Issue date/Distribution: Tuesday, February 14, 2012/ALL SQA-V Users

Subject: It is recommended that twice a year, the SQA-V/Spermalite calibration is checked against the original factory calibration parameters. Although, there are acceptable calibration RANGES for the SQA-V, the SQA-V calibration might be close to the high/low range and proactive maintenance will bring it into perfect range for continued and uninterrupted use. The document below can be downloaded HERE.

 

Also, please remember to check the Technical Bulletins section of the website often for updates HERE.

 

 

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DOWNLOAD SQA-V Motility_Morphology Technical Bulletin

DOWNLOAD SQA-V Motility_Morphology Testing Instructions

DOWNLOAD SQA-V Motility_Morphology Data Entry Spreadsheet

 

OVERVIEW FROM INSTRUCTIONS DOCUMENT ABOVE: It is recommended that the facility run two (2) live human semen samples and one (1) negative control QC sample in replicates of five (5) to validate the Intra-Assay Precision & Sensitivity (CV %) of the SQA-V Gold system Twice per year. This is to show Motility/Morphology Quality Control and user proficiency. Data collected should be entered in the Data Entry Spreadsheet provided by MES.  The Data Entry Document can be downloaded HERE. The document can also be e-mailed to the facility by MES upon request (service@mes-llc.com).  Upon completion, the user may e-mail the document back to MES for verification.

INSTRUCTIONS:

 

1. Collect two patient samples.

 

2. One sample should be a high concentration sample (greater than 50 Million per ML.) and one should be medium to low (less than 50 Million per ML.)

 

3. Both samples should have Motility greater than 30% and be as FRESH as possible for sample stability.

 

4. If there is no high concentration sample available, one can be made by combining two (or more) samples, centrifuging, and decanting the necessary percentage of seminal plasma.

 

5. Run five (5) replicates of each fresh semen sample as “Fresh Samples” from the Test New Patient section of the main menu (reference SQA-V User Guide page 13 for assistance). Do not discharge and refill the capillary between tests; re-run the same aliquot in the same capillary. The Negative Control sample should be run from the “Control Section” (Negative Control option).

6. Make sure to print out test results after each test (NOTE: If setup to do so, your instrument will print out all results automatically).

7. Import the test results to V-Sperm. Make sure each test is transferred over as this will keep a backup of all test results on file at the facility.

8. After each test, choose the “Retest Patient” option from the main menu to speed through put. NOTE: For sample stability, the five (5) replicates should be run as quickly as possible and continuously. Time is of the essence for best results!

9. Enter all data in the “Data Entry Spreadsheet” and return e-mail to MES (service@mes-llc.com) for verification.

NOTE: Updated service and support documents as well as current technical bulletins can be found at www.mes-global.com. Please check the site periodically for current protocols.


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The SQA-V grades “Normal Morphology” according to WHO 3rd, 4th, or 5th edition criteria. It does so by tracking the normal and abnormal motion patterns of the sperm cells in relation to the overall sample population (10,000+ cells analyzed vs. 200~400 manually). The SQA-V processes the differences in sperm motion patterns and correlate them to morphological defects via electro-optic infrared analysis.  Example: A man walking with a broken leg creates abnormal motion based on his abnormal morphology. His walking “pattern” can be abnormal even if he is moving “quickly”. The system cannot necessarily tell if it is a broken leg or another defect like a broken back – but the signals generated do show a problem. For this reason, the SQA-V only reports Normal vs. Abnormal as opposed to a full Morphology breakdown. The system includes a 500x visualization system that allows any operator to verify any result at any time. Used this way, the machine has been validated and certified all over the world and is in routine use at some of the top labs in America and beyond.

Although this is a non-standard approach to qualifying morphology, the correlation between abnormal motility and abnormal morphology is well documented (please see THIS DOCUMENT for references). MES dove deep into the causes of this relationship and have fine-tuned our morphology algorithm to include all relevant data to deliver the most accurate result possible during a routine semen analysis. And remember – ANY operator can run a sample on the SQA-V whereas it takes considerable expertise to perform a detailed manual morphology estimation.

Please check out THIS ARTICLE published in Fertility & Sterility comparing the SQA’s morphology assessment to that of two experienced manual operators – you can also find many additional studies HERE.  This study (and many like it) showcase the extreme variability associated with manual estimation. The typical aliquot analyzed manually (400 cells) represents less than .00001% of the total ejaculate and is subject to extreme subjective interpretation. To compound the problem there are many different “standards” that the tech can use to estimate the morphology. When all is said and done you are flipping a coin trying to achieve an accurate manual morphology count (check out the CAP manual morphology results to see the extreme variability). Unlike the manual method, the SQA-V delivers an OBJECTIVE and reliable normal vs. abnormal screening. When you combined the morphology result with the 15 additional reported parameters the system delivers a detailed report that quantifies sperm quality accurately, precisely, and VERY quickly.

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  Capillary Sensor Cover Installation - Issue date: May 22, 2011

  Understanding Sensitivity and Specificity as They Relate to Semen Analysis - Issue date: May 17, 2011

  SQA-V™ and QwikCheck™ Gold Motility and Morphology Quality Control - Issue date: May 15, 2011

  QwikCheck™ Gold vs. SQA-V™ Gold Differences - Issue date: May 15, 2011

  SQA-V™ Processor Re-Seating and Replacement - Issue date: March 18, 2010

  SQAII Series vs. WHO 5th Edition - Issue date: March 2, 2011

  WHO 5th Edition vs. WHO 4th Edition SQA-V Reporting Compliance - Issue date: February 13, 2011

You will need Adobe Reader to view these links.

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Sensitivity and Specificity are the elements that are used to perform what is called “ROC” analysis.  (ROC = receiver operating characteristic). ROC statistical analysis analyzes TRUE and FALSE POSITIVE and NEGATIVE clinical/disease test results as defined below:

• TN - True Negative (correctly classified as negative in absence of disease)
• TP - True Positive (correctly classified as positive in presence of disease)
• FN - False Negative (not correctly classified as negative in presence of disease)
• FP - False Positive (not correctly classified as positive in absence of disease)

 

Further:  In semen analysis, the “presence of disease" is related to abnormal semen test results. And the "absence of disease" is related to normal levels of semen test results.

• Sensitivity shows the % probability that a test result will be positive when the disease is present (TRUE POSITIVE) based on this formula: TP/(TP+FN)*100%
• Specificity shows the % probability that a test result will be negative when the disease is not present (TRUE NEGATIVE) based on this formula: TN/(TN+FP)*100%

 

When comparing a new method of analysis to the standard one, the results of the standard method (for example, manual) are accepted as the "true value" and the results of the new method are classified (graded) vs. these "true values" by using the reference cutoffs published by the WHO manual.

 

The following 4 combinations are possible:

• Both results are below the cutoff – TP (TRUE POSITIVE)
• Both results are above the cutoff – TN (TRUE NEGATIVE)
• Standard method shows result below the cutoff and the new method above – FN (FALSE NEGATIVE)
• Standard method shows result above the cutoff and the new method below – FP (FALSE POSITIVE)

 

Finally Sensitivity and Specificity are calculated from the numbers representing each combination. For statistically significant outcome, the sufficient number of observations equally representing normal and abnormal cases is required.

 

Example:

Morphology Reference Cutoff, %							15
MORPHOLOGY, %		Morph. Grade				Morph. Grade Final
SQA-V	Manual
47.0	34.0		TN			TP	7
8.0	7.0				TP	TN	9
3.0	5.0				TP	FP	1
20.0	23.0		TN			FN	1
12.0	34.0	FP
25.0	32.0		TN			Sensitivity = TP / (TP + FN) * 100
13.0	14.0				TP	87.5%
10.0	12.0				TP	Specificity = TN / (TN+FP) * 100
0.0	0.0				TP	90.0%
30.0	10.0			FN
64.0	54.0		TN
25.0	23.0		TN
42.0	40.0		TN
36.0	30.0		TN
9.0	8.0				TP
36.0	31.0		TN
7.0	6.0				TP
38.0	26.0		TN

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Testing Low Volume or Aged Post Vasectomy samples using the SQA-V™ Gold Visualization System (DOWNLOAD)

Overview: Low Volume, Aged, and Proficiency Post Vasectomy Samples can be run using only the SQA-V™ Gold
Visualization System only. The automated mode of the SQA-V™ Gold is designed to test Post Vasectomy samples
within 24 hours of collection and focuses heavily on differentiating between Motile and Non-Motile sperm - the
most clinically relevant aspect of the analysis. Due to the nature of aged samples (such as proficiency testing
materials mailed to you) Medical Electronic Systems suggests testing these types of samples using the calibrated
SQA-V™ Visualization System as follows:

Supplies needed:

 1” (25mm) x 3” (75mm) Standard Lab Slides
 22mm x 22mm Slide Covers
 SQA-V™ Gold Slide Adapter
 10μ (microliter) Pipette and Tips
 V-Sperm™ Gold Software
 MES Post Vasectomy Calculator

Standard Operating Procedure:

1. Allow the specimen to liquefy at room temperature for approximately 30 minutes.
2. If the sample remains viscous or not completely liquefied, add one (1) vial of QwikCheck-Liquefaction kit.
3. Record sample volume to the nearest 0.1 mL by using a 5-10 mL graduated cylinder or a serological pipette.
4. Open “Real Time Video” under the Video options in V-Sperm and select “full screen” for easiest viewing.
5. Thoroughly mix the specimen.
6. Prepare a standard slide according to the directions in the SQA-V Gold User Guide instructions (SQA-V Gold
User Guide, Version 2.48 I-button, Appendix 3: Using Standard Slides in the Visualization System, p. 34).
7. Center a 10 μL drop of semen at a distance of approximately 12 mm from the top edge of the slide.
8. Carefully place a standard (22 mm x 22 mm) cover-slip over the sample, closely observing that the droplet of
semen sample is evenly spread across the entire surface area of the cover-slip. The sample should spread
evenly without using ANY additional pressure applied to the cover-slip.
9. Carefully place the prepared slide on the slide adapter (with the sample and coverslip facing into the machine).
10. Make sure the slide “clicks” into place securely in the slide adapter and sits level.
11. Insert the fully loaded slide adapter into the visualization chamber of the SQA-V.
12. Press the ZOOM OUT key on the SQA-V keypad until the system is fully zoomed out (x300 magnification).
13. Optimize the video image until you see sperm/debris with the blue focus knob on the machine.
14. Change the field by turning the silver wheel on the slide adapter (this moves the slide “in and out”).
15. Count all Motile and Immotile spermatozoa separately for each field. It is recommended that you count at
least 20 unique fields per slide for Post Vasectomy samples.
16. Record results.
17. If no sperm are found, centrifuge (concentrate) the specimen (If > 0.5 ml) at 300XG (~1100 rpm) for 10
minutes. Remove all but 0.3 mL of the supernatant seminal fluid. Re-suspend the pellet in the remaining
supernatant.
18. Repeat steps 10-19 counting 2 separate slides (20 fields per slide).
19. When following this procedure every cell seen represents 1 Million/ML (per unique field). For
example, if you saw 40 cells in 20 unique fields the sample concentration would be 2 Million/ML.

NOTE: Semen samples with a volume of <0.5 ml (do not need to be concentrated). These samples will be
reported with an attached comment. See Reporting Result section.

For questions, assistance, or other inquiries please contact Medical Electronic Systems directly at 866-557-9064,
service@mes-llc.com or by visiting the website at www.mes-global.com

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MSDS Sheets Posted for all Medical Electronic Systems products:

  MSDS- SQA-V Automated Sperm Quality Analyzer

  MSDS - SQA-V Testing Capillary

  MSDS - SQA-V and SQAII Cleaning Kit

  MSDS - SQAIIC-P Testing Capillary

  MSDS - QwikCheck™ Quality Control Beads

  MSDS – QwikCheck™ Ph/WBC TestStrips

  MSDS – QwikCheck™ Liquefaction Kit

  MSDS – QwikCheck™ Dilution Kit




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Click Image to Download full instructions:




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