QwikCheck™
Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012
30
APPENDIX 9: Assayed Control – QwikCheck-beads™
A QUALITY CONTROL MATERIAL FOR AUTOMATED AND MANUAL SPERM COUNTING SYSTEMS
Introduction and Intended Use:
Q
wik
C
heck
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 l
aboratory’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.
Q
wik
C
heck
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
Q
wik
C
heck
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
Q
wik
C
heck
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
Q
wik
C
heck
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 5
th
Edition table 2.2 to determine if the duplicate counts are acceptable.
