Rapid - Objective - Standardized Semen Analysis Solutions... Remember, it ALL Started with a Sperm!
Medical Electronic Systems Studies and Publications
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 . 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 . 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.
SQA-Vision Beta Site Validation - SQA-V Gold Vs. SQA-VISION - WHO 5th Edition Criteria
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.
SQA-VISION Validation Report - Nantes University France
Objective - To test the new convenience features of the SQA-Vision vs. the SQA-V and manual semen assessment
Sample types testing include - Swim-up, Density Gradient, Longevity, Vitality, Morphology Counter, Scanning Debris / Round Cells, and SQA-Vision Visualization Validation. These parameters were always available to the SQA-V Gold customers, but were tracked or recorded manually on separate pages or forms. The new SQA-Vision system is based on the SQA-V platform, 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 semi-automated using the visualization system of the SQA-Vision instead of the microscope. In these cases, the microscope was considered the GOLD STANDARD for comparison.
226 human semen samples were tested at Medical Electronic Systems, LTD and Nantes University France to confirm the Accuracy and Precision of the SQA-VISION
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.
QAP semen analysis results using the SQA-V GOLD in compliance with ISO15189, independently performed by IVF Australia
Background - IVF Australia conducted a six center Quality Assurance Program (QAP) for semen analysis using the automated SQA-V GOLD sperm analyzer. Both precision and accuracy were assessed for concentration, morphology and motility parameters by running prepared frozen semen samples from the same donor distribution.
Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment
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. The main outcome measures were sperm concentration, total sperm number, total motility, progressive motility, non-progressive motility, morphology, motile sperm concentration (MSC) and progressively motile.
Automated Semen Analysis – The end of Manual Analysis?
Aim - To compare semen analysis parameters between an automated system (SQA-V Gold) and manual semen analysis. Method - 100 fresh semen samples were manually analyzed following WHO 5th Edition and tested on the SQA-V system. Scientists used for manual analysis were never more than +/- 1SD in external QAP. 56 samples were analyzed once by a human operator and once by SQA-V. 42 samples were analyzed twice by different human operators and then twice by the SQA-V Gold. Passing-Bablok regression plots were produced for concentration and ROC analysis was used for motility and morphology comparisons. Latex beads of known concentration were also counted by 2 operators and then twice by SQA-V Gold to obtain mean and CV for accuracy and precision.
Automation is the key to standardized semen analysis using the automated SQA-V sperm quality analyzer
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.
Process improvement Through Automated Semen Analysis
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.
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.
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.
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.
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.)
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.
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.
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.
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.
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).
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.
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!