Now, without any special equipment, you can detect
S. pneumoniae and Legionella with just one test.
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:
Two results with one easy test.
Confident diagnosis – initiate the course of antibiotics based on clear insight
Quick results – patients won’t have to wait long for their diagnosis
Requires no special training
Consists of a simple 3-step process
Takes up very little precious lab space
EASY
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 initiate 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.
DECLARATION OF CONFORMITY
MATERIAL SAFETY DATA SHEETS
PERFORMANCE
Urine Samples
Sensitivity (Urine) Based on culture vs comparator
| ImmuView Sensitivity | |||||
| S. pneumoniae | |||||
| (Blood culture only) | |||||
| L. pneumophila Sg 1 | |||||
| (U.S.) | |||||
| L. pneumophila Sg 1 | |||||
| (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 | |||||
| S. pneumoniae | |||||
| (Europe) | |||||
| L. pneumophila | |||||
| (U.S.) | |||||
| L. pneumophila | |||||
| (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 | |||
| ImmuView | Comparator positive | Comparator negative | Total |
| Positive | 72 | 6 | 78 |
| Negative | 3 | 225 | 228 |
| Total | 75 | 231 | 306 |
| Positive agreement | 96.0% | 95% CI (88.9%-98.6%) | |
| Negative agreement | 97.4% | 95% CI (94.5%-98.8%) | |
| Prospective samples positive agreement L. pneumophila SG1 | |||
| ImmuView | Comparator positive | Comparator negative | Total |
| Positive | 3 | 0 | 3 |
| Negative | 0 | 303 | 303 |
| Total | 3 | 303 | 306 |
| Positive agreement | 100.0% | 95% CI (43.9%-100%) | |
| Negative agreement | 100.0% | 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 | ||
| Positive | ||
| Negative | ||
| Total | ||
| Sensitivity | ||
| Specificity | ||
| 60 real human CSF samples 50 spiked with S. pneumoniae | |||
| ImmuView | Total | ||
| Positive | Negative | ||
| Positive | 50 | 0 | 50 |
| Negative | 0 | 10 | 10 |
| Positive agreement | 100% | 95% CI (92.9%-100%) | |
| Negative agreement | 100% | 95% CI (72.2%-100%) | |
MISCELLANEOUS
References
- 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.
Storage and Shelf Life
Store at room temperature. Expiry date is printed on the package.
| Cat. no. | Product | Number of tests | Packing |
| 2451 | ImmuView® S. pnemoniae and L. pneumophila Urinary Antigen Test | 22 | 1 box |
Testing for infection
Infection with both SARS-CoV-2 and with other respiratory viruses (e.g., influenza) or bacteria is well documented, and detection of another respiratory pathogen does not rule out COVID-19. We suggest not routinely testing urine for pneumococcal antigen in adults with CAP, except in adults with severe CAP. We suggest testing for Legionella urinary antigen in adults with severe CAP.
FDA Clearance
To all of my friends At Hardy; I am so blessed to have had a wonderful relationship with the best (and most well-run) company that I have had the pleasure to deal with.
Thanks again for all the wonderful years of service.
