CE marked for self testing.
PERiPLEX® is a new rapid point-of-care test for home use for the detection of infection in patients on Peritoneal Dialysis (PD). The test detects two critical biomarkers of infection in peritoneal dialysis waste fluid using a lateral flow immunoassay system, providing results within 10 minutes.
A positive result can give PD patients warning of an infection, prompting them to contact their healthcare provider to initiate antibiotic therapy. It is widely accepted that earlier identification of infection would enable pre-emptive use of available antibiotics, resulting in much better control of infection and prevention of infection-related damage to the peritoneal membrane.
Product Name: PERiPLEX®
Product Code: MPV1-3 (3 tests per kit, each individually pouched)
MPV1-35 (35 tests per kit, each individually pouched)
Format: Lateral flow immunoassay
Sample Type: Peritoneal dialysate from the waste bag
Detection Method: Visual
Assay Time: 5 minutes
Storage: 2o – 30oC
NOTE: PERiPLEX is designed to be compatible with peritoneal dialysis bags with sampling port/outlet tube of 8mm diameter.
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 incision 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 early 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, would enable earlier detection of infection, thereby allowing earlier implementation of antibiotic therapy.
PRINCIPLE OF THE ASSAY
PERiPLEX® detects two recognised markers of infection – Interleukin-6 (IL-6) and Matrix Metalloproteinase-8 (MMP-8) – using a multiplexed lateral flow immunoassay system.
The test device includes a shielded hypodermic needle which is used to pierce the seal on a PD waste bag, allowing waste peritoneal dialysate onto the lateral flow test strip. When present in a patient’s dialysate, MMP8 and IL6 are picked up by antibodies carried on the surface of gold nanoparticles. Any gold nanoparticles carrying MMP8 or IL6 (picked up from the test fluid) are then captured by immobilised anti-MMP8 Fab (BSA linked) and sheep anti-IL6 antibodies, respectively. These immobilised antibodies are laid down in 2 lines across the test strip, enabling visible red test lines to form in positive samples.
A procedural control line is included to indicate that the assay has been performed correctly.
The presence of any red line other than the Control line indicates a positive result.
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. If there are air bubbles trapped in the outlet tube, dislodge them by flicking the end of the tube. Keep upright.
- Open a PERiPLEX® pouch, and remove the device. Discard the silica gel sachet and pouch. Use the device within 10 minutes of opening pouch. NB: do not use if the silica gel is green.
- Gently insert the needle into the outlet tube by pushing the sampling barrel of the test device onto the outlet tube. As soon as liquid appears in the window remove the device from the bag. Failure to do so may result in a failed test. If no liquid appears within 30 seconds detach and re-run the test.
- Place the device on a clean dry surface with the read window facing upwards.
- Set the timer for 5 minutes.
- After 5 minutes, read and interpret the test results in the read window.
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.
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).
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