Immuview® S. Pneumoniae and Legionella

Note: ImmuView® is not cleared for sale in the US

Confident detection of 2 diseases with 1 test

ImmuView® S. pneumoniae and Legionella is the only Antigen test able to identify both S. pneumoniae and Legionella at the same time – with just one test

Quick, accurate and easy diagnosis is vital because S. pneumoniae is the leading cause of community acquired pneumonia. And Legionella causes costly hospital and ICU admissions. Not only that, the symptoms are difficult to tell apart – a huge challenge, as the treatment for each disease is different. That’s why medical guidelines recommend double testing.

As Easy as 123

Get results fast in 3 simple steps

1.
Introduce sample

Add the sample to the test tube

2.
Add buffer

Add the running buffer
and whirl gently

3.
Insert test

Insert the test and wait
just 15 minutes

See how easy it is with ImmuView®

Why test for 2 diseases in 1 go?

Similar symptoms – different treatment
Correct diagnosis and treatment to improve patient outcome
Identify double infections in patients
Detect Legionnaires’ – deadly for 10% and on the rise globally

FAQ

Find your question, click to get the answer

How many tests in the kit?

Answer:

22 test strips in a kit

How many controls in a Kit?

Answer:

1 positive and 1 negative control

Is there any additional equipment needed to run a test?

Answer:

Yes, a timer.

It only takes 15 minutes for a result, so a timer is needed. A standard sterile container is needed, for when the test is complete

How often do you run the controls? How does this fit into our lab policy?

Answer:

A positive and a negative control does not need to be performed every time the kit is used. We recommend each control is tested once when the kit is opened.

Additional control tests may be run if required by QA policy.

500 µl of each control is provided and each test requires 120 µl .

Which do you put in first, the positive or negative control?

Answer:

It does not matter which control tube is tested first. Prepare the samples and controls in their individual tubes according to the method, and then add one test strip to each tube. Wait 15 minutes and the test result should be read within 5 minutes after that.

What is the volume of urine pipetted?

Answer:

120µl of urine is used for the test (3 drops of 40µl each)

When is the best time to collect the sample?

Answer:

Morning urine samples are preferred as the concentration of antigens will be highest. But the test can also be used with sample collected throughout the day.

How can you tell that the test is working?

Answer:

It is very simple to see if the test is working.

If the control line on the strip is purple/grey, the test is working

If there is no control line on the strip, the test is invalid, and the sample should be retested.

A positive Legionella sample will show a blue line on the strip, and a grey/purple control line
A positive S. pneumoniae sample will show a red line on the strip, and a grey purple control line
A double infection will show a blue line for legionella, a red line for s. pneumoniae and a grey/ purple control line
If there is only a control line on the strip, the test is negative

Please notice, that a faint line for either S. pneumoniae or Legionella should be considered a positive sample

On the lid of the box you can easily see how the ImmuView strips should be interpreted, or you can watch the short video on this page to learn more.

Can we use the ImmuView test on frozen samples?

Answer:

The test has been validated for use with frozen samples stored for up to 2 weeks at -20°C.

Samples which has been frozen for a longer period of time, may result in a decrease in sensitivity of the assay.

Should you boil the positive samples?

Answer:

The kit does not require boiling

However, you can boil the sample to confirm a positive result, if the result is invalid, or if the urine sample contains visible blood.

Please refer to the IFU in the packaging for further explanation

Can we remove the test strips by hand?

Answer:

Yes – simply grab the top end of the strip and remove the strips from the tube. It is very easy.

Do not touch the test area where the lines become visible, or the bottom of the strip. Please see the video of how to use ImmuView, where the entire process of collecting a sample is shown.

We cannot see the sample and buffer moving up the test strip, should we add more running buffer?

Answer:

Do not add more buffer as this will dilute the sample. Wait until the end of 15 minutes and if the control line is not visible, repeat the test. If this happens again, contact SSI Diagnostica.

How do I read the results?

Answer:

The results are read by eye. Any blue or red line is regarded as positive, even if the line is faint. Please see the video of how to use ImmuView®, where you can see how to read and interpret the result

Do you have a Reader?

Answer:

Yes – please go to http://info.ssidiagnostica.dk/immuview-reader, to learn about our reader option

Is there a specific symptom that differentiate a Streptococcus pneumoniae and a Legionella infection?

Answer:

The clinical symptoms are to a large extent the same. This is one of the main reasons why it makes perfect sense to test for both Streptococcus pneumoniae and a Legionella infection with just 1 ImmuView test.

Does the Legionella part of the strip only detect serogroup 1?

Answer:

The ImmuView®S. pneumoniae and L. pneumophila has been shown to detect other non-serogroup 1 Legionella⁷

How do I order the kit?

Answer:

Please send us an email, and we will contact you. Emails can be send to: info@ssidiagnostica.com

Alternatively use one of the options on the webpage to order a sample and we will then contact you

Are there any age limitations with this kit?

Answer:

The ImmuView S. pneumoniae and L. pneumophila has been validated for samples from children above 8 years of age.

Is it possible to use urine samples where boric acid has been added?

Answer:

Yes

Is the test able to detect pneumococcus in synovial fluid?

Answer:

The test has not been validated for use with synovial fluid.

Is the test able to detect pneumococcus in cerebrospinal fluid (CSF)?

Answer:

Yes test has been validated for use with CSF samples.

Downloads

The efficacy and safety of ImmuView® tests are fully supported by clinical data and documentation.

Declaration of conformity DoC for ImmuView® S. Pneumoniae and L. Pneumophila urinary antigen test

Material safety data sheets MDSD for ImmuView® S. Pneumoniae and L. Pneumophila urinary antigen test

Packaging inserts See the packaging inserts for the entire range of ImmuView® urinary antigen tests

Performance

Urine samples

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

Urine	IMMUVIEW® SENSITIVITY	OTHER RAPID TESTS SENSITIVITY
S. pneumoniae	85% (60/71)	77% (55/71)
L.pneumophila SG1	89% (88/99)	72% (71/99)

Positive agreement with other UAT

S. pneumoniae positive agreement was made in a sample population containing blood culture positive samples. L. pneumophila positive agreement was made in a sample population containing culture and/or PCR positive samples.

S. pneumoniae Comparator Blood culture positive samples		Comparator
S. pneumoniae Comparator Blood culture positive samples		Positive	Negative
ImmuView®	Positive	58	5
ImmuView®	Negative	2	11
Total		60	16
Positive agreement 97% (58/60 CL: 89-99%)

L. pneumophila culture and/or PCR positive		Comparator
L. pneumophila culture and/or PCR positive		Positive	Negative
ImmuView®	Positive	64	10
ImmuView®	Negative	1	8
Total		65	18
Positive agreement 97% (58/60 CL: 89-99%)

Negative agreement with UAT

S. pneumoniae negative agreement was made in a sample population containing
non-pneumococcal cases (n = 90 bacteremic samples and n =6 non-bacteremic)⁶

L. pneumophila negative agreement was made in a sample population
prescreened with urinary antigen EIA. All samples included in the pool showed
a negative result when using the comparator (urinary antigen EIA)⁷

96 non-pneumococcal cases		Comparator
96 non-pneumococcal cases		Positive	Negative
ImmuView®	Positive	3	0
ImmuView®	Negative	0	93
Total		3	93
Negative agreement 100% (93/93 CL: 96-100%)

Negative urinary antigen EIAdirected at L. pneumophila sg. 1		Comparator
		Positive	Negative
ImmuView®	Positive	0	0
ImmuView®	Negative	0	456
Total		0	456
Negative agreement 100% (456/456 CL: 96-100%)

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.

CSF	ImmuView® Sensitivity	ImmuView® Specificity
S. pneumoniae	100% (27/27)	100% (205/205)

6. C. S. Jørgensen, S. A. Uldumb, J. F. Sørensenc, I. C. Skovsted, S. Otte, and P. L. Elverdal.; Journal of Microbiological Methods 116 (2015) 33-36

MISCELLANEOUS

The following countries have national guidelines which recommends testing for Pneumococcus and Legionella. Download or read the guidelines below.

Australia

Brazil

Denmark

Italy

Japan

Russia

Singapore

South Africa

Spain

Sweden

Switzerland

Ukraine

USA

ERS guidlines

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

Article number	Product	Number of tests	Packing
95389	ImmuView® S. pnemoniae and L. pneumophila Antigen Test	22	1 box

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., Arch Bronconeumol. 2010;46(10):543–558
Center for Disease control and prevention: www.cdc.gov/vitalsigns/legionnaires/infographic.html#graphic
ECDC SURVEILLANCE REPORT Legionnaires’ disease in Europe 2015
Center for Disease control and prevention: https://www.cdc.gov/vitalsigns/pdf/2016-06-vitalsigns.pdf
Athlin, Iversen, Özenci. (2017); Eur J Clin Microbiol Infect Dis. 2017 Jun 6. Epub 2017 Jun 6.
D. Lindsay et al. 2014, Poster on ESGLI 2016: Evaluation of the ImmuView® urinary antigen test for the detection of Legionella pneumophila and Streptococcus pneumoniae.

Book a meeting today

You probably have a lot of questions about ImmuView®. We have the answers. And we’d love to show you how easily you can take your testing to a new level of convenience, speed and accuracy. So book a demo today.

Confident detection of 2 diseases with 1 test

As Easy as 123

1.
Introduce sample

2.
Add buffer

3.
Insert test

See how easy it is with ImmuView®

Why test for 2 diseases in 1 go?

FAQ

Downloads

Performance

MISCELLANEOUS

Book a meeting today

ImmuView® Reader

ImmuView® product range

IMMUVIEW® LEGIONELLA PNEUMOPHILA AND LEGIONELLA LONGBEACHAE

IMMUVIEW® RESPIRATORY SYNCYTIAL VIRUS TEST (RSV)

IMMUVIEW® S. PNEUMONIAE ANTIGEN TEST

More about ImmuView®?

Confident detection of 2 diseases with 1 test

As Easy as 123

1. Introduce sample

2. Add buffer

3. Insert test

See how easy it is with ImmuView®

Why test for 2 diseases in 1 go?

FAQ

Downloads

Performance

MISCELLANEOUS

Book a meeting today

ImmuView® Reader

ImmuView® product range

IMMUVIEW® LEGIONELLA PNEUMOPHILA AND LEGIONELLA LONGBEACHAE

IMMUVIEW® RESPIRATORY SYNCYTIAL VIRUS TEST (RSV)

IMMUVIEW® S. PNEUMONIAE ANTIGEN TEST

More about ImmuView®?

1.
Introduce sample

2.
Add buffer

3.
Insert test