Validation Sets

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.

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Sperm Count Validation - 2 Levels

$265.00

VAL103

Contains: 

  • 2 300µL vials for multiple replicates of high and low concentrations for inter- and intra-run precision evaluation.

Method validation is required whenever a procedure is updated or changed.

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Sperm Count Validation - 10 Levels

$1,600.00

VAL203

Contains: 

  • 10 150µL vials ranging from 0 through ~70×106/mL for accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

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What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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Sperm Count Validation - 5 Levels

$700.00

VAL503

Contains: 

  • 5 150µL vials ranging from 0 through ~70×106/mL for accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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Sperm Morphology Validation - 5 Levels

$1000.00

VAL105

Contains: 

  • 2 Pap-stained smears, 3 VirtuMorph® Smears inter- and intra-run precision evaluation along with accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

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What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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Sperm Morphology Validation - 10 Levels

$1,800.00

VAL305

Contains: 

  • 5 Pap-stained smears, 5 VirtuMorph® Smears inter- and intra-run precision evaluation along with accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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Sperm Viability Validation - 5 Levels

$1000

VAL107

Contains: 

  • 5 coverslipped smears ranging up to ~90% viable for inter- and intra-run precision evaluation along with accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

  • adfhbadf
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Link to purchase this product:

Sperm Viability Validation - 10 Levels

$1,800.00

VAL207

Contains: 

  • 10 coverslipped smears ranging up to ~90% viable inter- and intra-run precision evaluation along with accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

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Link to purchase this product:

Post Vasectomy Validation - 3 Levels

$515.00

VAL111

Contains: 

  • 3 150µL vials ranging from negative to ~2.5×106/mL inter- and intra-run precision evaluation along with accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

  • adfhbadf
  • aefghabszdtgba
Link to purchase this product:

Sperm Motility CD-ROM Validation - 5 Levels

$300.00

VAL119

Contains: 

  • CD-ROM containing 5 motility videos inter- and intra-run precision evaluation along with accuracy and range linearity.

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

  • adfhbadf
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Link to purchase this product:

Sperm Motility Online Library - 5 Levels

$300.00

VAL419

Contains: 

  • 5 motility videos available online

Method validation is required whenever a procedure is updated or changed.

Access VideosExam Videos

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

  • adfhbadf
  • aefghabszdtgba
Link to purchase this product:
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Fertility Solutions is the only company offering human sperm quality products for semen analysis! Contact us today for more information or to place an order.
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