How is Lyme disease diagnosed?
Lyme disease is a clinical diagnosis based on history, symptoms, and exposure to a tick bite. Some patients show a rash, but in many cases a rash is not apparent. For this reason, laboratory testing is an important aid in diagnosing Lyme disease. Like many tests for infectious diseases, the Lyme tests measure antibodies in a patient’s blood. Since it can take several weeks for the body to produce sufficient antibodies, patients are usually tested 4 – 6 weeks after a tick bite.
What does the laboratory testing for Lyme disease involve?
The most common Lyme disease tests detect antibodies in the blood produced by the immune system to fight off the Lyme disease bacteria, Borrelia burgdorferi. Lyme disease bacteria are spread by ticks.
It may take up to two months after becoming infected before antibodies can be detected in a blood test. Once formed, antibodies usually stay in your system for many years, even after successful treatment of the disease.
Antibody testing for Lyme is typically a two-tiered process: A highly sensitive screening test done by ELISA followed by the more specific Western blot (also called Immunoblot) test for confirmation of infection. The Western blot test should be done in all people who have tested positive or borderline (indeterminate) in an ELISA test.
How long does it take for results?
Depending on the type of lab performing the testing, results are typically available in 2–17 days. Large reference laboratories can provide a 2–3 day turnaround for testing. Coppe Laboratories offers test results within five days of receipt of specimen.
What kind of sample is required?
Antibody tests for Lyme disease are done on a blood sample. Your doctor’s office will draw the blood and send it to Coppe Laboratories for testing.
Does the testing provide results for infections caused by multiple strains of Borrelia?
Lyme tests approved by the US Food and Drug Administration (FDA) only include the laboratory strain of Borrelia burgdorferi, the B31 strain. Diagnostic tests performed by Coppe Laboratories contain synthetic proteins from Borrelia that are designed to detect exposure to multiple strains of Borrelia burgdorferi as well as other Borrelia species known to cause human disease (Borrelia afzelii, Borrelia garinii,). Studies have shown Coppe Laboratories’ Lyme test detects infections with Borrelia miyamotoi, an emerging tick-borne bacteria found in Europe and North America. The benefit of testing with Coppe Laboratories’ Lyme Panel is that multiple strains and genospecies of Borrelia are included in the testing and the risk of false negative results is diminished.
Coppe Laboratories’ test strips contain antigens for multiple genospecies and strains of Borrelia.
How are the results reported?
After the confirmatory testing is performed, the bands are read by densitometry software. The use of this process allows for higher precision and better reproducibility. Unlike most testing, which is read by visual inspection, Coppe Laboratories testing is not subject to technical operator variability.
Coppe Laboratories’ results are clearly presented: We provide a report that contains an image of the actual Immunoblot with the intensity of each band recorded both numerically and graphically. The results are clearly presented at the bottom of the form.
Can you test for tick-borne infections other than Lyme?
Additionally, Coppe Laboratories has developed testing for the Powassan virus (POWV). Powassan is a tick-borne infection occurring in certain regions of North America and Canada. POWV has been cited as causing symptoms similar to Lyme disease. The virus is not susceptible to antibiotic therapy. Coppe Laboratories is be the first commercial laboratory to offer this testing.
Lyme disease can cause the body’s immune system to become abnormal. This imbalance may lead to reactivations of pathogens commonly present in the body that do not cause disease symptoms in individuals with a normal immune system. Human herpesvirus-6 (HHV-6), can cause problems in Lyme patients, and Coppe Laboratories offers specialized testing for this virus.
Is Coppe Laboratories’ test approved by the FDA?
Laboratory Developed Tests (LDTs), such as those offered by Coppe Laboratories, are classified as in vitro diagnostic devices by the FDA, which provides regulatory guidelines for such tests but does not confer specific approval. Performance characteristics of all tests are established by Coppe Laboratories. Coppe Laboratories is a CLIA (Health and Human Services) certified laboratory and licensed to perform high complexity clinical testing.
How have Coppe Laboratories’ Lyme tests been validated?
Coppe Laboratories’ Lyme disease tests are based on a European diagnostic Lyme disease assay. This assay was clinically validated by the manufacturer by analyzing blood samples from hundreds of patients with clinical and laboratory supported evidence of Lyme borreliosis along with hundreds of patients presenting with systemic illness not associated with tick exposure. In addition, Coppe Laboratories used qualified Lyme disease serum panels obtained from the United States Centers for Disease Control and Prevention (CDC) and commercial vendors to confirm the performance characteristics of our diagnostic Lyme disease tests. In short, Coppe Laboratories’ diagnostic tests undergo rigorous validation from both internal and external sources.
Will my insurance pay?
Coppe Laboratories requests that all payments be made in advance. We accept personal check, money order, VISA, MasterCard and American Express. Coppe Laboratories will file your medical claim and any necessary appeal with your insurance company. Payment from your insurance company will come to you. Many insurance companies pay some or all of the costs of the tests.