OSPA NEGATIVE ELISA FOR LYME DISEASE

一种新的用于莱姆病诊断的酶联免疫吸附试验(ELISA)。新的ELISA法将使用缺乏外表面蛋白(OSP)A的伯氏疏螺旋体作为抗原(DeltaOspA-B)。Burgdorferi)。一种基于OspA的重组莱姆病疫苗最近被FDA的一个小组建议批准。疫苗接受者产生OspA抗体，并在目前的莱姆病ELISA法中检测血清阳性，该方法使用表达OspA的伯氏杆菌全细胞裂解物。迫切需要一种参考实验室的酶联免疫吸附试验，以区分OspA疫苗接种和伯氏杆菌感染。我们将首先生产大量的DeltaOspA-B。Burgdorferi，这将在新的ELISA中使用。DeltaOspA-b伯氏杆菌酶联免疫吸附试验的敏感性和特异性将与目前标准的伯氏杆菌全细胞裂解物酶联免疫吸附试验进行比较，该方法使用莱姆病患者的血清以及可能导致与伯氏杆菌交叉反应的疾病。然后，我们将测试OspA疫苗接受者的血清，包括后来感染伯氏杆菌的个人。我们预计，新的DeltaOspA-B.burgdorferi酶联免疫吸附试验将区分感染和免疫，随着OspA疫苗的广泛使用，DeltaOspA-B。伯氏杆菌酶联免疫吸附试验将取代目前基于伯氏杆菌全细胞裂解物的检测方法。建议的商业应用：这项研究将导致用于商业参考实验室的人类莱姆病的血清学ELISA法诊断。

A new enzyme-linked immunosorbent assay (ELISA) to aid in the diagnosis of Lyme disease. The new ELISA will use Borrelia burgdorferi that lack outer surface protein (Osp) A as antigen (deltaOspA-B. burgdorferi). A recombinant OspA-based human Lyme disease vaccine was recently recommended for approval by a FDA panel. Vaccine recipients develop OspA antibodies and test seropositive in the current Lyme disease ELISA, which uses whole-cell lysates of B. burgdorferi that express OspA. There is an immediate need for a reference laboratory ELISA to distinguish OspA-vaccination from B. burgdorferi infection. We will first produce large quantities of deltaOspA-B. burgdorferi, which will be used in the new ELISA. The sensitivity and specificity of the deltaOspA-b burgdorferi ELISA will be compared with the current standard B. burgdorferi-whole- cell-lysate ELISA suing sera from patients with Lyme disease, and diseases that can result in cross-reactivity with B. burgdorferi. We will then test sera from OspA vaccine recipients, including individuals that subsequently developed B. burgdorferi infection. We anticipate that the new deltaOspA- B. burgdorferi ELISA, and not the current ELISA, will distinguish infection from immunization, and that as the OspA vaccine becomes widely used, the deltaOspA-B. burgdorferi ELISA will supplant current B. burgdorferi whole-cell-lysate based assays. PROPOSED COMMERCIAL APPLICATIONS: This research will lead to a serologic ELISA diagnostic for human Lyme disease for use in commercial reference laboratories.