EN TE R Assay Procedure Total hands-on time: < 1 minute ALERT TESTING M EN U Processing sample 2.00 min remaining ENTER MENU iUnwrap i an individual MiOXSYS Sensor and place into MiOXSYS Analyzer. iUsing i a pipette, transfer 30µL of sample to the Sample Application Port of the inserted MiOXSYS Sensor. iOnce i detected, the MiOXSYS Analyzer will begin processing the sample. MiOXSYS is a quantitative electrochemical test for accurate and easy detection of oxidative stress in fresh or frozen semen specimens. Catalog Information MiOXSYS System (100 sensors)................................. 100290 MiOXSYS Sensors (10 sensors).................................. 100283 MiOXSYS External Controls...................................... 100279 References 1. Khalil, Ashraf A. (2012): Oxidative stress induces idiopathic infertility in Egyptian Males. Afr. J. Biotechnol. Vol. 11 pp. 1516-1522. Introducing a simple approach to assess Oxidative Stress 2. Agarwal et al. Reproductive Biology and Endocrinology (2015) 3. Allied Market Research Report (2012) MiOXSYS™ Male Infertility Oxidative System 4. Sigman M, Howards SS (1998). Male infertility. In: Walsh PC, Retik AB, Vaughan Jr ED, Wein AJ, editors. Campbell’s Urology (7th ed.) Philadelphia:WB Saunders Company. pp.1287-1320 The most accurate, easy to use, and fastest oxidative stress result available today. 373 Inverness Parkway Suite 206 Englewood, CO 80112 ©2015 Aytu BioScience 100301 REV 10/2015 The Effect Having an accurate and fast oxidative stress test provides actionable information for clinicians to improve patient management and fertility outcomes. MiOXSYS provides efficient use of your resources in identifying, differentiating, and treating cases of male infertility attributed to oxidative stress. Oxidative stress, a condition where Augment Your Laboratory’s Semen Analysis Profile the production of reactive oxygen species overwhelms anti-oxidant levels, has been considered as one of the major factors believed to be involved in idiopathic male infertility1. 1. Deliver same day results to your clinicians Need Solution Impact on Laboratory Male Infertility Factor is the primary cause of infertility in 20-70% of the cases2. It is estimated that this condition affects 30 million globally2. Identifying idiopathic cases of male infertility requires an accurate, easy to use test that is capable of measuring oxidative stress. Luminometers • Approximately $244MM in healthcare costs associated with this condition3. • 25% of the male infertility cases are diagnosed as idiopathic and implicated due to oxidative stress4. • Current oxidative stress applications lack a complete measure and system that is easy to use in clinical practice. –– Existing measures often look at one aspect of oxidative stress, requiring the use of multiple tests, and a comprehensive analysis for clinical interpretation. –– Existing Systems lack standardization in clinical practice because they employ highly complex procedures, require dedicated tech time, and entail capital equipment costs. MiOXSYS’s sORP measure is based upon the principle of Oxidation-Reduction Potential, which measures the giving and taking of electrons. Unlike other measures, sORP represents an integrated measure of oxidants and reductants, making it a more clinically meaningful measure. • In clinical validation studies MiOXSYS’ sORP measure correlated with the known factors of fertility, –– Morphology: 96% Specificity 96% PPV –– Motility: 86% Specificity 76% PPV • The MiOXSYS System enables laboratory efficiencies with stat capability, requiring less than 1 minute hands on time, and results in 3 minutes. 2. Immediately identify male infertility cases associated with high oxidative stress 3. Implement management and treatment strategies early on Step Description MiOXSYS System Time (minutes) Step Description Time (minutes) 1 Immediately test sample (cannot use frozen samples) – 1 Test fresh or frozen sample – 2 Centrifuge sample 10 2 Load sensor and apply sample – 3 Prepare sample in buffer 10 3 Test and results in 5 minutes 5 4 Inoculate 400µL of sample into freshly prepared luminol buffer 5 Test and results in 15 to 30 minutes 5 to 6 15 to 30 When every drop matters Accurate: High Specificity and PPV with the known parameters of Fertility (Morphology 96% Specificity and 96% PPV, Motility 86% Specificity and 76% PPV); Accurate detection for better patient management and treatment goals related to Fertility. Ease of use: Less than 1 min hands on time, ensuring the most efficient use of your staff time; use of fresh or frozen samples Fast: Results in as quick as 5 minutes, so you can deliver same day results to your clinicians
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