MES SQA-V Gold - APPENDIX 18: Product Performance Data

Revision 21_Sep_2015 50
User Guide Version 2.60 I-button WHO 5th
APPENDIX 18: Product Performance Data
Abbreviations:
TSC: Sperm Concentration (Count) MSC: Motile Sperm Concentration
PMSC: Progressive Motile Sperm Concentration Morph Norm Forms: Morphologically Normal Forms
OD: Optical Density MV: Millivolt
Performance Data Summary
The performance the SQA-V is summarized in the text, tables and graphs below. All values concerning sperm
concentration measurements are expressed as x10
6
sperm cells per milliliter (M/ml). Motility and Morphology values
are expressed as a percent (%). All testing was performed using human patient and donor semen samples.
Calibration:
Each SQA-V is biologically calibrated against two reference systems at Medical Electronic System's laboratory.
Dynamic Range:
Precision and Accuracy Established Against a Known Target
(Latex beads)
Background: The precision and accuracy of the SQA-V was
compared to a known target value using latex beads (Accu-
beads®).
Latex beads are used as a quality control product to validate
the accuracy of sperm counting methods for two known levels
of concentration. In accordance with CLIA regulations such a
control is used to demonstrate operator proficiency using the
microscope and for validation of automated sperm counting
methods. The latex beads were run in the SQA-V in the same
manner semen samples are run on the system.
Limitations of method:
Latex beads cannot:
 Measure sperm motility or morphology
 Correct for inaccurate chamber depths or technician
errors
Method comparison:
A total of 320 latex bead samples were tested on ten SQA-V
systems (32 samples/SQA-V). SQA-V concentration readings
were compared to established target values +/- acceptable
range.
Latex beads established target values +/- ranges
(Hemacytometer):
 Vial #1: 47 +/- 7.0 M/ml
 Vial #2: 24 +/- 3.4 M/ml
Precision
SQA-V Accu-beads® CV, %
Intra-
device
Variability
High 47± 7.0 M/ml
≤
0.01
Low 24 ± 3.4 M/ml
≤
0.01
Inter-
device
Variability
High 47± 7.0 M/ml
≤
2.00
Low 24 ± 3.4 M/ml
≤
2.50
Accuracy: High Level Control
Accuracy: Low Level Control
SQA-V QUALITY CONTROL TEST
(High level of Accu-beads, target range: 40-54 M/ml)
56
52
48
44
40
36
0 1 2 3 4 5 6 7 8 9 10
Number of SQA-V tested
SQA-V QUALITY CONTROL TEST
(Low level of Accu-beads, target range : 20.6-27.4 M/ml)
30
28
26
24
22
20
18
0 1 2 3 4 5 6 7 8 9 10
Number of SQA-V tested
Accu
beads
concentration
in
millio ns
per
ml
Accu
beads
concentration
in
millions
per
ml
Sample
Type
Test
Mode
Sperm
Conc.
M/ml
Motility
%
Morph
%
MSC
M/ml
PMSC
M/ml
#Sperm
Cells/field
Fresh Normal 2-400 0-100 0-100 .2-400 0-400 -
Washed Normal 2-200+ 0-100 0-100 .2-200+ 0-200+ -
Frozen Normal - - - .2-200+ 0-200+ -
Post-Vasectomy - - - 0-2 - 0-30