Specializing in Lyme Disease and Associated Tick-Borne Diseases Over 20 Years Experience IGeneX Inc. What You Should Know About Lyme Disease What Is Lyme Disease? How Is Lyme Disease Diagnosed? Lyme disease is a world-wide infectious disease caused by microscopic bacteria carried by tiny ticks. Lyme disease is a clinical diagnosis. This means that the physician makes the diagnosis using your clinical history and symptoms. If a physician observes an EM rash, a diagnosis of Lyme disease will be made. If a rash is not seen by a physician, laboratory tests are often needed to help with the diagnosis. B. burgdorferi, a spiral bacteria that causes Lyme disease, seen through a microscope. How Is Lyme Transmitted? There are several species of deer ticks across the US that become infected with the spiral bacterium, Borrelia burgdorferi. Unsuspecting humans and animals walking through woodlands and brushy areas may be bitten by a tick and never know it. The tiny ticks, some the size of poppy seeds, may stay on your body for hours to days. The tick engorges itself with blood. If infected, the spirochete is transmitted to the bloodstream of the person or animal during the bite. Can Ticks Be Tested? Not all ticks are infected with the spirochete bacterium, B. burgdorferi. If the tick was saved, it can be tested by our laboratory for the presence of the Lyme bacteria using a test called PCR. We also test ticks for Babesia, Ehrlichia, Bartonella henselae and Rickettsia (Rocky Mountain Spotted Fever). These pathogens are also carried by ticks. A Tick Test Request Form is available on our website. What If I Suspect Exposure? Early recognition is important. If you find a tiny tick attached to your skin, if you were in a known tick-infested area, or if you have symptoms described herein, see your physician. What Are The Symptoms? A characteristic red bulls-eye rash (EM) at the site of the bite is present in less than 40% of patients. The rash may appear within days to weeks after the bite, but could be hidden in hairline or underarms. EM RASH - caused by B. burgdorferi usually appears days or weeks after the tick-bite, whereas rashes caused by other bacteria present in the tick usually show up immediately. Some patients report flu-like symptoms, fever, aches, fatigue, neck stiffness, jaw discomfort, muscle pain and stiffness, swollen glands, and red eyes. Symptoms may appear, disappear and reappear at various times. Nervous system abnormalities include memory loss and partial facial paralysis (Bell’s palsy). Migratory joint pains, and pains in the tendons, muscles and bones may occur later in the disease. Arthritic symptoms, if present, usually affect the large joints like the knees. From left to right: Larvae, Nymph, Female, Male Tick. Tick in Nymph stage is the size of a poppy seed. Are There Other Tick-Borne Diseases? The same tick that carries the bacteria that causes Lyme Disease, can also carry other pathogens. The most common are Babesiosis, Ehrlichiosis, Bartonellosis and Rickettsiosis (Rocky Mountain Spotted fever). It is estimated that up to 25% of the ticks that cause Lyme disease may transmit one or more of these other diseases. Babesiosis is like malaria with the symptoms of acute disease being fever, chills, vomiting and fatigue. It is usually self-limiting except in Lyme patients and those who have undergone splenectomy. There are two forms of Ehrlichiosis: Anaplasma phagocytophila (HGA) and HME (Human Monocytic Ehrlichiosis). HGA is primarily on the East coast, upper Midwest and California. HME is primarily in the Southeast, lower Midwest and Southwest, with cases reported in CA, NJ, NY, and WI. These acute diseases may have symptoms of fever, chills, vomiting and fatigue and require prompt antibiotics. Subclinical forms of these diseases may be present in patients with Lyme disease. Specializing in Lyme Disease and Associated Tick-Borne Diseases What Tests Are Available? Tests Offered Several tests are available for a diagnosis of Lyme disease. These include direct and indirect tests. Indirect tests look for the patient’s immune response to B. burgdorferi. Direct tests look for the presence of B. burgdorferi antigens or nucleic acids. Borreliosis (Lyme Disease) Indirect Tests – Lyme Serology Tests (ELISA, IFA, and Western Blots) The LYME ELISA test measures B. burgdorferi IgM and/or IgG antibodies in patient’s serum sample. The sensitivity and specificity of these tests is about 70%. The LYME IFA (performed as part of a Lyme Panel) detects IgG, IgM and IgA antibodies against B. burgdorferi. Antibodies to B. burgdorferi are detected about 2-3 weeks after infection and may remain elevated for a long time in some patients. The LYME WESTERN BLOTS (IgG and IgM) detect antibodies to B. burgdorferi, the causative agent of Lyme Disease. In some cases, the testing laboratory may be able to say that your “picture of Lyme antibodies” is consistent with early, late, persistent and/or recurrent disease. Unlike other diseases, IgM antibodies may persist for a very long time. Antibodies can be detected within one month of infection (usually IgM) and can be up to 25 years after an initial infection (IgG only; IgG and IgM; or IgM only). About 20% -30% of patients never make antibodies. Some patients with a “normal immune system” may not have made antibodies at the time of testing. Thus, the presence of antibodies alone does not make a diagnosis of disease. Over 20 Years Experience •IgG/IgM/IgA Screen (IFA)* •IgG/IgM and IgM Antibody ELISA •C6 Peptide •IgG Western Blot and IgM Western Blot •31 kDa Epitope Test* •Lyme Dot Blot Assay (LDA)* •Multiplex PCR for urine, whole blood, serum, CSF •Multiplex PCR for Miscellaneous samples (ex: Skin biopsy,breast milk)* Other Tick-borne Diseases About 30% of the Lyme patients are co-infected with one or more of the following tick-borne pathogens – Babesia, Anaplasma, Ehrlichia, Bartonella or Rickettsia. We offer immunofluorescent assays (IFA) for detection of pathogen specific antibodies in patient serum samples and PCR tests for detection of pathogen specific DNA in blood and cerebral spinal fluid (CSF) samples. In addition, we offer FISH (Fluorescent In Situ Hybridization) tests for direct detection of Babesia and Bartonella on blood smears. Unlike Giemsa staining, these FISH tests are highly specific. –Babesiosis •B. microti IgG/IgM Antibody •B. duncani IgG/IgM Antibody* •Babesia PCR Screen •Babesia FISH (RNA) –Ehrlichiosis Direct Tests The LYME DOT BLOT ASSAY (LDA) detects antigens of Lyme bacteria in urine samples. There is cross reaction to some of the pathogens present in urine samples. This test can be performed on urine samples and cerebral spinal fluid. The LYME MULTIPLEX PCR (Polymerase Chain Reaction) Test, a highly specific and sensitive test, detects the presence of the DNA of the Lyme bacteria. The PCR test is often the only marker that is positive in all stages of Lyme disease. The test can be performed on blood, serum, urine, CSF and miscellaneous fluids/tissues. Unfortunately, Lyme bacteria like to “hide” in the body, therefore, PCR can often be negative. Studies performed on different sample types suggest that performing PCR on multiple sample types improves assay sensitivity. Therefore, in the Lyme Panels, PCR on whole blood and serum is included to improve sensitivity. For patients with clinical symptoms of Lyme disease who test negative by the IFA Screen or IgG/ IgM Western Blots, the PCR on serum and whole blood, or the LDA/Multiplex PCR Panel on urine may be appropriate. There are physician developed antibiotic protocols to enhance the sensitivity of the LDA. Anaplasma phagocytophilum (HGA): •IgG/IgM Antibody •PCR Human Monocytic Ehrlichia (HME): •IgG/IgM Antibody •PCR –Bartonellosis •B. henselae IgG/IgM Antibody •Bartonella PCR •Bartonella FISH* –Rickettsiosis •Rickettsia rickettsii/typhi IgG Antibody •Rickettsia PCR (Only R. rickettsii PCR will be reported for NY residents*) *Not yet available for NY Residents Central Nervous System Borrelia, Bartonella and Rickettsia can cause neurological symptoms. Patients with neurological symptoms may test negative on clinical samples such as whole blood, serum or urine. Therefore, pathogen specific PCR or LDA should be performed on cerebral spinal fluid (CSF). How to Order Tests LYME PANELS have been put together to provide cost savings to the patient when more than one test is ordered. The Panels are listed on our Patient Test Requisition Form, including Co-Infection Panels for certain regions of the country you live in or may have visited. This information can be found on our website at www.igenex.com. Specializing in Lyme Disease and Associated Tick-Borne Diseases Over 20 Years Experience Miscellaneous Testing What Is The Treatment? IGeneX, Inc. offers the CD57* test and Chlamydophila pneumoniae IgG* and IgA* ELISA tests as part of a testing menu for chronic diseases. The CD57 test measures CD57 killer cells in patients’ EDTA whole blood samples. The CD57 killer cell count can be very low in patients with chronic diseases. It is reported that Lyme disease can be treated successfully with antibiotics if caught early in the infection. Prevention is the best cure for infection. Patients whose disease is caught late often need to be on antibiotics for longer periods of time. There is controversy among physicians as to the length of treatment. ILADS physicians’ feel treatment should continue for 2 months after patient’s symptoms improve. Ehrlichiosis is often treated with many of the same antibiotics used for Lyme disease. Babesiosis is often treated with Mepron and Zithromax. Many physicians believe that they need to treat the Babesiosis before treating Lyme disease to achieve clinical success. Therefore, for patients with a low CD57 count, Lyme disease and C. pneumoniae infection should be included in differential diagnosis. C. pneumoniae can cause acute respiratory disease, but it can also persist in some patients with chronic respiratory conditions and cardiovascular disease. How Can Lyme Disease Be Prevented? Wear long sleeve shirts and long pants when going into tick country. Light colors are best so ticks can be easily seen. Tuck pants into socks and spray the clothes with a known tick repellent. After being in an area known to harbor ticks, check skin and all hair areas thoroughly. Remove ticks promptly. Check pets carefully, they are a source of entry for ticks into the house. Deer hunters need to spend extra time checking their gear before bringing it into autos and homes. How Do You Remove A Tick? 1. Use tweezers or forceps. 2. Grasp the tick mouthparts close to the skin. 3. Avoid squeezing the tick, which may spread infected body fluids. 4. Pull the tick straight out. Do not twist. Do not attempt to burn the tick. 5. Save the tick (you may want to have it tested for B. burgdorferi or other tick-borne diseases). 6. Wash your hands with soap and water. 7. Apply antiseptic to bite site. *Not yet available for NY Residents For any questions regarding this information or inquiries on testing at IGeneX, please contact Customer Service at 800-832-3200. You may also contact us at customerservice@igenex.com. IGeneX Inc. 795/797 San Antonio Rd. Palo Alto, CA 94303 800/832.3200 650.424.1191 Fax 650.424.1196