Immuview® S. PNEUMONIAE ANTIGENT TEST
Why IMMUVIEW® S. pneumoniae?
• Rapid and simple detection of pneumococcus – when time is important
• Initiate the correct antibiotic treatment to improve patient outcome
• High sensitivity and specificity
• Broader detection of all pneumococcal serotypes
• Testing for S. pneumoniae is recommended in guidelines in several countries1,2
• Results in 15 minutes
Note: NOT CLEARED FOR SALE IN THE US
Streptococcus pneumoniae is the most common bacterial cause of community-acquired pneumonia worldwide.
Streptococcus pneumoniae bacteria can cause many types of illnesses, including: pneumonia (infection of the lungs), ear infections, sinus infections, meningitis (infection of the covering around the brain and spinal cord), and bacteremia (blood stream infection). Pneumococcus bacteria are spread through coughing, sneezing, and close contact with an infected person.
Symptoms of pneumococcal disease depend on the part of the body that is infected. They can include fever, cough, shortness of breath, chest pain, stiff neck, confusion and disorientation, sensitivity to light, joint pain, chills, ear pain, sleeplessness, and irritability. In severe cases, pneumococcal disease can cause hearing loss, brain damage, and death.
The clinical sensitivity and specificity were obtained by testing retrospective urine samples.
S. pneumoniae Antigen Test
* From the false positive samples, it was noty possible to culture any bacteria from the samples which can be caused by too many times of freezing and thawing of the sample.
Cerebrospinal 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.
S. pneumoniae Antigen Test
Store at room temperature. Expiry date is printed on the package.
ImmuView® S. pneumoniae
Q: Is it possible to use urine samples where boric acid has been added?
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: What is the "golden standard" for Pneumococcus diagnostics?
A: The "golden standard" for pneumococcus is blood 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 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 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: 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
NICE National Institute for Health and Care Excellence. Pneumonia in adults: diagnosis and Management. www.nice.org.uk/guidance/cg191 (published December 3, 2014).
R. Menéndez et al. Community Acquired Pneumonia. New Guidelines of the Spanish Society of Chest Diseases and Thoracic Surgery (SEPAR). Arch Bronconeumol. 2010;46(10):543–558