Appendix 18: Product Performance Data - MES SQA-V Gold User Manual

User Guide Version 2.60 I-button WHO 5th

APPENDIX 18: Product Performance Data

Abbreviations:
TSC: Sperm Concentration (Count)
PMSC: Progressive Motile Sperm Concentration
OD: Optical Density
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
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
Revision 21_Sep_2015
6
sperm cells per milliliter (M/ml). Motility and Morphology values
Sample Test
Type Mode
Fresh Normal 2-400
Washed Normal 2-200+
Frozen Normal
Post-Vasectomy
MSC: Motile Sperm Concentration
Morph Norm Forms: Morphologically Normal Forms
MV: Millivolt
Motility Morph
Sperm
Conc. % %
M/ml
0-100 0-100
0-100 0-100
- - -
- - -
SQA-V
Intra-
device
Variability
Inter-
device
Variability
56
52
48
44
40
36
30
28
26
24
22
20
18
50
MSC PMSC
M/ml M/ml
.2-400 0-400
.2-200+ 0-200+
.2-200+ 0-200+
0-2 -
Precision
Accu-beads®
High 47± 7.0 M/ml
Low 24 ± 3.4 M/ml
High 47± 7.0 M/ml
Low 24 ± 3.4 M/ml
Accuracy: High Level Control
SQA-V QUALITY CONTROL TEST
(High level of Accu-beads, target range: 40-54 M/ml)
0 1 2 3 4 5 6 7 8
Number of SQA-V tested
Accuracy: Low Level Control
SQA-V QUALITY CONTROL TEST
(Low level of Accu-beads, target range : 20.6-27.4 M/ml)
0 1 2 3 4 5 6 7 8
Number of SQA-V tested
#Sperm
Cells/field
-
-
-
0-30
CV, %
≤
0.01
≤
0.01
≤
2.00
≤
2.50
9 10
9 10