QwikCheck™
Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012
24
APPENDIX 5: 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 QwikCheck™ GOLD Sperm Quality Analyzer is the same as the SQA-V (Sperm Quality Analyzer
– VISUAL) as they share the same algorithms. Comparison data is available upon request. The following text, tables
and graphs demonstrate the performance of the SQA-V algorithms. All values concerning sperm concentration
measurements are expressed as 10
6
sperm cells per milliliter (M/ml). Motility and morphology values are expressed
as a percent (%). Unless otherwise noted all testing was performed using human donor semen samples.
Calibration:
Each SQA 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 was
compared to a known target value using latex 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 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
systems (32 samples/SQA). SQA concentration readings were
compared to established target /- acceptable range.
Latex beads established target /- ranges
(Hemacytometer):
Vial #1: 47 +/- 7.0 M/ml
Vial #2: 24 +/- 3.4 M/ml
Precision
SYSTEM
Latex-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
SQA-V QUALITY CONTROL TEST
(High level of Accu-beads, target range: 40-54 M/ml)
36
40
44
48
52
56
0
1
2
3
4
5
6
7
8
9
10
Number of SQA-V tested
Ac
cu
b
ea
d
s c
o
n
ce
n
tr
at
io
n
in
millio
n
s p
er
ml
Accuracy: Low Level Control
SQA-V QUALITY CONTROL TEST
(Low level of Accu-beads, target range: 20.6-27.4 M/ml)
18
20
22
24
26
28
30
0
1
2
3
4
5
6
7
8
9
10
Number of SQA-V tested
A
c
c
u
b
e
a
d
s
c
o
n
c
e
n
tr
a
ti
o
n
in
m
ill
io
n
s
p
e
r
m
l
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+
-
