SSI DiagnosticaHerredsvejen 23400 HillerødDENMARKT: (+45) 48 29 91 00EAN: 5790 002327452VAT: 37294535
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ImmuView® S. pneumoniae and L. pneumophila Antigen Test makes it possible to readily distinguish between S. pneumoniae and L. pneumophila in patients with presumed pneumococcal pneumonia and Legionella infection (Legionnaire’s disease) and thereby allows clinicians to initiate the correct antibiotic treatment to improve the outcome for the patient.
S. pneumoniae is the leading cause of community-acquired pneumonia and L. pneumophila causes costly hospital and ICU admissions. It is difficult to clinically distinguish between the two bacteria. Due to different treatment of the diseases, guidelines recommend double testing.1,2 NOT AVAILABLE FOR SALE IN THE U.S.
ImmuView® S. pneumoniae and L. pneumophila Antigen Test is the first of its kind to provide diagnostics for both S. pneumoniae and L. pneumophila in one test.
Improve your diagnostics with ImmuView® S. pneumoniae and L. pneumophila Antigen Test and benefit from several factors:
• Rapid and simple detection of both pneumococcus and Legionella in one test• Initiate the correct antibiotic treatment to improve patient outcome• Higher sensitivity and specificity• Broader detection of L. pneumophila serogroup 1 and non-serogroup 1• Testing for S. pneumoniae and L. pneumophila is recommended in guidelines in several countries.1,2 • Results in 15 minutes
Urine samples:The clinical sensitivity and specificity were obtained by testingretrospective urine samples.
Specificity of L. pneumophila was 100% (0/76) and S. pneumoniaewas 99% (1/76).3
Cerebral Fluid (CSF) Samples:
Sensitivity was tested with culture positive samples and spiked samples. Specificity was tested with culture positive samples for other bacteria, culture negative and donor samples.
The specificity of L. pneumophila was 100% (0/205). The sensitivity was not examined.
Store at room temperature. Expiry date is printed on the package.
The following countries have national guidelines recommending to test for Pneumococcus and Legionella. Download or read the guidelines below.
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Frequently asked questions about ImmuView® S. pneumoniae and L. pneumophila Antigen Test.
Declarations of Conformity
Material safety data sheets
Q: Is it possible to use urine samples where boric acid has been added?A: Yes
Q: Is it possible to use the assay on samples from children under 8 years of age?A: No, it has not been validated for samples from children under 8 years of age.
Q: The recommendation in our country is only to test for S. pneumoniae in urine. Why should we test for both?A: We have combined the two tests as many guidelines recommended examining moderate and severe pneumonia cases for both. Furthermore, a study from Germany showed that the incidence of Legionella was higher than what is normally reported. The two bacteria require different antibiotics.
Q: The recommendation in our country is only to test for Legionella in urine. Why should we test for both?A: We have combined the two test as many guidelines recommended examining moderate and severe pneumonia cases for both. Furthermore, Pneumococcus is the most frequent cause of pneumonia, and in most cases you will be able to treat it with penicillin. The two bacteria require different antibiotics.
Q: What is the "golden standard" for Pneumococcus and Legionella diagnostics?A: The "golden standard" for pneumococcus is blood culture and for Legionella it is culture.
Q: Most children are vaccinated for Streptococcus pneumoniae. Does that have a “false positive” effect on the test?A: We have not examined samples from children after vaccination, but we have looked at elderly (above 64 years) who have been vaccinated. 4 out of 24 were tested positive within the first 6 days. The 13-valent pneumococcal conjugate vaccine does not affect the ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test. However, we do not recommend to use the test within three days after vaccinating with a 23-valent vaccination since false-positive results might occur. The test is not recommended for children under 7 years because of carriage of Pneumococcus.
Q: Positive control: is it a liquid positive control?A: Yes, it is a liquid positive control. The positive control should, when tested, give three lines (Pneumococcus, Legionella and control line).
Q: Is the positive control for one or more tests?A: There is enough for at least three tests if the customer wants to use to three tests on positive control.
Q: For how long have you had guidelines for control of both pathogens at the same time?A: For approximately 10 years, the Danish guidelines have recommended to test for both pathogens if the patient is hospitalized with severe pneumonia.
Q: In our country people show more interest in Streptococcus pneumoniae than Legionella, why should we test for both?A: We have combined the two test as many guidelines recommended examining moderate and severe pneumonia cases for both. Furthermore, a study from Germany showed that the incidence of Legionella was higher than what they normally reported.
Q: Is there a symptom that differentiate a Streptococcus pneumoniae and a Legionella infection?A: No, the clinical symptoms are the same.
Q: Should you boil the positive samples?A: The kit does not require boiling, but in some countries the sample is boiled to make a confirmation of the test result. But If the urine sample contains visible blood, please confirm a positive result by boiling the sample.
Q: Should the test be run with urine samples taken in the morning or can urine from any time of day be used?A: Morning urine samples are to be preferred as the concentration of antigens will be highest in the morning. But the test can also be used with other urine samples.
Q: Is the test able to detect pneumococcus in synovial fluid?A: The test has not been validated for use with synovial fluid