S. pneumoniae + Legionella detection kit

Pathogen and product description Gram positive bacteria Streptococcus pneumoniae antimicrobial therapy is institutedted earlearly.y. KKnownnown is one of the most important pathogen that risk factors include immunosuppression,pressiiitton, ccigaretteigarette affects mainly children and elderly and can smoking, alcohol consumption andditt concomitant cause life-threatening diseases. Streptococcus pulmonary disease. Legionella pneumophila is pneumoniae infection leads to many clinical responsible for 80-90% of reported cases of manifestations including meningitis, septicaemia, Legionella infection with serogroup 1 accounting bacteraemia, pneumonia, acute otitis media and for greater than 70% of all legionellosis. sinusitis. Pneumococcal infection annually has CerTest Streptococcus pneumoniae + Legionella caused approximately 14.5 million cases of invasive one step card test offers a simple and highly pneumococcal disease (IPD) and 0.7-1 million sensitive assay to make a presumptive diagnosis deaths in children under five years old, mostly in of pneumoniae and/or Legionella caused by developing and underdeveloped countries. Streptococcus pneumoniae and/or Legionella Legionnaires’ Disease is caused by Legionella pneumophila in infected humans from urine samples. pneumophila and is characterized as an acute febrile respiratory illness ranging in severity from mild illness to fatal pneumonia. The resulting mortality rate, ranging from 25 to 40% can be lowered if the disease is diagnosed rapidly and appropriate S. pneumoniae + Legionella detection kit

Test procedure

step 1

Using a separate testing tube or vial for each sample, step 2 Add 2 drops of Reagent step 3 Use a separate pipette and device for each sample or add 6 drops of urine sample. into the testing tube or vial control. Dispense exactly 3 drops from the testing tube and mix. into the “A” circular window marked with an arrow.

15 min.

Wait for colored bands to appearappearr. Dispense exactly 3 drops from the same testing Readd tthehe resultsesults a att 15 minutes.minutes. step 5 tube into the “B” circular window marked withh step 4 Do not read the test result later than 15 minutes. an arrow.

Interpretation of results

S. pneumoniae S. pneumoniae S. pneumoniae S. pneumoniae Negative Positive Negative Positive Legionella Legionella Legionella Legionella Negative Negative Positive Positive

ANY OTO HER RERESUSULT: INVAALIL D Clinical Sensitivity and Specificity

Sensitivity Specificity PPV NPV

CerTest S. pneumoniae + Legionella (S. pneumoniae strip) vs. 89.2% 98.6% 97.1% 94.8% Binax NOW® Streptococcus pneumoniae Antigen Card (C.I. 74.6 – 97%) (C.I. 92.7 – 100%) (C.I. 84.7 – 99.9%) (C.I. 87.2 – 98.6%) CerTest S. pneumoniae + Legionella (Legionella strip) vs. 100% 99.2% 96.9% 100% Binax NOW® Legionella Urinary Antigen Card (C.I. 88.8 – 100%) (C.I. 95.4 – 100%) (C.I. 83.8 – 99.9%) (C.I. 96.9 – 100%)

CERTEST BIOTEC, S.L. Pol. Industrial Río Gállego II, Calle J, Nº 1 50840, San Mateo de Gállego, Zaragoza (Spain) www.certest.es NL8817EN