NADAL Astrovirus, test cassettes

General information about this test: NADAL Lyme Borreliosis IgG/IgM Test is a rapid qualitative test for immunological detection of anti-Borrelia IgG and IgM in human blood, plasma or serum. This test is designed to aid diagnosis of Lyme Borreliosis and is intended for professional use only. Reagents and material supplied: 10 NADAL Lyme Borreliosis IgG/IgM test cassettes (incl.disposable plastic pipettes) 1 buffer containing detergent and <0.1% NaN3 (6 mL) 1 package insert Sample volume needed: Blood – 50 ul Plasma – 25 ul Serum – 25 ul Test time: 10 min Performance characteristics: The NADAL Lyme Borreliosis IgG/IgM test shows no cross-reactions with syphilis. Specificity and sensitivity data for NADAL Lyme Borreliosis IgG/IgM Test were obtained by comparing with the results for 99 serum samples from different panels of European origin pre-assayed by EIA method (miniVIDASR Biomerieux, Liaison Diasorin and Enzygnost Dade-Behring). IgG: Sensitivity: 61/75 x 100 = 81% Specificity: 55/66 x 100 = 83% Overall agreement: (61+55)/(75+66) x 100 = 82% IgM: Sensitivity: 61/66 x 100 = 92% Specificity: 26/33 x 100 = 79% Overall agreement: (61+26)/(66+33) x 100 = 88% Test principles: NADAL Lyme Borreliosis IgG/IgM Test cassette consists of a plastic housing containing two test strips for the detection of IgG or IgM. Its high specificity and sensitivity are due to a unique combination of anti-human immunoglobulins-dye conjugates and highly purified Borrelia antigens immobilized on the solid phase of the test. A few drops of blood (serum or plasma) are added to each sample well of the test cassette. Thanks to capillary forces the sample makes its way along the test strip and anti-human immunoglobulins-dye conjugates bind to human IgM or IgG forming antibody-antigen complex. Further, in the case of positive results the antibody-antigen complexes bind to specific antigens in the test line region(s) (T) and produce pink-rose line(s). In case the sample lacks anti-Borrelia antibodies, no colorations in the T region is formed. The antigen-antibody complexes continue moving until reaching the control (C) region where they react with reagents producing pink-rose lines. Obtaining pink-rose coloration in the C region of the test guarantees that enough volume of specimen has been added to the wells and the test was run properly. The use of external positive and negative controls is recommended to ensure proper assay performance. 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.