Summary of clinical data Swelab Alfa Plus blood bank application

Introduction
The purpose of this document is to summarize the outcome of the clinical evaluations to validate that the Swelab
Alfa Plus blood bank application meet the performance claims . The Swelab Alfa Plus instrument was run with
reagents and checked with quality control material as indicated below.
Materials
Swelab Alfa Plus Hematology Analyzer, art no 1420046
Swelab AlfaDiluent; art no 1504124
Swelab AlfaLyse; art no 1504125
Boule Con-Diff Normal; art no 1504019
Boule Con-Diff High; art no 1504021

Study description
Correlation studies with PLT and RBC concentrates were performed in collaboration with a Swedish University
Hospital Blood bank against the reference instrument CA620 CellGuard, in accordance with the standard SS-EN
13612 for compliance with the demands in the European IVD directive (98/79/EC).
The test instrument was co-calibrated to the reference for the correlation study. PLT and RBC concentrates used
for the evaluation were taken from the normal routine production. After analysis on the reference instrument
samples were run in the open tube (OT) inlet on the Swelab Alfa Plus system. Single assays on the test and
reference instruments were compared and results presented in scatter plots with the 95% confidence interval
(confidence and prediction bands) of the linear regression indicated.
Linearity testing was performed using a linearity kit with 10 levels covering the range of the linearity claim in
accordance with CLSI Standard EP06-A.

Specifications

Correlation Linearity
Parameter R (correlation Difference Linearity Range
coefficient) (whichever is greater)
PLT ≥0.95 ± 10 × 109/L or ± 3% 20–5000 × 109/L
RBC ≥0.95 ± 0.05 × 1012/L or ± 2% 0.30-8.00 × 1012/L

Boule Medical AB Domnarvsgatan 4 SE-163 53 Spånga, Sweden Phone +46 8 744 77 00, Fax +46 8 744 77 20, E-mail: info@boule.se
PLT concentrates

Fig 1. Correlation PLT concentrates between test Fig 2. PLT linearity; recovered vs theoretical value.
system and reference system (n = 82).

Results RBC concentrates

Fig 3. Correlation RBC concentrates between Fig 4. RBC linearity; recovered vs theoretical value.
test system and reference system (n = 30).

Conclusion
Swelab Alfa Plus blood bank application measurement of PLT- and RBC-concentrations shows good correlation
and linearity compared to reference methods and is a useful tool for monitoring the quality in blood component
processing in blood banks.

Boule Medical AB Domnarvsgatan 4 SE-163 53 Spånga, Sweden Phone +46 8 744 77 00, Fax +46 8 744 77 20, E-mail: info@boule.se