NADAL Salmonella spp., rapid test

General information about this test : The NADAL IgG Urine Test is a rapid immunoassay for detection of IgG in urine. Presence of IgG in the urine is a sign of kidney failure. Hence the NADAL IgG Urine Test is suitable for fast and early detection of kidney failure especially in diabetic and hypertensive patients. Reagents and material supplied : 30 NADAL IgG Urine test cassettes (incl. disposable dropers) 1 package insert Test time : 5 min Performance characteristics : The lowest detectable IgG concentration for the NADAL IgG Urine Test is 10 mg/L. The NADAL IgG Urine Test do not show cross reactivity with the following substances likely to be found in urine: α1-microglobulin (10 mg/ml), TF (10 mg/ml), HSA (10 mg/ml), Hematoglobin (10 mg/ml), Total bilirubin (TBil; ≤200 μmol/L). The diagnostics sensitivity and specificity of the NADAL IgG Urine Test were confirmed by comparison of the results of this test with those obtained by applying clinical trials Relative sensitivity: 100% Relative specificity: 100% Overall agreement: 100% Test principle : The NADAL IgG Urine Test is a qualitative immunoassay for detection of IgG in urine. This test is based on the competitive inhibition principle. The test line (T) region of the membrane is pre-coated with human IgG. Upon addition of sample to the sample well, IgG, if present in the urine specimen in detectable concentration, interact with monoclonal anti-human IgG conjugated to colloidal gold particle, competing with the human IgG. This leads to formation of colored line in the test line region. The control line (C) region is pre-coated with polyclonal anti-mouse IgG which also reacts with the colloidal gold conjugates, this immunocomplex gives red color to the C region of the test strip. A colored line should always appear in the control line region (C), it serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. Clinical significance : Renal failure is a condition in which kidney functionality is lost and the glomerular filtration rate is lowered. Kidney failure is biochemically detected by increased level of serum creatinin. Other sings of renal failure used for diagnostics are: abnormal fluid levels in the body, increased acid levels, abnormal levels of potassium, calcium and phosphate, as well as (in the longerterm) anaemia. Renal malfunction can be a cause of broken bones healing. Hematuria (blood in the urine) and proteinemia (protein in the blood) may also occur. Decompensated diabetes mellitus and hypertension are predisposing factors for development of kidney failure.