Evaluation Background: Home Cholesterol Test Kits

September 6, 2023 | Evaluations & Guidance


Here's background for our Evaluations of home cholesterol test kits, outlining the key considerations for making wise purchasing decisions. Learn how the technology is used, which specs are important, and what factors we test for.

Home cholesterol test kits measure total cholesterol concentration in whole blood samples. They may be used by patients who are at risk of developing or who are actively managing certain cardiovascular diseases (e.g., atherosclerosis) to monitor their cholesterol concentration over time, possibly directed by their physician. Consumers may also buy the kits over the counter. These products are for home use and should not be used in clinical environments. They are FDA regulated.

Home cholesterol test kits are an evolving technology; three new kits have been cleared by FDA recently. There are also many test kits that are marketed to consumers but have not undergone FDA clearance; we do not recommend use of such kits due to uncertainty about their quality and accuracy.

Major components of a typical home cholesterol test kit include:

  1. Handheld meter with a user interface

a) Receives compatible total cholesterol test strips and measures total cholesterol concentration. May also receive compatible high-density lipoprotein (HDL) cholesterol and...

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