Validation with no Backup Method: How do we validate the machine if we don’t do semen analysis yet or don’t have a backup method?
As a first step, MES recommends our Validation Kit to cover most aspects of Linearity, Precision, Lower Limit Detection, and Concentration Accuracy. Additionally, our recommendation is to compare 20 live samples to an alternative method, whether that be a manual method on-site, another facility that performs semen analysis locally, or even a visiting CLS that can perform a manual method at your facility. Regulatory requirements vary from State to State, and it is best to see what is required in your area. From the Manufacturer’s perspective, the Validation Kit is acceptable to confirm instrument operation and user skill but most states and regulatory bodies will also want to see a comparison to another method as well.