Kategorier: Alle - efficiency - automation - workflow - training

av Ivo Miletic 6 år siden

333

Multicentre evaluation of the new ORTHO VISION® analyser

The ORTHO VISION® analyser was evaluated across multiple centers to determine its efficiency and improvements over the AutoVue system. The study found that the analyser maintained and enhanced efficiency in routine analytical determinations.

Multicentre evaluation of the new ORTHO VISION® analyser

Multicentre evaluation of the new ORTHO VISION® analyser E. Lazarova, Y. Scott, A. van den Bos, P. Wantzin, R. Atugonza, S. Solkar, N. Carpio

Study Concluded the

ORTHO VISION®
- It Maintained & improved efficiency over the AutoVue - with most types of routine analytical determinations which included

- an option to use selected cells in antibody identification - it minimises process interruptions with a dedicated reagent loading area and an independent review rack - maximised reagent utilisation by punching only the columns that are needed and allowing for reintroduction of partially used cassettes - combined with the improved onboard stability for the reagent red cells - quality inspection of each cassette prior to use increases the success rate of testing - cap detection at the time of sampling reduces risk of downtime - the ability to run serial dilution tests reduces the need for manual testing and increases standardisation - remote review function allows for efficient management of results - reflex testing - increased process control through Intellicheck® diagnostic checks eg. dispensing volumes, centrifuge speed.

& BLOODY LOUD!!!

was - Robust - Reproducible - had a dynamic workflow management - was intuitive & - user friendly - Ortho user training was well received - and the maintenance was logical

The Results

New tests tested were
Remote result review - tested by 1 Lab
Automated serial dilutions testing for alloantibody and isohaemagglutinin titration

5 out of 6 EU Labs tested this technical innovation - 17 samples were run & - ease of use analysed in Table 2 (rated 3.9/5) - results were compared to the manual tube method - (data was not shown)

VISION showed - 2 dilutions higher - titration results vs - manual tube method - probably due to the greater variability of the manual technique - these findings were in agreement with previously published data - comparing tube and CAT titres

of the study focused on - system efficiency & ease of use & NOT - concordance of results - however its worth noting - comparison testing in Belgium & Spain - showed 100% concordance of all results - though 10% of the samples in the - Reverse ABO testing - had one point weaker reaction strength by AutoVue than by VISION - this may be due to the upgraded image processing system
Ease of use - Table 2 & Table 3

- user satisfaction - level of proficiency - level of ease

TAT comparisons - Table 1

Data for - 108 specific case profiles eg titres - for 2 local centres was - performed but data was not shown

- DAT - new-born grouping with or without Rh/K - groups combined with DAT or with K antigen typing - cross-matches - antibody panel identification - serial dilutions

- STAT sample faster - Intuitive - User friendly

- load on the fly inc. continuous, random, STAT - minimized need for batching

Study Material & Methods broken into

Graphical and statistical analysis was through
Minitab® software

the P value of <0·05 was considered significant

The histogram curves assumed a normal distribution &

The Wilcoxon paired non-parametric test was used for - groups with non-Gaussian distribution

A paired Student's t-test - evaluated statistical significance for - parameters with normal distribution

Result reproducibility testing
- was performed at 2 centres - using the same operator - on 5 different work days - Testing was performed on the AutoVue & - repeated on VISION within 1 hour
System efficiency testing
was evaluated with each centre by running - a subset of their daily AutoVue workload on the VISION - note the loading patterns varied between centres

Importantly STAT GAS samples were evaluated by - 3 centres - they were introduced - in a batch of routine samples - every 10-15 min

1049 samples were tested in parallel against 26 profiles

- 108 specific cases

- 42 AB screens

- 160 ABD forward groups

- 473 forward groups & AB screens - 22 urgents

- 266 GAS - 10 Urgents

Data collection was through
Electronic data sets collected via - Ortho e-Connectivity®
Test types were
Identical in nature & set up for direct comparison of TAT's

- these included - ABO and D typing - Rh and K phenotyping - Antibody screening - XM - DAT

The Reagents used were
Reagent red blood cells used were

- 0·8% Surgiscreen - 0·8% or 3% Affirmagen - ORTHO Resolve® Panel C Reagent Blood Cells

ORTHO BioVue® CAT system based on the

Glass bead CAT in a cassette

the various casetter types include - ABD Confirmation, ABO-Rh/Reverse, Newborn or ABO-Rh Grouping cassettes - Anti-IgG or antihuman globulin (AHG) Polyspecific and Neutral cassettes - Reverse Diluent or Anti-IgG cassettes - Rh/K cassettes - Neutral cassettes - Direct antiglobulin test (DAT) cassettes (anti-IgG, anti-C3b, C3d).

Principle of Ag/Ab agglutination & traping by

ORTHO VISION® Analysers are
- fully automated

Integrate multiple step testing including

- liquid pipetting - reagent handling - incubation - centrifugation - reaction grading & - interpretation

ORTHO VISION® Analyser has automation advances over ORTHO AutoVue® Innova Analyser

- serial dilution tests availability - remote result review function - partial cassette usage and re-usage - the ability to use selected cells in antibody identification - temperature controlled on-board reagent storage - dedicated reagent loading area - - automated quality inspection of each cassette prior to use - cap detection at the time of sampling - independent review rack - Intellicheck® function, e.g. audit of each sample processing step

Study Design was based on
study took 4 to 6 weeks to complete
Evaluation of test cases

- was based on - training - system configuration - quality control - maintenance & - system efficiency & performed through

- Questionnaire ratings & - Daily activity reports

Staff training

- was by - e-learning modules & - in person training

Installation & design

- through - local system config - maintenance protocols & - QC

6 EU Participating Labs
- UK x 2 - The Netherlands - Spain - Denmark - Belgium

- they were based in - various hospital settings - had a wide range of test profiles and pre-transfusion practices - & were Guided by varying regulatory authorities

their Annual test volumes - 16 000 to 64 000

Study Objective

was a Multicentre evaluation of the
- efficiency - ease of use in - various clinical settings

ORTHO VISION® Analyser - introduced 2015

ABO/Rh Rh Phenotyping Antibody Screen Antibody identification Crossmatch (AHG) Direct Antiglobulin QC testing Antigen Testing Serial Dilutions for Titration Studies Selected Cell Panels for Antibody Identification

ORTHO AutoVue® Innova Analyser - introduced 1997 - major update 2004

A Transfusion service MUST provide

- safe & appropriate blood products - to the right patient at right time & - for the right reason
- in light of increasing - workload - budget restraints & - skills shortages

Automation is therefore Essential for Pre-Transfusion Testing as it

3. improves TAT

2. allows technique standardisation

1. reduces human errors