Medical Electronic Systems Studies and Publications

Medical Electronic Systems Studies and Publications
Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment. MES SQA-V Sperm Quality Analyzer and Hamilton Thorne CEROS
READ STUDY | Statistical analysis of the test results from the automated systems and the manual method demonstrated no significant differences for most of the semen parameters. The Spearman coefficients of rank correlation (rho) for CASA and the SQA-V GOLD automated systems vs. the manual method were: Sperm concentration (0.95 and 0.95), total sperm number (0.95 and 0.95), MSC (0.94 and 0.96) and PMSC (0.94 and 0.93) correspondingly | University Hospital of Nantes
Despite controversy regarding its clinical value, male fertility investigation mainly relies on semen analysis. Even though reference guidelines are available, manual sperm analysis still suffers from analytical variability, thus questioning the interest of automated sperm analysis systems. The aim of this study is to compared automated computerized semen analysis systems (SQA-V GOLD and CASA CEROS) to the conventional manual method in terms of accuracy and precision. Methods We included 250 men in this double-blind prospective study. The SQA-V GOLD (Medical Electronic Systems) and CEROS, CASA system (Hamilton Thorne) were compared to the standard manual assessment based on the WHO 5th Edition.
Is it time to switch to automated semen analysis? MES SQA-Vision and Microptic SCA Sperm Class Analyzer Compared to Manual Analysis. A comparative double-blind study
READ ESHRE POSTER | Both sperm analyzers had good repeatability (CV) regarding the 3 studied parameters. Mean sperm concentration, progressive and total motility were not statistically different between the 3 methods. In conclusion, both automated sperm analyzers appear to have acceptable analytical performance, and to be as reliable as manual assessment for sperm analysis, provided they are run by expert users and QC program is implemented | University Hospital of Nantes
Despite the WHO efforts to standardize manual semen analysis, the technique still lacks reproducibility and accuracy. Several automated sperm analyzers have been developed and improved over the last 20 years, based on various technological approaches, i.e. image analysis (CASA) or analysis of electro-optical signal. The main objectives of these systems were to improve lab’s workflow, precision and accuracy of semen analysis via objective and high-throughput cell analysis. Although most studies have reported modest or acceptable agreement between automated and manual semen analysis, but many andrology labs still remain reluctant to invest in this technology. The aim of our study was to compare results given by automated semen analyzers (CASA and electro-optical systems) to manual analysis performed according to WHO 2010 guidelines.
Automation is the key to standardized semen analysis using the automated SQA-V sperm quality analyzer. Double-blind prospective study
READ STUDY | A good agreement was seen between the results of sperm concentration reported by the SQA-V automated analyzer (Spermalite/SQA-V; Medical Electronic Systems) and those obtained manually. A similar linearity was seen when the SQA-V results were compared with the manual data and also when the manual results of individual operators were compared with each other. The automated assessment of morphology showed high sensitivity (89.9%) for identifying percent normal morphology, and the precision of the SQA-V was considerably higher when compared with the manual method. The interoperator variability for manual assessment was significant. The automated analysis was quick compared with the manual method | Cleveland Clinic
Accuracy and precision can only be achieved by eliminating human error, adhering to an effective and standardized protocol, and assessing a very large sample size. It is evident that automation is a key factor to address all of these objectives. New automated methods for semen analysis are of clinical interest if the automated system is proven to accurately report semen analysis parameters. The objectives of our study were: (1) Compare the sperm concentration, motility, and morphology results obtained manually by two independent operators to those run on a new automated sperm quality analyzer. (2) to assess the performance of the two methods for sensitivity, specificity, between-method, and interoperator agreement. And (3) to evaluate precision and accuracy of the automated and manual methods using both semen samples and a quality control material. Additionally, this study will evaluate the extent to which the SQA-V (Spermalite/SQA-V presents as a precise, rapid, and cost-effective alternative to existing automated semen analyzers that require extensive professional skill to operate effectively.
Amateur vs Professional Users of the YO Home Sperm Test: An Assessment of Usability
Objective: To assess the accuracy of the YO home sperm test by real-world/amateur users.

Methods: This multisite study investigated whether amateur users could use the FDA-cleared YO Home Sperm Test to obtain accurate motile sperm concentration (MSC) results when compared to trained laboratory technicians. The qualitative MSC results of amateur and professional YO users were compared to each other as well as to the results of an established automated sperm quality analyzer (SQA-V) above and below a 6 m/mL MSC cut-off.

Results: This was a blinded, prospective study of 316 amateur users and 3 professional laboratory technicians across 3 study sites. Amateur vs Professional YO users demonstrated an accuracy of >97%. Qualitative results of amateurs and professionals vs SQA-V results showed a >95.7% accuracy.
This largest study of its kind to date defining the experience of using the YO test, an at-home sperm testing technology demonstrated that amateur participants, selected to reflect real-world users, accurately assessed whether a semen sample had a low or moderate/normal MSC below and above a cut-off of 6 m/mL. YO results were also accurate when compared to a widely utilized automated semen analyzer, the SQA-V. Furthermore, the YO test instructions were reported to provide a positive user experience, making it a valuable and usable real-world home sperm screening device suitable for an initial male fertility assessment.
Automated Semen Analysis – The end of Manual Analysis? 100 fresh semen samples were manually analyzed following WHO 5th Edition and tested on the SQA-V system.
READ SUMMARY | This simple analysis methodology for concentration, motility and morphology, shows much lower CV than humans can count. Concentration is the only manual parameter similar to the automated system. Motility tends to be significantly over-estimated by manual methods, and morphology is confirmed to have the largest variation between operators. The ranges show that humans subconsciously have a low morphology reported range and higher motility range. | IVF Australia
The SQA-V system demonstrates a high degree of precision and much lower intra sample variation than a human. Concentration was the only parameter where manual analysis mean was similar to automated, although the CV from replicate analysis was 12.8% vs 2.3% Progressive motility had a low CV, however the manual reported mean was significantly larger (58.3% vs 38.7%) with a much narrower dynamic range. Manual morphology showed the greatest inter-operator variability with a CV of 29.9%, with a narrower dynamic range of morphologies than the automated system. Despite the differences in morphology value, 84% of manual morphology results were in the same 4% Reference range.
Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration
Objective: To test the ability of the smartphone-based YO Home Sperm Test to accurately and precisely measure motile sperm concentration (MSC) versus the SQA-Vision, an automated laboratory semen analyzer.

Design: MSC compared for the YO device on Galaxy and iPhone smartphones versus the SQA-Vision in a double-blind manner.

Main outcome measure(s): Accuracy, precision, and agreement assessed between the YO device and the SQA-Vision for MSC results.

Result(s): The YO device demonstrated good correlation and good to moderate agreement with the SQA-Vision for MSC results up to a range of 94 × 106/mL with Pearson and concordance correlation coefficient above 0.92. The YO also showed a very high level of accuracy (97.8%) with positive and negative percent agreement above 94%. The difference in coefficient of variation between the YO and the SQA-Vision was low (between 9.4% and 11.2%) and not statistically significant. The precision among the YO phone devices was lower (16.0%) than the manufacturer's claim of ≤20%.
The smartphone-based device has a high level of accuracy and precision when compared with the SQA-Vision. It can detect samples with abnormally "low" MSC (below 6 × 106/mL cutoff), which supports its use as an effective home sperm test for screening "low" and "moderate/normal" MSC cases. In addition, the device effectively identifies varying levels of normal MSC in a precise manner over a wide range of normal MSC. Thus, the YO Score can improve patient satisfaction and empowerment.
Precision Study Between SQA Devices | QAP semen analysis results using the SQA‐V GOLD in compliance with ISO15189
READ STUDY | The SQA‐V GOLD demonstrated high precision and no systematic discrepancy between the systems. The overall averaged device CVs are: 2.7% (intra‐lab) and 6.2% (inter‐lab). The overall CVs for the semen parameters tested are: ≤ 5.1% (Intra‐lab) and ≤ 10.7% (inter‐lab). The SQA‐V GOLD deviates less than ± 6%* from the overall mean values for semen parameters Concentration, PR and IM. The SQA‐V GOLD deviates less than ± 15%from the overall mean values for semen parameters NP and Morphology which are considered low quantification parameters. According to WHO 5th ed. manual (2010),20% precision is considered acceptable when dealing with lower limit quantification (p. 48) | IVF Australia
Samples were run in duplicate in a blinded fashion on the resident SQA‐V automated semen analyzer at six labs in various locations in Australia. The cumulative test results for Concentration, Motility categories (PR, NP, IM) and Normal Forms (Morphology) based on WHO 5th ed. Manual (2010) were sent to M.E.S. for statistical analysis. Accuracy was determined by comparing results from each participating lab to the overall mean and % deviation for each semen parameter. Intra‐device (intra‐lab) and inter‐device (inter‐lab) precision was evaluated by generating coefficients of variation (CV) from duplicate tests
A comparison of an automated computerized semen analysis system SQA-Vision to the conventional manual method in terms of accuracy and precision
SEE POSTER | SQA-Vision & manual semen parameters’ mean values are quite close demonstrating no systematic discrepancies. Sensitivity, specificity, concordance & correlation coefficients are very high indicating a high level of accuracy & close agreement between the 2 methods. Bias correction coefficients are between 0.95 & 1.0 for different semen parameters showing a high level of agreement. The automated semen analyzer SQA-Vision is faster and provides a higher level of standardization and precision vs. manual semen assessment. The simplicity of operating the automated SQA-Vision minimizes the need for highly skilled professionals | ISSRF - India
Manual semen analysis suffers from analytical variability & subjective variation. Manual assessment of sperm morphology is associated with difficulties related to lack of objectivity, variation in interpretation or poor performance in external quality control assessments. Objective: To compare an automated computerized semen analysis system (SQA-Vision) to the conventional manual method in terms of accuracy and precision. 250 fresh semen samples were tested by both, manual method & SQA-Vision, in duplicate at room temperature. Manual testing was done by 2 independent operators & 1 manual operator ran SQA-Vision immediately following the manual analysis of motility to prevent bias.
SQA-Vision vs. SQA-V Gold Validation at California Pacific Medical Center (CPMC) - San Francisco, California
READ STUDY | Based on results of the SQA-Vision CPMC trial, the system demonstrated that all assessed parameters passed the acceptance criteria and the results of the two systems (SQA-Vision and SQA-V) are in good Alignment. A high level of correlation between the SQA-Vision and SQA-V automated results demonstrated a tight agreement between these methods. The Sensitivity and Specificity levels for all assessed parameters are higher than the acceptance criteria. The overall conclusion is that the SQA-Vision system shows substantial equivalence to the SQA-V system | CPMC (California Pacific Medical Center)
The new SQA-Vision system from Medical Electronic Systems (MES) was compared to the SQA-V sperm quality analyzer (MES) at California Pacific Medical Center (CPMC). Over one hundred (100) human semen samples were run in parallel on the two systems according to the manufacturer’s guidelines. The following fresh semen parameters were compared: Concentration, Total Motility, Progressive Motility and Morphology.
Medical Electronic Systems SQA-Vision Development Validations
DEVELOPMENT OVERVIEW | 226 human semen samples were tested at MES, LTD and Nantes University France to confirm the Accuracy and Precision of the SQA-Vision | Medical Electronic Systems
To test the new convenience features of the SQA-Vision vs. the SQA-V and manual semen assessment: Swim-up, Density Gradient, Longevity, Vitality, Morphology Counter, Scanning Debris/Round Cells, SQA-Vision Visualization Validation. These parameters were always available to the SQA-V customers, but were tracked or recorded manually on separate pages or forms. The new SQA-Vision system is based on the SQA-V platform (1), but streamlines the assessment and data collection processes by allowing this information to be part of the standard patient record. The objective of this trial is to determine that these semen assessment features perform as designed, and provide the correct results vs. reference method (SQA-V and manual semen assessment where applicable) and vs. manufacturer claims. None of these convenience features include new algorithms for reporting semen values. Additionally, some of the features are not run automatically on the SQA-Vision, but are run manually using the visualization system of the SQA-Vision instead of the microscope. In these cases, the microscope will be considered the GOLD STANDARD for comparison.
The system that started it all | 8 studies of the SQAII, SQAIIB, and SQAIIC from the 1990's and 2000's | The II series is the original technology that has evolved into the SQA-Vision over the last 20+ years
Influence of Human Sperm Motility Ability and Sperm Morphology on Fertilization Rate and Pregnancy Rate in Conventional IVF | Performance of the sperm quality analyser in predicting the outcome of assisted reproduction | Evaluation of sperm fertilizing ability using the Sperm Quality Analyzer | Assessment of sperm quality analyzer II B: comparison with manual semen analysis and CASA | Comparison of the Sperm Quality Analyzer IIC variables with the computer-aided sperm analysis estimates | Sperm motility index: a quick screening parameter from sperm quality analyser-IIB to rule out oligo- and asthenozoospermia in male fertility study | Evaluation of Sperm Quality Analyzer | Assessment of the Sperm Quality Analyzer | Multiple Locations
Remember, it ALL Started with a Sperm" CONCLUSIONS: The Sperm Quality Analyzer is easy to use. The good correlation between the sperm motility index, motile sperm concentration, and, in addition, a number of other semen parameters supports the use of the Sperm Quality Analyzer for screening patients and in situations that warrant a rapid verification of semen quality, such as in the IVF or artificial insemination clinic.
Process improvement Through Automated Semen Analysis | A review of labor savings and cost reduction using the SQA Semen Analyzer
READ STUDY | Previously, with manual semen analysis, the average TAT was 3 days due to delays involved in manual processing, such as transport for staining and microscopic examination. Automating the process has decreased the turn-around-time for the majority of our specimens to under 3 hours. Through automation, we were able to reduce our average turn-around-time per case from 82 hours to 3 hours. Annualized, this freed up 0.5 FTE. We performed 161 cases in 2010. Overall, labor costs for semen analysis were reduced by $14,560.00 | Overlook Medical Center, Atlantic Health
Semen analysis is one of the clinical laboratory tests which has significantly benefited from automation. Manual counting methods, motility and morphology testing often resulted in prolonged turn-around-times and left our Laboratory faced with challenges of maintaining consistency in result reporting among Technologists. The projected shortage of laboratorians also weighed in our decision to automate, since finding skilled help might be a problem in the future. We decided to automate semen analysis testing with Medical Electronics SQA-V Semen Analyzer. This decision was the result of our laboratory’s use of LEAN practices which identified what we needed in order to streamline testing while providing clinicians with accurate and consistent results. Our main goals at this time were decreasing turn- around times and cost savings.
WHO 5th Edition Strict Criteria vs. Kruger for Normal Morphology Assessment
WHO 5th Edition Strict Criteria vs. Kruger for Normal Morphology Assessment
There is a very high similarity between the original Kruger strict sperm morphology criteria definitions and WHO 5th edition manual guidelines for % Morphology. The latter was updated with some details, however, the major requirements remained the same as proposed by Kruger et al (included articles below). In the practical semen analysis associated with objective difficulties and subjectivity as emphasized by the WHO 5th ed. manual, the minor differences in definitions of the original Kruger and WHO 5th strict morphology criteria should not have any significant impact on morphology results.
MISES A JOUR Study of Automation (in French)
Quelle place pour le spermogramme automatisé en 2016?
L’analyse des paramètres spermatiques que constitue le spermogramme est le premier outil diagnostic permettant l’évaluation du versant masculin du couple infertile. Cet examen indispensable avant toute prise en charge ultérieure se doit d’être réalisé à plusieurs reprises en raison des variabilités intra-individuelles [1]. Les résultats qui sont obtenus lors de cet examen, ainsi que le contexte clinique de l’infertilité du patient et de sa conjointe, sont déterminants pour orienter la prise en charge du couple. L’examen manuel macroscopique et microscopique de l’échantillon reste actuellement la méthode de référence pour la réalisation du spermogramme dans la majorité des laboratoires. Cette analyse souffre de grandes variabilités intra- et inter-laboratoires et d’un manque de précision malgré les efforts fournis [2]. Les dernières recommandations de l’OMS, concernant l’analyse du sperme, publiées en 2010, ont permis de sensibiliser les laboratoires à la mise en place stricte des techniques décrites et ainsi de tendre vers la standardisation des procédures. La participation à des contrôles qualité internes au laboratoire ou externes par le biais de sociétés spécialisées ou d’autres laboratoires partenaires est également un moyen de réduire les variabilités entre opérateurs ou laboratoires. Développés depuis plus de 20 ans, les automates de spermiologie ont progressé jusqu’à constituer aujourd’hui une alternative intéressante à l’analyse manuelle du spermogramme, permettant d’associer fiabilité des résultats et variabilité minimale.
Reproductive Medicine and Biology
Accuracy of sperm velocity assessment using the Sperm Quality Analyzer V
The correct diagnosis of the functional capacity of human sperm is limited. The Sperm Quality Analyzer (SQA) with the visualization system, SQA-V (Medical Electronic Systems) an upgraded version of SQA, was recently developed to provide a rapid and low-cost quantitative evaluation of sperm quality as well as sperm velocity assessment. The aim of the present study was to evaluate whether the SQA V’s new parameters correlate with computer aided sperm analysis (CASA) estimates. Methods - Semen quality analysis of 66 fresh samples was determined using SQA V and CASA.
Gribbles Pathology, Victoria, Australia
The Automated Spermalite / SQA-V Sperm Quality Analyzer - Visual (SQA-V) versus conventional microscopic semen analysis
Semen analysis is an important laboratory investigation when assessing male fertility. Performing the analysis is time consuming, and requires extensive training. However, it can still be subjective with varying results between trained scientists. The Sperm Quality Analyzer - Visual (SQA-V) is an analytical medical device that performs a complete quantitative and objective evaluation of semen parameters by combining electo-optics, computer algorithms, and video microscopy. The aim of our evaluation was to assess the reliability, accuracy, reproducibility, and efficiency of the SQA-V compared with conventional manual microscopic techniques for analyzing fresh human semen samples.
American Society of Reproductive Medicine
EVALUATION OF AUTOMATED SPERM CONCENTRATION ASSESSMENT USING SQA-V SPERM QUALITY ANALYZER
Objective - Manual assessment of sperm concentration remains one of the most important parameters in the evaluation of male infertility. The method is subject to high variability. New automated methods of semen analysis evaluation are of clinical interest. The objective of this study was to evaluate the sperm concentration measurement by the SQA-V (SQA-V; Medical Electronic Systems, Ltd.) in comparison with the standard values derive d from two independent operators. Design - Double-blind prospective study Materials and Methods: Semen samples of 50 healthy subjects were analyzed manually for sperm concentration by two independent operators using Makler counting chamber and SQA-V.
American Society of Reproductive Medicine
COMPARISON OF SPERM MOTILITY MEASUREMENT USING SQA-V AUTOMATED SPERM ANALYZER AND CONVENTIONAL MANUAL METHODS
Objective - The accuracy of manual sperm motility assessment is affected by a variety of factors. Automated systems may be a potential alternative to conduct an accurate semen analysis. The aim of our study was to evaluate the SQA-V device as an automated tool for the assessment of sperm motility. Design: Double-blind prospective study Materials and Methods: Semen samples (n = 50) collect ed from healthy subjects were analyzed microscopically for sperm motility by two independent operators using WHO 1999 guidelines. Semen samples were analyzed in parallel using the automated sperm quality analyzer (SQA-V; Medical Electronic Systems, Ltd.)
American Society of Reproductive Medicine
NORMAL SPERM MORPHOLOGY ASSESSMENT BY SQA-V ANALYZER AND MANUAL METHOD - A COMPARISON OF 2 METHODS
Objective - Manual assessment of sperm morphology is subjective and affected by various factors such as the fixation and staining techniques. The objective of our present study was to compare the normal morphology results obtained by the automated SQA-V analyzer and by the manual method. Design - Double-blind prospective study Materials and Methods: The semen samples of 50 healthy subjects were collected according to the WHO manual (4th edition) guidelines and analyzed for percent normal morphology under the microscope by two independent operators and using automated sperm quality analyzer (SQA-V; Medical Electronic Systems, Ltd.) For the manual assessment, air-dried smear s were stained by Diff-Quik method.
St. Antonius Ziekenhuis, Nieuwegein, and SALTRO, Utrecht, the Netherlands
THE ANALYTICAL EVALUATION OF SPERMALITE (SQA -V) FOR THE DETERMINATION OF SEMEN PARAMETERS
Semen analysis by using the WHO criteria (1) is very time consuming and prone to significant inter-observer irreproducibility, especially in the assessment of sperm motility and morphology. It is considered that by means of automation the semen analysis can be performed in more standardized manner, faster and with less efforts. The Spermalite (SQA-V) is a new analytical device for a quantitative evaluation of semen parameters using electro optics to determine concentration and motile sperm concentration (MSC). Motility is classified into the 4 classes A, B, C and D according to the WHO recommendations. The Spermalite is provided with a display, showing a visual impression of the semen sample to be analyzed. These video streams can be stored for retrospective evaluation. In this study results obtained with the Spermalite (SQA-V) are compared with those of the current standard procedure based on the WHO-recommendations. In addition, the between-device performance was evaluated.
Unit of Andrology Sheba Medical Center
An Evaluation Study of a New Sperm Quality Analyzer
The purpose of this study is to evaluate the performance, reliability, and accuracy of the new automated Sperm Quality Analyzer SQA-V (Medical Electronic Systems) that combines electro-optic and computing techniques with a flexible and convenient visualization system. The results are compared with conventional microscopic semen examination.
American Journal of Reproductive Immunology
A Digital Method of Sperm Immobilization Test: Comparison to the Conventional Method
Antisperm antibodies have been found in infertile patients and those causing immobilization of sperm are considered to be closely related to unexplained infertility. These antibodies are usually identified by a sperm immobilization test which involves counting motile sperm under microscope. This test is subjective as it relies on the judgement of the examiner with respect to sperm motility. In this study, we analyzed motile sperm by a digital method using Sperm Quality Analyzer. The results were compared with those obtained by the conventional method. We found that the two methods yielded identical results, with 14 of 66 samples tested being positive and 52 negative for sperm immobilizing antibodies. These results show that the digital method is objective and of value in the measurement of motile sperm in determination of sperm immobilizing antibodies.
The Journal of Theriogenology
Variation in Lipid Profiles with Semen Compartments - the Bovine Model of Aging
Semen was collected once a week (n = 5 samples per Bull). To eliminate any potential differences in sample quality due to serial ejaculates , the samples were obtained only once per day. Bulls were mounted on a live teaser and semen was collected into a disposable tube using a heated (38 degrees) sterile artificial vagina. The ejaculate was immediately transferred to a nearby laboratory, and the semen was evaluation by computerized sperm-quality analyzer for Bulls (SQA-Vb, Medical Electronic Systems).
Medical Electronic Systems, LTD
Automated Semen Analysis
Objective - To evaluate whether the automated SQA-V can replace manual semen analysis - The study was conducted at Tel Hashomer and Ramat Marpe Hospitals in Israel. 539 semen samples were analyzed manually and then compared to the SQA-V. Additional, 320 samples of commercially available latex bead controls (two levels of known concentration) were run. Semen analysis was conducted according to WHO manual, 4th edition guidelines.
Various - 30+ Articles across a wide variety of species
Human - Turkey - Bull - Horse - Pig
An overview of dozens of articles from all over the world featuring Medical Electronic Systems Automated Semen Analyzers and related products. Remember, it ALL Started with a Sperm!

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