Diagnostic Measurements Primer

Diagnostic Measurements Primer unravels the importance of direct and indirect measurements and their vital role in obtaining regulatory approval. This class begins with the art of constructing and reading a standard curve to determine unknown analyte concentrations. The agenda extends to testing accuracy, focusing on the ins and outs of specificity, sensitivity, false positives/false negatives, and true positives/true negatives. These concepts are reinforced with a graphics exercise on distributions, exploring the varied factors contributing to data variability and bi-modal distribution. This class ends with two real-world case studies critiquing data from mammography for breast cancer and PSA diagnostics for prostate cancer. Learn what it takes to secure diagnostic approval by learning acceptable measurement thresholds. Register today!

Section 1: Introduction to Measurements

Introduces the concept of measurements and discusses the process of producing, using and interpreting a standard curve when attempting to determine the results of a diagnostic test.

Section 2: Variability of Measurements

Explains how a diagnostic’s variability measurements determine if a patient falls into a normal or abnormal distribution for a disease.

Section 3: Examples of Test Distributions

Discover the relationship between blood pressure, cholesterol, and atherosclerotic disease, exploring the concept of bi-modal distribution and the ideal distribution of these health indicators.

Section 4: Testing Accuracy

Gain insights into measurement considerations, accuracy, false positives, false negatives, specificity, sensitivity, and predictive values, illustrated with examples such as mammography for breast cancer and PSA diagnostics for prostate cancer.

Five Takeaways


  1. Produce and interpret a standard curve to analyze a diagnostic’s results.
  2. Recognize types of data distributions and how each is used to determine if a patient’s
    condition falls in the normal or abnormal range.
  3. Explain how precision, bias, specificity, and sensitivity measurements determine the accuracy of a diagnostic.
  4. Discuss how false positive and false negative percentages and their comparison to the reference product determine regulatory approval for a novel diagnostic.
  5. Choose the correct measurement to determine a patient’s disease state.


  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates


  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.

Ready to get started?

Get in touch or enroll now

Powered By MemberPress WooCommerce Plus Integration