QwikCheck Gold User Manual

Sperm quality analyzer

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QwikCheck™
Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012
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 ,
2 0 1 2
1

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  • Page 1 QwikCheck™ Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012 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...
  • Page 2: Table Of Contents

    Filling the Testing Capillary with a Normal Volume Sample APPENDIX Filling the Testing Capillary with a Low Volume Sample APPENDIX Cleaning the Capillary Compartment APPENDIX Reference Values of Semen Variables APPENDIX Product Performance Data APPENDIX Measuring WBC's in Semen using QwikCheck Test Strips...
  • Page 3 QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 APPENDIX Dilution Media: QwikCheckDilution APPENDIX Treating Viscous Samples: QwikCheck™ Liquefaction APPENDIX Assayed Control – QwikCheck-beads™ APPENDIX Service Report APPENDIX QwikCheck Report Printouts APPENDIX Counting Chambers (Concentration Standard Settings)
  • Page 4: Section 1: System Overview

    QwikCheck™ Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012 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.
  • Page 5: Semen Parameters

    QwikCheck™ Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012 Semen Parameters Reported by the QwikCheck™ Automated Semen Parameters with QwikCheck GOLD Abbreviation in Brackets Test Results Sperm Concentration Velocity M/ml (SPERM CONC.) (VELOCITY) /sec Total Motility Sperm Motility Index (TOTAL MOTILITY <PR+NP )
  • Page 6: Section 2: Technology

    QwikCheck™ Sperm Quality Analyzer User Guide Version 1.00 I-Button WHO 5th _06_AUG_2012 SECTION 2: Technology Technology QwikCheck™ Optical Block Motility Density Optical Block Detector Detector M.E.S. Conv Micro Proprietary Processor Algorithms Step 1 Conv Semen Parameters Step 2 Step 3 Step 1: The capillary is inserted into the measurement compartment.
  • Page 7: Section 3: Getting Started / Set-Up

    SECTION 3: Getting Started / Set-Up Power-On NOTE:  Plug the system into a grounded electrical source. The QwikCheck GOLD  is loaded with a Turn the system on by pressing the main switch located on the rear panel. The minimal number of I- Power indicator will illuminate and the following screen will be displayed.
  • Page 8 QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012  Select either SYSTEM DEFAULTS or CONTROLS when the screen below appears: SERVICE: SET-UP SELECT: 1. SYSTEM DEFAULTS 2. CONTROLS SELECT AND PRESS ENTER  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.
  • Page 9: Patient Information

    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 –...
  • Page 10: Sample Testing: Fresh - Normal / Diluted / Low Volume Samples

    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: NORMAL VOLUME SPECIMEN TESTING FILL, CLEAN &...
  • Page 11 Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 Low Volume If the sample is < 0.5 ml two options are available: DILUTE the sample 1:1 (QwikCheck Samples Dilution medial) to obtain a full report or run a LOW VOLUME sample (reports motility parameters only).
  • Page 12: Low Quality Test Results - Frozen / Washed

    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.
  • Page 13: Section 5: Controls And Qc

    (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 Set-Up: Assayed Control: QwikCheck™Beads...
  • Page 14: Running Controls

    TESTING WILL BEGIN AUTOMATICALLY  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. ...
  • Page 15: Electronic Self-Test And Auto-Calibration

    Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 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.
  • Page 16: Add I-Button Tests

    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. QwikCheck...
  • Page 17: Section 7: Service Menu

    Service Data Click on this option to view all the SELF TEST, ALGORITHM and SERVICE DATA for the QwikCheck GOLD system. Click on the SET-UP option to set-up all the SYSTEM DEFAULTS (date format; time/date; # labels to print; automatic printing;...
  • Page 18: Section 8: Error Messages And Warning Messages

    (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.
  • Page 19: Electronic Noise

    Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 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: ...
  • Page 20: Appendix 1: Filling The Testing Capillary With A Normal Volume Sample

    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 Figure 2 capillary into the measurement compartment.
  • Page 21: Appendix 2: Filling The Testing Capillary With A Low Volume Sample

    Figure 4 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.
  • Page 22: Appendix 3: Cleaning The Capillary Compartment

    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 –...
  • Page 23: Appendix 4: Reference Values Of Semen Variables

    QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 APPENDIX 4: Reference Values of Semen Variables QwikCheck SEMEN PARAMETER REFERENCE RANGE* SOURCE TEST NAME Sperm Concentration (Count) SPERM CONC. ≥15 M/ml WHO 5th manual* TOTAL MOTILITY Total Motility (PR+NP) ≥40 %...
  • Page 24: Appendix 5: Product Performance Data

    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 sperm cells per milliliter (M/ml).
  • Page 25 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.
  • Page 26 QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 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).
  • Page 27: Appendix 6: Measuring Wbc's In Semen Using Qwikcheck 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 >...
  • Page 28 APPENDIX 7: Dilution Media Product Insert INTRODUCTION AND INTENDED USE The QwikCheck 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, 5 edition, pg.
  • Page 29 APPENDIX 8: Treating Viscous Samples Product Insert INTRODUCTION AND INTENDED USE The QwikCheck 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...
  • Page 30 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...
  • Page 31 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.
  • Page 32 QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 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.
  • Page 33 QwikCheck™ Sperm Quality Analyzer Guide Version 1.00 I-Button WHO 5th 06_AUG_2012 APPENDIX 11: QwikCheck™ TEST Reports Semen Analysis Report SYSTEM Default Settings Service Data Report CONTROLS QwikCheck™ GOLD QwikCheck GOLD QwikCheck™ GOLD SETTINGS Service Report SEMEN ANALYSIS REPORT DEVICE SN#...
  • Page 34 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.

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