Gold

IGeneX

Organization Address
797 San Antonio Rd
Palo Alto, CA 94303-4801

Organization Phone
(650) 424-1191

Website
www.igenex.com

Industry
Bioscience

Organization Description
IGeneX, Inc. Reference Laboratory Specializing in Lyme and Other Tick-borne Diseases The Complete Initial Lyme Panel **: includes IFA, IgG and IgM Western Blots and PCR (whole blood and serum): Panel 6050 #230 (Lyme IFA), #188, #189, #456, and #453 The Initial Lyme Panel: (Use for NY Residents) includes IgG and IgM Western Blots and PCR (whole blood and serum): Panel 5010 #188, #189 & #456, and #453 (IGeneX performs a courtesy PCR on whole blood in the above panels) Based on the data that we have collected to date, this panel will detect about 80% (sensitivity) of all Lyme patients. The overall specificity of this panel is greater than 95%. Note: If a patient's Western Blot is positive by either IgM or IgG and has only bands 31 and 41kDa, there is a chance that it is a false positive due to presence of antibodies to viruses or other spirochetes. Therefore, confirmation of band 31kDa is recommended ? Test 488 for IgM and Test 489 for IgG. Addition of this test improves specificity to greater than 97%. The follow-up test for Lyme disease, if the initial panel tests are negative, is the Lyme Dot Blot/PCR Panel - #875. This panel looks for pieces of the bacteria in urine as well as DNA of B. burgdorferi in the urine. Most physicians use an antibiotic challenge to make the test more sensitive. The antibiotic protocol, as well as the general instructions can be found in the urine testing kit available from the laboratory. You may also call IGeneX for a copy of the protocol. Based on the data collected to date, the Lyme dot-blot has sensitivity of 42% and specificity of 90%. Lyme PCR has about 30% sensitivity and >99% specificity. The combination of all of the above tests provides approximately 97% sensitivity and better than 95% specificity. Remember that Lyme disease is a clinical diagnosis and testing can support your clinical presentation. We also offer tests for the common other tick-borne diseases such as Babesia, Human Granulocytic Anaplasma (HGA) or Human Monocytic Ehrlichia (HME), and Bartonella and Rickettsia. These other tick-borne diseases are seen in approximately 20% of the patients with Lyme disease. The typical first tests to order for the other tick-borne diseases are IFA antibody tests dependent on the Region you live or have traveled in. The variety of Panels available are: 5080 Western Regional Complete Co-Infection Panel** Babesia duncani IgG & IgM, Babesia FISH, Bartonella IgG & IgM 5085 New Western Regional Complete Co-Infection Panel** Babesia duncani IgG & IgM, Babesia FISH, HME IgG & IgM, HGA IgG & IgM, Bartonella IgG & IgM, Bartonella FISH 5095 New Complete Co-Infection Panel** Babesia microti IgG & IgM, Babesia FISH, HME IgG & IgM, HGA IgG & IgM, Bartonella IgG & IgM, Bartonella FISH 5090 Complete Co-Infection Panel (Use for NY Residents) Babesia microti IgG & IgM, Babesia FISH, HME IgG & IgM, HGA IgG & IgM, Bartonella IgG & IgM. (Note: Bartonella FISH has not been submitted to New York State for approval) Many physicians also use the CD57 natural killer cell assay to monitor the immune health of their seriously ill patients. While the test may not be 100% specific for Lyme disease, it does appear useful for monitoring patients with chronic, persistent Lyme disease who are receiving immune supplements. Test kits are available with shipping materials at no charge from IGeneX, Inc. ? Call 800/832-3200 or send an e-mail to customerservice@igenex.com. Please include your name, complete mailing address and tests to be ordered. Nick S. Harris, Ph.D and Steven J. Harris, MD August 2011

Clinical Development Stage
Approved