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Drug Approval Primer
Drug Approval Primer

Know Your Numbers: Diagnostic Measurements Explained

by | Jun 10, 2025 | Medical Device & Diagnostic

When you take a diagnostic test—a COVID swab, cancer screening, or cholesterol check—you rely on invisible math to determine whether you’re healthy, sick, or somewhere in between. That math is all about sensitivity and specificity, two stats that can make or break a test’s usefulness. Let’s take a closer look at diagnostic measurements.

Why It Matters

Proven diagnostics don’t just spot disease, they accurately spot disease. That’s where four key terms come into play:

  • True Positive: You’re sick, and the test says you are.
  • True Negative: You’re healthy, and the test agrees.
  • False Positive: You’re healthy, but the test wrongly says you’re not.
  • False Negative: You’re sick, but the test fails to catch it.

Too many false results? That’s not just annoying, it’s dangerous!

Zoom In: Sensitivity

A test’s sensitivity tells us how good it is at catching all the people who actually have the disease. Think: “Of all the sick people, how many did we correctly call sick?”

A test with 100% sensitivity catches every sick person—there are no false negatives. But it might accidentally tag a few healthy folks, too (hello, false positives).

Zoom In: Specificity

Specificity tells us how well the test avoids raising the alarm for people who are actually healthy. Think: “Of all the healthy people, how many did we correctly call healthy?”

A test with 100% specificity won’t mislabel healthy people—there are no positives. But it might miss a few true cases.

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Zoom Out: The Trade-Off

No test is perfect. The more you crank up sensitivity, the more you risk lowering specificity and vice versa.

For example, a cancer screening might be ultra-sensitive (so it doesn’t miss a case) but less specific (causing anxiety-inducing false positives).

Most diagnostics aim for a sweet spot, catching the sick without scaring the healthy.

Diagnostic Recap

  Test Positive Test Negative
Has Disease True Positive False Negative
No Disease False Positive True Negative


Bottom Line

When your doc says your test result is “positive” or “negative,” it’s more than just a thumbs-up or down. It’s a carefully calculated call based on years of statistics and thousands of patients.

What To Watch

More AI-powered diagnostics are entering the healthcare scene. They promise better accuracy, but they’ll still be judged by these old-school stats because, in diagnostics, numbers don’t lie.

Cocktail Fodder

The home pregnancy test, launched in 1976, was the first commercially available home diagnostic test. It was called “e.p.t.” short for Early Pregnancy Test. Unlike the simple pee-on-a-stick tests we know now, the original version involved a test tube, dropper, and paper strip; basically, a mini science lab on your bathroom counter.

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