NADAL IgG Urine, test cassettes

General information about the test: NADAL Legionella Test is a rapid immunochromatographic test for qualitative detection of Legionella pneumophila serogroup 1-antigens in urine specimens from patients showing symptoms of pneumonia. For diagnosing Legionnaires’ disease it is recommended to use NADAL Legionella Test in conjunction with culture and other methods. Reagents and material supplied: 10 NADAL Legionella test cassettes (incl. disposable pipettes) 1 Positive Control: inactivated L. pneumophila swab, 1 Reagent Control + vial, 1 testing tube 1 Negative Control: L. pneumophila negative swab, 1 Reagent Control – vial, 1 testing tube 1 package insert Test time: 15 min Performance characteristics: NADAL Legionella Test shows no cross-reactivity with the pathogen Streptococcus pneumonia, occasionally present in urine, was demonstrated. Data for specificity and sensitivity of NADAL Legionella Test were obtained by comparison with the immunoassay BinaxNOW Legionella Urinary Antigen Test (ALERE, USA). The measure of concordance was calculated using Cohen’s kappa coefficient. The interpretation should be as follows: Kappa values (IK) <0.4 - weak concordance; Kappa values (IK) between 0.4-0.6 - high concordance; Kappa values (IK) >0.6 - excellent concordance Sensitivity: >99% Specificity: >99% Positive predictive value: >99% Negative predictive value: >99% Kappa value: 1 Test principles: NADAL Legionella Test is an immunoassay designed for detection of L. pneumophila serogroup 1 antigens in urine specimens from patients, exhibiting symptoms of pneumonia. During testing, the sample reacts with anti- L. pneumophila serogroup 1 antibodies which are pre-dried onto the internal test strip. The mixture then migrates along the membrane by capillary action. The specific antibodies present on the membrane will react with the mixture conjugates and generate one or two coloured lines. A coloration in the control (C) region of the test guarantees that a proper amount of the sample has been added to the specimen well and the test was run successfully. Clinical significance: Legionnaires’ disease is a type of pneumonia characterized with 10-15% mortality rate. Initially, the Legionnaire’s disease symptomps resemble that of flu, further they progress in dry cough and pneumonia. 30% of the patients infected develop diarrhea and vomiting and 50% show signs of mental confusion. The incubation period of Legionnaire’s disease is 2-10 days. L. pneumonia serogroup 1 expresses a specific soluble antigen detected in patients’ urine samples as early as 3 days after symptoms onset. Thus NADAL Legionella Test allows an early diagnosis of L. pneumophila serogroup 1 infection.