The Worldwide Leaders in Fully Automated Semen Analysis                
 

 
Company Products Support Distributors VideosOnline ShopContact
- News & Updates
- Contact
- Manufacturing
- Recommendations
- Shopping Policies
- Veterinary Line
- Distributor Support
- Analyzers
- QwikChecks
- LIS QwikLink
- Vet Products
- Validation Kit
- Validation
- Quality Control
- Proficiency
- Technical Bulletins
- Procedure Documents
- User Guides
- MSDS Sheets
- Training Videos
- Service Blog
- Studies
- Upgrades
- Batch Releases
- Luvv Letters
- Find a Distributor
- Distributor Support











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


Direct Link to this Post: Permalink     

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.



Direct Link to this Post: Permalink     

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.



Direct Link to this Post: Permalink     

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".


Direct Link to this Post: Permalink     

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

 



Direct Link to this Post: Permalink     

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.



Direct Link to this Post: Permalink     

Technical Bulletin Update | QwikCheck Test Strips QC

Monday, February 02, 2015

 

CLICK HERE TO DOWNLOAD PDF VERSION



Direct Link to this Post: Permalink     

Stabilized Sperm Proficiency Challenge for LOW LEVEL Target Values

Wednesday, October 29, 2014

Background:

 

The need for external quality control schemes for confirming diagnostic procedures/equipment is of utmost importance. A number of multicentre studies on semen quality confirm this fact (1, 2). Quality control materials are best suited when they closely replicate the actual material being tested. However, due to the biological nature of semen, providing external quality control materials presents a challenge. Semen is motile for a relatively short period of time and the sample degenerates quickly. Semen samples prepared by proficiency/quality control organizations are based on adding a fixative media to the donor semen samples. As a result, the original nature of the fresh semen is distorted. In addition, there can be significant batch-to-batch variations in the proficiency challenge sample matrix. This causes problems running such samples in the SQA-V - especially at the low end of concentration.

 

Matrix and Spermatozoa Modification by Fixative Materials


Stabilized sperm is made from a fresh semen sample. This fixative process impacts the original semen sample as described below:

 

• The spermatozoa are shrunk because of fixation which causes a change to their size and shape.

 

• The seminal plasma is diluted with a fixative or completely replaced with a media causing a decrease in the sample viscosity. The SQA-V algorithm works based on the optical density of SEMINAL PLASMA (not the dilution media or modified “seminal plasma” used in stabilized sperm).

 

• A decrease in sample viscosity and density results in rapid cell sedimentation and uneven distribution of the cells throughout the volume of the sample. These factors may result in inconsistent concentration of cells in the samples received by the labs and in the aliquots taken for analysis. The sample tested may no longer reflect the target value established by the manufacturer.


All of these facts will adversely impact the accuracy of automated testing especially in low concentration samples because the prepared quality control material is not the same as a normal semen sample. The SQA-V is designed to run semen samples within one hour of collection and the concentration dynamic range of the SQA-V is 2 M/ml on the low end. Therefore, running a quality control sample of very low quality on the SQA-V, may result in a ZERO reading.

 

Running Low Level Stabilized Sperm Samples on the SQA-V GOLD System

If a stabilized sperm sample run on the SQA-V GOLD in the stabilized sperm Quality Control mode results in ZERO (beyond 2 M/ml dynamic range), re-run the sample in the Fresh mode as outlined below:

·        Turn on the SQA-V GOLD system and wait until auto-calibration/self-testing is completed.

·        Go to: MAIN MENU>TEST NEW PATIENT and enter:

o      PATIENT ID: Sample #

o      BIRTH DATE: Test date

·          From the next screen select:

o  SAMPLE TYPE: FRESH

o  WBC CONC: < 1 M/ml

o  Select “Yes” when asked “IS SAMPLE VOLUME SUFFICIENT FOR COMPLETE RESTING >= .5 ml?

·        Vortex the stabilized sperm sample.

·        Transfer the sample from the original vial to the 10-ml collection cup and mark it with the sample #.

·        Mix the sample thoroughly and immediately fill the SQA-V capillary and run the test.

References

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

2.      Auger J. et al. Intra- and inter-individual variability in human sperm concentration, motility and vitality assessment during a workshop involving ten laboratories, Human Reproduction, 2000, Vol. 15, Issue11, pp. 2360-2368.

 

DOWNLOAD THIS TECHNICAL BULLETIN HERE



Direct Link to this Post: Permalink     

Importing the SQA-V Archive into V-Sperm

Tuesday, October 14, 2014

 

This training video provides instructions on how to import the SQA-V archive into V-Sperm. Periodically, the SQA-V archive may become full generating a message prompting your to clear it. Follow this guide to make that happen! Remember, it ALL Started with a Sperm!  See additional videos HERE



Direct Link to this Post: Permalink     

SQA-V Cleaning Procedure Update | Daily and Weekly Maintenance

Tuesday, October 07, 2014

 

As of mid 2014 the SQA-V cleaning procedure has been broken up into daily steps and weekly steps for ease of maintenance and to avoid excessive system cleaning. Keep follow these steps to keep your system reliable, accurate, and happy! Remember, it ALL Started with a Sperm!  See additional videos HERE



Direct Link to this Post: Permalink     

.

Search Tags (Alphabetical):