Quality Assurance at the Point of Care AM Manufacturer's Perspective. Eugen Ermantraut Alere Technologies, Jena

Transcription

1 Quality Assurance at the Point of Care AM Manufacturer's Perspective Eugen Ermantraut Alere Technologies, Jena 1

2 Definitions POC Testing: Diagnostic testing ti that t is performed near to or at the site of the patient care with the result leading to possible change in the care of the patient (ISO 22870: 2006) Quality assurance is the systematic ti monitoring i and evaluation of the various aspects of performing tests to maximize the probability that minimum standards of quality are being attained by the used processes. Two principles included in QA are: "Fit for purpose" - the product should be suitable for the intended purpose; and "Right first time" - mistakes should be eliminated. Quality control is a process by which the quality of all factors involved in performing a test is checked Quality Assurance makes sure you are doing the right things, the right way. Quality Control makes sure the results of what you've done are what you expected 2

3 Alere HIV VL Prototype Series; June 2011 While Intended Use Settings are different both devices have in common that Quality Testing must be assured. However schemes have to be adapted to the specific setting requirements. 3

4 Lab Performance It is important to understand the actual variability in laboratory data! The graph below shows SD data from 16 EQA samples that have been tested at app. 130 sites. The upper and lower dashed lines indicate an ATE tunnel of +/-30%. Quality designed POC products can perform much more consistent! 1500 Mean +/- N x SD CD3+CD4 4+/µl Mean vs Mean + SD Mean vs Mean - SD Mean vs Mean + 2SD Mean vs Mean - 2SD ATE+30% Mean CD3+CD4+/µl 4

5 The Alere Pima CD4 as an example of how technology may enable EQA at the POC Pima Analyser CD4 count in <20 minutes Battery or A/C powered Compact (L22cm x W13cm x H16cm), Portable & Robust Embedded software No External calibration On-board data archive Pima Test Cartridge Requires only few drops of whole blood sample No manual sample handling or processing All reagents sealed in disposable cartridge Dried reagents no refrigeration needed, reagents stable at 2 C-30 C 5

6 The Alere PIMA CD4 Test Process 6

7 Alere Pima CD4 Internal Controls In Principle Internal Controls provide sufficient information on quality of testing on respective device equivalent to an external material. Reagent Control Channel Filling Device QC Sample Volume Expiry Date Sample Volume Focus Focus in range Bi-colour bead counting Exposure time Image intensities Channel filling Outlier analysis Analysed blood volume Reagent control 7

8 Connectivity & Central Data Analysis Quality data from each test run can be collected and analyzed independently; internal controls provide means to monitor device and user performance continuously. GPRS data communication provides for independent d data review and feedback. Send generated test data to central data archive; Follow up on compliance with SOPs and performance (number of tests/period, Error Messages, EQA Data) System update; remote maintenance; provide feedback; remote shutdown 8

9 ALERE VL Outlook Pima like solution for viral load testing based on quantification of full length viral RNA in whole blood The platform consists of an analyser and a test cartridge While the system works well with Plasma EQA a new kind of EQA materials will be required to cover aspects of whole blood use and the respective sample collection methodology. 9

10 Summary - Lack of Performance is not acceptable at the POC! - Actual Test/Instrument performance can be picked up sufficiently well with internal controls - External controls are necessary to asses quality of the entire process and should focus on user error - Dedicated external controls need to be developed to cover user aspects in intended use setting - Connectivity provides effective means to monitor performance and manage many sites in real time - appropriate field support is required to make quality testing work 10

11 Thank You! 11