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Rapid - Objective - Standardized Semen Analysis Solutions... Remember, it ALL Started with a Sperm!











2016 CAP Proficiency Instructions for SQA Systems

Wednesday, April 27, 2016

 

 

TECHNICAL BULLETIN:  TESTING CAP PROFICIENCY SAMPLES ON SQA SEMEN ANALYZERS

For All SQA-V and SQA-VISION Systems Version 2.45 and above | UPDATE: April 27th, 2016

 

BACKGROUND:

The College of American Pathologists (www.cap.org) provides a nationwide proficiency challenge for automated methods of semen analysis.  These results are peer reviewed against other SQA users providing an objective and efficient way to maintain proficiency.  MES recommends this survey as an unbiased appraisal of user proficiency and system performance. 

TESTING INSTRUCTIONS FOR SQA-V/SQA-V GOLD/SPERMALITE SYSTEMS:

NOTE: The CAP proficiency material should first be run as Stabilized Sperm in the “Control” mode and re-run in the Test New Patient “Fresh” Mode if a result of 0.0 is reported in Stabilized Sperm Control mode.

 

SETTING UP THE DEFAULTS:

  • From the main menu of the SQA-V/SQA-V Gold/Spermalite select: SERVICE > SERVICE DATA.
  • From the V-Sperm computer, navigate to SET UP > SQA-V > SQA-V DEFAULTS and click “CONTINUE”.  You will now see a set-up screen displayed on the PC.
  • On the bottom half of the setup screen, select the “STABILIZED SPERM” option and enter the following for Level 1 and Level 2:    
    • Lot Number = Your Sample Reference # | Target = 50 | Range = 50 | Date = Today’s date.
    • Click “APPLY” and wait a few moments for the information to transfer to the SQA-V.
    • NOTE: Do not forget to change your defaults back to Latex Beads after running your CAP sample!

 

TESTING YOUR PROFICIENCY SAMPLES ON THE SQA-V/SQA-V Gold/Spermalite:

  1. From the MAIN MENU of the SQA select: RUN CONTROLS > LEVEL 1 and allow system to calibrate.
  2. Mix the sample well by aspirating it in and out 10 times with a transfer pipette.  Avoid bubbles!
  3. Load the SQA-V testing capillary and check CLOSELY for bubbles then wipe the capillary tip clean.
  4. Insert capillary into the testing chamber when prompted to do so.
  5. If a sample result of 0.0 is received, re-run the sample as a FRESH sample.
  6. To Re-Run sample as FRESH, select “Test New Patient” from the main menu and enter the CAP sample number as the Patient ID.
  7. All other entries on the first screen may be skipped.
  8. On the second screen select “FRESH” under sample type and < 1 M/mL for WBC CONC. (all other entry fields may be skipped).
  9. Select YES when asked if sample is sufficient for complete testing > 0.5 M/mL.
  10. Allow system to calibrate and insert the capillary when prompted.
  11. Report the results received.
  12. Repeat Steps 1 – 11 for the second CAP proficiency material level.

 

TESTING INSTRUCTIONS FOR SQA-VISION SYSTEMS:

 

SETTING UP THE DEFAULTS:

  1. From the MAIN MENU of the VISION PC, select SETTINGS > PROIFICIENCY. 
  2. Enter a SAMPLE ID, DATE, and a NOTE (if necessary).
  3. Click SAVE.

TESTING YOUR PROFICIENCY SAMPLES ON THE SQA-VISION:

  1. Select QC / PROFICIENCY from the main MENU and touch TEST NOW on the desired option.
  2. Mix the sample well by aspirating it in and out 10 times with a transfer pipette.  Avoid bubbles!
  3. Load the SQA-V testing capillary and check CLOSELY for bubbles then wipe the capillary tip clean.
  4. Insert capillary into the testing chamber when prompted to do so.
  5. Report the results received.
  6. Repeat steps 1 through 5 for all samples.

 

DOWNLOAD THESE INSTRUCTIONS HERE



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SQA-VISION Training Outline Now Available

Thursday, March 31, 2016

Click the image below for a screen shot overview of the SQA-VISION instrument.  The document may be used as a training reference tool for MES distributors and end users looking to train new staff members.  Remember, it ALL Started with a Sperm!

 



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What is the clinical relevance of distinguishing spermatids from WBCs during a semen analysis?

Monday, February 29, 2016

Answer: Leukocytes, predominantly polymorphonuclear leukocytes (PMN, neutrophils), are present in most human ejaculates (Tomlinson et al., 1993; Johanisson et al., 2000). They can sometimes be differentiated from spermatids and spermatocytes in a semen smear stained with the Papanicolaou procedure. Differentiation is based on differences in staining coloration, and on nuclear size and shape (Johanisson et al., 2000). Polymorphonuclear leukocytes can easily be confused morphologically with multinucleated spermatids, but stain a bluish colour, in contrast to the more pinkish colour of spermatids (Johanisson et al., 2000). Nuclear size may also help identification: monocyte nuclei exhibit a wide variation in size, from approximately 7 µm for lymphocytes to over 15 µm for macrophages. These sizes are only guidelines, since degeneration and division affect the size of the nucleus.  There are several other techniques for quantifying the leukocyte population in semen. As peroxidase-positive granulocytes are the predominant form of leukocytes in semen, routine assay of peroxidase activity is useful as an initial screening technique (Wolff, 1995; Johanisson et al., 2000) / (WHO 5th ed. manual, p. 102).


The test can be useful in distinguishing polymorphonuclear leukocytes from multinucleated spermatids, which are peroxidase-free (Johanisson et al., 2000).  (WHO 5th ed. manual, p. 103).

The total number of peroxidase-positive cells in the ejaculate may reflect the severity of an inflammatory condition (Wolff, 1995). This is obtained by multiplying the concentration of peroxidase-positive cells by the volume of the whole ejaculate.  Excessive numbers of leukocytes in the ejaculate (leukocytospermia, pyospermia) may be associated with infection and poor sperm quality.  Leukocyte-dependent damage to spermatozoa depends on the total leukocyte number in the ejaculate and the number of leukocytes relative to the number of spermatozoa.  Leukocytes can impair sperm motility and DNA integrity through an oxidative attack.  (WHO 5th ed. manual, p. 107).

Therefore distinguishing spermatids from WBCs during a semen analysis is of great clinical value. Using the QwikCheck Test Strips for WBC detection allows this differentiation, as this kit is specific for leukocyte (granulocyte) detection.


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Temperature Controls for Storing QwikCheck Dilution Kits After Opening

Monday, August 24, 2015
BACKGROUND:

QwikCheck™ Dilution media is currently labeled “Store at 4°C” after opening. This very specific instruction has been found to be too restrictive and not required.

UPDATED INSTRUCTIONS:

The QwikCheck™ Dilution kit instructions for storage have been updated to read “Refrigerate after opening 2-8°C” as this is found to be adequate for sustaining the integrity of the media. The new labeling will be seen on the outer box, the bottle label and the product insert for all batches released as of September 1, 2015.

THE FULL BULLETIN MAY BE DOWNLOADED HERE


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QwikCheck Semen Test Strips vs. Combur Urine Test Strips for WBC Assessment in Semen

Tuesday, August 18, 2015
Background:

For testing pH and WBC in semen, Medical Electronic Systems (www.mes-global.com) provides FDA cleared QwikCheck™ Test Strips which are specifically labeled for semen sample testing. Customers have requested a comparison of the QwikCheck™Test Strips to urine Test Strips.  Please find a link to the comparison below:

 

QwikCheck™Semen Test Strips vs. Combur Urine Test Strips

 

Note: False positive results may occur when using urine test strips (for semen samples with WBC ≥ .5M/ml and ≤ 1M/ml (as the upper range for Urine test strips is .5M/ml.



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How the SQA-V System Calculates Sperm Per Scan on Post Vas Mode

Wednesday, August 05, 2015

Question - What goes into the calculation of "Sperm Per Scan" on the Post Vasectomy mode of the SQA-V Automated Sperm Quality Analyzer?

 

Answer - The # Motile Sperm Per Scan is assessed automatically by the SQA-V algorithm based on detections of electronic signal spikes generated by the system when sperm cells cross the light beam in the thin section of the capillary (~ 10 µL volume, area 33mm2, 300µm depth). To compare to manual semen assessment, the "high power field" (x400) under the microscope using a standard slide contains 0.0024 µL of semen (area 0.12 mm2 X depth 0.02 mm). The total number of motile spermatozoa detected automatically in a 5-minute testing cycle is reported as # Motile Sperm Per Scan.



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Clinical Validation Limits in Semen Analysis | CAP | CLIA

Monday, August 03, 2015
Question: Are there any officially published recommendations from CAP or CLIA regarding acceptable “comparison limits” to backup methods?

Answer: Analytical Quality Requirements based on CLIA regulations can be found in the links below:

https://www.westgard.com/clia.htm

 

Total Allowable Error Limits Table


It is seen from these documents that allowable error limits vary based on the parameter tested. Also of note is that the requirements don’t include validation of a new method (comparison) or include semen analysis. Nevertheless the concept of Total Allowable Error limits can be used for a new method validation in semen analysis. In the document below, 3 standard deviations (3SD) or 25% error limits are quite frequent in the endocrinology and immunology analytes.

If 200 spermatozoa counted twice as required by the WHO 5th ed. manual, Sperm Concentration 3SD allowable error limit will be: 3SD = 3 X √400 = 60 that is: 60/400 X 100% = 15%.

The 3SD error formula for parameters expressed in percentages is different: 3 X √p(100-p)/N, where P = percentage, N = number of cells counted.

For example, 3SD allowable error limit for 40% Motility (WHO 5th cutoff) is:
3 X √40(100-40)/400 = 18% and results in 22% - 58% variability.

For 4% Morphology (WHO 5th cutoff), the 3SD allowable error limit is:
3 X √4(100-4)/400 = 3% and results in 1% - 7% variability.

The errors specified by the WHO 5th manual are purely statistical and do not cover the multiple issues impacting semen analysis results (sample mixing, dilution errors, non-equal aliquots, subjectivity, etc.). Therefore it will be safe to conclude that 3SD or 25% error limits (whatever is greater) similar to CLIA requirements for endocrinology and immunology analytes can be applied to semen analysis "comparison limits".


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MSDS | SDS Sheets for ALL MES Products

Wednesday, April 29, 2015

MES has updated all MSDS / SDS sheets for our product line.  Please find them here: www.mes-global.com/msds

 



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Routine Calibration Confirmation | Printing the Self Test Data

Monday, April 13, 2015

Every 6 months MES recommends that our SQA customers send us a copy of their "Self-Test" data for comparison back to your systems initial calibration parameters.  This is a free service for all SQA users.  Please follow the instructions in the Technical Bulletin below to send us your Self Test Data.

 
Issue Date: March 15th, 2015 | Printing the SQA Self Test Data Report for Calibration Confirmation 

 

-Remember, it ALL Started with a Sperm.



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Technical Bulletin Update | QwikCheck Test Strips QC

Monday, February 02, 2015

 

CLICK HERE TO DOWNLOAD PDF VERSION



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