Partnering with microbiologists to diagnose and prevent diseaseTM

ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test [ImmuView® P&L]

ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test [ImmuView® P&L] is the only urinary Antigen Test
capable of identifying both S. pneumoniae and Legionella pneumophila at the same time – with just one test.

now available from

EASY. FAST. RELIABLE.

The fast way to deliver pneumonia testing with confidence

DIAGNOSE WITH CONFIDENCE

DELIVER RAPID RESULTS
WITH MINIMUM EFFORT

ImmuView® P&L is the only urinary Antigen Test capable of identifying both
S. pneumoniae and Legionella pneumophila at the same time – with just one test.

ImmuView® P&L enables physicians to offer patients:

An effective addition to the lab technician’s toolkit, ImmuView® P&L:

blue check

Two results with one easy test.

blue check

Confident diagnosis – initiate the course of antibiotics based on clear insight

blue check

Quick results – patients won’t have to wait long for their diagnosis

blue check

Requires no special training

blue check

Consists of a simple 3-step process

blue check

Takes up very little precious lab space

immuview-strips
easy_123_icon

EASY

Now, without any special equipment, you can detect
S. pneumoniae and Legionella with just one test.

FAST

The test delivers results for S. pneumoniae and
Legionella pneumophila in just 15 minutes.

RELIABLE

With ImmuView® P&L you get clear insight to inititate the right treatment from the beginning, thereby improving diagnostics.

FAST, RELIABLE URINARY ANTIGEN TEST

CONFIDENT DETECTION OF TWO DISEASES WITH ONE TEST

ImmuView® P&L is the only urinary Antigen Test capable of identifying both S. pneumoniae and Legionella pneumophila at the same time – with just one test.

Quick, accurate and easy diagnosis is crucial because S. pneumoniae is the leading cause of community acquired pneumonia. Additionally, Legionella pneumophila causes costly hospital and ICU admissions. Patients that are suffering from either disease present symptoms that are difficult to tell apart. This is a huge challenge, as the treatment for each disease is different. That’s why medical guidelines recommend double testing.

WHY SHOULD YOU
TEST FOR TWO
DISEASES AT ONCE?

Similar symptoms – different treatment

Correct diagnosis and treatment to
improve patient outcome

Identify a potential double infection in patients

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

FAQ

Find your question, click to get the answer

The Kit

How many tests in the kit?

22 test strips in a kit.

How many controls in a kit?

One positive and one negative control.

Is there any additional equipment needed to run a test?

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?

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 your lab’s IQCP 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?

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?

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

The Procedure

When is the best time to collect the sample?

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?

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?

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?

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?

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?

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 Hardy Diagnostics.

How do I read the results?

The results are read by the naked 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

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

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.

Other

Are there any age limitations with this kit?

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

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

Yes

Is the test able to detect pneumococcus in synovial fluid?

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

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

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.

PERFORMANCE

Urine Samples

Sensitivity (Urine) Based on culture vs comparator

ImmuView Sensitivity
ImmuView
Comparator
S. pneumoniae
78% (78/100)
80% (76/95)a
(Blood culture only)
L. pneumophila Sg 1
97.7% (42/43)
100% (43/43)
(U.S.)
L. pneumophila Sg 1
80.0% (44/55)
66.7% (36/54)b
(Europe)
a: 5 samples were QNS (quantity not sufficient) for testing, b: 1 sample was QNS for testing

 

Specificity  (Urine) Based on culture vs comparator

ImmuView Sensitivity
ImmuView
Comparator
S. pneumoniae
98.2% (217/221)a
97.8% (218/223)
(Europe)
L. pneumophila
100% (19/19)
100% (19/19)
(U.S.)
L. pneumophila
99.5% (220/221)b
99.6% (223/224)
(Europe)
a: 3 samples were QNS (quantity not sufficient) for testing, b: 3 sample was QNS for testing

Positive agreement with other UAT

Prospective samples positive agreement S. Pneumoniae
ImmuViewComparator positiveComparator negativeTotal
Positive72678
Negative3225228
Total75231306
Positive agreement96.0%95% CI (88.9%-98.6%)
Negative agreement97.4%95% CI (94.5%-98.8%)
Prospective samples positive agreement L. pneumophila SG1
ImmuViewComparator positiveComparator negativeTotal
Positive303
Negative0303303
Total3303306
Positive agreement100.0%95% CI (43.9%-100%)
Negative agreement100.0%95% CI (98.8%-100%)

* of the 306 samples, a total of 92 had to be frozen before testing could be performed.

Clinical sensitivity and specificity - CSF

ImmuView
S. pneumoniae samples
Culture positive
Culture Negative
Positive
13
7
Negative
1
162
Total
14
169
Sensitivity
92.9% (13/14)
95% CI (68.5%-98.7%)
Specificity
96.0% (162/169)
95% CI (91.7%-98.0%)

 

60 real human CSF samples 50 spiked with S. pneumoniae
ImmuView
Comparator
Total
PositiveNegative
Positive50050
Negative01010
Positive agreement100%95% CI (92.9%-100%)
Negative agreement100%95% CI (72.2%-100%)

MISCELLANEOUS

References

  1. NICE National Institute for Health and Care Excellence. Pneumonia in adults: diagnosis and Management. www.nice.org.uk/guidance/cg191 (published December 3, 2014).
  2. R. Menéndez et al. Community Acquired Pneumonia., Arch Bronconeumol. 2010;46(10):543–558
  3. Center for Disease control and prevention: www.cdc.gov/vitalsigns/legionnaires/infographic.html#graphic
  4. ECDC SURVEILLANCE REPORT Legionnaires’ disease in Europe 2015
  5. Center for Disease control and prevention: https://www.cdc.gov/vitalsigns/pdf/2016-06-vitalsigns.pdf
  6.  Athlin, Iversen, Özenci. (2017);  Eur J Clin Microbiol Infect Dis. 2017 Jun 6. Epub 2017 Jun 6.
  7.  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.

Storage and Shelf Life

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

 

Cat. no.ProductNumber of testsPacking
2451ImmuView® S. pnemoniae and L. pneumophila Urinary Antigen Test221 box

SEE IT FOR YOURSELF!

You probably have a lot of questions about ImmuView® P&L. 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.