Multicentre evaluation of the new ORTHO VISION® analyser

E. Lazarova, Y. Scott, A. van den Bos, P. Wantzin,
R. Atugonza, S. Solkar, N. Carpio

- 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

1. reduces human errors

2. allows technique standardisation

3. improves TAT

was a Multicentre evaluation
of the

- efficiency
- ease of use in
- various clinical settings

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

ORTHO VISION® Analyser
- introduced 2015

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 Design was based on

Installation & design

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

Staff training

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

Evaluation of test cases

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

- Questionnaire ratings &
- Daily activity reports

study took 4 to 6 weeks
to complete

ORTHO VISION® Analysers
are

- fully automated

Integrate multiple step testing
including

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

The Reagents used were

ORTHO BioVue®
CAT system based on the

Principle of Ag/Ab agglutination & traping by

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).

Reagent red blood cells used were

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

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

Data collection was through

Electronic data sets collected via
- Ortho e-Connectivity®

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

1049 samples were tested in parallel
against 26 profiles

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

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

Graphical and statistical analysis was through

Minitab® software

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

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

The histogram curves assumed a normal distribution &

the P value of <0·05 was considered significant

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

TAT comparisons
- Table 1

- STAT sample faster
- Intuitive
- User friendly

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

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

Ease of use
- Table 2 & Table 3

New tests tested were

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

Remote result review
- tested by 1 Lab

ORTHO VISION®

was
- Robust
- Reproducible
- had a dynamic workflow management
- was intuitive &
- user friendly

- Ortho user training was well received
- and the maintenance was logical

- 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.