Multicentre evaluation of the new ORTHO VISION® analyser

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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