction detection of Lyme disease, Am J Clin Pathol, May 96



Other Serologic Tests for Lyme disease

MEDLINE - Agglutination Tests AND Lyme disease - 34 on 20 Sep 99
MEDLINE - Antinuclear Antibodies (ANA) AND Lyme disease - 20 on 20 Sep 99
MEDLINE - Blood Sedimentation AND Lyme disease - 7 on 20 Sep 99
MEDLINE - Borreliacidal Antibody Test (BAT) AND Lyme disease - 8 on 20 Sep 99
MEDLINE - Cytotoxicity Tests AND Lyme disease - 3 on 20 Sep 99
MEDLINE - Diagnostic Reagent Kits AND Lyme disease - 12 on 20 Sep 99
MEDLINE - Immune Complex Test AND Lyme disease - 5 on 20 Sep 99
MEDLINE - Radioimmunoassay AND Lyme disease - 8 on 20 Sep 99
MEDLINE - Warthin-Starry Stain AND Lyme disease - 13 on 20 Sep 99 - latest = Nov/Dec 1997

MEDLINE - Serologic Test/Tests/Testing [in Title] and human AND LD - 31 on 20 Sep 99
MEDLINE - Serologic Test/Tests/Testing and human AND Lyme disease - 390 on 20 Sep 99
MEDLINE - Serologic Test/Tests/Testing AND Lyme disease - 431 on 20 Sep 99



Bacteria Culture Tests for Lyme disease

MEDLINE - culture and human AND Lyme disease - 180 on 20 Sep 99
MEDLINE - culture and human and blood or serum AND Lyme disease - 76 on 20 Sep 99
MEDLINE - culture and human and skin/rash/migrans/lesion AND LD - 72 on 20 Sep 99
MEDLINE - culture and human and tissue AND Lyme disease - 27 on 20 Sep 99
MEDLINE - culture and human and CSF AND Lyme disease - 25 on 20 Sep 99
MEDLINE - culture and human and synovial fluid AND Lyme disease - 9 on 20 Sep 99
MEDLINE - culture and human and urine AND Lyme disease - 7 on 20 Sep 99
MEDLINE - staining and human AND Lyme disease - 65 on 20 Sep 99

The Difficulty of Culturing Spirochetes, Tom Grier
Bb detected by culture, PCR in clinical relapse of disseminated Lyme borreliosis, Ann Med, Jun 99
Implication of the Recent Lyme Culture Technique for the Diagnosis of Syphilis, 12th ICLD, Apr 99
A Proposal for the Reliable Culture of Bb from Patients with Chronic LD, Even from Those Previously Aggressively Treated, Infection 26 (1998) 364-367



Neurological or Psychological Tests for Lyme disease

MEDLINE - Neurological Tests AND Lyme disease - 88 on 29 Jun 01
MEDLINE - Neurological Diagnostic Techniques AND Lyme disease - 56 on 29 Jun 01
MEDLINE - nerve conduction AND Lyme disease - 22 on 29 Jun 01
MEDLINE - Evoked Potentials AND Lyme disease - 15 on 29 Jun 01
MEDLINE - EMG AND Lyme disease - 8 on 29 Jun 01

MEDLINE - Psychological or Neuropsychological Tests AND Lyme disease - 35 on 29 Jun 01
MEDLINE - Magnetic Resonance Imaging (MRI) [in Title] AND Lyme disease - 14 on 29 Jun 01
MEDLINE - Magnetic Resonance Imaging (MRI) AND Lyme disease - 100 on 29 Jun 01
MEDLINE - brain imaging AND Lyme disease - 3 on 29 Jun 01
MEDLINE - perfusion or hypoperfusion AND Lyme disease - 4 of 6 citations found on 5 March 00

IGeneX Inc, - Neurological Symptoms and testing of Lyme Disease
Functional brain imaging and neuropsych testing in Lyme disease, Fallon, Clin Infect Dis Jul 1997
Conference Abstract: Psychiatric Aspects of LD and the Use of SPECT Imaging, Apr 97
Brain Scans Distinguish Lyme Disease From Primary Psychiatric Disorders



SPECT scan test for Lyme disease

MEDLINE - tomographic or tomography AND Lyme disease - 108 on 29 Jun 01
MEDLINE-single photon emission computed tomographic (SPECT) imaging and LD-12 on 6Aug00

Atlas of Brain Perfusion SPECT: Contents
Atlas of Brain Perfusion SPECT: Lyme Disease

The Whole Brain Atlas - basic SPECT imaging
Lyme Encephalopathy: overlay -- Slice #20 (see other slices)

Tc-99m HMPAO Brain SPECT Imaging in Chronic Lyme Disease
SPECT Imaging in Dementia
Conference Abstract: Psychiatric Aspects of LD and the Use of SPECT Imaging, April 28-30,1997
Brain Scans Distinguish LD From Primary Psychiatric Disorders, Doctor's Guide, 24 Oct 97
Neurologic Lyme Disease, Brian A. Fallon, MD, 12th ICLD, April 9, 1999
Functional brain imaging and neuropsych testing in LD, Fallon, abstract, Clin Infect Dis 1997 Jul;25
Brain Scans Distinguish LD From Primary Psychiatric Disorders, 24 Oct 97
Lyme Disease: A Neuropsychiatric Illness, by Fallon, M.D., M.P.H., and Nields, M.D., 1994
Lyme Disease and Psychiatric Disorders, [P&S Journal:Winter:98]



Other tests for Lyme disease, VCS, etc.

Visual contrast sensitivity (VCS) Test Center - tests for neurotoxins



New Tests for Lyme Disease

FDA Premarket Notification 510(k)s for Lyme Disease Tests from 1987 thru June 2001

New test - circa 6 Jun 01, the "C6 test" - Immunetics, Inc. version C6 Lyme Peptide ELISA
New test - circa 1 Mar 01, Announced by Researcher at Children's Hospital of Philadelphia
New test - circa Aug 00, Boston Biomedica, Inc. Announces New Lyme Disease Test
New test - circa Nov 99, Schutzer, et al. - tests for immune complexes
New test - circa Oct 99, Immunetics/QualiCode Western Blot Kits
New test - circa Sep 99, "IgG Avidity" test - France
New test - circa Feb 99, PreVue, in-office test by Chembio Diagnostic Systems
New test - circa Nov 98, new culturing technique, Phillips & Mattman
New test - circa Aug 98, Mayo/Imugen, discriminates vaccine from Lyme disease
New test - circa Mar 97, Uconn/Institute Merieux - Connaught/Krider & Bushmich

New test - circa 6 Jun 01, the "C6 test" - Immunetics, Inc. version C6 Lyme Peptide ELISA

NIAID Collaboration Yields New Test [C6 test] For Lyme Disease, ScienceDaily Mag, 21 Jun 01
NIAID Collaboration Yields New Test for Lyme Disease, NIH, 18 Jun 01 [pdf]

New test - circa 1 Mar 01, Announced by Researcher at The Children's Hospital of Philadelphia

MEDLINE: New method for detection of Bb antigen complexed to antibody in seronegative LD.
CHOP scientist develops Lyme disease test, Philadelphia Business J, 12 Mar 01
New Test for Lyme Disease Described, Reuters Health, 1 Mar 01
More Accurate Test for LD... at The Children's Hospital of Philadelphia, PRN, 1 Mar 01

New test - circa 23 Aug 00, BBI Announces New Lyme Disease Test [C6 Lyme Peptide ELISA]

BBI: C6 Lyme Peptide ELISA (VlsE) - New Test Announcement
BBI: New Lyme Disease Assay - C6 Lyme Peptide ELISA (VlsE), 23 Aug 00
BBI: C6 Lyme Peptide ELISA (VlsE) Technical Bulletin #107
Sensitive and Specific Serodiagnosis of LD by ELISA...JCM Dec 99 -- Liang et al. 37 (12): 3990
BBI Announces the Availability of a New Test for Lyme Disease, PRNewswire, 28 Aug 00
A New Test For Lyme Disease, Hartford Courant, 26 Aug 00 [C6 Lyme Peptide ELISA]
New Lyme Disease Assay, BBI, 23 Aug 00
Boston Biomedica, Inc. Announces New Lyme Disease Test
Lyme - Using Cassettes, LDF, 22 Aug 00

New test - circa Nov 99, Schutzer, et al. - tests for immune complexes

Test Detects Lyme Disease in First Week, Dermatology Times, Feb 00
Bb-Specific Immune Complexes in Acute Lyme Disease, JAMA 1999 - for JAMA subscribers only
New test detects Lyme disease earlier, Bergen Record, 24 Nov 99
PubMed: Bb-specific immune complexes in acute LD, Schutzer SE, et al., JAMA. 1999 Nov 24
New Test May Detect Early Lyme Disease, Medscape (Reuters Health), 30 Nov 99
Augusta Georgia: technology@ugusta: Lyme disease test catches infection earlier, AP, 25 Nov 99
New test detects Lyme disease earlier, Bergen Record, November 24, 1999
New Test for Lyme Disease Developed, WebMD Medical News, 23 Nov 99
Test detects Lyme disease quickly, Detroit News, 11/24/99
Early, Accurate Test To Diagnose Active Lyme Disease, UMDNJ--Media Alert, 9-24-99

New test - circa Oct 99, Immunetics/QualiCode Western Blot Kits

FDA Approves Immunetics QualiCode Bb IgG and IgM WB Kits for diagnosing LD, 1 Oct 99
FDA: K991062, 510(k) Safety and Effectiveness Summary, IgM WB Kit, 9 Sep 99 - pdf file
FDA: K991063, 510(k) Safety and Effectiveness Summary, IgG WB Kit, 9 Sep 99 - pdf file

New test - circa Sep 99, "IgG Avidity" test - France

PubMed: Differentiation...early/late...Lyme borreliosis by...IgG avidity, Guerineau, Lancet,25Sep99
Improved Blood Test May Facilitate Diagnosis of Lyme,Lancet 24 Sep 99, [IgG avidity - France]
Test May Better Diagnose Lyme Disease - HealthScout September. 23, 1999

New test - circa Feb 99, PreVue, in-office test by Chembio Diagnostic Systems in Medford, NY

Dattwyler/Luft/Stony Brook/Brook Biotechnology, Inc/Chembio Diagnostic Systems/PreVue
Wampole Laboratories Rapid Test For LD Cleared For Use By FDA, Cranbury, NJ 15 Apr99
New Test for Lyme Disease Cleared, Medscape Newsbriefs - April 1999
New Test for Lyme Disease Speeds Up Early Detection, Jefferson Health System, 23 Feb 99
FDA Clears New Test For LD, PreVue B. burgdorferi Antibody Detection Assay, 16 Feb 99
FDA: FDA Clears New Test For Lyme Disease, Talk Paper, February 16, 1999
New test for Lyme disease approved, MSNBC, 16 Feb 99
ABCNEWS.com : Test Catches Lyme Disease Early, 16 Feb 99
Medscape New Products - April 1999
Medscape, Updates From The FDA, [Medical Tribune 40(6):9, 1999
Intellihealth, ROCKVILLE, MD, Feb 17 (FDA)
FDA Approves New Test For Lyme Disease, 17 Feb 99

New test - circa Nov 98, new culturing technique, Phillips & Mattman

PubMed: A proposal for reliable culture of Bb..., Phillips; Mattman et al., Infection 1998 Nov-Dec
Bacterial Bombshell, NOW On / NewsFront/ Feature, JUNE 3-9, 1999
News Release: Lyme Disease Discovery Raises New Concerns - culture technique, 9 Apr 99
New test reveals more about Lyme disease, Reuters Health, 4 Jan 99
New test for Lyme unveiled, from the Connecticut Post, 4 Jan 99
New test reveals more about Lyme disease, SOURCE: Infection 1998;26:364-367, 4 Jan 99
New culture method for detecting Lyme disease, abstract, Phillips, Mattman, et al., 1998
Dr. Phillips and the New Lyme Test (audio file)
LA: Study Reports New Lab Test For Lyme, Phillips/Mattman culturing technique

New test - circa Aug 98, Mayo/Imugen, discriminates vaccine from Lyme disease

New Tests Set Standard for Diagnosing LD, Mayo/Imugen, Inc., "discriminates between vaccine and true Lyme infection"

New test - circa Aug 98, Mayo/Imugen, discriminates vaccine from Lyme disease

New Tests Set Standard for Diagnosing LD, Mayo/Imugen, Inc., "discriminates between vaccine and true Lyme infection"

New test - circa Mar 97, Uconn/Institute Merieux - Connaught/Krider & Bushmich

UConn receives additional $100,000 in grant funding for Lyme disease researchers, 31 Mar 99
UConn: Contract renewed for new Lyme disease test - March 28, 1997



Miscellaneous Articles and Information on Testing for Lyme Disease

Lyme Disease: Testing the Waters, 14th Int. Sci. Conference on Lyme Disease, 23 Apr 01
[Full text] Serologic Testing for Lyme Disease, Letters, JAMA, Vol. 284 No. 6, 9 Aug 00
Borreliacidal Antibody Test for Serodiagnosis of Lyme Borreliosis, 13th Int. Sci. Conf. LD, Mar 00
CDC...criteria for surveillance of LD not appropriate for clinical diagnosis, Medscape, Sep 99
CDC: Erratum: Vol. 48, No. RR-7, Effect of Vaccination on Serologic Diagnosis of LD, 24Sep99
JAMA Vol. 282 No. 1 pp 62-66, Role of Serology in the Diagnosis of Lyme Disease, July 1999
FDA: Lyme Disease Test Kits: Potential for Misdiagnosis, FDA Medical Bulletin * Summer 1999
Serology Useful to Support a Clinical Diagnosis of Lyme Disease, JAMA 1999;282:62-66,79-80.
Doctors Ticked Off on Lyme Disease Diagnosis, Clinical Psychiatry News 27(6):8, 1999
NIH/NIAID: Conference on the Laboratory Diagnosis of Lyme Disease (August 30 1998)
NIAID/CDC/ORD-Sponsored Conference on the "Laboratory Diagnosis of Lyme Disease"
Simultaneous Elisa And Western Blot Testing In Evaluation..., Abstract, April 28-30, 1997
Study shows Lyme testing has long way to go - March 1997
Letter to the editor - Response to March 1997 letter - Fall 1997
Interlaboratory comparison of test results for detection of LD ...J Clin Microbiol 1997 Mar
Discrimination of OspA Vaccination from Spirochete Infection - Jan 1997
Infectious Disease - Sigal on Lyme disease testing, March 16, 1998
B. burgdorferi in the Urine of Treated Patients with CLD Symptoms, Infection 24 (1996) No.5
Improved Serodiagnostic Testing for Lyme Disease - 1996 - Steere, Sigal, et al.
Creating a solid foundation for Lyme disease testing, CAP Today (Vol. 9, No. 10), Oct 1995
CDC: Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease, 11 Aug 95 - (so called "Dearborn criteria")
LA: Reasons Why Seronegative Test Results Might Occur



Miscellaneous Articles and Information on Testing

FDA Examines Regulations Governing Diagnostic Tests, Reuters Health, 15 Aug 00
FDA Considering New Waiver Criteria for Simple, Point-of-Care Diagnostic Tests



General Testing Resources

Blood and Urine Results Interpretation - from Laboratory Test Handbook 4th ed.
Blood test descriptions 1 Comprehensive Wellness Profile (CWP) from HealthChoice
Blood test descriptions 1 Comprehensive Wellness Profile (CWP) from HealthChoice
Laboratory Tests at The University of Pennsylvania School of Medicine

ARUP Laboratories - excellent reference for test details and interpretation
ARUP Guide to Clinical Laboratory Testing (Associated Regional and University Pathologists)
ARUP User's Guide (Associated Regional and University Pathologists)
MedCalc Connect(r) Catalog
Health Logic Optimum Health Plan

Laboratory Interpretation - Montrose Clinic
Blood Panel Explanation - BaySport
Laboratory Reference - Ranges



See also:

Food and Drug Administration (FDA) and tests for Lyme disease



For more information on Lyme disease see: Lots Of Links On Lyme Disease

Comments or questions concerning this page should be directed to Art Doherty.

Last updated on 1 July 2001 by
Art Doherty
Lompoc, California
doherty@utech.net