QwikCheck™ Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012
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QwikCheck™
S p e r m Q u a l i t y A n a l y z e r
U S E R G U I D E
W H O 5 t h V e r s i o n
V e r s i o n 1 . 0 0 I - B u t t o n
Catalog # F-A-00767-00
A U G U S T 6 , 201 2
QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012
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Table of
Contents
SECTION 1: System Overview
Front Panel 4
Key Pad Navigation 4
Measurement Capillary 4
Semen Parameters 5
Dynamic Range 5
SECTION 2: Technology
Concentration Measurement 6
Motility Measurement 6
SECTION 3: Getting Started / Set-Up
Power-On 7
Auto-Calibration and Self-Test 7
Set-Up System Defaults: Time, Date, Printing, WHO Morphology 7
Set-Up Controls 8 and 13
SECTION 4: Testing Semen Samples
Patient Information 9
Sample Data 9 Sample Type: Fresh, Washed, Frozen, Postvasectomy 14
Sample Testing: Fresh – Normal / Diluted / Low Volume Samples 10-11
Low Quality Test Results – Frozen / Washed 12
Printing 12
SECTION 5: Controls and QC
Control Set-Up and Testing 13
Set-Up: Assayed Control 13
Set-Up: Non Assayed Control 13
Running CONTROLS 14
Electronic Self-Test and Auto-Calibration 15
SECTION 6: I-Button Loading
Add I-button tests 16
SECTION 7: Service Menu
Service Data 17
Set-up 17 33
Service Personnel 17
Printing System Default Settings 17
SECTION 8: Error Messages and Warning Messages
Stabilization Failed 18 36
Self-Test Failed 18 36 33
Electronic Noise 19 36 33
Concentration Out of Range 19
APPENDIX 1: Filling the Testing Capillary with a Normal Volume Sample 20
APPENDIX 2: Filling the Testing Capillary with a Low Volume Sample 21
APPENDIX 3: Cleaning the Capillary Compartment 22
APPENDIX 4: Reference Values of Semen Variables 23
APPENDIX 5: Product Performance Data 24
APPENDIX 6: Measuring WBC's in Semen using QwikCheck Test Strips 27
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APPENDIX 7: Dilution Media: QwikCheckDilution 28
APPENDIX 8: Treating Viscous Samples: QwikCheck™ Liquefaction 29
APPENDIX 9: Assayed Control – QwikCheck-beads™ 30
APPENDIX 10: Service Report 31
APPENDIX 11: QwikCheck Report Printouts 33
APPENDIX 12: Counting Chambers (Concentration Standard Settings) 34
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SECTION 1: System Overview
The QwikCheck™ is a high performance, menu driven analytical medical device for
assessing human semen. The combination of technology in electro-optics and computer
algorithms results in a precise and accurate 75-second semen analysis. The system is
self-testing and self-calibrating and runs latex beads or stabilized sperm quality controls.
QwikCheck™
Keypad
QwikCheck™
Testing
Capillary
Keypad Navigation
Use NUMERIC keys to enter data; ARROW keys to move to the next field.
Press ENTER to select menu options, confirm data entries and to move to the
next screen or field.
Use the ESC button to return to the previous screen or field.
Testing Capillary
Disposable, designed to collect and test samples in a biologically safe manner.
Motility is measured in the 0.3 mm (thin) "Capillary Section." This section
requires 20 micro liters of semen.
Concentration is measured in the 10 mm (tall) "Cuvette Section." This section
requires 450 microliters of semen.
Automated
Measurement
compartment
Power
Indicator
Operational
display
I-Button
Keypad
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Semen Parameters Reported by the QwikCheck™
Automated
Test Results
Dynamic
Range
Semen Parameters with QwikCheck GOLD Abbreviation in Brackets
Sperm Concentration
(SPERM CONC.)
M/ml
Velocity
(VELOCITY)
mic
/sec
Total Motility
(TOTAL MOTILITY <PR+NP)
%
Sperm Motility Index
(SMI)
#
Progressive Motility
(PROG. MOTILITY <PR>)
%
Total Sperm Number / ejaculate
(SPERM #)
M
Non-progressive Motility
(NONPROG. MOTILITY <NP>)
%
Total Motile Sperm / ejaculate
(MOT. SPERM)
M
Immotility
(IMMOTILTIY <IM>)
%
Progressively Motile Sperm
Concentration (PMSC)
M/ml
Sperm Morphology (normal forms,
%)(MORPH. NORM. FORMS, WHO 5th)
%
Total Progressively Motile Sperm /
ejaculate (PROG. SPERM)
M
Motile Sperm Concentration
(MSC)
M/ml
Functional Sperm Concentration:
Progressively Motile Sperm without
Morphology (FSC)
M/ml
Total Morphologically Normal Sperm /
ejaculate (MORPH. NORM. SPERM)
M
Total Functional Sperm / ejaculate
(FUNC. SPERM)
M
Table of the Dynamic Range of the QwikCheck™
DYNAMIC RANGE OF THE SYSTEM Gold
SAMPLE
SPERM CONC in M/ml
MSC in M/ml
Motility %
FRESH
2-400 or < 2 M/ml
0.2-400 or <0.2 M/ml
0-100%
WASHED
2-200 or < 2 M/ml
0.2-200 or <0.2 M/ml
0-100%
FROZEN
Not reported
0.2-200 or <0.2 M/ml
Not reported
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SECTION 2: Technology
Technology
Step 1: The capillary is inserted into the measurement compartment.
Step 2: Concentration:
Millions of sperm cells are analyzed: A very specific wavelength of light
is absorbed by the sperm cells in the concentration chamber of the
testing capillary.
An detector measures the amount of light absorbed by the cells and
converts it to optical density (OD).
The “OD” reading is translated into sperm concentration by a
microprocessor based on proprietary algorithms.
Step 3: Motility:
Tens of thousands of sperm cells are analyzed in the thin section of the
testing capillary as they move through a light beam in the system,
causing light disturbances.
These light disturbances are converted into electronic signals with
“peaks and valleys.”
The electronic signal peaks are analyzed by microprocessor software
based on a proprietary MES algorithm and translated into motility
parameters.
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
0.8
Voltage [volts]
Time [sec]
Electronic Signal of Motile Sperm
QwikCheck™
Optical Block
LED
Conv
OD
Conv
Micro
Processor
M.E.S.
Proprietary
Algorithms
Semen
Parameters
LED
Density
Detector
Motility
Detector
Step 1
Step 2
Step 3
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SECTION 3: Getting Started / Set-Up
NOTE:
The QwikCheck GOLD
is loaded with a
minimal number of I-
Button tests in
memory. However, the
user must load tests
right away to insure
that testing will not be
interrupted. Please
refer to the I-Button
loading section of this
manual for instructions!
Power-On
Plug the system into a grounded electrical source.
Turn the system on by pressing the main switch located on the rear panel. The
Power indicator will illuminate and the following screen will be displayed.
Auto-Calibration and Self-Test
NOTE:
Do not use any of the
keyboard functions
during stabilization.
Press ON/OFF key on the keypad and auto-calibration will begin.
This process takes 5-7 minutes.
When the system stabilization and auto-calibration processes are complete, a
series of tests will be run.
Do not insert a capillary into the device or use any of the keyboard functions
until instructed to do so by the system.
The MAIN menu will appear when the self-test process is complete. The
system is now ready for use.
Set-up System Defaults
Before running a test for the first time, set up the system defaults by going to:
MAIN MENU > SERVICE > SET-UP
QwikCheck GOLD
SPERM QUALITY ANALYZER
VERSION 1.0
PRESS ON/OFF KEY
TO ACTIVATE THE UNIT
QwikCheck GOLD
SPERM QUALITY ANALYZER
PLEASE WAIT
SYSTEM STABILIZATION AND
AUTOCALIBRATION
MAIN MENU
TEST NEW PATIENT
RUN CONTROLS
ADD I-BUTTON TESTS
SERVICE
SERVICE MENU
SERVICE DATA
PRINT SELF-TEST DATA & SETTINGS
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Select either SYSTEM DEFAULTS or CONTROLS when the screen below appears:
SYSTEM DEFAULTS: Select the desired date/time formats, label printing
preference and concentration standard (see Appendix #12 for a table of counting
chambers: NEUBAUER vs. MAKLER type) when the screen below is displayed.
Press ENTER to accept.
CONTROLS: Follow the screen prompts and enter the appropriate information
from the control (Latex beads or Stabilized Sperm) product labeling.
Select the type of controls to be run (Latex Beads/Stabilized Sperm)
Select the LEVEL (1, 2, or NEGATIVE)
Enter the LOT #/ EXPIRATION DATE and TARGET VALUE from the product
labeling.
The QwikCheck™ is now ready to test samples and controls!
SERVICE: SET-UP
SELECT:
1. SYSTEM DEFAULTS
2. CONTROLS
SELECT AND PRESS ENTER
SYSTEM DEFAULT SETTINGS
DATE FORMAT: MM/DD/YY / DD/MM/YY
DATE/TIME SETTING: 01/04/05 08:15:45
AUTO PRINTING: YES/NO
# LABELS TO PRINT: 1 / 2
CONC. STD: 1 / 2
SERVICE: SET-UP CONTROLS
SELECT: LATEX BEADS/STABILIZED
SPERM
SELECT: LEVEL 1 / LEVEL 2 / NEGATIVE
PRESS ENTER TO CONTINUE
ESC TO RETURN TO SERVICE MENU
SET-UP: LATEX BEADS
LEVEL 1
LOT #: 0013122009
EXP DATE: 12/03/2010
TARGET VALUE: 46 +/- 6.4
PRESS ENTER
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Testing
Samples
SECTION 4: Test New Patient: FRESH, WASHED and FROZEN samples are all
run following similar screen instructions. Once the sample type is selected, the menu will
direct how to run the sample and what volume is required. If the sample is low quality,
the system will perform an additional 2 minute test.
From the MAIN MENU select TEST NEW PATIENT and the ENTER PATIENT/
SAMPLE DATA screen is displayed.
Enter the requested sample/patient information using the keypad:
PATIENT ID – patient identifying #(Maximum 20 numbers can be entered).
BIRTH DATE – Birth date of the patient.
ABSTINENCE - Number of days since the patient's last ejaculation.
SAMPLE/ACCESSION # - Up to 20 numbers identifying the sample
COLLECTED – Date and time the sample was collected.
RECEIVED – Date and time the sample was received.
Press ENTER to view the next screen:
Sample Data
Select: SAMPLE TYPE based on the following options:
FRESH – Sample not enriched, diluted or treated and is within 1 hour of
collection. Exception: Low volume samples diluted 1:1 with QwikCheck
dilution media can be used according to User Guide instructions.
WASHED – Sample enriched or prepared for artificial insemination using a
commercial media to replace seminal plasma. Frozen samples containing egg
yolk buffer are excluded.
FROZEN – Samples that have been frozen. Only motility parameters will be
reported (MSC, PMSC, SMI and VELOCITY).
Enter the remaining sample information:
VOLUME – Volume of the whole ejaculate in milliliters
WBC CONC. – select < 1 M/ml (normal) or >=1 M/ml (abnormal) leukocytes
(required entry). (QwickCheck Test Strips recommended).
PH – pH of the semen sample (QwickCheck Test Strips recommended).
Patient
Information
PLEASE NOTE:
The QwikCheck is
calibrated to run semen
specimens at room
temperature. It is not
necessary nor will the
user get accurate
motility results if the
sample is heated to
37ºC.
Sample
Information
PLEASE NOTE:
Refer to the appendix
section of this user
guide for information
on how to measure
semen WBC’s and pH
and how to handle
viscous samples.
ENTER SAMPLE DATA
SELECT FRESH / WASHED / FROZEN
VOLUME 2.5 ml
WBC CONC. SELECT < 1 M/ml / >= 1 M/ml
PH 7.0
ENTER PATIENT / SAMPLE DATA
PATIENT ID: 5788114
BIRTH DATE: 01/01/85
ABSTINENCE: 4 DAYS
SAMPLE / ACCESSION # 58888
COLLECTED: DD/MM/YY HH:MM
RECEIVED: DD/MM/YY HH:MM
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Normal
Volume
Samples
PLEASE
NOTE:
The QwikCheck will
begin testing when a
capillary is placed into
the testing chamber.
Sample Volume
After entering the patient and sample data, the screen above will be displayed.
SELECT: YES for NORMAL VOLUME samples ≥0.5 ml.
SELECT: NO for LOW VOLUME samples < 0.5 ml.
If YES: The sample is ≥0.5 ml the screen below provides instructions for
PREPARING a testing capillary. Do not touch the system at this time as it is
calibrating for the testing cycle.
Fill the testing capillary according to the instructions in the Appendix section of
this user guide: “Filling the SQA Capillary with a Normal Volume Sample”.
Insert the testing capillary into the measurement chamber of the QwikCheck
GOLD when instructed by the screen below:
Testing will begin automatically – do not touch the system or capillary during
testing.
Test results will be displayed when finished:
IS SAMPLE VOLUME SUFFICIENT FOR
COMPLETE TESTING >= .5 ml?
YES/NO
NORMAL VOLUME SPECIMEN
FILL, CLEAN & WIPE CAPILLARY
AUTOCALIBRATION-DO NOT TOUCH UNIT
NORMAL VOLUME SPECIMEN
FILL, CLEAN & WIPE CAPILLARY
INSERT IN CHAMBER
TESTING
DO NOT MOVE CAPILLARY OR
OPERATE DEVICE DURING TESTING
TEST RESULTS
SPERM CONC. 32.6 M/ml
TOTAL MOTILITY <PR+NP> 28.0 %
PROG. MOTILITY <PR> 5.2 %
NON PROG. MOTILITY <NP> 8.7 %
IMMOTILITY <IM> 72.0 %
MORPH.NORM.FORMS,WHO 5TH 20.6 %
TEST RESULTS
MSC 9.1 M/ml FSC 3.2 M/ml
PMSC 5.2 M/ml VELOCITY 20mic/sec
SMI 72
TOTALS PER VOLUME
SPERM # 65.2M MOT. SPERM 18.2M
PROG.SPERM 10.4M FUNC SPERM 6.4M
MORPH. NORM. SPERM 4.8M
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Low Volume
Samples
Diluted
Samples
Recommendation
for sample
dilution media:
Use QwikCheck™
Dilution Media for
best results and if
the sample is
viscous, FIRST treat
with QwikCheck-
Liquefaction kit,
then dilute.
20µl Low
Volume
Samples
If the sample is < 0.5 ml two options are available: DILUTE the sample 1:1 (QwikCheck
Dilution medial) to obtain a full report or run a LOW VOLUME sample (reports motility
parameters only).
To run a LOW VOLUME DILUTED sample, select option “1” when the screen below
is displayed:
Dilute the sample 1:1 with QwikCheck dilution media (see appendix section).
Follow the instructions in the appendix section of this User Guide: Filling the
Testing Capillary with a Normal Volume Sample.
The system will report accurate results only if the sample has been diluted 1:1
prcisely and the sample is adequate to fill the testing capillary after dilution.
To run a LOW VOLUME sample, select option “2” from the screen displayed below:
Aspirate only 20 µl of sample into the motility section of the capillary following
the instructions in the Appendix section of this User Guide: “Filling the SQA
Capillary with a Low Volume Samples”.
FRESH: LOW VOLUME SPECIMEN
PLEASE SELECT SAMPLE TESTING
OPTION:
1. DILUTE 1:1 WITH MEDIA
2. RUN 20 µl SAMPLE–LIMITED
REPORT
FRESH: LOW VOLUME SPECIMEN
PLEASE SELECT SAMPLE TESTING
OPTION:
1. DILUTE 1:1 WITH MEDIA
2. RUN 20µl SAMPLE-LIMITED
REPORT
LOW VOLUME SAMPLE
FILL CAPILLARY–20 MICROLITERS
CLEAN AND WIPE CAPILLARY
INSERT CAPILLARY INTO CHAMBER
TEST RESULTS
MOTILITY PARAMETERS ONLY
MSC 18.1 M/ml VELOCITY 3 mic/sec
PMSC 1.0 M/ml SMI 26
TOTALS PER VOLUME
MOT SPERM 18.5M PROG SPERM 6.7M
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Low Quality
Test Results
FROZEN,
WASHED
SAMPLE
TESTING
When a sample is LOW QUALITY, test results may be reported as < or > when
parameters fall below the dynamic range of the system. Only the following parameters
will be reported: Sperm Concentration, Motility, SMI and Motile Sperm Concentration due
to the limited number of cells, very low motility and/or poor morphology.
Examples of test results reported in this manner are seen in the screens below:
Run FROZEN and WASHED samples in the same manner by selecting SAMPLE TYPE:
FROZEN (or WASHED) from the MAIN MENU > TEST NEW PATIENT > ENTER SAMPLE
DATA screen. Follow the on-screen instructions.
FROZEN samples require only 20 microliters of sample and motility parameters
only are reported
WASHED sample can be run with a large or small volume sample (motility
parameters only will be report if using 20 microliters)
Printing
If the QwikCheck was set to automatically print test results on the label maker
they will now print.
If the default was not set, press the PRINT button on the keypad.
TEST RESULTS
SPERM CONC. <2.0 M/ml
TOTAL MOTILITY <PR+NP> < 22 %
PROG. MOTILITY <PR> %
NONPROG. MOTILITY <NP> %
IMMOTILITY <IM> %
MORPH. NORM. FORMS, WHO 5TH
%
TEST RESULTS
MSC < 0.2 M/ml FSC M/ml
PMSC M/ml VELOCITY mic/sec
SMI 17
TOTALS PER EJACULATE
SPERM # N.A. MOTILE SPERM N.A.
PROG.SPERM N.A. FUNC SPERM N.A.
MORPH. NORM. SPERM N.A.
TESTING
LOW QUALITY SAMPLE
TESTING WILL TAKE 2 MORE MINUTES
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Control
Set-Up and
Testing
Set-Up
Please note:
When a new control lot
is used, the control
default settings must
be changed prior to
initiating a test.
Please note:
For the QwikCheck
GOLD to test
CONTROLS accurately,
the CONTROL defaults
must be set-up. If
some control
information is not
available, enter the
current date in the EXP
Date field and zeros in
all other fields.
SECTION 5: Controls
From the MAIN MENU select: RUN CONTROLS in order to run external quality control
samples (CONTROLS). Commercially available stabilized sperm can be run as non-
assayed controls. QwikCheck™ beads produced by Medical Electronic Systems are
assayed for the QwikCheck GOLD. It is recommended that controls be run daily or
based upon laboratory protocols.
Set-Up: Assayed Control: QwikCheck™Beads
For each new box of controls, system defaults need to be set-up/updated. To do this:
Go to: MAIN MENU > SERVICE > SET-UP > CONTROLS to view the screen
below:
Select the type of control (LATEX BEADS or STABILIZED SPERM)
Select the level of the control (LEVEL 1, LEVEL 2 or NEGATIVE)
PRESS: ENTER and the screen below will be displayed:
From the box/product labeling enter:
LOT#: number identifying the control media lot.
EXP. DATE: control expiration date (MM = month, YY = year).
TARGET VALUE and +/- Range: Manufacturer's labeled "Target Value
and +/- Range” for the level of the control being set-up.
PRESS ENTER to save the set-up information.
Continue to set-up each of the other levels of controls.
To run a non-assayed control, the Target Value and +/- range must be established by
the laboratory. Once this is determined, set-up the defaults and test the control in the
same way as QwikCheck Beads assayed control.
SERVICE: SET-UP CONTROLS
SELECT: LATEX BEADS / STABILIZED SPERM
SELECT: LEVEL 1/LEVEL 2/NEGATIVE
PRESS ENTER TO CONTINUE
ESC TO RETURN TO SET-UP MENU
SET-UP: LATEX BEADS LEVEL #1
LOT #: 112233445566778899
EXP DATE: 04/09 MM/YY
TARGET VALUE: 45 +/- 6.3
PRESS ENTER
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Testing will begin automatically.
Control test results will be displayed on the QwikCheck GOLD screen.
LOW, HIGH or NORM. will be displayed based on the testing outcome vs.
target value and +/- range.
Test results can be printed by pressing the PRINT button on the keypad.
Running
Controls on
the
QwikCheck
GOLD
Please note:
For the QwikCheck
GOLD to test
CONTROLS accurately,
the CONTROL defaults
must be set-up. Please
refer to the section
above to set-up the
controls.
Please note:
Insert the testing
capillary with the
control media ONLY
when prompted by the
screen.
CONTROL Testing
To run controls go to: MAIN MENU > RUN CONTROLS and press ENTER
When the screen below is displayed: Select the CONTROL LEVEL: #1, #2 or
NEGATIVE (LEVEL #3) that is being tested.
Press ENTER to continue.
Fill the testing capillary with the Control media as if you are running a normal
volume semen sample.
After a screen that asks you to PLEASE WAIT while the system auto-calibrates,
the screen below will be displayed:
CONTROL: LATEX BEADS, LEVEL #1
FILL, CLEAN AND WIPE CAPILLARY
INSERT IN CHAMBER
TESTING WILL BEGIN
AUTOMATICALLY
MAIN MENU
TEST NEW PATIENT
RUN CONTROLS
ADD I-BUTTON TESTS
SERVICE
RUN CONTROLS: LATEX BEADS
SELECT:
CONTROL LEVEL:
LEVEL #1/LEVEL #2/NEGATIVE CONTROL
PRESS ENTER TO CONTINUE
CONTROL TEST RESULTS
DATE 01/12/06 DD/MM/YY TIME 15:09:08
LEVEL #1 LOT# 11223344556677889900
EXP. DATE 04/09 MM/YY
TYPE: LATEX BEADS
TARGET VALUE: 45.0 +/- 6.3 M/ml
CONC. RESULTS: 45.4 M/ml NORM.
ACCEPTABLE RANGE: 38.7 – 51.3 M/ml
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Electronic Self-Test and Auto Calibration
The QwikCheck automatically runs a series of tests to check calibration
settings and the internal operating system. Tests are run when the system is
turned on and prior to testing a sample.
Start-up:
Stabilization and auto calibration: Checks system stability and reference
ranges. The system sensors are analyzed for several minutes to insure that
the values are within a very narrow acceptable range. Once the system is
stable for 30 seconds it will pass stabilization and auto calibration. The system
will fail if it is not stable for at least 30 seconds and a warning message will be
displayed.
System noise: Measures the electronic noise level of the system to insure
effective measurement of electronic signals.
Self-test: The system produces electronic signals that simulate motility and
concentration measurements in order to check the performance of the system
and verify that the calibration settings are consistent with the factory
specifications. The QwikCheck will report failures (see section on error and
warning messages) and "freeze" the system if the system is not within the
established self-test ranges.
Prior to testing a sample:
Auto calibration verification: Reference values are read again. The
electronic parameters of the concentration and motility channels are measured
(without a testing capillary).
System noise: Measures the electronic noise level of the system to insure
effective measurement of electronic signals. Prior to running a test, the
QwikCheck will automatically adjust the noise level thresholds to insure
accurate readings.
Electronic spikes: Checks for any measurement points that are out of range
electronically. More than three such points will fault the system and a warning
message will be displayed.
Instructions for printing the QwikCheck GOLD Self Test parameters to
prepare for technical support:
How to print a copy of the SELF TEST DATA:
Remove the testing capillary from the system.
When a FAILED SELF TEST message appears select: MAIN MENU >
SERVICE> PRINT SELF TEST DATA AND SETTINGS > SELF TEST DATA.
Press ENTER after highlighting SELF TEST DATA to print a copy of the data.
How to view the system parameters FROM QwikCheck GOLD:
Go to: MAIN MENU > SERVICE > SERVICE DATA. All of the service screens
can be viewed by pressing ENTER.
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Customer Support/Troubleshooting: To quickly assess if the QwikCheck GOLD is
in good calibration, refer to the table and values below. The S/W Ver. 1.00 column
provides reference ranges for calibration. Enter information from the SELF TEST DATA
in the “QwikCheck Value" column to see if the system requires troubleshooting.
#
Parameter
S/W Ver. 1.00
QwikCheck
Value
Pass
Fail
1.
Ref 1
150 – 350 mV
2.
LED Cur 1
5 – 25 mA
3.
Amplitude
50 – 100 mV
4.
Zero Level
500 - 525
5.
Ref 2
2500 – 3500 mV
6.
LED Cur 2
10 – 32 mA
7.
CONC. 1
0 – 1 M/ml
8.
CONC. 2
50-150 M/ml
9.
CONC. 3
300-600 M/ml
10.
Count (Service
Data, Item #12)
26 - 36
I-Button
loading
SECTION 6: Add I-Button Tests
To add I-button tests, go to: MAIN MENU> ADD I-BUTTON TESTS and
press ENTER. The screen below will be displayed.
In each box of 50 testing capillaries, a new i-button is included that has 50
test credits loaded on the button.
Follow the on-screen instructions, holding the new i-button firmly against the
i-button port located on the side of the QwikCheck GOLD system.
The screen above will be displayed when the i-button is successfully loaded!
MAIN MENU
TEST NEW PATIENT
RUN CONTROLS
ADD I-BUTTON TESTS
SERVICE
TO ADD MORE TESTS
HOLD NEW I-BUTTON AGAINST PORT
AND PRESS ENTER
PRESS ESC TO EXIT
# TESTS ADDED: 50
# OF TESTS NOW REMAINING: 76
PRESS ESC TO EXIT
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SECTION 7: Service Menu
System set-up, maintenance and troubleshooting can be performed from the SERVICE
MENU. To activate this screen, press SERVICE in the MAIN MENU.
Service Data
Click on this option to view all the SELF TEST, ALGORITHM and
SERVICE DATA for the QwikCheck GOLD system.
Set-up
Click on the SET-UP option to set-up all the SYSTEM DEFAULTS
(date format; time/date; # labels to print; automatic printing;
morphology setting) or to set-up the CONTROL DEFAULTS.
Service
Personnel
A code is required to access SERVICE PERSONNEL. This option
allows a qualified service technician to access calibration and
maintenance settings.
Print system
Default Settings
The system SELF-TEST DATA and DEFAULT SETTINGS can be
printed to the label maker by selecting this option.
SERVICE MENU
SERVICE DATA
SET-UP
SERVICE PERSONNEL
PRINT SELF-TEST DATA & SETTINGS
SYSTEM DEFAULT SETTINGS
DATE FORMAT: MM/DD/YY / DD/MM/YY
DATE/TIME SETTING: 01/04/05 08:15:45
AUTO PRINTING: YES/NO
# LABELS TO PRINT: 1 / 2
SERVICE: SET-UP CONTROLS
SELECT: LATEX BEADS / STABILIZED SPERM
SELECT: LEVEL 1/LEVEL 2/NEGATIVE
PRESS ENTER TO CONTINUE
ESC TO RETURN TO SET-UP MENU
HIGHLIGHT OPTION
AND PRESS ENTER TO PRINT
1. SELF-TEST DATA
2. CONTROLS / TEST SETTINGS
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SECTION 8: Error Messages and Warning Messages
Stabilization Failed:
Ensure there is no testing capillary in the measurement compartment.
Remove the SYSTEM from sources of electronic noise (cell phones, etc.) and
vibrations (centrifuge).
Clean measurement compartment (refer to Appendix).
Reboot the QwikCheck system without a testing capillary in the chamber:
Turn system OFF then back ON at the main switch on the rear panel.
Press the front panel ON/OFF key to begin Auto-Calibration/Stabilization.
Call technical support if failure recurs.
Self-test Failed:
Ensure there is no testing capillary in the measurement compartment.
Remove the QwikCheck from sources of electronic noise (cell phones, etc.)
and vibrations (centrifuge).
Clean measurement compartment (refer to Appendix).
Reboot the QwikCheck system without a testing capillary in the chamber:
Turn the system OFF then back ON at the main switch on the rear panel.
Press the front panel ON/OFF key to begin Auto-Calibration and
Stabilization.
Call technical support if this message is displayed again. Prepare for technical
support by printing a copy of the SERVICE DATA:
Press the SERVICE key on the keypad to activate the SERVICE MENU
screen.
Select: PRINT SELF TEST DATA AND DEFAULT SETTINGS>SELF
TEST DATA.
Press ENTER
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Electronic Noise:
Ensure there is no testing capillary in the measurement compartment.
Remove the QwikCheck from sources of electronic noise (cell phones, etc.)
and vibrations (centrifuge).
Clean measurement compartment (refer to Appendix) and after cleaning:
Turn the system OFF then back ON at the main switch on the rear panel.
Press the front panel ON/OFF key to begin Auto-Calibration and
Stabilization.
From MAIN menu: Select TEST NEW PATIENT and rerun the test.
Call technical support if this message is displayed again. Prepare for technical
support by printing a copy of the SERVICE DATA:
Press the SERVICE key on the keypad to activate the SERVICE MENU
screen.
Select: PRINT SELF TEST DATA AND DEFAULT SETTINGS>SELF
TEST DATA.
Press: ENTER
Concentration Out of Range
Testing Semen Sample:
A message will appear indicating that the tests results for Sperm Conc and/or
MSC are beyond the upper limits of the dynamic range established by the
manufacturer for testing. This message will appear when:
SPERM CONC > 500 M/ml or
MSC > 450 M/ml
Review sample handling technique (see Appendix "Filling the SQA Capillary").
Re-test the sample using a new SQA capillary. If the message appears again,
reboot the system.
Call for technical assistance if problem persists.
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APPENDIX 1: Filling the Testing Capillary with a Normal Volume Sample
Sample size, collection container and preparation:
1. Sample volume should be at least .5 ml If sample volume is less than
.5 ml see Appendix 2.
2. The semen sample must be completely liquefied and well mixed
prior to aspiration. WARNING: Do not shake nor use a pipette to
aspirate and dispense specimen in order to mix, otherwise air bubbles
will form.
3. Carefully check that liquefied, fully mixed specimen is free of air
bubbles before aspirating a sample.
Filling the capillary:
1. Push the syringe piston in fully. Place only thin part of the capillary
into the bottom of the sample while angling the sample container at
about 45 degrees (Figure 1).
2. Place two fingers below the piston head and pull the piston back slowly
while keeping the tip of the capillary well below the sample level and
below any surface bubbles (Figure 1). Continue to aspirate the sample until it
appears in the Luer adaptor (figure 2).
3. Hold the capillary in a vertical position to confirm that the sample has
completely filled the thin section (without a meniscus) and the cuvette section
(Figure 2).
4. Tap on the syringe to make sure there are no air bubbles in the sample.
If, after tapping, some air bubbles appear below the Luer adaptor, dip the
capillary into the semen sample again and aspirate a small quantity of semen to
draw the air bubbles into the syringe.
5. Quickly (to avoid wicking) wipe the outer surface of the capillary - both top
and bottom with a wipe to prevent the QwikCheck optical chamber from
becoming clogged (Figure 3).
6. Slowly push-in the separating valve all the way (Figure 4). Insert the
capillary into the measurement compartment. Testing begins automatically.
Figure 1
Figure 2
Figure 3
Figure 4
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APPENDIX 2: Filling the Testing Capillary with a Low Volume Sample
Sample size, collection container and preparation:
1. A sample as small as 20 micro liters can be tested for motility parameters by filling ONLY the thin
section of the testing capillary (Figure 1).
2. The semen sample must be completely liquefied and well mixed prior to
aspiration. WARNING: Do not shake nor use a pipette to aspirate and
dispense specimen in order to mix, otherwise air bubbles will form.
3. Carefully check that the liquefied, fully mixed specimen is free of air
bubbles (or that there is an adequate amount of sample below the air
bubbles) before immersing the capillary into the specimen, thus ensuring that
no air bubbles will be aspirated into the capillary.
Figure 2
Figure 1
Filling the capillary:
1. Push the syringe piston in fully. Place only the thin part of the capillary
into the bottom of the sample (Figure 1).
2. Pull the piston back slowly without withdrawing the capillary from the
sample. Fill only the (thin) capillary chamber with 20 micro liters of
semen (Figure 1).
3. The quantity aspirated can be determined by the gradations on the 1 ml
syringe. Aspirate the sample until it just appears in the cuvette.
4. After filling, visually inspect the capillary to ensure that the sample has
completely filled the thin section (no meniscus).
5. Quickly (to avoid wicking) wipe the outer surface of the capillary tip with
a wipe to remove all semen in order to prevent the QwikCheck optical
chamber from becoming clogged.
6. Visually confirm that the thin chamber of the capillary is still full of semen
after completing the cleaning process. If some of the sample has been
depleted push-in the piston slightly until the first drop appears on the
capillary tip and then fill the capillary again from the sample container.
Figure 3
Figure 4
7. The separating valve must now be removed. Detach the entire syringe from the hub (Figure 2) and
use the syringe tip to firmly push-out the separating valve from the underside of the capillary
(Figure 3). Completely detach the separating valve (Figure 4). The capillary is now ready to be
inserted into the QwikCheck measurement compartment.
PLEASE NOTE: Test Low Volume samples as soon as the sample is aspirated into the
capillary.
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APPENDIX 3: Cleaning the Capillary Compartment
When to clean:
Daily or after every 10-15 tests
If the system fails SELF-TEST
Cleaning kit components:
Blue Dot capillaries – one time use only (fig 1)
Sponge-tipped drying capillaries – one time use (fig 2)
Cleaning brush -wooden-handled (fig 4)
Cleaning fluid
PLEASE NOTE: both the cleaning and drying capillaries are for ONE
TIME USE ONLY – repeated use can damage the system!
Figure 1
Figure 2
CLEANING: STEP 1
1. Use a BLUE DOT fibrous material capillary (fig 1)
Moisten with ONE drop of cleaning fluid, shaking
off excess fluid.
Insert into the measurement compartment -
fibrous material facing up. Move back and forth a
few times. Repeat with the material facing down.
2. Use a sponge-tipped drying capillary to dry the same
compartment. (fig 3)
Figure 3
CLEANING: STEP II
Insert the brush (bristle-side down) into the lower
chamber of the QwikCheck system (fig 5)
Pull the brush out of the chamber while sweeping
or "dusting off" the lens (you will feel a step or
shelf at the back and top of the chamber – this is
the top of the lens).
Switch QwikCheck ON and observe self-test
results. The QwikCheck should now PASS the
self-test. If not, repeat cleaning procedure with the
brush.
Figure 4
Figure 5
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APPENDIX 4: Reference Values of Semen Variables
SEMEN PARAMETER
QwikCheck
TEST NAME
REFERENCE RANGE*
SOURCE
Sperm Concentration (Count)
SPERM CONC.
≥15 M/ml
WHO 5th manual*
Total Motility (PR+NP)
TOTAL MOTILITY
<PR+NP>
≥40 %
WHO 5th manual*
Progressive Motility (PR)
PROG. MOTILITY
<PR>
≥32 %
WHO 5th manual*
Non-progressive Motility (NP)
NONPROG.
MOTILITY
<NP>
-
-
Immotility (IM)
IMMOTILITY
<IM>
-
-
Sperm Morphology (normal forms, %)
MORPH. NORM
FORMS, WHO 5th
≥4%
WHO 5th manual*
Motile Sperm Concentration
MSC
≥6 M/ml
MES*
Progressively Motile Sperm
Concentration
PMSC
≥5 M/ml
MES*
Functional Sperm Concentration
FSC - -
Velocity (Average path velocity – VAP)
VELOCITY
≥5 mic./sec.
MES*
Sperm Motility Index
SMI
≥80
MES*
Total Sperm Number
SPERM #
≥39 M
WHO 5th manual*
Total Motile Sperm
MOT. SPERM
≥16 M
MES*
Total Progressively Motile Sperm
PROG. SPERM
≥12 M
MES*
Total Functional Sperm
FUNC. SPERM
-
-
Total Morphologically Normal Sperm
MORPH. NORM.
SPERM
≥2 M
MES*
* The ranges established above are based on WHO 5th reference values or MES (for proprietary semen parameters).
Each laboratory should establish their own requirements and cut-offs for semen parameters.
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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 106 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 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
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
Accu beads concentration in
millions per ml
Accuracy: Low Level Control
SQA-V QUALITY CONTR OL 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 teste d
Accu beads concentra tion 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+
0200+
-
Frozen
Normal - -
-
.2-200+
0200+
-
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Precision and accuracy established in clinical trials
using human semen samples
Clinical claims:
Specificity
Concentration: 85%
Motility: 80%
Morph. Norm Forms (WHO 3rd): 65%
Morph. Norm Forms (WHO 4TH): 60%
Postvasectomy: 95% of motile cells detected
Sensitivity
Concentration: 90%
Motility: 85%
Morph. Norm Forms (WHO 3rd): 85%
Morph. Norm Forms (WHO 4TH): 65%
Correlation to Manual Method
Concentration: 0.9
Motility: 0.85
Morph. Norm Forms (WHO 3rd): 0.65
Morph. Norm Forms (WHO 4th strict): 0.45
Linearity
Linear Sperm Concentration throughout the SQA dynamic
range of 2M/ml to 400M/ml
Squared regression coefficient of Dilution Curve R2 ≥0.9.
Averaged coefficient of variation CV of measured vs.
expected sperm concentration ≤ 20%.
Note: Claims are less than actual correlations noted (see
tables 1 and 2)
Background: The SQA concentration, motility and
morphology readings were compared to standard
microscopic readings using a Makler or Neubauer chamber
based on WHO 4TH standards and MES protocols. Three
independent clinical trials were conducted at three sites. A
total of 539 human semen samples were analyzed as
described below: 342 samples were of low quality and were
tested in the High Sensitivity mode.
Precision (Table #3): Duplicate samples were assessed
using 2 SQA’s. The coefficients of variation (CV)
characterizing precision were calculated for Sperm
Concentration and Motility and were below 6%.
Specificity:
To achieve analytical specificity a specific wave length of
light which is maximally absorbed by sperm cells and
minimally absorbed by other cells and seminal plasma is
used.
Low noise and high electronic resolution hardware
components and compensation circuits ensure that
analytical specificity is optimized.
Limitations of clinical specificity:
Highly viscous samples cannot be read accurately unless
treated with QwikCheck Liquefaction.
% Normal Morphology is a parameter derived from the
correlation between morphology and progressive motility.
This is not a direct measurement.
Dynamic range limitation as stated above.
#Samples
Fresh
Washed
Frozen
High
Sensitivity
539
125
42
30
342
Limitations of method:
Samples were assessed by different operators using a
microscope and the SQA. Inter-operator subjectivity may
have affected the results of the study.
Table 1: Sensitivity/Specificity
SQA vs.
Microscope
Sensitivity
Specificity
Trial #1:
Concentration
100%
95%
Motility
97%
85%
Morph Norm
Forms (WHO
3rd )
94%
75%
Trial #2:
Concentration
94%
90%
Motility
87%
90%
Morph Norm
Forms (WHO
4th )
69%
70%
Trial #3: High Sensitivity* (see table#4)
Motile Sperm
Cells
95%
95%
Immotile
Sperm Cells
99%
100%
Table #2: Correlation to Manual Method
Parameters
Correlation Coefficients
Trial #1
Trial #2
Sperm Concentration
M/ml
0.93
0.94
Motility %
0.86
0.87
Morphology WHO 3rd
0.66
NA
Morphology WHO 4th
NA
0.49
MSC
NA
0.79
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Method comparison:
SQA was compared to the microscope based on WHO 4TH
guidelines.
Sensitivity and specificity were calculated using ROC
curves. WHO 4TH guidelines were used to establish
cutoffs for reference values (see table #1).
218 of the 342 semen specimens contained motile cells
and were used as the basis for the method comparison
(Table #4).
SQA Linearity
Clinical claims:
Linear Sperm Concentration throughout the SQA
dynamic range of 2M/ml to 400M/ml:
Squared regression coefficient of Dilution Curve
R2 ≥0.9.
Averaged coefficient of variation CV of measured vs.
expected sperm concentration ≤ 20%.
Goal: To demonstrate the ability of the SQA to accurately
report sperm concentration along the dynamic range of the
system using sequentially diluted human semen samples.
Methodology: 4 fresh human semen samples were pooled,
divided into two aliquots and centrifuged at 600g for 15
minutes. The seminal plasma was decanted and the pellets
were re-suspended in washing media: DPBS & HepesHTF.
Sequential dilutions were run in 4 SQA systems.
Limitations of method:
Dilution errors contribute to the accuracy of the
linearity test results.
Sample handling errors such as the introduction of
bubbles into the testing capillary can cause inaccurate
readings.
Table #3: Precision
Parameter
Range
Method
SQA
CV%
Microscope
CV%
Sperm
Concentration
M/ml
Entire Range
3.1
6.1
5-40
5.2
5.9
41-80
2.1
5.5
>80
2.5
3.2
Motility
%
Entire Range
5.1
7.2
10-50
7.6
10.3
51-55
1.5
3.4
>55
6.0
4.1
Table #4: Percentage Motile Cells Detected
Method Comparison of
218 Samples with
Motile Cells
# Samples
Motile Sperm
Detected
% Samples
Motile Sperm
Detected
SQA Automated
System and
Visualization System
207
95%
Visualization System
only
193
89%
Microscope only
161
74%
Results:
1. Squared regression coefficient R2 of Dilution Curve
(trend line) was found to be 0.992 (note graph
displaying results of four SQA’s and DPBS and Hepes
dilution media).
2. Averaged coefficient of variation CV of measured vs.
expected sperm concentration was 10%.
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APPENDIX 6: Measuring WBC's in Semen
QwikCheckTest Strips for Semen
Place one drop of semen on the test patch for WBC's (leukocytes) and follow the instructions on the TEST
STRIP label/insert. Compare the patch to the color scale for WBC on the container. If the patch exceeds
the darkest lavender color on the scale it indicates that WBC concentration in the sample is abnormal or
>1 Million/ml.
NOTE: Test strips are also supported for pH testing of semen.
Clinical Trial
The WBC patch of the test strip changes color due to a chemical reaction caused by the presence of
esterase in granulocytes. Esterases cleave to indoxyl ester, liberating the indoxyl which then reacts to
diasonium salt to produce a violet dye. This chemical reaction is not affected by bacteria, trichomonads or
erythrocytes present in the specimen.
QwikCheck test strips were evaluated by Medical Electronic Systems Ltd. (MES) for use as a qualitative
indicator (WBC's >1M/ml) of WBC's in human semen. To test this application WBC's were isolated from
blood and re-suspended in seminal plasma. Varying concentrations of WBC's in seminal plasma were
tested using the test strips. Test results were analyzed visually and by spectrophotometer readings.
Results and Conclusion
When the WBC concentration in semen is >1 Million/ml the WBC patch of the QwikCheck test strips
exceeds the darkest lavender color on the color chart after the testing time. (This reading corresponds to
WBC concentration > 1 Million/ml that is considered abnormal according to WHO 2010 5
th
edition, Pg.
107). A NEG includes both the NEG color on the label AND any color of lavender LIGHTER than the >1M
patch on the label.
References
WHO 2010 5TH edition laboratory manual for the examination of human semen, Pg. 16 (pH) and 107
(Leukocytes), Cambridge University Press.
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APPENDIX 7: Dilution Media
Product Insert
INTRODUCTION AND INTENDED USE
The QwikCheck
TM
Dilution Kit is to be used to dilute semen samples prior to automated/manual testing
and for semen sample preparation. The dilution media is Earle’s balanced salt solution which contains
ingredients to support sperm motility and viability and is recommended by WHO 2010, 5th edition, pg.
163 for semen sample preparation. The product is intended for in vitro use only.
KIT CONTENTS
50 ml of sterile Earle’s Balanced Salt solution
Product Insert
STABILITY AND STORAGE CONDITIONS
The product has one-year shelf life. Note the expiration date on the box and bottle.
Store bottle in the refrigerator upon receipt. Bring to room temperature (22-26°C) prior to use.
Avoid prolonged exposure to light.
Do not use if the solution contains precipitate or is cloudy.
INSTRUCTIONS FOR USE:
AUTOMATED SQA-V:
1. Measure the volume of the neat semen sample.
2. If the volume is less than 0.5 ml, dilute 1:1
3. Open the dilution kit bottle and pipette an amount of Earle’s solution that is equal to the semen
sample volume measured in step 1.
4. Add the Earle’s solution to the neat semen sample and thoroughly mix the sample by rotating the
container in a circular manner. This will evenly distribute the spermatozoa throughout the sample
without introducing bubbles.
5. Fill the SQA-V testing capillary immediately after the sample is mixed following the SQA-V onscreen instructions
MANUAL:
Follow laboratory sperm preparation protocols for diluting semen samples for testing.
PRECAUTIONS AND WARNINGS
Exercise appropriate precautions to minimize direct contact with skin or eyes and prevent inhalation.
REFERENCES:
WHO 2010 Laboratory Manual for the Examination of Human Semen, 5
th
Edition, Cambridge University
Press, 2010, pg. 163.
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APPENDIX 8: Treating Viscous Samples
Product Insert
INTRODUCTION AND INTENDED USE
The QwikCheck
TM
Liquefaction Kit can be used to promote and accelerate the liquefaction of
viscous semen samples that remain viscous thirty minutes after collection. High viscosity can
impact the accurate measurement of motility and concentration and antibody coating. The
QwikCheck
TM
Liquefaction Kit is used to prepare viscous semen samples for automated or
manual semen analysis and is for in-vitro use only.
KIT CONTENTS
20 single dose, 5 mg vials of lyophilized α-Chymotrypsin.
Product Insert
STABILITY AND STORAGE CONDITIONS
The product has a one year shelf life. Note the expiration date on the box and vials.
Vials can be stored at room temperature.
INSTRUCTIONS FOR USE
1. Select one vial of α-Chymotrypsin.
2. Tap the vial to move the contents to the bottom of the vial prior to opening.
3. Add the entire contents of one vial to a viscous semen sample.
4. Gently mix the sample to dissolve the powder.
5. Once the sample has liquefied (5-10 minutes), immediately perform automated testing
or neutralize the enzymatic activity (optional) by adding of Human Serum Albumin
(HSA) (not provided in this kit).
PRECAUTIONS AND WARNINGS
Each vial contains α-Chymotrypsin, a protease. This protease may cause irritation to eyes,
respiratory system or skin. In case of contact with eyes, rinse immediately with plenty of water
and seek medical attention. Observe the following precautions when handling the product:
Wear suitable protective clothing: Mask, gloves and laboratory coat.
Avoid dispersing material over the working area.
REFERENCES:
WHO Laboratory Manual for the Examination of Human Semen, 5th Edition, Cambridge
University Press, 2010
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APPENDIX 9: Assayed Control – QwikCheck-beads™
A QUALITY CONTROL MATERIAL FOR AUTOMATED AND MANUAL SPERM COUNTING SYSTEMS
Introduction and Intended Use:
QwikCheck
TM
beads is an in-vitro use only external quality control material for automated and manual sperm counting systems. It has been
developed as a tool to assess the accuracy and precision of the laboratory’s sperm counting methods by providing a known target value and +/range. The beads were developed for use on the SQA-V semen analyzer however, they are also labeled for manual proficiency testing and
calibration on hemacytometers such as Neubauer counting chambers, Makler chambers and conventional fixed coverslip chambers.
QwikCheck
TM
beads is supplied in a kit containing known concentrations of 4-micron latex beads suspended in an aqueous solvent and negative
concentration/motility control. The beads should be run according to the directions below for the type of system used in the lab. According to the
CLIA ’88 regulations, “…for most moderately complex tests, the general requirement is to analyze two levels of QC m aterials on each day of
testing.” It is recommended that QwikCheckTM beads be run on the SQA-V automated and visualization systems prior to each day of semen
analysis testing.
For in-vitro use only:
Each kit contains two known concentrations of QwikCheck
TM
beads in two 5 ml aliquots and one 5 ml negative concentration and motility control.
Store the beads at room temperature (20-25ºC or 65-77ºF). The expiration date assumes that QwikCheck
TM
beads are stored at room temperature
in their original containers and tightly capped to prevent evaporation. Open vial shelf-life is 90 days (tightly capped, stored in the original container at
room temperature or refrigerated @ 5-15 degrees Centigrade).
Target Value and +/- Ranges
Target Values and +/- Ranges unique to the batch have established for each batch of QwikCheck beads. Each box and each control bottle is
labeled with these Target Values and Ranges. In addition, the MES website: www.mes-global.com provides Batch Release Forms by batch # with
details.
Warning:
Contains 0.1% Sodium Azide as a preservative. Other ingredients are not harmful due to the low concentration in the beads. For additional
information, please refer to the QwikCheck-beads Material Safety Data Sheet # QCB 001
Basic Instructions for using QwikCheck
TM
beads
1. Mix the beads in the closed container before use to evenly distribute the beads in the suspension and insure accurate testing outcomes.
To mix, gently rotate the beads by hand (do not use a vortex).
2. Open the container and immediately withdraw a sample of the control material. Tightly close the container after withdrawing the sample.
3. Follow the detailed instructions below for the type of system/chamber used.
Instructions for running QwikCheck
TM
beads QC material on automated and manual sperm counting systems:
SQA-V Automated System:
1. Refer to the SQA-V User Guide “CONTROLS” section for an explanation of how to set-up the SQA-V to test automated Level 1/Level 2
and Negative Control QwikCheck
TM
beads. Follow the SQA-V onscreen instructions in the “Controls” section of the SQA-V User Guide:
2. Gently rotate the closed container of beads by hand (do not use a vortex).
3. Aspirate a sample of the beads or negative control into the SQA-V capillary in the same manner you would fill the capillary for a normal
volume specimen. Make sure that the cuvette section of the SQA-V capillary is completely full of liquid and free of bubbles.
4. Insert the testing capillary into the SQA-V measurement chamber when prompted.
5. Transfer the Control test results to V-Sperm when prompted.
SQA-V Visualization System using a standard slide:
1. Refer to the SQA-V User Guide “Operating the Visualization System” to understand how to use a standard slide in the SQA-V.
2. Gently rotate the closed container of beads by hand (do not use a vortex).
3. Pipette 10 µL of QwikCheck
TM
beads onto a standard slide, cover with a 22x22 mm coverslip to provide a 20-micron sample depth.
4. If air bubbles or liquid spillage occurs, prepare a new slide to ensure an accurate reading.
5. Insert the slide into the slide adaptor and then into the visualization chamber of the SQA-V. Press Zoom-Out all the way to set the
magnification at x300 and FREEZE the image using V-Sperm software on the computer.
6. Count the beads manually per WHO guidelines: Duplicate counts of at least 200 beads are required (turn the slide adaptor knob to view
multiple fields). Divide the final number of beads counted in the multiple fields by the number of screens viewed. Each bead on the SQA-V
screen (V-Sperm III or the SQA-V screen) represents 1 M/ml.
7. Refer to WHO Manual 5th Edition table 2.2 to determine if the duplicate counts are acceptable.
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APPENDIX 10: Service Report
SQA SERVICE SUPPORT
Parameter Report
Device number: _______ Software Version: ___________ Date: __________
Instruct the user to run a SERVICE report. For the QwikCheck GOLD system go to: MAIN MENU > PRINT
SELF TEST DATA AND DEFAULT SETTINGS>SELF TEST DATA.
Calibration parameters:
Fill-in the USER REPORT column with the calibration parameters found in the INTERNAL DATA SECTION of the
SERVICE DATA REPORT of the QwikCheck GOLD. Contact your local distributor for the initial calibration
parameters. These parameters should not have changed.
Parameter
Service
Report
Item #
User Report
Initial
Calibration
settings
Comments
CONTR.REF1
#1 OD AMPLIF.
#13
MSC AMPLIF
#8 OD VALUE
#15
OD CORR
#16 LB OD AMP
#18
CONTR. Z.L*
#11
*CONTR. Z.L. can be adjusted in the field by a MES trained service technician
Algorithm parameters
Fill-in the User Report values for the following algorithm parameters found in the SERVICE DATA REPORT.
The QwikCheck algorithm settings are defined and should not have changed.
Parameter
Service
Report
Item #
User
Report
Initial
Settings
Comments
MIN.SP.HEIGHT
#2
MIN.SP.WIDTH
#9
MAX.SP.WIDTH
#3
NOISE THRESH
#10
SMI THRESH
#4
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Self Test Parameters:
Fill-in the QwikCheck SELF TEST PARAMETERS from the SELF TEST printout in V-Sperm:
From the MAIN MENU go to: SERVICE>PRINT SELF TEST DATA AND DEFAULT
SETTINGS>SELF TEST DATA.
Verify that the parameters listed below fall within the established range
Highlight the discrepancies and report to MES
Parameter
S/W Ver. 2.48
Criteria
SYSTEM Self-Test
Parameters
Ref. 1
150 – 350 mV
LED Current 1
5 – 20 mA
Original
value
Amplitude
50 – 100 mV
Count (#12)
26 – 36
Zero Level
500 – 525
Ref. 2
2500 – 3500
LED Current 2
10 – 32 mA
Original
value
TSC 1 or CONC 1
0 – 1 M/ml
TSC 2 or CONC 2
50 – 150 M/ml
TSC 3 or CONC 3
300 – 600 M/ml
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APPENDIX 11: QwikCheck™ TEST Reports
Semen Analysis Report SYSTEM Default Settings Service Data Report
CONTROLS
QwikCheck™ GOLD
SETTINGS
DEVICE SN# 382
SW VER. 01.XX.XX
PRINT DATE 14/01/04 15:33
DATE FORMAT DD/MM/YY
TIME FORMAT HH:MM
CONTROLS
LATEX BEADS (or STABILIZED
SPERM)
LEVEL 1
LOT # 5435334656565656
EXP. DATE 05/05
TARGET VALUE 45M/ml
RANGE +/- 5.0M/ml
LEVEL 2
LOT # 75664767676776
EXP. DATE 05/05
TARGET VALUE: 23M/ml
RANGE +/- 2.1M/ml
LEVEL NEGATIVE
LOT # 546456546565566
EXP. DATE 05/05
TARGET VALUE: 0.0M/ml
QwikCheck GOLD
Service Report
DEVICE SN# 382
SW VER. XX.XX.XX
PRINT DATE 01/12/08
SELF-TEST DATA
REF1 230 REF2 2925
LED1 9 LED2 24
AMP 65 CONC1 0.0
SMI 409 CONC2 104.6
ZL 508 CONC3 418.9
AW 14987
SERVICE DATA
1. 16 7. 0.000 13. 100
2. 5 8. 115 14. 100
3. 150 9. 10 15. 1.70
4. 28 10. 6 16. 100
5. 0.95 11. 130 17. 3
6. 512 12. 31 18. 1000
QwikCheck™ GOLD
SEMEN ANALYSIS REPORT
DEVICE SN# 382
SW VER. 01.XX.XX
TEST DATE 3/12/04 15:26
PATIENT ID
XXXXXXXXXXXXXXXXXXXX
BIRTH DATE 11/22/51
ABSTINENCE 3 DAYS
ACCESSION #:
XXXXXXXXXXXXXXXXXXXX
COLLECTED 11/22/04 12:20
RECEIVED 11/22/04 12:25
TYPE FRESH/WASHED
VOLUME 3.5ml
WBC CONC. < 1M/ml
PH 7.5
TEST RESULTS
CONC. 32.6M/ml
TOTAL MOTILITY
<PR+NP> 28%
MOTILITY GRADES:
PROG. <PR> 16%
NONPROG. <NP> 12%
IMMOT. <IM> 72%
MORPH. NORM. FORMS
<WHO 5th> 10%
MSC 9.1M/ml
PMSC 6.4 M/ml
FSC 3.2M/ml
VELOCITY 29 mic/sec
SMI 341
TOTALS PER VOLUME
SPERM # 114.1M
MOTILE SPERM 31.9M
PROG. SPERM 22.4M
FUNC. SPERM 11.2M
MORPH. NORM.
SPERM 11.4M
-----------------------------------------
SYSTEM DATA
5. 14.08 7. 0.644 12. 456
AW 123456
-----------------------------------------
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APPENDIX 12: COUNTING CHAMBERS (Concentration Standard Settings)
A number of commercially available counting chambers are used in laboratories for manually counting
sperm cells. These chambers vary by depth and one type requires a diluted sample. It has been clinically
established that counts vary by approximately 30% depending on the chamber used.
The QwikCheck GOLD HUMAN permits the user to select the type of chamber the laboratory has
implemented as a standard for manual semen analysis. Once the concentration standard (CONC.
STANDARD) has been selected the QwikCheck GOLD will automatically run semen samples based on that
standard.
SQA-V Set-Up:
From the MAIN MENU select: SERVICE > SET-UP > SYSTEM DEFAULTS to view the screen
below:
Select a CONC. (concentration) STD (standard) 1 or 2 based on the options shown in the
table below.
Commercially available counting chambers are divided into two unique groups:
1. Standard #1: 10-20 micron depth and do not require sample dilution.
2. Standard #2: 100 micron depth (haemocytometers) that require sample dilution.
The table below classifies some commercially available chambers:
CHAMBER STANDARD #1
CHAMBER STANDARD #2
Makler
Beurker-Tuek
Micro-Cell
Buerker
Fixed Cover slip disposable chambers
Fuchs-Rosenthal
Fuchs-Rosenthal (modified)
Improved Neubauer
Neubauer
Malassez
Thoma
Thoma Modified
SYSTEM DEFAULT SETTINGS
DATE FORMAT: MM/DD/YY / DD/MM/YY
DATE/TIME SETTING: 01/04/05 08:15:45
AUTO PRINTING: YES/NO
# LABELS TO PRINT: 1 / 2
CONC. STD: 1 / 2
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