ImmuView® S. pneumoniae Antigen Test

ImmuView® S. pneumoniae Antigen Test is the rapid test that detects all pneumococcus serotypes with high sensitivity and specificity in both urine and cerebrospinal fluid (CSF) and offers broader detection of all pneumococcal serotypes to the benefit of patients.

ImmuView® is based on SSI Diagnostica’s long tradition of premium quality antibody production.

ImmuView s pneumoniae antigen test

Product Description

ImmuView® S. pneumoniae Antigen Test makes it possible to readily detect S. pneumoniae in patients with presumed pneumococcal pneumonia or meningitis 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 bacteria pneumonia1.

Benefits:

• 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 countries2,3.
• Results in 15 minutes

Sensitivity & Specificity

Urine samples:
The clinical sensitivity and specificity were obtained by testing retrospective urine samples.


ImmuView®
S. pneumoniae Antigen Test
Sensitivity (n=30)
93%
Specificity (n=121)*
98%

* 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.


ImmuView®
S. pneumoniae Antigen Test
Sensitivity (n=11)
100%
Specificity (n=163)*
98%

Storage and Shelf Life

Store at room temperature. Expiry date is printed on the package.

Article
number
Product  Number
of tests
Packing
98748 ImmuView® S. pneumoniae Antigen Test 22 1 box

References 

  1. Anevlavis S; Bouros D (February 2010). "Community acquired bacterial pneumonia". Expert Opin Pharmacother. 11 (3): 361–74.
  2. NICE National Institute for Health and Care Excellence. Pneumonia in adults: diagnosis and Management. www.nice.org.uk/guidance/cg191 (published December 3, 2014).
  3. 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

Spørgsmål og svar vedr. ImmuView® S. pneumoniae Antigen Test

Print

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: 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

 

Spørgsmål og svar

Downloads

Webshop

Find produktet i vores webshop

SHOP.SSIDIAGNOSTICA.COM

Shopping


Printet fra www.ssidiagnostica.dk den 21.11.2017, kl. 10:55
© Statens Serum Institut 2017

Siden kan findes på adressen: