ENDOSAFE®-PTS

Charles River Laboratories’ newest endotoxin detection product, the Endosafe®-PTS*(PTS), is a rapid, point-of-use test system that utilizes existing FDA-licensed LAL reagents in a test cartridge with a hand-held spectrophotometer. The PTS can effectively be used to obtain fast, quantitative LAL test results at the point of sample collection. The assessment of samples in multiple locations can be completed efficiently and accurately. Each assay result is available in about 15 minutes.


Test Technology
The PTS mimics licensed LAL kinetic chromogenic methodology by measuring color intensity directly related to the endotoxin concentration in a sample. Each cartridge contains precise amounts of licensed LAL reagent, chromogenic substrate and control standard endotoxin (CSE). The cartridges are manufactured in a qualified class 100,000 GMP manufacturing area according to rigid quality control procedures promoting test accuracy and consistency and product stability.

Test Procedure
To perform the test, the user simply pipettes 25 µl of a sample into each of the four sample reservoirs of the cartridge (Figure 1). The reader draws and mixes the sample with the LAL reagent in two channels (the Sample Channels) and with the LAL reagent and positive product control in the other two channels (the Spike Channels). The sample is incubated and then combined with the chromogenic substrate. After mixing, the optical density of the wells are measured and analyzed against an internally-archived standard curve. The PTS simultaneously performs testing in duplicate and averages the results in keeping with USP guidelines.
 

 
Product Applications
The PTS will be evaluated by the FDA for licensing as an alternative to traditional LAL testing methods for in-process and final product release testing of biomedical products. Pending FDA approval, the PTS can be used in the QC laboratory to effectively troubleshoot problematic products and to get a quick read on in-process samples and raw materials. Because licensed LAL reagents are used in thePTS, some users may choose to follow their internal QA procedures to validate the PTS format against their standard LAL protocols.

In addition, the PTS may be used in research laboratories for water and sample testing in R&D applications. Non-technical staff can be trained easily on this new technology. Results are obtained quickly - preventing costly delays in research or production. The Endosafe®-PTS provides significant advantages over traditional LAL test methods while still relying on validated and proven LAL technology.

Advantages of Endosafe®-PTS
  • Portable, hand-held LAL test system
  • Fast results at sample collection sites
  • Simple, one button operation
  • Single step, quantitative LAL test
  • Results in about 15 minutes
  • LAL test components all included
  • Detects between 0.05 - 5 EU/mL and 0.10 - 10 EU/mL

  • Data downloadable to a central PC

Assay Procedure

  • Add 25 µl of sample to each of 4 channels in a cartridge

  • Press enter

  • Pump moves samples through cartridge (about 15 minutes)

  • Optical cells are read kinetically at 395nm +/- 20nm

  • Results displayed on screen

 

Endosafe®-PTS Product Applications

  • Laboratory water systems

  • Research samples

  • Rapid test for in-process non- licensed applications

  • Cleaning validations

  • Raw materials for medical devices -water filters, medical grade tubing

  • Water for microchip production

PTS Instrument Features

  • Portable with re-chargeable power block

  • Easy-to-read display screen Keypad operation 

  • Stores 100 test results

  • Stores 50 sample classifications

  • Transfers data for formatting into standard reports and trending software applications

  • Prints out results

  • Protective case with cover

Data Analysis and Acceptance Criteria
With the PTS, data reporting is simple. At the conclusion of the test, the endotoxin measurement and the assay acceptance criteria are displayed on the screen. The instrument can be used to detect endotoxin levels as high as 10 EU/mL and as low as 0.05 EU/mL. Charles River's acceptance criteria for a valid assay is an archived curve correlation coefficient of >|-.980| and positive product control (spike) recovery of 50-200%. 

Internally, The PTS reader measures the reaction time in each channel. An archived standard curve specific for each batch of cartridges is constructed using the log of the reaction time vs. the log of the concentration. The sample and spike values are calculated by interpolation of the standard curve using the reaction times.