NADAL Bence Jones, test strips

General information about this test: NADAL Borreliosis Ag Test is a rapid membrane-based immunological test for direct detection of Borrelia antigens (B. garinii , B. afzelii и B. burgdorferi sensu strict and B. spielmanii) in ticks. NADAL Borreliosis Ag Test is designed for small to medium-size ticks (≤8mm). A positive result indicates that Borrelia is present in the tick. Reagents and material supplied: 5 NADAL Borreliosis Ag test cassettes (incl. pipettes and desiccants) 5 tick tubes containing buffer (0.2 mL) 5 wooden sticks 1 tick removal device 1 package insert Additional materials required: Timer Storage and stability: The test kit should be stored at 2-30°C until the expiry date printed on the packaging. The test cassette should remain in the sealed foil pouch until use. Do not freeze the test kit. Sample volume needed: 1 small to medium-sized tick extracted with buffer (0.2 mL in test tubes) Test time: 10 min Performance characteristics: Sensitivity: 92.86% Specificity: 95.83% Positive predictive value: 86.67% Negative predictive value: 97.87% Total Test Performance: 95.16% Test principles: The NADAL Borreliosis Ag Test is a membrane-based immunoassay for the rapid, direct detection of Borrelia antigens in ticks. Capillary forces drive movement of the sample along the test strip. In case of presence of Borrelia antigens in the tick extract they bind consequently with polyclonal antibodies and conjugated antibodies resulting in the formation of antibody-antigen-antibody complex. Formation of this complex produces appearance of colored line in the test (T) region of the test cassette – indication of a positive result. If Borrelia antigens are absent in the tick extract, no antibody-antigen-antibody complex is rendered and thus no coloration in the T region of the cassette is observed (negative result). It is vital that coloration is produced in the control (C) region of the test cassette. This is a sign that proper volume of the specimen has been added and the assay was run successfully. Clinical significance: Lyme disease or Lyme borreliosis is caused by the spirochete Borrelia burgdorferi which uses ticks as parasite vector. Contagious insects, infected by Borrelia burgdorferi sensu lato , are mainly present in North America ( Ixodes scapularis or Ixodes pacificus ) and in temperate Western European areas ( Ixodes ricinus ). European tick species transmit Borrelia burgdorferi , B. afzelli and B. garinii. The first clinical sign in 30-80% of the cases is skin rash ( Erythema chronicum migrans ) developing after 3 to 10 days at the site of bite. Even in the absence of skin rash after 1 to 3 months neurological signs such as headache and severe disorders like myelitis appear. Intermittent attacks of articular arthritis, myocarditis or acrodermatitis may occur even several years after infection.