PERiPLEX

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CE MARKED FOR SELF-TESTING

PERiPLEX® is a simple, 5-minute point-of-care test for home use as an aid to diagnosis of infection in patients receiving Peritoneal Dialysis (PD) treatment. The test detects two recognised markers of infection, Matrix MetalloProteinase-8 (MMP-8) and Interleukin-6 (IL-6) in a lateral flow assay using peritoneal dialysate taken from the waste bag.

Detection of either, or both, markers will give PD patients warning of an infection, prompting them to seek medical assistance. Early treatment is known to result in better control of infection, and helps prevent infection-related damage to the peritoneal membrane.

PERiPLEX® can be used in a variety of situations to provide reassurance to PD patients, particularly for new users, or for patients who have previously had peritonitis. the

The PERiPLEX technology was developed following a collaborative project with Cardiff University Medical School, funded by the National Institute of Health Research (NIHR).

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PRODUCT INFORMATION

Product Name                     PERiPLEX®

Product Code                       11011203          (3 tests per kit, each individually pouched)

   11011235          (35 tests per kit, each individually pouched)

Sample Type                        Peritoneal dialysate from the waste bag

Assay format                       Lateral flow immunoassay with visual read

Assay Time                          5 minutes

Storage                                 2o – 25oC


 

Further Information

Click on the images below to download more information

Hires_ML170906 PERiPLEX_Brochure_FINAL

 

This document can also be downloaded in a number of languages by clicking the following links:

FR: Brochure


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This document can also be downloaded in a number of languages by clicking the following links:

NL: Gebruiksaanwijzing

IT: Istruzioni per l’uso

DE: Gebrauchsanweisung

FR: Mode d’emploi


Ordering Information

FOR UK CUSTOMERS ONLY, PERIPLEX 3-TEST KIT IS AVAILABLE FOR PURCHASE DIRECTLY FROM US FOR £49.99 INCLUDING VAT AND DELIVERY. IF YOU WOULD LIKE TO PURCHASE A PERIPLEX KIT, PLEASE CLICK THE PAYPAL BUTTON BELOW.

 

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Distributors

FRANCE

Medisur

Website: www.medisur.fr

Email: contact@medisur.fr

Telephone: 04 42 96 09 68


 

SWITZERLAND, AUSTRIA, GERMANY, ITALY, NETHERLANDS

Peripal

Website: www.peripal.com

Email: info@peripal.com

Telephone: +41 44 221 95 40


 

PERiPLEX® TEST PROCEDURE

Ensure that a 5 minute timer is available to use before starting. The test should be performed in a well-lit area. Gently mix the contents of the waste bag by inverting or shaking.

#1. Remove test device from foil pouch, and remove cap from the device.

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#2. Expose the wick to the waste dialysate solution until a pink wash appears in the read window.

 

#3. Remove the device from the fluid and replace cap. Place device on a flat surface and read after 5 minutes

Proc_3

INTERPRETATION OF RESULTS

If the test has been performed correctly, the green Control line (C) will turn red.

If one or both TEST lines appear, this indicates infection and medical advice should be sought.

If no TEST lines appear, no further action is required (check limitations).

If no red Control line (C) appears, repeat the test with a new device.

 

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PERFORMANCE CHARACTERISTICS

The performance of the PERiPLEX® test was assessed using 121 frozen samples of waste dialysate from PD users:

  • 66 samples from users clinically diagnosed with peritonitis
  • 55 samples from users without peritonitis

The test gave a positive result for 65 of the 66 peritonitis-positive samples (98.5% sensitivity), and a negative result for 52 of the 55 peritonitis-negative samples (94.5% specificity).

The data above was generated using Version 1 of the PERiPLEX test. A further study has been performed to demonstrate performance equivalence between Version 1 and Version 2. This additional data is available on request.

BACKGROUND

Peritoneal Dialysis (PD) is widely accepted as the preferred method for managing severe chronic kidney disease (CKD)/end stage renal disease (ESRD) in the home environment, offering patient mobility and independence, and reducing cost when compared to other dialysis options. PD requires the infusion of a sugar solution into the peritoneal cavity of a patient, where it dwells for a period of time during which metabolic toxins in the blood diffuse passively into the dialysis fluid. Infusion of the bag contents is achieved through the surgical insertion of a catheter that crosses into the peritoneal cavity.

This method of management can be hampered by infrequent but recurrent infection via the catheter site, which may progress to peritonitis. Such infections can lead to the need for line replacement, and/or emergency treatment with antibiotics, while subsequent damage to the peritoneal membrane  or the formation of scar tissue can prevent the long-term use of this technique. Early decisive antimicrobial intervention can prevent membrane damage and extend PD utility, however until now there has been no rapid diagnostic test available to provide PD patients with warning of an infection.

Peritonitis is currently detected when the patient or carer notices a change in the colour, opacity, or aroma of the waste PD fluid (‘cloudy bag’) at the time of disposal, with patients also noticing a change in their wellbeing in more advanced cases of infection. At this stage, patients contact their GP or treatment centre where samples are collected and tested using traditional microbiological methods which could take at least 24 hours to deliver a result, allowing infection if present to take hold. A rapid diagnostic test, used in the patient’s home, could enable earlier detection of infection, thereby allowing earlier implementation of antibiotic therapy.

Lab statistics

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Peptides synthesised

10

this year to-date

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Problems solved

79

this year

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Hours in the lab

67500

so far this year

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Assays completed

2700

this month

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