SSI DiagnosticaHerredsvejen 23400 HillerødDENMARKT: (+45) 48 29 91 00EAN: 5790 002327452VAT: 37294535
Streptocococcus (S.) pneumoniae is a major cause of invasive infection, and WHO estimates that approximately 1.6 million people die of severe pneumococcal infections every year.1
S. pneumoniae is the leading cause of community-acquired pneumonia and may be the most important agent in community-acquired pneumonia of unknown etiology.2 S. pneumoniae infection can lead to bacteremia, meningitis, pericarditis, empyema, purpura fulminans, endocarditis and/or arthritis.
A rapid diagnosis of especially pneumococcal pneumonia and meningitis is important as these infections can normally be treated with penicillin, which is inexpensive, and does not induce antibiotic resistance at the same level as other antibiotics.3
The ImmuLex™ S. pneumoniae Omni is a rapid latex agglutination test for detection of S. pneumoniae.
It is a ready-to-use latex test for quick detection of 92 S. pneumoniaeserotypes directly from a positive blood culture or from a pure culture. A positive reaction is visible to the naked eye within 10 seconds for blood culture and pure culture.
The above illustration shows four reactions. From left to right: Circle 1 and 2 are positive reactions - the first in pure culture, and the second in blood culture. Circle 3 and 4 are negative reactions. Notice that circle 3 reaction shows some granules, but these are not true positive reactions.
The test is developed for clinical microbiological laboratories and reference laboratories.
ImmuLex™ S. pneumoniae Omni kit contains a bottle of latex particles coated with pneumococcal antiserum raised in rabbits (0.0975% sodium azide as preservation), a positive and a negative control, and 25 reaction cards. ImmuLex™ S. pneumoniae Omni is provided in a 1 mL vial, which corresponds to approximately 75 tests.
A drop of latex suspension is placed next to a drop of positive blood culture medium in the circle on the reaction card. The two drops are quickly mixed with a mixing stick and spread to cover the complete area of the circle. A positive result will show within 10 seconds for blood culture and pure culture. A reaction after 15 seconds is a negative result. Procedure for pure culture, please see package insert.
When testing the performance of ImmuLex™ S. pneumoniae Omni, it proved a sensitivity of 98 % and a specificity of 96 %.
Store at 2-8 °C in a dark place. Expiry date is printed on the package. Do not freeze (if the reagents have accidentally been frozen, they should not be used).
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