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Technical Release Bulletin: QwikCheck™ Beads Open Vial Shelf Life

Wednesday, April 11, 2018

Background: 
QwikCheck™ Beads (Medical Electronic Systems) have an open and a closed vial shelf life. This labeling insures accurate results that could be compromised due to bead evaporation over time which can be related to high ambient laboratory temperature and/or infrequent use of the beads.

Storage conditions:
The stability of the QwikCheck™ Beads control material is highly dependent on maintaining an intact matrix volume.  Therefore, special storage conditions and timeframes for use after opening are recommended as follows:   
1. Each kit contains two known concentrations of QwikCheckTM Beads in two 5 ml aliquots and one 5 ml negative concentration and motility control.  
2. Store unopened bead kits @ 15-30°C (60-86°F). 
3. After opening for the first time, refrigerate @ 2-8°C (36-46°F) for 90 days or store @ 15-30°C (60-86°F) for 30 days.
4. Refrigerated bottles must be brought to room temperature before use. 
5. The labeled storage expiration date assumes that QwikCheckTM Beads are stored in their original containers and are tightly capped to prevent evaporation. 
6. QwikCheckTM beads are stable and show no loss of expected performance characteristics after transport/storage over a period of 72 hours at the temperature range of -20°C to +37°C (-4°F to +99°F).






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Technical Release Bulletin: SQA Preventative Maintenance Recommendations

Wednesday, April 11, 2018
Background:

The SQA (Sperm Quality Analyzer) instrument produced by Medical Electronic Systems is a reliable tool for conducting automated semen analysis. Like any high technology system, it is recommended that periodic preventative maintenance be conducted to ensure top performance.  This bulletin provides timing recommendations and an overview of the PM process.


Preventative Maintenance Timeline Recommendations and Overview:
It is Recommended that Preventative Maintenance be performed on SQA instruments at some point between 13 and 24 months after the installation date and once per 12 months thereafter. A routine yearly PM will address the following areas of performance and reliability:

  1. 60 Point Inspection of All System Components and Software.
  2. Software and Firmware Upgrades.
  3. Hardware Upgrades.
  4. Repairs / Part Replacements.
  5. Calibration Confirmation.
  6. Updated Documentation, Recommendations, Technical Bulletins.
  7. New Products / Features.



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Debris Scanning on the SQA-Vision Automated Sperm Quality Analyzer

Thursday, March 29, 2018
 
An overview of different Debris classifications that should be selected when using the SQA-Vision Debris Scanner. Semen Sample Debris can influence a semen analysis as sperm can be covered or mistaken. The Debris Scanning option with optimize accuracy and provide the doctor with clinical information about the sample.


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TECHNICAL BULLETIN: DNA INTEGRITY ASSAY ON THE SQA-VISION

Monday, March 26, 2018

GOAL:  

The goal of this document is to introduce the new SQA-Vision DNA fragmentation test. This new feature can be easily implemented by using commercially available kits.

BACKGROUND:

The genetic integrity of the sperm is necessary for successful fertilization and normal embryo development. Including an analysis of sperm DNA fragmentation along with other semen parameters provides important fertility information and has been found to assist the practitioner to direct care.

DNA fragmentation assay by SCD (Sperm Chromatin Dispersion) technique encompasses a visual observation of sperm cells, differentiating between cells with a “halo” and cells without. A halo effect is seen in sperm with dispersed DNA loops of cells with non-fragmented DNA. Sperm with fragmented DNA do not produce a halo.

A special DNA FRAGMENTATION feature/mode was developed for the SQA-Vision to provide visualization/counting and reporting of the prepared sample. Cells are counted based on the HALO / NO HALO principle.

CLINICAL VALIDATION:

Two commercially available kits* were validated for use on the SQA-Vision by the MES laboratory:

- Halosperm® by HALOTECH.

- Sperm DNA Fragmentation Assay Kit by BASO® diagnostics.

*NOTE: Other kits were not tested and therefore their performance on the SQA-Vision is unknown.

TESTING DNA FRAGMENTATION ON THE SQA-VISION:

To successfully perform DNA fragmentation testing on the SQA-Vision using one of the recommended kits:

- Follow the kits instructions for sample preparation
- Two paths are available for testing on the SQA-Vision:
- Following the automated test by selecting the option “DNA FRAG” (located below the test results)
- Off-line by selecting “VISUALIZATION” from the main menu and then selecting “DNA FRAG”

Marina Friling, Clinical Manager, MEDICAL ELECTRONIC SYSTEMS



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Technical Release Bulletin: SQA-V/Vision & QwikCheck Gold Sperm Analyzer Quality Controls

Thursday, December 14, 2017

Background:  Organizations providing semen analysis proficiency testing/QC programs (CAP, NEQAS) require laboratories to show proficiency and quality control across three main semen analysis parameters: Sperm concentration, motility and morphology. To date, the QC/proficiency testing samples provided by these organizations are for testing only sperm concentration. Motility and morphology challenges currently require a live semen sample which is too complex to deliver and the target values are not standardized between labs (Exception: IVF Australia Proficiency challenge).


Response:  In order to ensure that the automated sperm analyzer is providing high quality and consistent test results and that the laboratory is maintaining appropriate proficiency, MES has established four independent concentration/motility/morphology quality control systems: 

1. Autocalibration and Self-Test
2. QwikCheck Quality Control Material (including zero level lower limit motility detection)
3. Calibration Parameter Confirmation 
4. Routine Concentration, Motility and Morphology analyzer validation

AUTOCALIBRATION AND SELF-TEST:  An electronic testing process that is initiated each time the analyzer is activated. 

• Modulated analog signals are generated by the system. These signals are similar to signals detected during actual semen testing (when spermatozoa cross the instrument light beam in the thin section of the SQA testing capillary). 
• The same motility and morphology algorithm used for converting electronic signals into clinical test results is used in this electronic simulation of motility and morphology. 
• If the Self-Test simulation reports a reading that exceeds the allowable range, the system will report FAILED SELF-TEST and will not allow a test to be run. Corrective action instructions are displayed on the screen. 
• When the SQA passes Auto-Calibration and Self-Test, a “Service Parameters” report can be printed and kept on file to prove system preparedness and compliance.

EXTERNAL QUALITY CONTROL
QwikCheck™ Beads are an assayed external quality control for testing Concentration and zero level Motility (manufactured by Medical Electronic Systems – www.mes-global.com): 

• Three concentration levels are provided in a kit. 
• The Negative Control level of the QwikCheck™ Beads kit verifies that the SQA is not reporting false positive readings for both concentration and motility (MSC) at level = 0. 
• A printed report of the control results will demonstrate the accuracy of the system and the operator’s proficiency

CALIBRATION PARAMETER CONFIRMATION
Once or twice per year, the Self-Test data of the SQA can be sent to MES for calibration verification. Based on a comparison of the initial analyzer calibration data maintained by the manufacturer (MES) and the current self-test data, the status of the SQA calibration can be evaluated.

CONCENTRATION, MOTILITY AND MORPHOLOGY VALIDATION ON THE SQA ANALYZER
Based on CLIA regulations and MES recommendation, it is advisable to run the QwikCheck Beads Validation and Training kit that verifies: 

• Linearity and Reportable Range 
• Precision – Replication & Detection Limit 
• Accuracy 

MES also recommends that the SQA is validated semi-annually using the QwikCheck Beads Precision and Linearity kit to verify: 

• Linearity and Reportable Range 
• Precision and Lower Limit Detection 
• Concentration Accuracy

In addition and in coordination with the QwikCheck Beads kit testing, MES recommends assessing fresh semen concentration, motility and morphology to confirm the SQA accuracy and user proficiency. The following is a protocol for running the automated analyzer and comparing the results to manual analysis (back-up method): 

• Run, in duplicate, 10 fresh semen samples on the SQA; 5 should be low motility (<40%) and 5 normal motility (>=40%) range.
• In parallel assess, in duplicate, the concentration, motility and morphology of the same samples under the microscope per WHO 5th edition manual guidelines. 
• Run samples at room temperature within a 2 minute timeframe between the two methods (manual morphology can be assessed > 2 minutes following the laboratory protocol for manual morphology assessment). 
• Compare the automated and manual results (Can be sent to MES for statistical evaluation). 

In conjunction with the Auto-Calibration, Self-Test, External Daily QC, Calibration Parameter Confirmation and running Validation kits, this routine mini-validation proves system function, accuracy and user proficiency for Concentration, Motility and Morphology.



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Technical Release Bulletin: Fixed Coverslip Slides Sperm/Bead Counting Principles

Thursday, November 16, 2017
Segre Silberberg Effect
Capillary flow into a 20-micron counting chamber (fixed coverslip type) follows a classical Poiseuille flow. The flow of the fluid is dominated by its viscosity. A maximum velocity is reached at exactly half the depth of the chamber while the velocity at the chamber walls equals 0 micron/second. The sperm cells or beads (further – “particles” for simplicity) in the middle of the chamber height move faster than the ones near the wall. It has been shown that during chamber filling all particles move to two planes at equidistance from each chamber wall with velocity gradient. The distance of these planes from the wall depends on several parameters:

• Development of full Poiseuille flow
• Chamber height
• Surface properties of the counting chamber
• Surface tension
• Fluid viscosity
• Flow velocity
• Particle diameter

Because particles in the two Segre Silberberg planes move faster than the average fluid velocity, there is an accumulation of them at the filling front that impacts their distribution throughout the chamber volume. As sample viscosity is not a constant parameter for semen and beads (semen is much more viscous as compared to beads spread in a water-based media), it impacts their distribution in a fixed coverslip chamber. Correspondingly concentration of the sperm and beads cannot be accurately counted under the SAME conditions. In fact, semen viscosity prevents the even spread of spermatozoa throughout the fixed coverslip volume resulting in accumulation at the filling point, whereas the water-based suspension of beads is loaded faster with minimal accumulation at the filling point.

Counting Sperm
In order to insure accurate manual counting of SPERMATOZOA using a fixed coverslip chamber in the SQA-V or SQA-Vision visualization compartment, the assessment should be performed at ZOOM-OUT (low magnification and wide field of view) which will compensate for the impact of semen viscosity.

Counting Beads
For accurate manual counting of BEADS using a fixed coverslip chamber in the SQA-V or SQA-Vision visualization compartment, assessment should be performed at ZOOM-IN (high magnification and narrow field of view) which will compensate for the very low bead viscosity.

Notes
• This technical bulletin is related to fixed coverslip slides only.
• It is not related to the other counting chambers which have different loading principles such as the hemocytometer, Makler chamber and standard slides.

Compliance Date: Effective November 15, 2017
Authority: Lev Rabinovitch, PhD CTO
Distribution: MES LLC, all MES Ltd. distributors

DOWNLOAD Technical Release Bulletin: Fixed Coverslip Slides Sperm/Bead Counting Principles


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Technical Release Bulletin for QC of Morphology Pre-stained Slides

Saturday, October 07, 2017
Technical Release Bulletin for QC of Morphology Pre-stained Slides

Background:
To perform quality control of the Morphology pre-stained smears please follow the instructions below.

Preparing QC semen samples:
•  Pool around 5 FRESH semen samples and wash according to the following procedure:
1. Mix the semen sample well.
2. Split into 5 equal volume samples.
3. Dilute each sample to 10 ml with 0.9% (9 g/l) saline or Earle’s buffer.
4. Centrifuge at 800g for 10 minutes.
5. Tip off and discard all but 20–40 μl of the supernatant.
6. Re-suspend the sperm pellet in the remaining supernatant by gentle pipetting.
7. Pool all washed samples.
8. Dilute the pool to 2 ml with 0.9% (9 g/l) saline or Earle’s buffer.
9. Add 20 μl of 35% formalin.
• Distribute 50 μl aliquots of pooled semen samples into the screw cap cryo vials and store at 4 °C.
• Assay sperm Morphology of these QC pool using the standard lab method to establish Morphology Target Range (Papanicolaou is recommended).
• Establish pre-assayed Morphology Target Range: Mean Value +/- 3 standard deviations or 25% whatever is greater (please refer to the link below):
http://www.mes-global.com/_blog/MES_Service_Blog/tag/Acceptable_Ranges_for_Semen_Analysis/

Morphology pre-stained slide QC procedure:
• Assess the QC samples using Morphology pre-stained slides at pre-defined by the lab intervals according to the product insert procedure.
• Compare Morphology QC results with the pre-assayed Morphology Target Range.
• PASS/FAIL: Morphology QC results should fall into the pre-assayed Target Range.

Reference:
WHO laboratory manual for the examination and processing of human semen - 5th ed., World Health Organization 2010.

Compliance Date: Effective October 7th, 2017
Authority: Dr. Lev Rabinovitch, CTO
Distribution: Morphology pre-stained slide users

DOWNLOAD Technical Release Bulletin for QC of Morphology Pre-stained Slides

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New SQA-Vision Upgrade | Version 44.3.193

Tuesday, August 29, 2017
Medical Electronic Systems is officially announcing the release of a new SQA-Vision Semen Analyzer software update.  The new version will be 44.3.193.  If you are currently on 44.3.167, you will see the following changes:

Flexible Report ‐ A new custom (flexible) report feature was added. This allow the user to design their own report.  MES has publish a guide on how to build out the Flexible report.  Note: Programming Skills required.

Post Vas Counting Mode ‐ A new counting mode was added to the Post Vas. test. The new mode enable the user to scan an entire slide and click to count the cells without entering the number of fields and cells counted.  The user will count all 50 fields available through the lab slide.

Multiple Users ‐ An option to add multiple users and password was added.

Range Icons – Pass vs. Fail indication was replaced with up and down arrows based on the cutoff.

LIS Interface ‐ There is now an option to re‐send a specific patient record as opposed to a whole date range.

Additionally, an option to change the time out delay was added.

Time Format ‐ The time format is now set to a 24hour clock.

Debris Scanning Options ‐ A Gross Debris option was added to the debris scanner.


If you are currently on version 44.3.180 or 44.3.182 you will see the following changes:

Back and Restore – The process has been updated for ease of use and reliability.

Upgrade Process – Streamlined and simplified for future versions.

Debris Scanner Workflow – If the Low Quality Counter is turned off and the Debris Scanner is turned on the Debris Scanner will activate on Low Quality samples.

Stability Improvements – The quality of data transfer and video interfacing is greatly improved for reliability.

To request this free upgrade please submit a request through the website HERE or send an e-mail to service@mes-llc.com.

DOWNLOAD A PDF DOCUMENT OF THE SOFTWARE CHANGES HERE



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QwikCheck™ Liquefaction Kit Product Update

Thursday, August 24, 2017
BACKGROUND

The QwikCheck™ Liquefaction kit manufactured by Medical Electronic Systems (MES) is used to accelerate the liquefaction of viscous or incompletely liquefied semen samples that remain viscous thirty minutes after collection.

The kit contains: 20 single dose, 5 mg vials of lyophilized α-Chymotrypsin and a product insert.

OVERVIEW

Recently the Chymotrypsin used in the kit has changed in the following ways:

1.  New supplier
2.  Chymotrypsin is now a thin powder (previously it was irregular crystalized particles).
3.  Although the 5mg powder weight is exactly the same as the irregular crystalize particles of the previous Chymotrypsin, it can be seen to occupy a    smaller volume in the individual single dose vials.

Notes:

• Clinical testing of the new Chymotrypsin vs. the old did not demonstrated any significant change or negatively impact semen parameters.
• The required amount of 5 mg of chymotrypsin per vial has not changed
• The product insert (instructions) has not changed.



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How to Utilize the Backup and Restore Feature of the SQA-Vision

Monday, August 14, 2017
BACKGROUND:

The SQA-Vision system has a backup and restore feature which can be utilized manually or on a set automatic schedule. For SQA-Vision version 44.3.193 the process has been improved for reliability and simplified for routine use. After upgrading to version 44.3.193 please follow these instructions.

BACKING UP YOUR DATA AUTOMATICALLY:

Step 1: Insert an external hard drive into an available USB port.
Note: If there are no available USB ports you may use a USB Hub to connect less critical items together such as the mouse, keyboard and printer.
Step 2: Open SQA-Vision Application.
Go into “SETTINGS” then select “SERVICE” from the top tab list. In the BACKUP FREQUENCY box indicate how often you would like the backup to run. If you do not want the system to backup automatically, leave the “BACKUP EVERY” box blank.
Note: The auto-backup will begin upon shut down of the Vision application.
Select “BROWSE” and locate the external hard drive by expanding “This PC.” Select the “BACKUP (E:)” hard drive and hit “OK.”

BACKING UP YOUR DATA MANUALLY:

Step 1: Go into “SERVICE” and select “BACKUP” in the SQA-VISION BACKUP STATUS box.
Note: The BACKUP PATH will still need to be set from the SETTINGS MENU.
Step 2: Backup will begin to copy all data to the external hard drive. Hit “OK” when complete.
Step 3: Verify the Backup has successfully saved your data by checking the external hard drive for the Vision backup file: Folder name: SQAVisionBck_DDMMYYYY_HHMMSS.

RESTORING YOUR DATA:
Note: In the event that your Vision PC is damaged you may restore your database to a new PC that has been loaded with the Vision Application.

Step 1: Ensure that the Vision Application is installed on an MES supplied PC.
Step 2: Ensure the MES backup external hard drive is inserted.
Step 3: Locating the backup folder.
- Open SQA-Vision application and select “SERVICE” then “RESTORE”.
- Select the desired backup file by clicking the drop-down arrow on the right.
- Select the file name and “Launch Restore”.
- Once the restore is complete launch the Vision App and all data should be available.
Note: Restoring your data from an older backup file will overwrite your current data. It is recommended that the restore feature only be used to re-build new PCs.

For detailed instructions, please download and read our tech bulletin: How to Utilize the Backup and Restore Feature of the SQA-Vision

If you have any further questions or concerns, please feel free to contact elizabeth@mes-llc.com


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