The researchers evaluated 142 samples, including patients with early Lyme disease, healthy individuals from areas where Lyme disease is endemic, and those with Lyme arthritis. Their findings were published today in the Journal of Clinical Microbiology. burgdorferi bacterium in the serum, and OPKO Health, which provided microfluidic cassettes. Sia's group worked in collaboration with Maria Gomes-Solecki from Immuno Technologies, which found a combination of three proteins that identified antibodies specific to the B. "This means that our test could easily be used directly in a doctor's office, obviating having to send the samples out to a laboratory that needs at least a couple of hours, if not days, to get test results." "Our findings are the first to demonstrate that Lyme disease diagnosis can be carried out in a microfluidic format that can provide rapid quantitative results," says Sia, whose lab is focused on using microfluidics to build low-cost, integrated devices for performing sophisticated medical tests, together with developing new treatment modalities based on cell therapy and implantable devices. A team led by Sam Sia, professor of biomedical engineering at Columbia Engineering, has developed a rapid microfluidic test that can detect Lyme disease with similar performance as the STT in a much shorter time - 15 minutes. For more details, see: Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease.Current testing for Lyme disease, called the standard 2-tiered approach or the STT, involves running two complex assays (ELISA and western blot) to detect antibodies against the bacterium, and requires experienced personnel in a lab, and a few hours to carry out and interpret. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration (FDA). New tests may be developed as alternatives to one or both steps of the two-step process. Positive IgM results should be disregarded if the patient has been ill for more than 30 days.ĬDC supports the development of new tests Some tests give results for two types of antibody, IgM and IgG.Infection with other diseases, including some tickborne diseases, or some viral, bacterial, or autoimmune diseases, can result in false positive test results.Antibodies normally persist in the blood for months or even years after the infection is gone therefore, the test cannot be used to determine cure.Antibodies can take several weeks to develop, so patients may test negative if infected only recently.Most Lyme disease tests are designed to detect antibodies made by the body in response to infection.The overall result is positive only when the first test is positive (or equivocal) and the second test is positive (or for some tests equivocal). If the first step is positive or indeterminate (sometimes called “equivocal”), the second step should be performed. If this first step is negative, no further testing is recommended. Both steps are required and can be done using the same blood sample. Results of laboratory tests, when indicatedĬDC currently recommends a two-step testing process for Lyme disease.The possibility that other illnesses may cause similar symptoms.The likelihood that the patient has been exposed to infected blacklegged ticks.When assessing a patient for Lyme disease, health care providers should consider:
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