Every time a new test or testing method are introduced to a laboratory, CLIA requires method validations must be performed. These validations must analyze the inter-run and intra-run precision, accuracy, linearity and, if a change to an existing method, compare to the previous or reference methodology. Because Semen Analysis is a composite of multiple tests, each individual test is required to have these. These typically include Sperm Count, Sperm Motility, Progressive Sperm Motility, Sperm Morphology, Sperm Viability and Post Vasectomy Testing. Assembling enough samples with assayed values to perform all of these studies can be time consuming and difficult.
To that end, we can make validation sets to meet your needs that include each of these parts of semen analysis. These sets can include different quantities of samples depending on your needs. Samples will span the clinical range observed in semen analysis. All Validation sets come with a documentation binder to store all of the Levey-Jennings charts, SDS, and other documentation to make Management review, inspection and implementation easier.
Our Semen Analysis Validation Sets are the only sets on the market that are made using human sperm. Why is that important? Sperm have oval heads with a long tail. The overlapping and coiling tails cause visual confusion. Sperm surrogates such as latex beads or animal sperm do not mimic clinical specimens, so are not suitable to validation a method of analyzing human sperm.
Because these sets are assembled on demand, lead time for the product can be as much as 2-3 weeks, but some are available sooner. Please contact us for more information. Please note if these options do not fit your needs, custom options can be made, such as 1 mL volumes for use with analyzers or other modifications.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
Method validation is required whenever a procedure is updated or changed.
